MANAGEMENT GUIDELINES FOR ANXIETY DISORDERS IN CHILDREN AND ADOLESCENTS Prabhat Sitholey1 , Anil Nischal2 Anxiety disorders represent one of the most common categories of psychopathology in children and adolescents. Apart from separation anxiety disorder, a well recognized problem of childhood, it is now widely accepted that generalized anxiety disorder, social phobia, specific phobia, posttraumatic stress disorder, obsessive compulsive disorder and panic disorder all occur during the childhood and adolescent years. Numerous studies examining the nature and treatment of anxiety disorders have appeared during the recent years. Significant advances in this area include the investigation of pharmacological agents and development of effective psychosocial interventions. Prevalence rates for having at least one childhood anxiety disorder vary from 6% to 20% over several large epidemiological studies (Costello et. al., 2004). Co-morbidity is extremely common among children and adolescent suffering from anxiety disorders. A recent study of children aged 8 - 13 years, having a primary diagnosis of anxiety disorder revealed that 79% of the sample also had another co-morbid anxiety disorder, mood disorder or behavior disorder (Kendall et. al., 2001). In view of such findings, consideration needs to be given to co-morbidities as their presence will guide selection of specific treatments. The objective of these guidelines is to provide up-to-date information about management of anxiety disorders. Literature was reviewed by a computerized search in the month of June 2007 using the keywords child, adolescent, anxiety disorder, treatment, and management. The search covered a period of 10 years (1997 through 2007).Articles retrieved and their relevant references were reviewed for the purpose of framing these guidelines. The information has been presented in two sections Assessment and Treatment. Certain statements in this guideline are followed by abbreviations MS or CG. MS stands for minimal standards and reflects that the statement is based on rigorous empirical evidence while CG stands for clinical guidelines indicating that the statement is based on empirical evidence and/or strong clinical consensus. ASSESSMENT Defining the boundary between extremes of normalcy and psychopathology is a dilemma that pervades all psychiatry. In many cases of childhood anxiety disorder this dilemma is at its zenith. The defining point for caseness is often ambiguous as many childhood anxieties are not only common but also have an adaptive role in human development. It is strongly recommended that psychiatric assessment of children and adolescents should routinely include screening questions about anxiety symptoms [MS]. If the screening indicates significant anxiety, then the clinician should do a formal evaluation to determine subtype of anxiety disorder, the severity of anxiety symptoms and functional 1. MD Professor and Head, 2. MD Assistant Professor, Department of Psychiatry, CSM Medical University UP, Lucknow, India (218) impairment [MS] (Connolly et. al., 2007). Anxiety may be considered symptomatic when it is impairing and prevents / limits developmentally appropriate adaptive behavior. A useful rule for determining diagnostic threshold is the child's ability to recover from anxiety and to remain anxiety-free when the provoking situation is absent. The child's lack of flexibility in affective adaptation is an important pathological indicator. In addition, the degree of distress and dysfunction associated with anxiety also help in reaching a diagnosis. Anxiety disorders impair emotional, cognitive, physical and behavioral functioning in multiple areas and are usually chronic in nature. Hence, the child needs to be evaluated in context of his family, school, community, and culture. Important areas of assessment include history of onset and development of anxiety symptoms, associated stressors, medical history, school history, family psychiatric history and mental status examination. The psychiatric assessment should always consider differential diagnosis of physical conditions & psychiatric disorders that may mimic anxiety disorders [MS]. Early detection and effective treatment may reduce the impact of anxiety on academic and social functioning in youth and may reduce the persistence of anxiety into adulthood. INSTRUMENTS FOR ASSESSMENT Earlier, determination of childhood anxiety largely relied on rating scales or interviews inquiring about multiple unrelated fears and worries generating a count without a clear clinical meaning (Lapouse & Monk, 1958). The emphasis has now shifted to the study of diagnostic groups that reflect explicit clinical criteria. A comprehensive evaluation should include a detailed structured or semi structured psychiatric interview to establish the anxiety disorder diagnosis and detect co-morbid psychiatric disorders. In addition, clinical rating scales, self report scales and parent report instruments may be used to determine the type and severity of anxiety symptomatology. This practice also allows for monitoring of these symptoms over time. Over the last two decades there has been a proliferation of instruments to determine the presence of anxiety disorders in children or quantify levels of anxiety. Assessment instruments include paperand-pencil scales for children, parents and teachers, as well as child and parent interviews. Interested readers are referred to a review of commonly used instruments by Brooks & Kutcher, 2003. An overview is provided below. Rating scales: Rating scales serve diverse purposes. They are used to screen large groups, to examine the relative contribution of genetics and environment, to assess severity and as outcome measures of treatment efficacy. Rating scales that anteceded the present nosology of anxiety disorders were designed to assess a plethora of factors such as worry, physiological anxiety, fear of bodily harm, etc. rather than anxiety syndromes. These include the Revised Children's Manifest Anxiety Scale (RCMA; Reynolds &Richmond, 1985), the State Trait Anxiety Inventory for Children (STAIC; Spielberger, 1973) and the Revised Fear Survey Schedule for Children (FSSC-R; Scherer and Nakamura 1968; Ollendick 1983). In addition, the Child Behavior Checklist (CBCL; Achenback 1991) which generates a non specific factor of emotional disturbance, called the “internalizing factor" may be used as a rating scale. The limitations of the older rating scales and increasing interest in childhood anxiety disorders has led to development of more sensitive and diagnostically relevant measures of childhood anxiety. Recent efforts reflect the classification of anxiety disorders and a move towards specificity of content, with relevance to diagnostic grouping. Newer scales devised with these considerations include the Social Anxiety Scale for Children (La Greca et.al., 1988; La Greca & Stone, 1993) and for Adolescents( La Greca & Lopez, 1998), the Multidimensional Anxiety Scale for Children (MASC; March et. al., 1997; March & Albano,1998) and the Screen for Child Anxiety Related Emotional Disorders (SCARED), which has a parent version also (Birmaher et. al.,1997; Monga et. al., 2000). The MASC and SCARED appear to be promising for clinical purpose according to Research Unit on (219) Pediatric Psychopharmacology Anxiety group study, 2001. A major clinical challenge is to differentiate between anxiety and depression. Anxiety scales do not adequately distinguish between children with anxiety disorders and those with other diagnosis (Klein, 1994). Therefore, though anxiety scales may provide an overall estimate of anxiety levels, they cannot be viewed as contributing to the diagnosis of anxiety disorders, and clinicians would be unwise to rely on them only for differential diagnostic decisions. Diagnostic Interviews: Several systematic diagnostic interviews for children and for parents as informants have been devised to meet different purposes and vary accordingly. The Diagnostic Interview Schedule for Children (DISC; Shaffer et. al, 1996) was developed for use in epidemiological studies. It is highly structured and can be used even by individuals who have no clinical training. A computer based version is also available. The Diagnostic Interview for Children and Adolescents (DICA; Herjanic & Reich, 1982; Reich et. al., 1991) is another highly structured instrument. The Child and Adolescent Psychiatric Assessment (CAPA; Angold & Costello, 1995) also devised for epidemiological studies, requires adequate training as it is less structured than DISC. The CAPA, in comparison to other instruments, additionally covers assessment of functioning in school, social relationship, etc. along with specific symptoms, allows for clarification of questions and more closely resembles usual clinical interview. The Kiddie Schedule for Affective Disorder and Schizophrenia (K-SADS) has been developed from a clinical perspective. Its present and lifetime version allows full latitude of inquiry. (Chambers et. al. 1985, Kaufmen et al, 1997). The Anxiety Disorder Interview Schedule for Children (ADIS) originally prepared to assess anxiety disorders has been expanded to provide diagnosis for other major disorders. This can be employed to collect detailed information in a flexible clinical fashion (Silverman & Albano 1996). All the instruments described above have demonstrated modest to adequate test-retest reliability with anxiety disorders faring no better or worse than most other diagnosis. There is little to guide selection of instruments in terms of better reliability or validity but the DISC is the most widely used worldwide.In Lucknow K-SADS-PL (Kaufmen et al, 1997) is the preferred tool. We understand that many of the above mentioned tools not be available easily, others might not be suitable for use in Indian population due to variety of reasons. The authors recommend use of K-SADS for diagnostic assessment, CGI for severity evaluation and CGAS (Shaffer et al, 1983) for global assessment of functioning as a minimal standard. Additionally, DOTES may be used for monitoring medication sideeffects (Campbell et al, 1985). Although conceived for research purposes, diagnostic interviews may be useful to clinicians as they provide a comprehensive coverage of symptomatic status, are excellent teaching tools and allow comparisons. In the end it needs to be said the though many instruments are available all of them have not been conclusively shown to distinguish between various anxiety disorders or anxiety disorders and other child psychiatric disorders. As such, a sufficient level of precision for diagnostic classification has not been reached. Available evidence only supports the diagnostic validity of social phobia but not other disorders. OUTLINE OF DIAGNOSTIC ASSESSMENT A. Obtain history from parents, patient, and other pertinent informants. 1. Note onset and development of symptoms and the context in which symptoms occur and are maintained. a. DSM - IV target symptoms, with particular attention to the following: i. Determination of whether anxiety is stimulus specific, spontaneous, or anticipatory. ii. Evaluation for avoidant behavior (degree of constriction of daily life). (220) b. Biopsychosocial stressors. c. Co morbid psychopathological symptoms, maladaptive personality traits, and internal conflicts. d. Impact of symptoms on the daily life of the patient and family. e. Social and familial reinforcers of symptoms. 2. Emphasize developmental history with special consideration of the following: a. Temperament b. Ability to sooth self or be soothed. c. Quality of attachment. d. Adaptability. e. Stranger and separation responses. f. Childhood fears. 3. Obtain medical history, especially noting the following: a. Numbers of visits to physician or emergency room for these or other symptoms. b. Medications taken by the patient that could produce anxiety symptoms. c. Medical disorders 4. Obtain school history. a. Academic, athletic, social and behavioral functioning. b. Disparity between potential and actual achievement. c. Patterns of attendance. 5. Obtain social history. a. Environmental stressors such as disorganized home, presence of child abuse (physical, emotional or sexual) or neglect, mental or physical illness or death in family members, or exposure to danger or violence. b. History of separations and losses. c. Degree of involvement with peer group and social competence. 6. Obtain family history with particular attention to the following: a. Patient's past and present role in the context of family functioning. b. Family stresses, resources, and coping style. c. Family psychiatric history with emphasis on the following: i. Anxiety disorders (including obsessive compulsive disorders). ii. Mood disorders. iii. ADHD. iv. Psychoactive substance use disorders. v. Tic disorders. vi. Psychotic disorders. vii. Suicidal behavior. B. Interview the patient, including a mental status examination with special note of the following: 1. Patient's reports of symptoms, including self-assessment of impairment. 2. Objective signs of anxiety, including motor tension, autonomic hyperactivity, vigilance and scanning, variations in speech patterns and production and separation difficulty. 3. When developmentally appropriate, communication of anxiety through play and drawings. Play techniques can be used to understand a child fears and reasons for anxiety. C. Conduct family assessment. 1. Evaluation of family interactions and dynamics. 2. Assessment of parent -child relationship. (221) D. Administer structured or semi structured interview for anxiety and comorbid diagnosis. E. Administer clinical, self-report, and parent-report instruments for severity of anxiety symptoms. F. Refer for IQ and psychological testing if indicated clinically and for learning disability, and speech and language testing if required and facilities are available. G. Conduct physical evaluation of the child or adolescent. 1. Physical examination. 2. Consultation and collaboration with family practitioner, pediatrician or other specialties as per need. 3. Evaluation of medical and neurological conditions as indicated. (See sec II.A below) DIFFERENTIAL DIAGNOSIS A. Consider physical conditions that may mimic anxiety disorders. 1. Documented hypoglycemic episodes. 2. Hyperthyroidism. 3. Cardiac arrhythmias 4. Caffeinism. 5. Pheochromocytoma. 6. Seizure disorders. 7. Migraine. 8. Central nervous system disorders (e.g., delirium or brain tumors). 9. Medication reactions: antihistamines, antiasthmatics, sympathomimetics, steroids, SSRIs, anti-psychotics (akathisia), and nonprescription preparations, including diet pills and cold medicines. B. Screen for psychiatric disorders that may be comorbid with or misdiagnosed as anxiety disorders. 1. Mood disorders. 2. ADHD. 3. Adjustment disorder. 4. Substance use disorders, including alcohol, nicotine, marijuana, cocaine, stimulants, inhalants, and hallucinogens. 5. Borderline or other personality disorders. 6. Eating disorders. 7. Somatoform disorders. 8. Tic disorders. 9. Trichotillomania. 10. Reactive attachment disorder. 11. Pervasive developmental disorders. 12. Schizophrenia. 13. Sleep Terror Disorder. C. Establish diagnosis of specific type of anxiety disorder. More than one may be present. (222) 1. 2. Anxiety disorder beginning in childhood and adolescence: separation anxiety disorder. Anxiety disorders affecting children, adolescents and adults. a. Generalized anxiety disorder (inclusive over-anxious disorder of childhood). b. Specific phobia. c. Social phobia. d. Panic disorder. e. Obsessive - compulsive disorder. f. Posttraumatic stress disorder. Treatment The evidence that childhood anxiety disorders cause suffering and impairment and may entail long term liability highlight the need for effective treatments. Some interventions, such as CBT, are based on theoretical models of anxiety while others such as medication, follow demonstrated efficacy in adult anxiety disorders. Child and adolescent psychiatrists usually employ an integration of several approaches in treating patients with anxiety disorders. In general, treatment planning should consider severity of and impairment produced by the anxiety disorder. A multimodal approach is advisable and psychotherapy should be considered an integral part of the management of childhood anxiety disorder [CG] (Connolly et. al., 2007). Literature is replete with case reports and studies evaluating various approaches. Wherever controlled studies are available, case reports have not been considered in framing the recommendations. We initially brief the different approaches followed by disorder-specific recommendations. BEHAVIOR THERAPY: Behavior therapy targets the patient's overt behavior and emphasizes treatment in context of family and school instead of focusing on intrapsychic conflicts. (Bernstein et. al., 1997). Etiology is not the focus of attention (Kazdin, 1991).Two comparative studies demonstrate efficacy of behavior therapy (systematic desensitization) in treatment of children with school refusal. (Miller, 1972; Blagg and Yule, 1984). CONGNITIVE BEHAVIOUR THERAPY: CBT is the most well studied intervention. It integrates the behavioral approach with an emphasis on changing the cognitions associated with the patient's anxiety. The basic notion is that distorted cognitions about the dangerousness of the environment underlie anxiety symptoms. The aim is to replace negative beliefs with more neutral realistic ones. The technique encourages the patients to restructure their thoughts into a more positive framework resulting in more assertive and adaptive behavior (Bernstein et. al., 1997). Cognitive interventions include identifying anxious feelings and thoughts, recognizing somatic responses to anxiety, and devising a plan to deal with these symptoms. Behavioral interventions include modeling, role-playing, relaxation techniques, exposure and rewards. CBT has been used for a variety of childhood anxiety disorders and is said to be effective (Roblek & Piacentini ,2005; Cartwright-Hatton et. al., 2004). Another major advantage of CBT is availability of treatment manuals that allow comparison across studies. The controlled studies of CBT may be divided into those that have used a no-treatment waiting list control group, and those that have compared CBT to a non-specific control intervention. Early trials often used waiting list controls. The problem with this methodology was that this confirms to patients that they require treatment, but withholds it. Another limitation is that this control does not reveal the specific usefulness of an intervention, because there is no way of determining whether treatment was effective because of its particular nature, or because of non-specific factors such as therapist's interest and concern, or the family mobilizing itself to bring the child for treatment. Even if control psychotherapy is used, it should be equivalently appreciated by recipients, so that treatment effects (223) are not due to difference in treatment credibility. The most informative studies are those which rely on a comparison treatment that is reasonable and credible i.e. use attention controls. CBT was examined in two systematic studies by Kendall (Kendall 1994, Kendall et al. 1997) and he reported that the group receiving CBT had significantly better outcome. However, two other studies of CBT using attention controls reported no difference in efficacy (Last 1998; Silverman et. al., 1999). Other studies have examined parental involvement (Bernstein et. al.,2005, Spence et. al., 2000, Mendlowitz et. al. 1999) and report benefits of the same. In a study on family cognitive behavioral therapy for childhood anxiety disorders Wood et. al., 2006 report that family CBT may provide additional benefit over and above child-focused CBT. These findings provide preliminary support and encourage further research in parental participation in treatment for childhood anxiety. Many other studies are available, most of them suffer from methodological limitations, but there is evidence of improvement which is sustained over time (Kendall et al. 1996, Barrett et al.2001, Kendall et al. 2004). A recent review of CBT studies concluded that cognitive behavioral therapy appears an effective treatment for childhood and adolescent anxiety disorders in comparison to waiting list or attention control. There was no evidence for a difference between an individual, group or parental/family format. CBT can be recommended for the treatment of childhood and anxiety disorders, although with only just over half improving, there is a need for further therapeutic developments (James et. al., 2005). PSYCHOANALYSIS AND PSYCHODYNAMIC PSYCHOTHERAPY: Clinical data on psychoanalysis consists largely of case reports and most accounts report favorable results. Systematic studies of psychoanalysis (Heinicke and Ramsey-Klee, 1986; Target and Fonagy,1994) relevant to childhood anxiety disorders report improved capacity for relationships, frustration tolerance, balanced use of defenses and improvement in adaptation. Psychodynamic psychotherapy is a derivative of psychoanalysis with modifications such as less frequent appointments, greater participation of parents in treatment, and more explicit use of active support, practical guidance and environmental interventions (Bemporad, 1991). Anxious children generally benefit from mastering themes of separation, autonomy, self-esteem, and age appropriate behavior (Bernstein et al., 1997). Studies documenting efficacy in children are available (Muratori et. al.2003, Barett et. al., 1998, Hampe et al 1973, Miller et al, 1972). Overall, it is an effective but time consuming approach. Until recently this approach was widely practiced and accepted but has been overtaken by CBT now. PARENT CHILD INTERVENTIONS AND FAMILY THERAPY: Early temperamental traits of passivity, shyness, behavioral inhibition, fear & withdrawal in unfamiliar situations and insecure mother-child relation have been associated with increased risk of developing anxiety disorders during childhood (Capsi et al, 1995; Kagan et al 1988; Biederman et al, 1993; Warren et al, 1997; Prior et.al. 2000; Williams et. al. 1990). Therefore, attention to temperament and parent- child relationship is vital. Parent child interventions include helping parents encourage the child to face new situations, refraining from excessive criticism and intrusiveness, responding to child's emotional needs and encouraging child to engage in activities despite anxiety (Ginsburg et. al.,2002; Barrett P M, 1996; Crawford et. al. 2001). Family theory views anxiety symptoms in interpersonal terms and postulates that anxiety symptoms reflect problems in the family system (Last et. al. 1991). Bernstein et al .1990 in a study of 76 families identified family difficulties in areas of role performance, values and norms. It has been suggested that working with the family is a key to decrease anxiety symptoms experienced by the child. The aim of the therapy is to disrupt the dysfunctional family interactions that promote insecurity and to support areas of family competence (McDermott et. al. 1989). (224) PHARMACOLOGICAL TREATMENT: Pharmacotherapy should preferably be used as adjunct to behavioral or psychotherapeutic interventions rather than as a sole intervention. This approach is important to prevent symptom return after discontinuation of medications. SSRI's have been extensively used for adult anxiety disorders and have documented safety and efficacy. Although several open trials of SSRI's in children have appeared, the most important study till date is a large multicentric, placebo controlled study (Research Unit on Pediatric Pharmacology Anxiety Group, 2001) documenting efficacy of fluvoxamine in children with mixed anxiety disorders (Social phobia, separation anxiety and generalized anxiety disorder), without major depression. 79% of the children on medication improved, as compared to 28% on placebo over a period of 8 weeks. Williams & Miller, 2003 after reviewing evidence state that the serotonin selective reuptake inhibitors should be considered firstline pharmacological treatment for anxiety disorders in children and adolescents [CG]. However, medications other than SSRIs may also be considered for treatment of anxiety disorders in children and adolescents [CG]. Klein, 1994 in his review of literature on TCAs states that the support for the efficacy of TCAs in children with separation anxiety is inconsistent. Bernstein el. at., 2000 reported efficacy of imipramine compared to placebo in adolescents with school refusal and anxiety disorders. Although there are reports supporting efficacy of benzodiazepines in childhood anxiety disorders, the safely profile of SSRIs and evidence of their recent usefulness weaken consideration of benzodiazepines. However, they may be used on short term basis for immediate respite from anxiety symptoms. Less commonly buspirone and â-blockers may be employed if required. At this time, there are no specific dosing guidelines for children and adolescents with anxiety disorder. Experts recommend starting at low doses, monitoring side effects closely, and then increasing the dose slowly on the basis of treatment response and tolerability. Clinicians need to appreciate that anxious child and anxious parents may be especially sensitive to any worsening in the child's somatic symptoms or emergence of even transient side effects of medications. Selection of medication is guided by several factors, primarily co morbidity and side effect profile (Connolly et. al., 2007). DISORDER SPECIFIC RECOMMENDATIONS Separation Anxiety Disorder, Generalized Anxiety Disorder and other Anxiety Disorders: Majority of pharmacological studies of children and adolescents with anxiety disorders enroll a mixed diagnostic group including with SAD, GAD and/or Social phobia. Several trials support efficacy of SSRIs in treatment of anxiety disorders in children. Efficacy and safety of fluovoxamine & Paroxetine in children and adolescent with SAD, GAD and/or social phobia, of sertraline for youth with GAD, and of fluoxetine for youth with SAD, GAD and/or social phobia has been documented in well designed trials (Reinblatt et.al.,2007; Seidel et.al.,2006; Muller et. al., 2005; Wagner et.al.,2004; Birmaher et. al. 2003; Brent D A, 2003; Pine DS, 2002; RUPP study, 2001; Rynn et. al. 2001). The most common side effects reported were abdominal discomfort and headache. No major problems were reported. Currently, an SSRI is the first line choice medication for children and adolescent with anxiety disorders, including those with SAD. Fluoxetine has also been reported to be clinically effective as maintenance treatment of anxiety disorders in children and adolescents (Clark et. al., 2005). Preliminary findings from controlled trials of extended release venlafaxine in treatment of youths with generalized anxiety disorder (Rynn et. al.2002, Rynn et. al.2007) and social phobia (Tourian et.al.2004) suggest it may be well tolerated and effective. Tricycles antidepressants are an alternative choice. However, scientific data for this group is much less convincing than that for SSRI's. Controlled studies for TCA's in SAD and/or school refusal report contrasting findings (Bernstein et. al. 1996). A study comparing CBT + Imipramine and CBT + placebo for adolescent school refusal with co-morbid anxiety and depression reported response rate of 70% and 28% respectively after 8 weeks of treatment. The point to be noted is that these patients did not suffer from pure anxiety problems (Bernstein et. al. 2000). Use of BZD's in treatment of youth with anxiety disorders is backed by limited (225) data. Due to dependence potential this class of medications is reserved for short term use, typically in combination with an SSRI's or TCA while waiting for the onset of therapeutic effect of SSRI / TCA. It has been recommended that the SSRI should be continued for approximately one year after remission of target symptoms. Subsequently, during a low stress period a watchful medication free trial may be given. If relapse occurs SSRI should be immediately reinstated (Pine D S, 2002). In terms of psychotherapeutic interventions, CBT has the greatest empirical support (Albano et. al., 2002; Bernstein et. al., 2000; Dadds et. al. 2001; Velting et. al. 2004; Barrett PM, 1998; Kendall et. al. 1996; Last, 1998). The common components are 1. Education about nature of anxiety. 2. Activities to increase recognition of anxious thoughts and feelings. 3. Coping strategies such as adaptive self talk (cognitive-modification), progressive muscular relaxation and diaphragmatic breathing, and 4. Exposure to anxiety-provoking stimuli. The role of family therapy as a positive addition has also been documented along with efficacy in group format for SAD, GAD and social phobia (Barrett et. al. 1996; Dadds et. al. 2001; Kearney et. al. 2003). Data strongly supports short term efficacy of group/ individual CBT and SSRI's for youth with anxiety disorders. In anxiety disorders of mild severity, CBT should be initiated first, followed by SSRI in case of non-response. In practice, the two approaches are often combined for severe, impairing anxiety disorders. In cases of Generalized Anxiety Disorder CBT or CBT plus medication both are appropriate approaches based on severity of the case. Medication alone is not recommended. In mild to moderate cases CBT alone usually suffices (Connolly et. al., 2007). Social Phobia: CBT and SSRIs are the first line treatments. To our knowledge there is no published study examining efficacy of SSRIs in a sample of pure social phobia. However, studies of CBT in such samples are available and report CBT to be effective (Dadds et. al. 2001; Velting et. al. 2004; Beidal et. al. 2000). Depending on presentation, treatment may begin with CBT alone or CBT plus an SSRI (Mancini C. et. al., 2005). CBT here consists of social skills training, increased social opportunities, relaxation techniques, adaptive self-talk (cognitive restructuring), exposure and response prevention. Individual, group and school-based all interventions have found to be effective (Albano et. al. 1999; Masia et. al. 2001; Baer et. al. 2005) Specific Phobia: Treatment for specific phobias differs from CBT of SAD, GAD and social phobia. It primarily involves graded exposure to the feared stimuli, imaginary or actual, according to hierarchy constructed by the child progressing gradually from mild to most significant fears (Velting et. al. 2004). When exposure is paired with relaxation the technique is referred to as systematic desensitization. Other treatments include modeling, and cognitive exercises to facilitate adaptive thoughts. These also can be paired with graded exposure. Outcome studies report significant and sustained improvement with these approaches (Muris et. al. 1999; Bernstein et. al. 2005; Silvermann et. al. 1999; Berman et. al. 2000). Panic Disorder: CBT again is the first line of treatment. Components include 1. Education about the physical experience associated with panic attacks. 2. Breathing and relaxation exercises. 3. Interceptive exposure (i.e. exposure to cues associated with panic). 4. In vivo exposure. 5. Cognitive modification to reduce catastrophic misinterpretation. Ollendick, 1995 reported efficacy of this approach in a multiple-baseline design analysis. In practice an SSRI may be added to CBT (Masi et. al. 2001). Masi et. al. 2006 after reviewing the empirical evidence of pharmacotherapy in early-onset panic disorder, including selective serotonin re-uptake inhibitors, benzodiazepines and tricyclics conclude that the data supporting efficacy are still limited, and no controlled studies are available. Research in this area is wanting. (226) Posttraumatic Stress Disorder Although only some of the children and adolescents exposed to traumatic life events develop fullblown posttraumatic stress disorder, many others experience some PTSD symptoms and associated functional impairments. A variety of psychopharmacological and psychosocial treatments are currently available for this group of anxiety disorders but the effectiveness of most of those interventions has not been adequately evaluated. Only trauma-focused cognitive behavioral interventions and SSRIs enjoy empirical evidence of efficacy. Psychotherapeutic treatments: Trauma-Focused CBT: Widely regarded as the first line treatment for PTSD. Several RCTs proving trauma focused CBT to be superior to other treatment are available. It decreases PTSD, depressive and behavioural symptoms, and /or functional impairment in traumatized children. Majority of research has been done on sexually abused children (Cohan et al, 2004). Typically 10-16 treatment sessions are given. The major components of this treatment are - Psycho education about traumatic reactions and PTSD - Stress-inoculation- including affective modulation, muscle relaxation, focused breathing, thought stopping, and cognitive coping techniques. - Gradual exposure- consisting of carefully calibrated efforts to encourage the child to recall and describe increasing details about the traumatic events as well as thoughts, feelings and physical sensations experienced at the time of the original trauma as well as during retelling. - Cognitive processing - Parental treatment component Eye Movement Desensitization And Reprocessing (EMDR): Variant of trauma focused CBT, in which exposure and cognitive reprocessing interventions are paired with directed eye movements; fewer sessions are required. Crisis Intervention: Consist of one to three sessions provided in the immediate aftermath of a traumatic event. It is often provided in a community setting and includes encouragement to discuss feelings, provision of emotional support and psycho education about common reaction to stress and advice about managing these reactions. Play Therapy: Therapists do not direct the form or content of child's play but rather interpret themes in it thought to be representative of certain inner conflicts. Other Techniques Psychodynamic & psychoanalytical technique Parent-child interaction therapy Dialectical behaviour therapy Relationship based conjoint parent-child treatment Pharmacological treatment: The data supporting efficacy of pharmacotherapy in early-onset panic disorder, including selective serotonin re-uptake inhibitors, benzodiazepines & tricyclics is limited (Masi et. al.,2006). Only one randomized trial has been conducted. This study evaluated the comparative impact of imipramine vs chloral hydrade on development of PTSD in acutely burnt children and demonstrated the efficacy of imipramine (Robert et. al, 1999). Several open trials have demonstrated clinical improvement with adrenergic blockers (PPNL), clonidine, dopamine antagonists (risperidone) and opiates. In practice SSRI's, TCA's, venlafaxine, bupropion or any of the above mentioned medications may be used. No information is available with regard to optimal length of treatment, need for maintenance treatment or use of multiple medications in treatment of childhood PTSD. (227) Obsessive Compulsive Disorder: It is now being increasingly appreciated that although OCD in children is often chronic and can be severe, the outlook for patients receiving prompt diagnosis and appropriate treatment is quite positive. Considerable progress has been made in testing and refinement of both pharmacological and psychosocial treatments. Both forms of treatment are very effective in symptom relief and produce improvements in functioning, Clinical consensus suggests that combined treatment has added benefits. Treatments should begin with educating the family of the child about how to handle their child's behavior, which may be disrupting family life. On the internet www.ocdresource is a useful source of information about the disorder. If the disorder is hampering school performance, teachers need to be told about the child's problem and if possible be involved in the child's behavioral program. Choice of first line therapy depends on the symptom pattern, severity, and the patient's and family's preference. Whatever is used, it is important to urge flexibility, as combination therapy may be eventually required. Cognitive-Behavior Therapy: The technique of CBT needs to be modified in accordance with the developmental age of the child. CBT for pediatric OCD basically encompasses three techniques 1. Exposure and Response prevention 2. Cognitive therapy and 3. Relaxation training. ERP is the most recommended and effective approach. Cognitive therapy, which involves changing false beliefs, challenging reality of obsessions and necessity of compulsions, is usually ineffective as a sole treatment for OCD. However, it is a useful complement in most cases. Relaxation therapy is primarily used to manage anxiety produced by exposure but has no direct affect on O.C. Symptoms. Older children and adolescents respond well to CBT modeled on approaches used for adult OCD. However, younger children require a number of modifications. These include additional efforts to educate child and family about the nature of excessive anxiety and the role of treatment, sensitizing the child to the impact of OCD on his/her life and fostering motivation for change through his/her cooperation and perseverance in treatment, building a shared language to better communicate the nature of associated feelings or cognitions, and including behavioral rewards for maintaining engagement in treatment. Manuals for modified CBT for OCD suitable for children are available. Methodology, though undergoing continued refinement currently involves. 1. Daily exposure to cues avoided because of associated discomfort and rituals, and 2. Maintaining exposure and not ritualizing for at least an hour or until discomfort subsides. Developmentally modified forms of CBT for children appear to confer similar benefits in children as observed for adult population (O'Kearney et. al., 2006). Uncontrolled trials of CBT appear highly promising, with excellent response in up to 75% of the patients. Although, gains from ERP persist beyond discontinuation, booster treatment may help long term progress, and additional treatment may be needed for relapses brought on by stress. O'Kearney et. al., 2007 after reviewing evidence on benefits of cognitive-behavioural therapy for children and youth with obsessive-compulsive disorder report that CBT should be regarded as a first line equivalent to anti-OCD medication with the potential to lead to better outcomes when combined with medication than medication alone can provide. Additional studies are needed to further clarify CBT's benefits and to investigate how it can be made more available as a treatment option for children and youth who suffer from OCD. Pharmacological Treatment: Although pediatric trials of SSRIs have lagged behind those in adults, there is now extensive substantiation of the utility of pharmacotherapy in pediatric OCD. An initial trial of Serotonin Reuptake (228) Inhibitor (SRI), most often an SSRI is the treatment of choice. If there is inadequate response at 10-12 weeks, another SSRI may be tried. Serotonergic Agents: Clomipramine was the first agent shown to be effective in O.C.D. A meta-analysis suggested that it may possess greater efficiency for pediatric OCD than the SSRIs (Allen, 1994; Practice Parameters for OCD, 1998). De Veaugh-Geis et.al, 1992 documented the efficacy of clomipramine in pediatric O.C.D in randomized controlled trial. However, being a tricyclic, it is associated with significantly greater risk of side effects and therefore is relegated to a second or third line treatment choice in children and adolescent with OCD. The evidence base supporting the efficacy and safely of SSRIs has considerably strengthened over the last few years (Geller et. al. 2004; Geller et. al. 2003; Practice Parameters for OCD, 1998). Anti-obsessive efficacy of fluoxetine, fluvoxamine and sertraline has been reported by controlled trials (March et.al.1998 Geller et. al. 2002; Liebowitz et. al. 2002, Riddle et. al. 2001). Similar benefits have been reported for Paroxetine (Geller et. al. 2003) and for Citalopram (Mukkades et. al. 2003). Low initial doses, with slow upward titration, are the rule. Patients should be told trials of more than one agent may be required, at times with augumenting agents. In controlled trials reduction in baseline symptom rating with treatment of upto 16 weeks has been relatively consistent, although modest, ranging from 18 to 44 percent (Geller et. al. 2003; Geller et. al. 2002; Liebowitz et. al. 2002; Riddle et. al. 2001). Studies including long term observation report continued symptom reduction upto one year. Data suggests that treatment benefits with SSRIs are stable and can be expected to strengthen in many with continued treatment. Overall, SSRIs have been found to be well tolerated by child and adolescent patients with OCD. However, almost 50% of the children and adolescents treated with an SSRI continue to have interfering symptoms and may require trials of alternative SSRIs, combined pharmacotherapy and addition of psychotherapeutic interventions. Augmenting Strategies and Adjunctive agents: Up to 50% childhood OCD cases show no or partial response to SRI treatment, even if two different SRIs are used (Geller et.al ,2003). Hence, augmentation strategies may be required. There are no randomized controlled trials of the utility of augmentation strategies in Pediatric OCD. However, based on experiences in adult patients, augmentation of an SRI might be considered for pediatric patients with a partial response or intolerance to higher doses. In adults, three agents, Clonazepam, Haloperidol, and Risperidone (Mc Dougle et.al., 1995; Pigott et.al.,1992) have been shown to be effective in controlled trials. These agents are worth a try. Another strategy, addition of a second concurrent SRI, has been used to a limited extent in children. An open table trial of six adolescents (Simeon et.al. 1990) combined fluoxetine and clomipramine and reported decreased doses requirement for both medications and fewer side effect. Figueroa et.al., 1998 described an open series of seven patients given clomipramine and SSRI (fluoxetine, sertraline or paroxetine) and followed through 5-22 months. Combination therapy appeared to be more effective than monotherapy for all cases. Adjunctive treatment may be indicated for children and adolescent with OCD with comorbidities. The comorbidity of tic disorders may require the addition of a-agonists or neuroleptics. Co-morbid anxiety symptoms are benefited by addition of BZDs or Buspirone. Depressive Symptoms may improve with lithium addition. Treatment Planning: Many experts and consensus guidelines recommend CBT as the first line approach for the majority of children and adolescents with OCD. However, more severe symptoms, comorbid depression or limited cooperation may prompt the clinician to consider medication alone or in combination with CBT. One half or more of the young patients with OCD usually require combined therapy at some point of (229) time to achieve complete remission. OCD is often chronic and long-term medication treatment is often required to maintain symptom control (Leonard et.al. 1991). Whenever discontinuation is attempted, tapering should be gradual usually over several weeks. Long term (indefinite) drug maintenance is suggested after 2-4 relapses. Concomitant CBT has been observed to assist medication discontinuation in some patients (Stanley & Turner 1995; Wever & Rey 1997). Periodic resumption of CBT may be necessary to combat symptom exacerbation in response to stress or development transitions. In general, OCD in children & adolescent is very responsive to treatment. Majority of patients should experience significant relief and return to functioning. Reducing delays in diagnosis and aggressive treatment, often with combined approaches goes a long way in minimizing impact of the disorder on children development. Selective Mutism: Data on treatment of selective mutism is mostly limited to single case studies. Controlled trials are lacking. In spite of this, the conviction that behavioral techniques are an essential component of management of selective mutism is widespread. Reports describe successful use of techniques such as contingency management, stimulus fading, systematic desensitization, negative reinforcement and shaping. A combination of behavioral techniques is probably the most common and successful treatment approach (Anstending K, 1998; Dow et. al. 1995; Holmbeck et. al. 1992; Watson et. al. 1992). A hierarchy of situations in which the child has difficulty speaking is prepared. Then, the child is guided to systematically engage in speaking- related behaviors (e.g. mouthing speech, making sounds , whispering and so on.) in increasingly more difficult situations. With repeated attempts, associated anxiety dissipates through autonomic habituation. When the feared consequences of speaking fail to occur anxiety is further reduced. Typically, child is given rewards after attempts to engage in desired behaviors. The young age of most children with selective mutism and the fact that most of these children initially do not speak to the therapist necessitates parental involvement in treatment. Traditional anxiety-reducing behavioral techniques like shaping, gradual exposure and reinforcement are often used in initial sessions. Involvement of school personnel for providing regular communication and support in school is also highly recommended. Other Psychosocial therapies: Although behavior therapy is most commonly employed, accounts of successful treatment of selective mutism with use of play therapy, family therapy, psychodynamic therapy, and group therapy are also available (Watson et.al. 1992; Tatem et.al. 1995; Dow et. al.; Bozigar & Hansen, 1984; Anstendig et. al. 1998). These strategies may be used as per need. It is common for children with selective mutism to have some degree of speech or language difficulties which exacerbate speechrelated anxiety. 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Mar;45(3):314-21. (240) Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 REVIEW Open Access Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders Martin A Katzman1*, Pierre Bleau2, Pierre Blier3, Pratap Chokka4, Kevin Kjernisted5, Michael Van Ameringen6, the Canadian Anxiety Guidelines Initiative Group on behalf of the Anxiety Disorders Association of Canada/ Association Canadienne des troubles anxieux and McGill University Abstract Background: Anxiety and related disorders are among the most common mental disorders, with lifetime prevalence reportedly as high as 31%. Unfortunately, anxiety disorders are under-diagnosed and under-treated. Methods: These guidelines were developed by Canadian experts in anxiety and related disorders through a consensus process. Data on the epidemiology, diagnosis, and treatment (psychological and pharmacological) were obtained through MEDLINE, PsycINFO, and manual searches (1980–2012). Treatment strategies were rated on strength of evidence, and a clinical recommendation for each intervention was made, based on global impression of efficacy, effectiveness, and side effects, using a modified version of the periodic health examination guidelines. Results: These guidelines are presented in 10 sections, including an introduction, principles of diagnosis and management, six sections (Sections 3 through 8) on the specific anxiety-related disorders (panic disorder, agoraphobia, specific phobia, social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, and posttraumatic stress disorder), and two additional sections on special populations (children/adolescents, pregnant/lactating women, and the elderly) and clinical issues in patients with comorbid conditions. Conclusions: Anxiety and related disorders are very common in clinical practice, and frequently comorbid with other psychiatric and medical conditions. Optimal management requires a good understanding of the efficacy and side effect profiles of pharmacological and psychological treatments. Introduction Anxiety and related disorders are among the most common of mental disorders. Lifetime prevalence of anxiety disorders is reportedly as high as 31%; higher than the lifetime prevalence of mood disorders and substance use disorders (SUDs) [1-5]. Unfortunately, anxiety disorders are under-diagnosed [6] and under-treated [5,7,8]. These guidelines were developed to assist clinicians, including primary care physicians and psychiatrists, as well as psychologists, social workers, occupational therapists, and nurses with the diagnosis and treatment of anxiety and related disorders by providing practical, * Correspondence: mkatzman@startclinic.ca 1 Department of Psychiatry, University of Toronto, Toronto, ON, M5S 1A1, Canada Full list of author information is available at the end of the article evidence-based recommendations. This guideline document is not focused on any individual type of clinician but rather on assessing the data and making recommendations. Subsequent “user friendly” tools and other initiatives are planned. The guidelines include panic disorder, agoraphobia, specific phobia, social anxiety disorder (SAD), generalized anxiety disorder (GAD), as well as obsessive-compulsive disorder (OCD), and posttraumatic stress disorder (PTSD). Also included are brief discussions of clinically relevant issues in the management of anxiety and related disorders in children and adolescents, women who are pregnant or lactating, and elderly patients, and patients with comorbid conditions. © 2014 Katzman et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 2 of 83 Methods Table 2 Treatment recommendation summary These guidelines are based on a thorough review of the current literature and were developed by a panel of Canadian experts in anxiety and related disorders through a consensus process. Data on the epidemiology, diagnosis, and treatment (psychological and pharmacological) were obtained through MEDLINE searches of English language citations (1980–2012), using search terms encompassing the specific treatments and specific anxiety and related disorders. These searches were supplemented with data from PsycINFO and manual searches of the bibliographies of efficacy studies, meta-analyses, and review articles. Treatment strategies were rated on strength of evidence for the intervention (Table 1). A clinical recommendation for each intervention was then made, based on global impression of efficacy in clinical trials, effectiveness in clinical practice, and side effects, using a modified version of the periodic health examination guidelines (Table 2). The guidelines were initiated prior to the introduction of the American Psychiatric Association’s (APA) fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and the committee was sensitive to potential changes to the nosology of anxiety and related disorders and its impact on the guidelines. However, it was agreed that, since the evidence for treatment is based on studies using DSM-IV criteria (or earlier), the introduction of the DSM-5 would not fundamentally alter the evidence and recommendations at this time. Whether using DSM-5 diagnostic criteria for the inclusion patients in clinical trials in the future will have an impact on outcomes, remains to be seen. The panel of Canadian experts in anxiety and related disorders responsible for the development of these guidelines via consensus process included 10 psychiatrists and seven psychologists who were organized into subpanels based on their expertise in particular anxiety or related disorders as well as in treating specific patient populations. Preliminary treatment recommendations First-line Level 1 or Level 2 evidence plus clinical support for efficacy and safety Second-line Level 3 evidence or higher plus clinical support for efficacy and safety Third-line Level 4 evidence or higher plus clinical support for efficacy and safety Table 1 Levels of evidence 1 Meta-analysis or at least 2 randomized controlled trials (RCTs) that included a placebo condition 2 At least 1 RCT with placebo or active comparison condition 3 Uncontrolled trial with at least 10 subjects 4 Anecdotal reports or expert opinion Levels of evidence do not assume positive or negative or equivocal results, they merely represent the quality and nature of the studies that have been conducted. Level 1 and Level 2 evidence refer to treatment studies in which randomized comparisons are available. Recommendations involving epidemiological or risk factors primarily arise from observational studies, hence the highest level of evidence for these is usually Level 3. Recommendations, such as principles of care, reflect consensus opinion based on evidence from various data sources, and therefore are primarily Level 4 evidence. Not Level 1 or Level 2 evidence for lack of efficacy recommended and the evidence upon which they had been based were reviewed at a meeting of the panel in December 2012; subsequently, draft guidelines were prepared by the subpanels which were then circulated to the entire group for consensus ratification during 2013. Preliminary recommendations were also presented to the Canadian psychiatric community for input in September 2012 at the Canadian Psychiatric Association annual conference. These guidelines are presented in 10 sections, the first of which is this introduction. In the following section, the principles of diagnosis and management of anxiety and related disorders are covered. That section provides an overview of the differential diagnoses associated with anxiety and related disorders in general, discusses issues that affect all anxiety disorders, and presents the general advantages and disadvantages of psychological treatment and pharmacotherapy options. In the subsequent six sections (Sections 3 through 8), the specific diagnosis and management of the individual anxiety and related disorders (panic disorder, specific phobia, SAD, OCD, GAD, and PTSD) are reviewed and recommendations are made for psychological and pharmacological treatments. Section 9 discusses issues that may warrant special attention pertaining to anxiety and related disorders in children and adolescents, pregnant or lactating women, and the elderly. The last section of these guidelines addresses clinical issues that may arise when treating patients with anxiety and related disorders who are also diagnosed with comorbid psychiatric conditions such as major depressive disorder (MDD), bipolar disorder, or other psychoses, and attention deficit/hyperactivity disorder (ADHD), or medical comorbidities, such as pain syndromes, cardiovascular disease, and diabetes/metabolic syndrome. Principles of diagnosis and management of anxiety and related disorders Epidemiology Prevalence and impact Anxiety and related disorders are among the most common mental disorders, with lifetime prevalence rates as high as 31% [1-5] and 12-month prevalence rates of about 18% [3,4]. Rates for individual disorders vary widely. Women generally have higher prevalence rates Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 3 of 83 for most anxiety disorders, compared with men [4,5,9]. Anxiety and related disorders are associated with an increased risk of developing a comorbid major depressive disorder [10-12]. Anxiety and related disorders put a significant burden on patients and their family members [13]. They are associated with substantial functional impairment, which increases as the severity of anxiety [14] or the number of comorbid anxiety disorders increases [7,15]. In addition, studies have demonstrated quality of life impairments in patients with various anxiety and related disorders [16,17]. Anxiety has a considerable economic impact on society as well, being associated with greater use of health care services [5,18] and decreased work productivity [18,19]. Importantly, studies report that about 40% of patients diagnosed with anxiety and related disorder are untreated [5,7]. Asking patients if they are feeling nervous, anxious or on edge, or whether they have uncontrollable worry, can be useful to detect anxiety in patients in whom the clinician suspects an anxiety or related disorder [7]. The DSM-5 suggests the questions shown in Table 4 for the identification of anxiety-related symptoms; items scored as mild or greater may warrant further assessment [26]. If anxiety symptoms are endorsed, they should be explored in more detail by including questions about the onset of the anxiety symptoms, associations with life events or trauma, the nature of the anxiety (i.e., worry, avoidance, or obsession), and the impact they have had on the patient’s current functioning. Table 5 presents suggested screening questions for individual anxiety and related disorders, from various validated screening tools [27-30], some of which are freely available online (e.g., http://www.macanxiety.com/ online-anxiety-screening-test). Suicide risk Conduct differential diagnosis In large surveys, anxiety and related disorders were independently associated with a significant 1.7-2.5 times increased risk of suicide attempts [20-23]; however, data are conflicting as to whether the risk is moderated by gender [20,23]. Increased risk of suicide attempts or completed suicide has been reported for patients with panic disorder, PTSD [20,24], and GAD [24], even in the absence of a comorbid mood disorder. These data indicate that patients with an anxiety disorder warrant explicit evaluation for suicide risk. The presence of a comorbid mood disorder significantly increases the risk of suicidal behavior [22,25]. The differential diagnosis of anxiety and related disorders should consider whether the anxiety is due to another medical or psychiatric condition, is comorbid with another medical or psychiatric condition, or is medication-induced or drug-related [32]. When a patient presents with excessive or uncontrollable anxiety it is important to identify other potential causes of the symptoms, including direct effects of a substance (e.g., drug abuse or medication) or medical condition (e.g., hyperthyroidism, cardiopulmonary disorders, traumatic brain injury), or another mental disorder [26]. However, since comorbid conditions are common, the presence of some of these other conditions may not preclude the diagnosis of an anxiety or related disorder. Certain risk factors have been associated with anxiety and related disorders and should increase the clinician’s index of suspicion (Table 6) [4,9,33-37]. A family [33] or personal history of mood or anxiety disorders [34,35] is an important predictor of anxiety symptoms. In addition, family history is associated with a more recurrent course, greater impairment, and greater service use [33]. A personal history of stressful life events is also associated the development of anxiety and related disorders [36,37], in particular, childhood abuse [37]. Women generally have higher prevalence rates across all anxiety and related disorders, compared with men [4,5,9]. The median of age of onset is very early for some Initial assessment of patients with anxiety The management of patients presenting with anxiety symptoms should initially follow the flow of the five main components outlined in Table 3. Screen for anxiety and related symptoms Anxiety and related disorders are generally characterized by the features of excessive anxiety, fear, worry, and avoidance. While anxiety can be a normal part of everyday life, anxiety disorders are associated with functional impairment; as part of the key diagnostic criteria for anxiety disorders is the requirement that the symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning [26]. Table 3 Overview of the management of anxiety and related disorders • Screen for anxiety and related symptoms • Conduct differential diagnosis (consider severity, impairment, and comorbidity) • Identify specific anxiety or related disorder • Psychological and/or pharmacological treatment • Perform follow-up Table 4 General screening questions • During the past two weeks how much have you been bothered by the following problems? ○ Feeling nervous, anxious, frightened, worried, or on edge ○ Feeling panic or being frightened ○ Avoiding situations that make you anxious Adapted from reference [26]. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 4 of 83 Table 5 Screening questions for specific anxiety and related disorders Panic disorder – MACSCREEN [29,30] • Do you have sudden episodes/spells/attacks of intense fear or discomfort that are unexpected or out of the blue? If you answered “YES” then continue • Have you had more than one of these attacks? • Does the worst part of these attacks usually peak within several minutes? • Have you ever had one of these attacks and spent the next month or more living in fear of having another attack or worrying about the consequences of the attack? SAD (Based on Mini-SPIN [28]) • Does fear of embarrassment cause you to avoid doing things or speaking to people? • Do you avoid activities in which you are the center of attention? • Is being embarrassed or looking stupid among your worst fears? GAD [31] • During the past 4 weeks, have you been bothered by feeling worried, tense, or anxious most of the time? • Are you frequently tense, irritable, and having trouble sleeping? OCD – MACSCREEN [29,30] Obsessions: • Are you bothered by repeated and unwanted thoughts of any of the following types: ○ Thoughts of hurting someone else ○ Sexual thoughts ○ Excessive concern about contamination/germs/disease ○ Preoccupation with doubts (“what if” questions) or an inability to make decisions ○ Mental rituals (e.g., counting, praying, repeating) ○ Other unwanted intrusive thoughts • If you answered “YES” to any of the above… Do you have trouble resisting these thoughts, images, or impulses when they come into your mind? Compulsions: • Do you feel driven to perform certain actions or habits over and over again, or in a certain way, or until it feels just right? Such as: ○ Washing, cleaning ○ Checking (e.g., doors, locks, appliances) ○ Ordering/arranging ○ Repeating (e.g., counting, touching, praying) ○ Hoarding/collecting/saving • If you answered “YES” to any of the above… Do you have trouble resisting the urge to do these things? PTSD – MACSCREEN [29,30] • Have you experienced or seen a life-threatening or traumatic event such as a rape, accident, someone badly hurt or killed, assault, natural or man-made disaster, war, or torture? If you answered “YES” then continue • Do you re-experience the event in disturbing (upsetting) ways such as dreams, intrusive memories, flashbacks, or physical reactions to situations that remind you of the event? phobias and for separation anxiety disorder (seven to 14 years), but later for GAD, panic disorder, and PTSD (24-50 years) [1,2]. Loneliness [38], low education [38], and adverse parenting [39], as well as chronic somatic illnesses, such as cardiovascular disease, diabetes, asthma, and obesity may increase the risk for a lifetime diagnosis of anxiety [34,40]. Comorbid medical and psychiatric disorders Anxiety and related disorders frequently co-occur with other psychiatric disorders [3]. More than half of patients with an anxiety disorder have multiple anxiety disorders [3,15], Table 6 Common risk factors in patients with anxiety and related disorders • • • • • • Family history of anxiety [33] Personal history of anxiety or mood disorder [34,35] Childhood stressful life events or trauma [36,37] Being female [4,9] Chronic medical illness [34,40] Behavioral inhibition [41,42] and almost 30% will have three or more comorbid anxiety or related disorders [3]. Anxiety is often comorbid with substance use and mood disorders [3,40]. An estimated 52% of patients with bipolar disorder [43], 60% of patients with MDD [44], and 47% of those with ADHD [45] will have a comorbid anxiety or related disorder. Therefore, anxiety disorders should be considered in these patients. The high frequency of comorbidity must be considered when diagnosing anxiety and related disorders since this can have important implications for diagnosis and treatment [32]. Anxiety disorders comorbid with other anxiety or depressive disorders are associated with poorer treatment outcomes, greater severity and chronicity [46-49], more impaired functioning [46], increased health service use [50], and higher treatment costs [51]. The impact tends to increase with an increasing number of comorbid conditions [46]. Patients with anxiety disorders have a higher prevalence of hypertension and other cardiovascular conditions, gastrointestinal disease, arthritis, thyroid disease, Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 respiratory disease, migraine headaches, and allergic conditions compared to those without anxiety disorders [16,52]. Comorbid anxiety and related disorders have a significant impact on quality of life (QoL) in patients with medical conditions [52]. Baseline assessment Baseline assessment should include a review of systems, prescribed medications, over-thecounter agents, alcohol use, caffeine intake, and illicit drug use, in addition to evaluation of the anxiety symptoms and functioning [32]. Table 7 lists potential investigations that can be considered based on an individual patient’s presentation and specific symptoms (e.g., dizziness or tachycardia). Ideally, a physical examination and baseline laboratory investigations should be performed before pharmacotherapy is initiated, with repeat assessments according to best practice guidelines [32]. Patients with anxiety and related disorders should be monitored initially every one to two weeks and then every four weeks for weight changes and adverse effects of medications, as this is a major factor contributing to discontinuation of medication. Closer monitoring may be required in children younger than 10 years of age, older or medically ill patients, patients on medications associated with metabolic changes, and those on multiple medications [32]. Identify specific anxiety or related disorder The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) has been finalized by the American Psychiatric Association (APA) [26]. The new DSM-5 provides diagnostic criteria for psychiatric disorders based on scientific reviews of the literature, field trial data, internal evaluations, public comments, and a final review by APA’s Board of Trustees. The “anxiety disorders” chapter now includes panic disorder, agoraphobia, GAD, selective mutism, separation anxiety disorder, SAD (social phobia), specific phobia, substance/medication-induced anxiety disorder, as well as anxiety disorder due to another medical condition or not elsewhere classified. OCD and PTSD have been moved to separate chapters on obsessive-compulsive and Table 7 Considerations for baseline laboratory investigations (as needed based on patient’s presenting symptoms) Basic lab tests • Complete blood count • Fasting glucose • Fasting lipid profile (TC, vLDL, LDL, HDL, TG) • Thyroid-stimulating hormone • Electrolytes • Liver enzymes If warranted • Urine toxicology for substance use Adapted from references [32,53]. HDL = high density lipoprotein; LDL = low density lipoprotein; TC = total cholesterol; TG = triglyceride; vLDL = very low density lipoprotein. Page 5 of 83 related disorders and trauma- and stressor-related disorders, respectively [26]. Table 8 provides a brief summary of the key DSM-5 diagnostic features of the anxiety and related disorders that are included in these guidelines [26]. While the DSM-5 is the most up-to-date diagnostic criteria, it is important to note that the evidence for treatment is based on studies using DSM-IV criteria (or earlier) for inclusion of patients. However, most of the diagnostic criteria have not changed substantially (see Sections 3–9 for more information on diagnosis); the exception being agoraphobia, which is now designated as a separate diagnosis. Specific individual anxiety and related disorders should be diagnosed with the DSM-5 criteria in the sections devoted to each anxiety disorder. An accurate diagnosis is important to help guide treatment. Psychological and pharmacological treatment Treatment options for anxiety and related disorders include psychological and pharmacological treatments. All patients should receive education about their disorder, efficacy (including expected time to onset of therapeutic effects) and tolerability of treatment choices, aggravating factors, and signs of relapse [32]. Information on self-help materials such as books or websites may also be helpful. The choice of psychological or pharmacological treatment depends on factors such as patient preference and motivation, ability of the patient to engage in the treatment, severity of illness, clinicians’ skills and experience, availability of psychological treatments, patient’s prior response to treatment, and the presence of comorbid medical or psychiatric disorders [32]. A brief overview of psychological and pharmacological treatments is provided below, with more specific recommendations in the individual sections for each anxiety and related disorder. Overview of psychological treatment Psychological treatments play an important role in the management of anxiety and related disorders. Regardless of whether formal psychological treatment is undertaken, patients should receive education and be encouraged to face their fears. Meta-analyses have demonstrated the efficacy of psychological treatments in group and individual formats in patients with panic disorder [54-56], specific phobia [57], SAD [58,59], OCD [60-63], GAD [55,64,65], or PTSD [66-69], particularly exposure-based and other cognitive behavioral therapy (CBT) protocols [70,71], as well as mindfulness-based cognitive therapy (MBCT) [72]. When choosing psychological treatments for individual patients, the forms of therapy that have been most thoroughly evaluated in the particular anxiety or related disorder should be used first. CBT is not a single approach to treatment, but rather a process that focuses on addressing the factors that Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 6 of 83 Table 8 Key features of specific anxiety and related disorders Disorder Key features Panic disorder • Recurrent unexpected panic attacks, in the absence of triggers • Persistent concern about additional panic attacks and/or maladaptive change in behavior related to the attacks Agoraphobia • Marked, unreasonable fear or anxiety about a situation • Active avoidance of feared situation due to thoughts that escape might be difficult or help unavailable if panic-like symptoms occur Specific phobia • Marked, unreasonable fear or anxiety about a specific object or situation, which is actively avoided (e.g., flying, heights, animals, receiving an injection, seeing blood) Social anxiety disorder (SAD) • Marked, excessive or unrealistic fear or anxiety about social situations in which there is possible exposure to scrutiny by others • Active avoidance of feared situation Generalized anxiety disorder (GAD) • Excessive, difficult to control anxiety and worry (apprehensive expectation) about multiple events or activities (e.g., school/work difficulties) • Accompanied by symptoms such as restlessness/feeling on edge or muscle tension Obsessive–compulsive disorder (OCD) • Obsessions: recurrent and persistent thoughts, urges, or images that are experienced as intrusive and unwanted and that cause marked anxiety or distress • Compulsions: repetitive behaviors (e.g., hand washing) or mental acts (e.g., counting) that the individual feels driven to perform to reduce the anxiety generated by the obsessions Posttraumatic stress disorder (PTSD) • Exposure to actual or threatened death, serious injury, or sexual violation • Intrusion symptoms (e.g., distressing memories or dreams, flashbacks, intense distress) and avoidance of stimuli associated with the event • Negative alterations in cognitions and mood (e.g., negative beliefs and emotions, detachment), as well as marked alterations in arousal and reactivity (e.g., irritable behavior, hypervigilance) Adapted from reference [26]. caused and maintain the individual patient’s anxiety symptoms [73]. Some of the core components of CBT are shown in Table 9 [73]. CBT can be effectively delivered as individual or group therapy for most anxiety and related disorders. In addition, a variety of self-directed or minimal intervention formats (e.g., bibliotherapy/self-help books, or internet/ computer-based programs with or without minimal therapist contact) have demonstrated significant improvements in anxiety symptoms [74-79]. Meta-analyses have also shown that exposure therapy can be effectively administered in a virtual reality format [80,81]. These strategies may be particularly useful in cases where real-life exposure is difficult due to inconvenience, expense, or patient reluctance. Psychotherapy and pharmacotherapy generally demonstrate about equivalent efficacy for the treatment of most anxiety and related disorders [71,82]. Results with combination therapy vary for the different anxiety disorders, and results have been conflicting [82,83] (see Sections 3– 9 for evidence and references regarding combination therapy). Therefore, current evidence does not support the routine combination of CBT and pharmacotherapy as initial treatment. However, when patients do not benefit from CBT or have a limited response, a trial of pharmacotherapy is advisable. Similarly, patients who show limited benefit from pharmacotherapy may benefit from CBT. All patients being treated with pharmacotherapy should be instructed to gradually face their fears (exposure to decrease avoidance). Table 9 Components of cognitive behavioral interventions Exposure • • • • Safety response inhibition • Patients restrict their usual anxiety-reducing behaviors (e.g., escape, need for reassurance) • Decreases negative reinforcement • Coping with anxiety without using anxiety-reducing behavior enhances self-efficacy Cognitive strategies • Cognitive restructuring, behavioral experiments, and related strategies target patients’ exaggerated perception of danger (e.g., fear of negative evaluation in SAD) • Provides corrective information regarding the level of threat • Can also target self-efficacy beliefs Arousal management • Relaxation and breathing control skills can help patient control increased anxiety levels Surrender of safety signals • Patient relinquishes safety signals (e.g., presence of a companion, knowledge of the location of the nearest toilet) • Patients learn adaptive self-efficacy beliefs Adapted from reference [73]. Encourage patients to face fears Patients learn corrective information through experience Extinction of fear occurs through repeated exposure Successful coping enhances self-efficacy Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 7 of 83 Overview of pharmacological treatment This section provides a general overview of some of the commonly recommended pharmacological agents. Evidence and recommendations for specific medications are described in the individual sections for each of the anxiety and related disorders. Table 10 shows medications that have Health Canada approved indications for use in different anxiety and related disorders [84], and dosing suggestions are shown in Additional file 1. Various antidepressants including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), noradrenergic and specific serotonergic antidepressants (NaSSAs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), and reversible inhibitors of monoamine oxidase A (RIMAs) have demonstrated some efficacy in the treatment of anxiety and related disorders (see Sections 3–9 for evidence and references). SSRIs and SNRIs are usually preferred as initial treatments, since they are generally safer and better tolerated than TCAs or MAOIs [32]. Benzodiazepines may be useful as adjunctive therapy early in treatment, particularly for acute anxiety or agitation, to help patients in times of acute crises, or while waiting for onset of adequate efficacy of SSRIs or other antidepressants [32]. Due to concerns about possible dependency, sedation, cognitive impairment, and other side effects, benzodiazepines should usually be restricted to short-term use, and generally dosed regularly rather than as-needed [32]. Several anticonvulsants and atypical antipsychotics have demonstrated efficacy in some anxiety and related disorders, but for various reasons, including side effects, as well as limited randomized controlled trial (RCT) data and clinical experience, these agents are generally recommended as second-line, third-line, or adjunctive therapies (see Sections 3–9 for evidence and references). The choice of medication should take into consideration the evidence for its efficacy and safety/tolerability for the treatment of the specific anxiety and related disorder, as well as for any comorbid conditions the patient might have, in both acute and long-term use. Safety and side effects Antidepressants: The most common side effects seen with SSRIs and SNRIs include headache, irritability, gastrointestinal complaints, insomnia, sexual dysfunction, weight gain, increased anxiety, drowsiness, and tremor [85-88]. Patients report that the most common bothersome side effects are sexual dysfunction, drowsiness, fatigue, and weight gain [87,88]. Most side effects occur early and transiently during the first two weeks of treatment, but others, such as sexual dysfunction and weight gain, may persist for the duration of treatment [85,87,89]. Use of SSRIs or SNRIs has been associated with an increased risk of upper gastrointestinal bleeding, Table 10 Medications with Health Canada–approved indications for anxiety and related disorders Anxiety disorders Panic disorder Social anxiety disorder Obsessive–compulsive disorder Generalized anxiety disorder Escitalopram (Cipralex®) X X Fluoxetine (Prozac®) X Posttraumatic stress disorder ANTIDEPRESSANTS SSRIs Fluvoxamine (Luvox®) X Paroxetine (Paxil®) X X Paroxetine CR (Paxil® CR) X X Sertraline (Zoloft®) X X X X X TCAs Clomipramine X Other antidepressants Venlafaxine XR (Effexor® XR) X Duloxetine (Cymbalta®) X X X AZAPIRONES Buspirone (BuSpar®, Buspirex®) BENZODIAZEPINES* X X Data from respective Canadian product monographs [84]. *Multiple generic and brand name products, consult product monographs: alprazolam, bromazepam, chlordiazepoxide, clorazepate, diazepam, lorazepam, and oxazepam are indicated for anxiety disorders; alprazolam is also indicated for panic disorder. CR = controlled release; SSRI = selective serotonin reuptake inhibitor; TCA = tricyclic antidepressant; XR = extended release. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 particularly when used in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) [90,91]. SSRI use has also been associated with low bone mineral density [92,93], as well as an increased risk of fractures [94] and hyponatremia [95]. Abrupt discontinuation of SSRIs or SNRIs can lead to a discontinuation syndrome with gastrointestinal, psychiatric, vasomotor, and other symptoms [85,96]. Health Canada and the US Food and Drug Administration (FDA) require antidepressants to include a warning regarding an increased risk of suicidal ideation and behavior in children and adolescents [97,98]. The increased risk of suicidal behavior reported in pediatric patients [99] does not appear to be seen in adults, and may in fact be decreased [99,100]. Careful monitoring for evidence of self-harming or suicidal thoughts or behaviors is important in both adult and pediatric patients. SSRIs and SNRIs are generally better tolerated and safer than TCAs and MAOIs, having less anticholinergic effects, toxicity, lethality, and psychomotor or cognitive impairment [85,101]. MAOIs are generally reserved for second- or third-line treatment because of side effects, drug interactions, and dietary restrictions [32]. Anxiolytics: The most common side effects associated with benzodiazepines include primarily sedation, fatigue, ataxia, slurred speech, memory impairment, and weakness [85]. Benzodiazepines are associated with withdrawal reactions, rebound, and dependence, with the risk being greater with short- and intermediate-acting compared to long-acting agents [102]. These agents should be used with caution in patients with SUDs [85,103]. Older patients (generally over 65 years of age) may be at high risk for falls and fractures due to psychomotor impairment associated with benzodiazepines [104,105]. Cognitive impairment has been reported [106], some of which may persist after cessation of therapy [107]. In particular, memory impairment has been associated with high-dose or high-potency benzodiazepines, particularly in older people [102,107]. Reported side effects of azapirones (buspirone) include dizziness, drowsiness, and nausea [32,108]. Atypical antipsychotics: Atypical antipsychotics are associated to varying degrees with weight gain, diabetes, and other metabolic side effects, including alterations in glucose and lipid levels [109-116]. Metabolic disturbances generally appear to be higher with olanzapine, intermediate with risperidone and quetiapine, and lower with aripiprazole, asenapine, lurasidone, and ziprasidone [109-114]. Atypical antipsychotics have varying sedative effects, with quetiapine, clozapine, asenapine, and olanzapine generally causing more sedation than ziprasidone, risperidone, lurasidone, or aripiprazole [111,115]. Data on cognitive effects are conflicting, with some studies suggesting improvements [111], while other data suggest greater Page 8 of 83 cognitive dysfunction in patients using, versus those not using, antipsychotics [117]. Because of the risks of diabetes and weight gain, and the fact that there is limited RCT evidence of the efficacy of these agents in anxiety and related disorders, atypical antipsychotics are generally recommended as second-line, third-line, or adjunctive therapies (see Sections 3–9 for evidence and references). Anticonvulsants: Anticonvulsants are associated with gastrointestinal side effects, somnolence, weight gain, tremor, as well as dermatologic and hematologic side effects [111,118]. In addition, several anticonvulsants have a potential risk of serious rash, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis [111]. Regular monitoring of serum medication levels and liver function is required for patients on divalproex [84,111]. Follow-up Anxiety and related disorders are often chronic and a systematic approach to treatment should include patient education, assessment of comorbidities, and evidencebased pharmacological and psychological interventions with adequate monitoring and duration. Pharmacological treatment is often associated with a delay of about two to eight weeks in onset of symptom relief, with full response taking up to 12 weeks or more. Longer-term therapy has been associated with continued symptomatic improvement and the prevention of relapse, and therapy should be continued for at least 12-24 months for most patients [32]. Medication should be initiated at low doses and titrated to the recommended dosage range at one- to two-week intervals over four to six weeks. Once the therapeutic range has been achieved, improvement is usually seen over the next four to eight weeks. Followup should occur at two-week intervals for the first six weeks and monthly thereafter [32]. For a patient undergoing psychotherapy, the treatment schedule is structured around weekly contact with a therapist for about 12-20 weeks, although shorter protocols and minimal intervention programs have also proven effective (see Sections 3–9 for evidence and references). A followup appointment four weeks later and then every two to three months is usually sufficient [32]. Assessing response to treatment Therapy should seek to improve symptoms and distress. The optimal goal is full remission of symptoms and return to a premorbid level of functioning [32,85]. However, goals may need to be individualized for some patients with disorders that have been present since childhood as they may never have had adequate premorbid functioning. A response to therapy is often defined as a percentage reduction in symptoms (usually 25-50%) on an appropriate scale. Remission is often defined as loss of diagnostic status, a pre-specified low score on an appropriate disorder-specific scale, and Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 no functional impairment in fully recovered patients as measured by a scale such as the Sheehan Disability Scale or SF-36 [32,119,120]. Objective scales can be used to help assess a patient’s progress. The Clinical Global Impression (CGI) scale is brief, comprehensive, and can easily be used at each appointment to assess improvement. The clinician-rated Hamilton Anxiety Rating Scale (HARS) can assess anxiety symptoms in general and is often used in clinical trials but is less practical in clinical practice. A variety of self-report and clinician-rated scales are available to assess the specific anxiety or related disorder. Page 9 of 83 or related disorder, mood disorder, impulse-control disorder, or SUD [121,137]. MDD is very common, occurring in an estimated 35-40% of patients with panic disorder [121]. Panic disorder also frequently co-occurs with agoraphobia [138]. Panic disorder is more prevalent in patients with medical conditions, including thyroid disease, cancer, chronic pain, cardiac disease, irritable bowel syndrome, migraine, as well as allergic and respiratory diseases compared with the general population [85,139-141]. The presence of medical comorbidity is associated with greater severity of panic disorder symptoms and disability [140,142]. Panic disorder and agoraphobia Epidemiology Diagnosis The lifetime and 12-month prevalence of panic disorder have been estimated at 4.7-5.1% and 2.1-2.8%, respectively [121,122]. The estimated prevalence of panic attacks is considerably greater at 28.3% (lifetime) and 6.4-11.2% (12-month) [121,123]. Youth with panic attacks (which often do not meet diagnostic criteria for panic disorder) will frequently have or develop other psychiatric disorders including mood disorders (bipolar disorder and MDD), other anxiety or related disorders, SUDs, eating disorders, psychotic disorders, and personality disorders [122,124,125]. Annually, 8-10% of the general public will have a panic attack without ever developing any identifiable psychopathology [126]. About 40-70% of patients with panic disorder experience nocturnal panic (waking from sleep in a state of panic) [127]. Rates of 12-month and lifetime agoraphobia (without panic) are quite low, at 0.8% and 1.4%, respectively [2,3]. The risk of panic disorder and agoraphobia is higher in women than men, and patients who are middle-aged, widowed/divorced, and those of low income [122]. In the Canadian Community Health Survey 1.2 (CCHS 1.2) there were no differences in the rates of panic disorder or agoraphobia in urban versus rural settings [128]. Panic disorder has a negative impact on both psychological and physical functioning, and puts a substantial burden on the patient’s family [13]. Patients with panic disorder have more QoL impairment and dissatisfaction [16,17], greater likelihood of suicide attempts [20], and increased cognitive and emotional dysfunction [129-133] compared to healthy controls. Panic disorder is also associated with substantial societal costs [134], both in terms of health care utilization [135] and loss of workplace productivity [136]. In a 2012 survey, panic disorder conferred a substantial rate of work absenteeism (mean: 36.0 days/year) [136]. For a diagnosis of panic disorder, a patient must have had recurrent, unexpected panic attacks (Table 11), followed by at least one month of persistent concern or worry about further attacks or their consequences, or a significant maladaptive behavioral change related to attacks (Table 12) [26]. A panic attack continues to be considered a noncodable event in the DSM-5, with only minor revisions, including removal of the “10-minute” window, changing “hot flushes” to “heat sensations,” and the re-ordering of the list of symptoms to increase clinical utility [26,143]. Compared to the DSM-IV-TR [144], changes to the diagnostic criteria for panic disorder largely consisted of minor phrasing changes to improve clinical utility, with the most substantial change being the title of the disorder [26,143]. The DSM-5 now lists agoraphobia (anxiety about having a panic attack in certain situations, which are avoided or endured with marked distress) as a separate codable disorder, whereas previously panic disorder could be diagnosed as “panic disorder with agoraphobia” or “panic disorder without agoraphobia” [26,145]. For a diagnosis of agoraphobia, a patient must have intense fear about at least two different types of Comorbidity Patients with panic disorder, or those experiencing panic attacks, have significantly increased odds of being diagnosed with a comorbid disorder, including another anxiety Table 11 DSM-5 criteria for panic attacks • An abrupt surge of intense fear or intense discomfort that reaches a peak within minutes, and includes ≥4 of the following symptoms: (1) Palpitations, pounding heart, or accelerated heart rate (2) Sweating (3) Trembling or shaking (4) Sensations of shortness of breath or smothering (5) Feelings of choking (6) Chest pain or discomfort (7) Nausea or abdominal distress (8) Feeling dizzy, unsteady, light-headed, or faint (9) Chills or heat sensations (10) Paresthesias (numbness or tingling sensations) (11) Derealization (feelings of unreality) or depersonalization (being detached from oneself) (12) Fear of losing control or going crazy (13) Fear of dying Adapted from reference [26]. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Table 12 DSM-5 diagnosis of panic disorder • The person has experienced both of the following: ○ Recurrent unexpected panic attacks ○ ≥1 of the attacks followed by ≥1 month of 1 or both of the following: • Persistent concern or worry about additional panic attacks or their consequences • Significant maladaptive change in behavior related to the attacks Adapted from DSM-5 [26]. situations, with the fear resulting from thoughts that escape may be difficult or help may be unavailable if panic-like symptoms occur (Table 13) [26,145]. The situations provoke anxiety and are avoided or endured with intense fear or anxiety, or may require that a companion be present. The resultant fear or anxiety is out of proportion to any actual danger from the situation, causes substantial functional impairment, and usually lasts for six months or longer [26]. While the most up-to-date DSM-5 diagnostic criteria are presented here, the treatment data described within this section are based on studies involving patients meeting DSM-IV panic criteria (or older). Establishing the context in which panic attacks occur, and whether there is any prior history of recurrent, unexpected panic attacks, is important for accurate diagnosis. Panic attacks frequently occur in other psychiatric disorders (e.g., MDD, PTSD), and medical conditions (e.g., cardiac, respiratory), and the DSM-5 has identified panic attacks as a specifier to be used in the absence of a diagnosable panic disorder [85]. Another disorder may better account for the panic attacks; for example, panic attacks in social situations may be SAD, those related to defined phobic objects or situations may be specific phobia, those related to reminders of traumatic events Table 13 DSM-5 diagnosis of agoraphobia • Marked fear or anxiety about ≥2 of the following 5 groups of situations: (1) Public transportation (e.g., traveling in automobiles, buses, trains, ships, or planes) (2) Open spaces (e.g., parking lots, market places, or bridges) (3) Being in shops, theatres, or cinemas (4) Standing in line or being in a crowd (5) Being outside of the home alone in other situations • The individual fears or avoids these situations due to thoughts that escape might be difficult or help might not be available in the event of panic-like symptoms • The agoraphobic situations almost always provoke fear or anxiety • The situations are actively avoided, require presence of a companion, or endured with marked fear or anxiety • The fear or anxiety is out of proportion to actual danger posed by agoraphobic situation • The fear, anxiety, or avoidance is persistent, typically lasting ≥6 months • The fear, anxiety, and avoidance cause clinically significant distress or functional impairment Adapted from DSM-5 [26]. Page 10 of 83 may be PTSD [26,85], and those related to being kidnapped by extraterrestrials may be schizophrenia [26]. Some medical conditions that can be associated with panic symptoms include hyper- or hypothyroidism, hypoglycemia, seizure disorders, and cardiac conditions [26,85]. Panic attacks may also be associated with intoxication or withdrawal from drugs of abuse, medications such as decongestants, stimulants, or beta-adrenergic agonist inhalers, or caffeine [85]. Psychological treatment CBT has been extensively studied, and is an efficacious psychological treatment for panic disorder (Level 1) [56,70,146,147]. In fact, CBT was significantly favored over medications for the treatment of panic disorder in a meta-analysis [71]. In a meta-analysis of 42 studies, exposure and combinations of exposure, cognitive restructuring and other CBT techniques had the most consistent evidence of efficacy for the treatment of panic disorder [56]. Strategies that included exposure were the most effective for panic measures. For measures of agoraphobia, combined strategies were more effective than single techniques, which did not result in significant improvements. Factors that improved the effectiveness of treatments were the inclusion of homework and a follow-up program [56]. Another meta-analysis also found that CBT that included interoceptive exposure was superior to relaxation therapy for panic symptoms [55]. CBT can be effectively delivered in both individual and group settings [56,148,149]. Conducting exposure in virtual reality appears to be effective when used as part of a CBT protocol [150-154]. Minimal intervention formats, such as self-help books (bibliotherapy) [75,76,155-158], treatment via telephone/ videoconferencing [75,159-161], and internet-based CBT (ICBT) [75,79,162-169] have been shown to be more effective than wait-list or relaxation controls, as effective as face-to-face CBT, and may be cost-effective options particularly for agoraphobic patients who are unwilling or unable to attend a clinic. When using bibliotherapy, providing information all at one time was as effective as pacing [157], and therapist support does not appear to be essential [75,158]. Most ICBT programs have some therapist contact by either telephone or email, and once weekly contact appeared to be as effective as more frequent contact [168]. CBT panic disorder protocols usually involve 12-14 weekly sessions, but briefer strategies of six to seven sessions have been shown to be as effective [148,149,170]. In addition, compressing the duration of therapy by administering 13 sessions over three weeks has also been shown to be as effective as traditional weekly CBT [171]. Patients with higher baseline severity, disability, or comorbidity may have better outcomes with standard Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 CBT [172]. CBT programs sometimes include one or more follow-up or “booster” sessions [170,173]. Predictors of decreased response to CBT were severity of panic disorder, strength of blood/injury fears, earlier age of initial onset of panic symptoms, comorbid social anxieties, and degree of agoraphobic avoidance [174,175]. Changes in symptoms are preceded by changes in beliefs during therapy [176], and change in beliefs and avoidance behaviors are considered key process variables [170,176]. Eye movement desensitization and reprocessing (EMDR) does not appear to offer advantages over the same strategy without the eye movement component for the treatment of panic disorder [177,178]. Combined psychological and pharmacological treatment A meta-analysis of 21 trials found that combination psychotherapy and pharmacotherapy with antidepressants was superior to CBT or pharmacotherapy alone during the acute treatment phase and while medication was continued [179,180]. After termination of treatment, combined therapy was more effective than pharmacotherapy alone and was as effective as psychotherapy [179,180]. Prior meta-analyses have reported similar findings [54,146,181], suggesting that CBT alone or CBT combined with pharmacotherapy should be considered as first-line treatment. A meta-analysis of the combination of psychotherapy and benzodiazepines included only three trials, and found no benefit to combination therapy compared with psychotherapy or medication alone [182]. The follow-up data suggested that the combination might be inferior to behavior therapy alone [182]. Adding self-administered CBT to SSRI therapy did not result in significant improvements overall, but patients did report a significantly greater rate of decline in fear of bodily sensations compared to medication alone [183]. Early results suggest a benefit of MBCT as an adjunct to pharmacotherapy in relieving anxiety and depressive symptoms in patients with panic disorder [184,185]. Providing CBT sessions around the time of medication discontinuation was associated with a lower relapse rate during follow-up among patients treated with antidepressants [186]. In addition, CBT has been shown to be helpful in facilitating benzodiazepine discontinuation [187,188]. A cost-effectiveness study found that combined CBT and pharmacotherapy was associated with a robust clinical improvement compared to usual care, with only a moderate increase in costs [189]. In a RCT, buspirone enhanced the effects of CBT in the short-term, but had no significant benefit over CBT alone during long-term follow-up [190]. Data on the efficacy of d-cycloserine as an adjunct to CBT are conflicting, with one study suggesting significant benefits at posttreatment and one-month follow-up Page 11 of 83 [191], while another found an acceleration of symptom reduction in severely ill patients but no significant improvement in outcomes overall [192] compared to CBT plus placebo. Another compound acting at the N-methyl-D-aspartate (NMDA) receptor, Org 25935, demonstrated no benefit over placebo in augmenting CBT for panic disorder [193]. Long-term effects of psychological treatment In naturalistic long-term follow-up studies, the benefits of CBT were maintained for up to three years [148,169, 170,188]. At two-year follow-up, individual, group, and brief CBT were associated with lower relapse rates compared to the wait-list control [148]. A long-term follow-up study of patients who had become panic-free with exposure therapy found that 93% remained in remission after two years and 62% after 10 years [194]. A meta-analysis found that at six to 24 months followup, remission/response rates with the combination of psychotherapy and antidepressants continued to be superior to antidepressants alone, or to psychotherapy as long as therapy was continued [179,180]. Pharmacological treatment The management of patients with panic disorder should follow the principles discussed in Section 2. Pharmacological interventions that have good evidence for efficacy in treating panic disorder include SSRIs, TCAs, and other antidepressants, as well as benzodiazepines. Treatments that have been investigated for use in panic disorder have been assessed according to the criteria for strength of evidence (Tables 1 and 2) and are summarized in Tables 14 and 15. First-line agents SSRIs: Evidence from meta-analyses [195-197] and RCTs supports the use of the SSRIs citalopram [198-200], fluoxetine [201-204], fluvoxamine [195,205-210], paroxetine [211-219], and sertraline [183,220,221,223,224] (all Level 1), as well as escitalopram [198] and paroxetine controlled-release (CR) [225] (both Level 2) for the treatment of panic disorder. In meta-analyses, SSRIs demonstrated significant improvements in panic symptoms, agoraphobic avoidance, depressive symptomatology, and general anxiety [195-197,226]. Effect sizes for SSRIs and TCAs are similar [195,196], although dropout rates may be lower with SSRIs [195]. SNRIs: Venlafaxine extended-release (XR) has been shown to be useful in reducing the severity of panic disorder symptoms in RCTs (Level 1) [215,216,227-229]. Two studies found significantly greater rates of panicfree patients compared with placebo [215,216] while two did not [228,229]. Second-line agents TCAs: There is good evidence from RCTs to support the use of the TCAs clomipramine [199,211,213,232,233] Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 12 of 83 Table 14 Strength of evidence for pharmacotherapy for panic disorder Agent Level of evidence Agent Level of evidence Antidepressants SSRIs TCAs Citalopram [198-200] 1 Clomipramine [199,211,213,232,233] 1 Fluoxetine [201-204] 1 Imipramine [207,224,233-240] 1 Fluvoxamine [195,205-210] 1 MAOIs and RIMAs Paroxetine [211-219] 1 Phenelzine [240] 2 Sertraline [183,220-224] 1 Moclobemide [204,232,241,242] 1* 3 Escitalopram [198] 2 Tranylcypromine [243] Paroxetine CR [225] 2 Other antidepressants SNRIs Reboxetine [200,219,244] 1 Venlafaxine XR [215,216,227-229] 1 Mirtazapine [203,245,246] 2 Duloxetine [230] 3 Bupropion SR [247,248] 3* Milnacipran [231] 3 Other therapies Anxiolytics Benzodiazepines Alprazolam [234,249-254] 1 Atypical antipsychotics Risperidone [217,267] 2 Olanzapine [268] 3 Clonazepam [218,250,255-258] 1 Quetiapine [267] 3 Lorazepam [251,259,260] 1 Adjunctive aripiprazole [269] 3 Diazepam [261-263] 1 Adjunctive olanzapine [270] 3 Adjunctive clonazepam [264,265] 1 Adjunctive risperidone [271] 3 Adjunctive alprazolam ODT [266] 3 Anticonvulsants Other treatments Buspirone [254,282] 1 (-ve) Divalproex [272-275] Levetiracetam [276] Trazodone [283] 2 (-ve) Gabapentin [277] 2 (-ve)† Propranolol [262,284,285] 2 (-ve) Tiagabine [278,279] 2 (-ve) Adjunctive pindolol [286] 2 Carbamazepine [280] 3 (-ve) Adjunctive divalproex [281] 3 3 3 *Conflicting data. †No significant superiority over placebo in overall population, but significant benefits in subgroup of more severely ill patients. CR = controlled release; MAOI = monoamine oxidase inhibitor; ODT = orally disintegrating tablets; RIMA = reversible inhibitor of monoamine oxidase A; SNRI = serotonin– norepinephrine reuptake inhibitor; SR = sustained release; SSRI = selective serotonin reuptake inhibitor; TCA = tricyclic antidepressant; XR = extended release; (-ve) = negative. and imipramine [207,224,233-240] in panic disorder (Level 1). In meta-analyses, TCAs have demonstrated efficacy for the treatment of panic symptoms and agoraphobia [195-197,226]. Efficacy is generally equivalent to SSRIs, however, since TCAs tend to be less well tolerated and have higher discontinuation rates than SSRIs [195], they are recommended as second-line options. Other antidepressants: Although there is level 1 evidence to support the use of reboxetine [200,219,244], limited experience with this agent in Canada, and its side effect profile, which includes dry mouth, constipation, and insomnia [244], led to its recommendation as a second-line option. Mirtazapine has demonstrated efficacy for the treatment of panic disorder in several open Table 15 Recommendations for pharmacotherapy for panic disorder First-line Citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, paroxetine CR, sertraline, venlafaxine XR Second-line Alprazolam, clomipramine, clonazepam, diazepam, imipramine, lorazepam, mirtazapine, reboxetine Third-line Bupropion SR, divalproex, duloxetine, gabapentin, levetiracetam, milnacipran, moclobemide, olanzapine, phenelzine, quetiapine, risperidone, tranylcypromine Adjunctive therapy Second-line: alprazolam ODT, clonazepam Third-line: aripiprazole, divalproex, olanzapine, pindolol, risperidone Not recommended Buspirone, propranolol, tiagabine, trazodone CR = controlled release; ODT = orally disintegrating tablets; SR = sustained release; XR = extended release. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 trials [245,246] and one small RCT [203] (Level 2). It appears to be as effective as fluoxetine [203] and may be a useful second-line choice. Benzodiazepines: Alprazolam [234,249-254], clonazepam [218,250,255-258], lorazepam [251,259,260], and diazepam [261-263] have demonstrated efficacy for the treatment of panic disorder (Level 1). While it has been suggested that alprazolam may be more effective, a metaanalysis found no evidence that it was superior to other benzodiazepines for the treatment of panic disorder [252]. Although benzodiazepines are second-line options, they may be useful at any time during therapy for the short-term management of acute or severe agitation or anxiety. They may also be useful at the initiation of SSRI treatment to hasten response (Level 1) [264-266]. Third-line agents MAOIs and RIMAs: Results with moclobemide for the management of panic disorder have been conflicting (Level 1). In clinical trials, moclobemide demonstrated efficacy similar to that of clomipramine and fluoxetine [204,232], but was not superior to placebo [241,242]. However, significant efficacy in more severely ill patients [241], suggests it may be useful in treatment-resistant patients. In a RCT, phenelzine was more effective than placebo and as effective as imipramine (Level 2) [240]. In a small randomized, uncontrolled trial, tranylcypromine demonstrated efficacy for patients with comorbid panic and social anxiety disorders (Level 3) [243]. Atypical antipsychotics: There is some evidence that atypical antipsychotics may have some benefits in the treatment of patients with refractory panic disorder [217,267,268]. In a RCT, risperidone monotherapy was as effective as paroxetine (Level 2) [217]. Open-label data also support the use of risperidone [267], olanzapine [268], and quetiapine [267]. There are also open-label data supporting the use of some atypical antipsychotics as adjunctive therapy (see below). Other therapies: The antidepressants duloxetine [230], milnacipran [231], and bupropion sustained release (SR) [247,248] have shown some efficacy in open trials, as have the anticonvulsants divalproex [272-275] and levetiracetam [276] (all Level 3). In a RCT, gabapentin was superior to placebo in patients who were more severely ill, but not in the overall group (Level 2, negative) [277]. These agents are recommended only as third-line options in patients with refractory panic disorder. Adjunctive therapy There is good evidence that adjunctive clonazepam [264,265] (Level 1), and open-label evidence that adjunctive alprazolam orally-disintegrating tablet (ODT) [266] (Level 3), used short-term (<8 weeks including taper) at the initiation of SSRI treatment, can lead to a more rapid response [264-266]. Page 13 of 83 In a RCT, pindolol added to fluoxetine therapy in patients with treatment-resistant panic disorder was associated with significant improvement in panic disorder symptoms compared with fluoxetine plus placebo (Level 2) [286]. Open-label data also support the use of the atypical antipsychotics aripiprazole [269], olanzapine [270], and risperidone [271] (all Level 3), as well as the anticonvulsant divalproex [281], as adjunctive strategies for patients with treatment-resistant panic disorder. Not recommended Buspirone (Level 1, negative) [254,282], propranolol (Level 2, negative) [262,284,285], tiagabine [278,279] (Level 2, negative), and trazodone (Level 2, negative) [283] have not demonstrated efficacy and are not recommended for the treatment of panic disorder. Carbamazepine (Level 3, negative) [280] also does not appear to be effective in this disorder. Maintenance pharmacological treatment In long-term, open, follow-up studies, citalopram [287,288], fluoxetine [204,288], fluvoxamine [288], paroxetine [288-290], and moclobemide [204], as well as clomipramine [287,289] and imipramine [291,292] demonstrated maintenance of benefits and continued improvements over six months to three years of ongoing treatment. In a RCT, sertraline and imipramine were equally effective over a six month period [224]. However, in another RCT, imipramine was not superior to placebo in the proportion of panic-free patients after eight months of therapy [293]. Venlafaxine XR [294] and imipramine [295] have been shown to prevent relapse in randomized, placebo-controlled, discontinuation studies. After three months of acute treatment, relapse rates were significantly lower with ongoing venlafaxine XR [294] or imipramine [295] therapy compared with switching to placebo during six to 12 months of follow-up. Benzodiazepines are generally recommended for shortterm use only. However, several trials have demonstrated the benefits of up to two years of alprazolam maintenance therapy [291,293]. There was no evidence of tolerance, but up to one-third of patients were unable to discontinue therapy [293]. The efficacy of clonazepam was maintained over a three-year course of treatment [290], and patients who had been asymptomatic for at least one year were able to successfully discontinue the medication, using a slow tapering strategy over four to seven months, and improvement in panic disorder was maintained [296]. Biological and alternative therapies Biological therapies: In open-label case series, noninvasive brain stimulation using a radioelectric asymmetric conveyor (REAC) demonstrated efficacy for panic symptoms Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 and agoraphobia (Level 3) [297,298]. A small case series suggested repetitive transcranial magnetic stimulation (rTMS) could improve panic and anxiety in patients with panic disorder with comorbid MDD (Level 4) [299]. However, a small RCT found no additional benefit of rTMS compared to sham rTMS as an add-on to SSRI therapy in patients with panic disorder (Level 2, negative) [300]. Alternative therapies: In a RCT, capnometry-assisted respiratory training was as effective as cognitive training in reducing panic symptom severity and panic-related cognitions and improving perceived control (Level 2) [301]. However, breathing training did not significantly improve reactivity or recovery after a respiratory challenge in another small trial (Level 2, negative) [302]. In a RCT, patients with panic disorder randomized to the exercise groups (plus paroxetine or placebo) had a trend toward better improvement compared to relaxation training, but this was not significant (Level 2, negative) [303]. However, in an open cross-over study, acute aerobic exercise was found to reduce anxiety as well as panic attack frequency and intensity in patients with panic disorder compared to a quiet rest condition (Level 3) [304]. These therapies may be useful for some patients; however, more data are needed. Page 14 of 83 maintained during follow-up. In addition, data suggest that combination of psychotherapy and pharmacotherapy may be superior to pharmacotherapy alone during follow-up. Pharmacotherapeutic approaches should begin with a first-line agent. If response to optimal dosing is inadequate or the agent is not tolerated, treatment should be switched to another first-line agent before considering second-line medications. First-line options for the treatment of panic disorder include citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine XR, escitalopram, or paroxetine CR. Second-line choices include the TCAs (clomipramine and imipramine), mirtazapine, reboxetine, or benzodiazepines (alprazolam, clonazepam, lorazepam, and diazepam). Patients who do not respond to first- or second-line agents are considered to have treatment-refractory illness. In such patients it is important to reassess the diagnosis and consider comorbid medical (e.g., ischemic heart disease) and psychiatric conditions (e.g., SUDs) that may be affecting response to therapy. Third-line agents, adjunctive therapies, as well as biological and alternative therapies may be useful when patients fail to respond to an optimal treatment trial of first- and second-line therapies used alone and in combination. Summary As much as 40% of the general population has experienced a panic attack at some point in their lifetime. However, patients with actual panic disorder experience recurrent, unexpected panic attacks as well as persistent concern or behavioral change around further attacks. Data support pharmacotherapy, CBT alone, and CBT combined with pharmacotherapy as initial treatments for panic disorder. CBT alone may be insufficient in patients with comorbid moderate-to-severe major depression, or in those with severe, frequent panic attacks, or rapid worsening of agoraphobia, and/or suicidal ideation, as well as in situations where one might consider initial rescue treatment with a benzodiazepine to minimize or stop the panic attacks while waiting the 4-12 weeks for the firstline pharmacotherapy to become effective. Also there are patients who are not motivated to participate in CBT (preferring medication as initial treatment) or are too fearful to engage in any kind of exposure before being treated with a first-line pharmacotherapeutic agent. At the very least, if agoraphobic distress or avoidance persists, these patients need instruction and support to engage in exposure exercises. For panic symptoms, strategies should include exposure; and combined strategies should be considered for patients with agoraphobia. CBT can be effectively delivered in both individual and group settings, as well as via self-help books, virtual reality, and internet-based programs. The benefits of CBT are Specific phobia Epidemiology A specific phobia is an intense fear of a specific object or situation and is usually associated with avoidance of the feared object. The most prevalent phobia types include animal (e.g., insects, snakes), natural environment (e.g., heights, storms, water), situational (e.g., flying, enclosed spaces), and blood-injection-injury (B-I-I) (e.g., blood, dentists, hospitals) [305,306]. Large US and European epidemiologic surveys report lifetime prevalence estimates of 10-13% and 12-month prevalence rates of 7-9% [2,3,305,307]. Rates among adolescents may be particularly high with lifetime prevalence estimates of 36.5% and 12-month prevalence rates of 27.3% being reported [308]. Specific phobias are more common in women than men [306]. Age of onset is usually in the range of five to 12 years (median: seven years) [2]; however, this varies by type of phobia. Animal and B-I-I phobias generally begin in childhood, whereas situational phobias (e.g., driving phobia, claustrophobia) have a later onset, typically during late adolescence or early adulthood [306]. Specific phobias are associated with significant distress, regardless of the number of feared stimuli reported [305]. Specific phobias have a negative impact on social/occupational functioning and lead to restriction of usual daily activities, which increases with an increasing number of fears [305]. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 15 of 83 Comorbidities Table 17 Specific phobia specifiers in DSM-5 Specific phobias tend to co-occur with other specific phobias, with less than 10% of patients having only one fear [305]. The mean number of fears, in one survey, was three [305]. In addition, specific phobias are frequently comorbid with other psychiatric disorders, including SUDs, mood disorders, and other anxiety or related disorders (particularly panic disorder, SAD, and GAD), as well as personality disorders [305,309,310]. Specifier Examples Animal Spiders, insects, dogs Natural environment Heights, storms, water Blood-injectioninjury Needles, invasive medical procedures Diagnosis Adapted from DSM-5 [26]. To receive a DSM-5 diagnosis of specific phobia a patient must experience marked (intense) fear or anxiety about a specific object or situation, which is associated with significant distress or functional impairment (Table 16) [26]. The object or situation will be actively avoided or endured with intense anxiety. Compared to the DSM-IV-TR criteria for specific phobia [144], few changes were made in the DSM-5 [26,306]. Of note, recognition that the fear is excessive or unreasonable has been removed and a new criterion stating “the fear or anxiety is out of proportion to danger posed” has been added. Avoidance has been clarified as “actively avoided” to distinguish the avoidance seen in specific phobias from passive avoidance that may occur for other reasons [26,306]. While the most up-to-date DSM-5 diagnostic criteria are presented here, it is important to note that most of the treatment data described within this section are based on patients meeting DSM-IV criteria (or older). Specific phobias are delineated into five types: animal type, natural environment type, B-I-I type, situational type, or other type (Table 17) [26]. The fear of contracting an illness has been removed because of high relatedness to OCD and anxiety disorder related to medical condition [26]. Specific phobias can be difficult to distinguish from panic disorder [311]. It is important to consider the focus of apprehension (e.g., fear of crashing while on an airplane versus fear of having a panic attack on an airplane), the types of panic attacks experienced (e.g., expected versus unexpected), and the range of situations associated with fear and avoidance [311]. Table 16 DSM-5 diagnosis of specific phobia • Marked fear or anxiety about a specific object or situation (e.g., flying, seeing blood) • The phobic object or situation almost always provokes immediate fear or anxiety and is actively avoided or endured with marked fear or anxiety • The fear or anxiety is out of proportion to the actual danger posed by the specific object or situation • The fear, anxiety, or avoidance is persistent, typically ≥6 months • There is marked distress or functional impairment Adapted from DSM-5 [26]. Situational Airplanes, elevators, enclosed spaces Other Choking or vomiting. In children, loud sounds or costumed characters Psychological treatment Psychosocial interventions, particularly exposure-based treatments, are the treatments of choice and are associated with a high degree of success in providing remission of specific phobias [311]. Both in vivo exposure and virtual reality exposure (VRE) can be effective [57,311,312], with in vivo exposure being shown to be superior to alternative types (e.g., imaginal, virtual reality, etc.) at posttreatment but not at follow-up [57]. In general, exposure-based therapy has been shown to be more effective if: sessions are grouped closely together; exposure is prolonged, real (not imagined), and provided in multiple different settings; and there is some degree of therapist involvement (not entirely self-directed) [32,311]. While one-session treatments have demonstrated efficacy [313], a meta-analysis found that a greater number of sessions predicted more favorable outcomes [57]. There is no evidence that either flooding or gradual exposure is more effective [314], however, progressive exposures are generally more tolerable to patients [311]. An example of graded exposure in a patient with arachnophobia would be to look at pictures of spiders, hold a rubber spider, look at a live spider in a jar, touch the jar containing the spider, stand two feet from a live spider, and finally touch a live spider. This approach can be used to guide exposure depending on the patient’s symptom severity and tolerance to each level of exposure. While a meta-analysis of 33 RCTs of psychological approaches found that treatment outcomes were not moderated by type of specific phobia [57], studies have suggested that certain subtypes may respond more favorably to specific types of treatment (Table 18). For patients with B-I-I phobias, exposure therapy combined with muscle tension exercises (applied tension) designed to prevent fainting [311] has been shown to be effective [315,316]. Use of stress-reducing medical devices, such as decorated butterfly needles and syringes, has been shown to significantly reduce needle phobia and stress in both pediatric and adult patients [317]. CBT reduced avoidance of oral injections and decreased anxiety in patients with dental phobias [318]. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 16 of 83 Table 18 Psychological treatments with demonstrated efficacy in specific phobias Psychological treatment Phobia Exposure-based treatments All specific phobias [57,311,312] Virtual reality exposure Heights [327-329], flying [319,321-324], spiders [331,332], claustrophobia [330] Computer-based self-help programs Spiders [334,335], flying [323], small animals [336,337] Applied muscle tension (exposure combined with muscle tension exercises) Blood-injection-injury type [311,315,316] Cognitive therapy and exposure Dental [318], flying [319,320] Fear of flying has been effectively treated with group CBT [319,320]. In addition, computer-generated VRE has demonstrated efficacy [319,321-324], which was comparable to standard exposure therapy in several studies [322,324], and can have long-term benefits [325,326]. Bibliotherapy was found to be less effective than VRE or CBT for patients with fear of flying [319]. VRE has also been shown to be effective for patients with a fear of heights [327-329], and those with claustrophobia [330]. This approach may also be useful for treating fears for which in vivo exposure may not be practical (e.g., fear of storms) [32]. Arachnophobia has been successfully treated with in vivo [331] and VR [331,332] exposure, with little difference between the two modalities [331]. A spiderless form of VRE, which presented images that were not spiders, but had some of the characteristics of spiders, was shown to be useful in patients with severe arachnophobia who were reluctant to undergo direct exposure or VRE [333]. An internet-based self-help program was associated with improvement, but was not as effective as one session of in vivo exposure at the post-treatment assessment, although results were similar at follow-up [334]. However, even one session of VRE was associated with greater fear reduction compared to a control group, and may be a useful self-help intervention to reduce fear of spiders [335]. Computer-based self-help has also shown promise for other small-animal phobias (e.g., cockroaches, mice) [336,337]. Combined psychological and pharmacological treatment It has been speculated that d-cycloserine, a partial agonist at the NMDA receptor, may improve extinction of fear in patients with phobias undergoing behavioral exposure therapy [338]. In a RCT (n=28), d-cycloserine as an adjunct to VRE resulted in significantly larger reductions of acrophobia symptoms compared with VRE alone [338]. In another study (n=100), adjunctive d-cycloserine did not improve the reduction of spider fears compared to exposure-based therapy alone, however, patients had heightened, but subclinical, spider fears [339]. In two RCTs, use of adjunctive cortisol, a glucocorticoid, significantly enhanced the benefits of exposure therapy compared with placebo in patients with acrophobia (n=40) [340] and arachnophobia (n=20) [341], with evidence suggesting that cortisol may facilitate the extinction of phobic fear at follow-up. Enhanced emotional memory may be stimulated through elevated noradrenaline levels, and data suggest that yohimbine hydrochloride, a noradrenaline agonist, can facilitate fear extinction. In RCTs, there were no significant VRE-enhancing effects with adjunctive yohimbine compared with placebo in patients with fear of flying (n=48) [342] or claustrophobia (n=24) [343]. However, in the claustrophobia study, patients treated with yohimbine showed greater improvements in outcomes at the one-week follow-up [343]. In contrast, naltrexone was found to render one-session exposure therapy less effective compared with placebo or no treatment in 15 patients with specific phobias (animals) [344]. Long-term effects of psychological treatment Long-term treatment of specific phobia is rare. As discussed above, CBT and exposure therapies have demonstrated sustained benefits at long-term follow-up assessments [325,326]. Pharmacological treatment There is a minimal role for pharmacotherapy in the treatment of specific phobias, largely due to the lack of research on medications in this condition, and the success of exposure-based therapies [32,311]. Antidepressants have been investigated in two small RCTs [345,346]. In a small RCT, paroxetine was significantly more effective than placebo in resolving anxiety in patients with specific phobias (n=11) [345]. Similarly, escitalopram was associated with a strong treatment effect in a small RCT (n=12); however, the trial was under-powered to show statistically significant superiority over placebo on the primary outcome [346]. In addition, cases of successful treatment of flying phobias with fluoxetine [347], and storm phobia with fluvoxamine [348], have been reported. Benzodiazepines have usually been assessed as adjuncts to exposure therapy, and these studies have found no additional benefit with medication [349-351]. Benzodiazepines are often used in clinical practice to Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 provide acute symptom relief when it is necessary for a patient with a specific phobia to face a feared situation (e.g., dental procedure, magnetic resonance imaging [MRI], unexpected flight) [32]. Nasal midazolam has proven useful in facilitating MRI in claustrophobic patients [352,353]. Summary Specific phobia is quite common, particularly among adolescents. Patients with specific phobia exhibit an intense fear or anxiety about a specific object or situation which is associated with significant distress or functional impairment. The most prevalent phobia types include animal, natural environment, situational, and B-I-I. Exposure-based techniques, including virtual exposure, are highly effective, and are the foundation of treatment for specific phobias. Pharmacotherapy is generally unproven, and thus not a recommended treatment for most cases. Social anxiety disorder Epidemiology SAD is one of the most common anxiety disorders, with lifetime prevalence estimates ranging from 8-12% among the international general population [2,354-356]. It is more common in women than men [355,357-360], and higher rates have been reported in developed (6.1%) versus developing (2.1%) countries [361]. SAD has an early age of onset, typically during adolescence (mean 12 years), and tends to have a chronic and unremitting course [2,362,363]. Factors such as low educational achievement, low socioeconomic status, being single or separated, and having comorbid MDD have been associated with a higher prevalence of SAD in epidemiological studies [359,360,364]. SAD is associated with significant impairments including problems with educational and occupational performance, family functioning, and an overall reduced QoL [14,15,17,354,363,365-369]. SAD also confers a substantial economic burden upon afflicted individuals and society in terms of work days missed and health care costs [370,371]. Canadians with SAD were twice as likely to report at least one disability day in the past two weeks, compared to those without SAD [356]. Psychiatric comorbidity SAD is associated with significant comorbidity, with up to 72% of patients reporting criteria for another psychiatric disorder [372]. The highest rates of comorbidity have been found with MDD and other anxiety or related disorders [355,356,360]. Avoidant personality disorder [373], body dysmorphic disorder [374,375], SUD [356,376], ADHD [377,378], and schizophrenia [379] also commonly occur with SAD. Page 17 of 83 Diagnosis SAD is characterized by a persistent fear that in social and performance situations the individual will say or do something that will lead to humiliation, embarrassment, or negative evaluation by others (Table 19) [26]. Social situations are actively avoided or endured with distress, and the individual recognizes the fears as excessive or unreasonable. The avoidance or anxiety induced by these fears incurs significant functional impairment and distress [144]. Compared to the DSM-IV-TR [144], changes to the diagnostic criteria for SAD in the DSM-5 have been minimal, largely consisting of minor phrasing changes to improve clinical utility [26]. The criterion that the “person recognizes that the fear is excessive or unreasonable” has been changed to “out of proportion to the actual threat posed by the social situation.” Since patients with SAD are often unable to recognize that their fear may be excessive the clinician may be in a better position to judge this. The DSM-IV-TR criteria excluded social fears/avoidance associated with and secondary to medical conditions, however, the DSM-5 recognizes that SAD may be secondary to a medical condition. Some patients experience excessive social anxiety about their medical symptoms (e.g., stuttering, tremulousness from Parkinson’s disease, obesity, disfigurement from burns or injury), and may experience disability due to their social anxiety [26]. In addition, the “generalized” subtype specifier included in DSM-IV-TR has been removed, while the “performance only” specifier has been added [26,380] for DSM-5. This change was made because there was little supporting evidence for the generalized specifier, and the evidence that SAD symptoms fall along a continuum of severity characterized by the number of fears [380]. The “performance only” specifier appears to represent a subset of SAD patients typically experiencing Table 19 DSM-5 diagnosis of SAD (social phobia) • Marked fear or anxiety about social situations in which the person may be exposed to scrutiny by others • Fear that actions or showing anxiety symptoms will cause negative evaluation (e.g., embarrassment, humiliation) or offend others • The social situation: ○ Almost always provokes fear or anxiety ○ Is actively avoided or endured with marked fear or anxiety • The fear, anxiety, or avoidance: ○ Is out of proportion to the actual threat posed by the social situation ○ Is persistent, typically ≥6 months ○ Causes significant distress or functional impairment • If another medical condition is present (e.g., stuttering, obesity), the disturbance is unrelated or out of proportion to it • Specify “performance only” if the fear is restricted to speaking or performing in public Adapted from DSM-5 [26]. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 impairment from performance fears primarily related to their professional lives [26]. While the most up-to-date DSM-5 diagnostic criteria are presented here, it is important to note that all of the treatment data described within this section are based on patients meeting DSM-IV criteria (or older). Psychological treatment Psychological treatment, in the form of CBT, is considered to be the gold-standard nonpharmacological treatment in SAD. Cognitive techniques involved in CBT for SAD include restructuring and challenging of maladaptive thoughts, while the behavioral component is typically in the form of exposure therapy. The efficacy of CBT compared with placebo, treatment-as-usual, or wait-list conditions, is supported by many RCTs as well as meta-analytic evidence [58,59,70,71,381]. Although results vary, several studies of acute SAD treatment have also found a similar efficacy between CBT and pharmacotherapy [382-387]. Some reports suggest that after treatment discontinuation, gains achieved with CBT may persist longer than those achieved with pharmacotherapy [388,389]. CBT for SAD can be administered in group or individual formats. Although some studies have reported that individual CBT is superior to group CBT [390,391], meta-analyses have failed to find significant differences in efficacy between the two modalities [58,59,381]. The treatment literature has also examined the efficacy of the individual components of CBT. There is evidence to support the effectiveness of exposure therapy alone [389,392], however the efficacy of exposure alone compared with CBT is equivocal in the current treatment literature [392-395]. There are several variants of CBT that have been examined in the literature. For example, videotaped feedback was not shown to enhance the effects of exposure-based treatment [396]. However, CBT with VRE was found to be more effective than wait-list control and as effective as CBT with imaginal or in vivo exposure according to two meta-analyses [80,150]. A form of CBT focused on interpersonal behavior found similar improvements in social anxiety compared to standard CBT but also increased relationship satisfaction and social approach behaviors [397]. Evidence to support interpersonal therapy (IPT) in SAD is conflicting [398-400]; while some results have been negative [398], it is likely that IPT is more effective than wait-list control [399], but less effective than traditional CBT [399,400]. Similarly, while less effective than traditional CBT, mindfulness-based therapy (MBT) has been associated with improvements in symptoms of SAD [401]. In addition, small studies of attentional bias training suggest there may be some benefit associated with training Page 18 of 83 patients to disengage from negative social cues, but data are conflicting [402,403]. ICBT is a newer treatment that may increase the availability of CBT for anxiety and mood disorders in the future. Studies have evaluated this treatment in comparison to individual and group CBT. ICBT has demonstrated efficacy in RCTs of SAD, significantly improving social anxiety symptoms compared to wait-list control conditions [404-410]. Most ICBT programs include minimal therapist contact via email [404-410] or telephone [405,409]. Many programs involve a component of interaction with other participants through the use of internet discussion groups [411]. However, it remains unclear whether the therapist component is necessary, and studies comparing guided with unguided ICBT have yielded conflicting results. In one RCT, clinician-assisted ICBT was more effective than a self-guided ICBT, and the self-guided ICBT was not significantly better than the wait-list condition [406]. Similarly, a self-help program augmented with minimal therapist contact was more useful than a pure self-help strategy [412]. However, several other RCTs have found that unguided ICBT self-help was as effective as ICBT with therapist involvement [410,411]. A few ICBT programs included face-to-face in vivo exposure sessions [409,413], but one RCT found that adding this component did not significantly improve outcomes versus ICBT with self-directed exposure [413]. In addition, several RCTs have shown ICBT (with minimal therapist contact) to be as effective as face-to-face CBT [414,415], while being more cost-effective [416]. As with other RCTs, research on ICBT has involved prescreening of participants in-person or by telephone, with posttreatment and follow-up assessments by telephone or through self-report measures. Little is known about the effectiveness of self-administered treatments (ICBT or self-help books) used with no pre-screening or planned follow-up contacts. Combined psychological and pharmacological treatments When used in combination, pharmacotherapy has not been shown to add to the benefits of CBT in some studies [387,417], while one study found the combination of phenelzine and CBT superior to either modality alone [418]. D-cycloserine has also been found to enhance treatment outcomes when used during exposure exercises as an adjunct to exposure alone [419,420]. In addition, a study of psychodynamic group therapy with or without the addition of clonazepam also found combination treatment to be superior to clonazepam treatment alone [421]. Long-term effects of psychological treatment The benefits of CBT have been found to be maintained at six to 12 month follow-up visits [58,382,390,393,409, 413,422,423], with sustained improvement being reported Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 19 of 83 at five years posttreatment [424,425]. Long-term assessments post-ICBT have shown sustained improvement at one to five years follow-up [409,413,423,424]. Long-term benefits with psychotherapy appear to be more enduring than those of pharmacotherapy after treatment discontinuation [388,389]. Pharmacological treatment The management of patients with SAD should follow the principles discussed in Section 2. Pharmacological interventions that have good evidence for efficacy in treating SAD include SSRIs, SNRIs, anticonvulsants, and benzodiazepines. Treatments that have been investigated for use in SAD have been assessed according to the criteria for strength of evidence (Tables 1 and 2) and are summarized in Tables 20 and 21. First-line agents Antidepressants: Meta-analyses demonstrate that SSRIs and SNRIs are significantly more effective than placebo [58,426-429] and RIMAs [426,428] for the treatment of SAD. There is level 1, RCT evidence supporting the use of the SSRIs escitalopram [430,431], fluvoxamine [433-435], fluvoxamine CR [436,437], paroxetine [431,438-444], and sertraline [445-448], as well as the SNRI venlafaxine XR [439,441,454-456], for the first-line treatment of SAD. There is also good evidence for the efficacy of paroxetine CR (Level 2) [452]. Pregabalin: Pregabalin has also demonstrated efficacy versus placebo for the treatment of SAD in RCTs at higher (600 mg/day) but not lower dose levels (150-300 mg/day) (Level 1) [474,475]. Although there is Level 1 evidence for pregabalin, it is not clear how its efficacy compares to that Table 20 Strength of evidence of pharmacotherapy for SAD Agent Level of evidence Agent Level of evidence Antidepressants SSRIs [58,426-429] 1 TCAs Escitalopram [430-432] 1 Clomipramine [458,459] Fluvoxamine [433-435] 1 Imipramine [460] 3 3 (-ve) Fluvoxamine CR [436,437] 1 MAOIs and RIMAs Paroxetine [431,438-444] 1 Phenelzine [384,386,418,461,462] 1 Sertraline [445-448] 1 Moclobemide [417,462-466] 1* Fluoxetine [382,387,449] Citalopram [450,451] 1* 2 Other antidepressants Mirtazapine [467,468] 1* Paroxetine CR [452] 2 Bupropion SR [469] 3 Adjunctive paroxetine [453] 3 Anticonvulsants Pregabalin [474,475] 1 SNRIs Venlafaxine XR [439,441,454,255,456] 1 Duloxetine [457] 2 Other therapies Anxiolytics Benzodiazepines Clonazepam [385,470,471] 1 Gabapentin [476,477] Alprazolam [386] 2 Levetiracetam [478-480] 2 Divalproex [481] 3 Tiagabine [477,482] 3 Topiramate [483] 3 Bromazepam [472] Adjunctive clonazepam [473] 2 (-ve) Other treatments Atenolol [461,484] Buspirone [383,485] Atomoxetine [486,487] Propranolol [488] Atypical antipsychotics 1 (-ve) 1 (-ve) 2 2 (-ve) 1* Adjunctive aripiprazole [496] 3 Adjunctive risperidone [271] 3 3 Pergolide [490] 3 (-ve) Adjunctive pindolol [492] Olanzapine [493] Quetiapine [494,495] 2 (-ve) Selegiline [489] Adjunctive buspirone [491] 2 2 (-ve) 3 2 (-ve) *Conflicting data. CR = controlled release; MAOI = monoamine oxidase inhibitor; RIMA = reversible inhibitor of monoamine oxidase A; SNRI = serotonin– norepinephrine reuptake inhibitor; SR = sustained release; SSRI = selective serotonin reuptake inhibitor; TCA = tricyclic antidepressant; XR = extended release; (-ve) = negative. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 20 of 83 Table 21 Recommendations for pharmacotherapy for SAD First-line Escitalopram, fluvoxamine, fluvoxamine CR, paroxetine, paroxetine CR, pregabalin, sertraline, venlafaxine XR Second-line Alprazolam, bromazepam, citalopram, clonazepam, gabapentin, phenelzine Third-line Atomoxetine, bupropion SR, clomipramine, divalproex, duloxetine, fluoxetine, mirtazapine, moclobemide, olanzapine, selegiline, tiagabine, topiramate Adjunctive therapy Third-line: aripiprazole, buspirone, paroxetine, risperidone Not recommended: clonazepam, pindolol Not recommended Atenolol*, buspirone, imipramine, levetiracetam, propranolol*, quetiapine CR = controlled release; SR = sustained release; XR = extended release. *Beta-blockers have been successfully used in clinical practice for performance situations such as public speaking. Note: although there is limited evidence for citalopram in SAD, it is likely as effective as the other SSRIs, in contrast there are negative trials of fluoxetine in SAD suggesting it may be less effective than other SSRIs [382,449]. of SSRIs. In addition, SSRIs may have a broader spectrum of efficacy for common comorbid conditions. Second-line agents Benzodiazepines: In RCTs, the benzodiazepines clonazepam (Level 1) [470][385,471], alprazolam [386], and bromazepam [472] (both Level 2) have demonstrated efficacy in the treatment of SAD. Although, a meta-analysis found benzodiazepines to be as effective as SSRIs [58], these agents are recommended as second-line options because of the lack of effect on common comorbidities and the potential for abuse/ dependence in individuals with a history of SUDs. Antidepressants: In RCTs, citalopram was found to be significantly more effective than placebo [451], and as effective as moclobemide [450] (Level 2). Although there is limited evidence for citalopram in SAD, it is likely as effective as the other SSRIs. The efficacy of phenelzine has been established in multiple RCTs (Level 1) [384,386,418,461,462]; however, this agent is recommended as a second-line option because of concerns regarding dietary restrictions, drug interactions, and the potential for hypertensive crisis. Anticonvulsants: Gabapentin was significantly more effective than placebo in a RCT [476], and as effective as tiagabine in a small cross-over study (Level 2) [477]. Third-line agents Antidepressants: Results with fluoxetine have been mixed (Level 1, conflicting) [382,387,449]. A large RCT found that fluoxetine was more effective than placebo and as effective as CBT [387]. However, in two other small RCTs, fluoxetine alone or when added to selfexposure showed no benefit over placebo, with or without self-exposure [382,449]. These negative trials with fluoxetine suggest it may be less effective than other SSRIs [382,449]. Similarly, results with moclobemide have also been mixed (Level 1, conflicting) [417,462-466], with some RCTs demonstrating significantly higher response rates with moclobemide compared with placebo (Level 1) [462-464], while others have not [465,466]. Moclobemide was found to be superior to CBT early in treatment; however, after six months CBT was found to be superior. Data from two small RCTs assessing mirtazapine were also mixed (Level 1, conflicting), with one showing significant improvements over placebo [468] and the other showing no differences [467]. In a dose-finding study in which patients treated with open-label duloxetine 60 mg/day were randomized to continue or double their dose, both doses improved symptoms, but there was no significant advantage to the higher dose (Level 2) [457]. Small open-label trials have also suggested that bupropion SR [469] and clomipramine [458,459] (both Level 3) may be effective in patients with SAD. Anticonvulsants: Open-label studies have demonstrated some efficacy with divalproex [481], topiramate [483], and tiagabine [482] (all Level 3). In addition, tiagabine was comparable to gabapentin in a small RCT, crossover study in eight adults [477]. Other treatments: Olanzapine was effective in a small RCT (Level 2) [493], and selegiline demonstrated efficacy in a small, open-label trial (Level 3) [489]. In a RCT, atomoxetine significantly improved SAD symptoms compared with placebo [487]; however, in a another small RCT, atomoxetine showed no significant difference in outcomes compared with placebo (Level 1, conflicting) [486]. All of these agents are recommended as third-line options, and may be useful in refractory patients after first- and second-line monotherapies and adjuncts have been unsuccessful. Adjunctive therapy Adjunctive strategies have generally been studied in patients who have had an inadequate response to antidepressant therapy and can be considered for patients with treatment-resistant SAD. Third-line adjunctive therapies: Open-label studies and case series have suggested that patients with refractory Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 SAD may benefit from adjunctive therapy with aripiprazole [496], risperidone [271], buspirone [491], or paroxetine [453] (all Level 3). Not recommended adjunctive or combination therapies: In RCTs, clonazepam [473] combined with paroxetine and pindolol augmentation of paroxetine [492] (both Level 2, negative) were not significantly superior to placebo in augmenting the effects of SSRI treatment for SAD. Not recommended In RCTs there was no evidence of benefits with the betablockers atenolol (Level 1, negative) [461,484] or propranolol (Level 2, negative) [488], or for the following treatments: buspirone [383,485], levetiracetam [478-480] (both Level 1, negative), or quetiapine (Level 2, negative) [494,495]. These agents are not recommended for SAD. Imipramine [460] and pergolide (both Level 3, negative) [490] also do not appear to be effective in this disorder. Maintenance pharmacological treatment Long-term therapy has been evaluated in relapse prevention and naturalistic follow-up studies. Relapse-prevention studies are those in which responders to medication are randomized to continued active treatment or placebo. A meta-analysis of four relapse prevention studies included 760 patients with SAD and found a highly significant reduction in relapse rates with continued SSRI treatment compared with placebo over three to six months. The relative risk (RR) for relapse was 0.39 (95% CI 0.30– 0.49) and number needed to treat (NNT) was 3.57 (95% CI 2.94–4.76) [497]. The anticonvulsant pregabalin has also demonstrated reductions in relapse rates over six months [498]. In RCTs, escitalopram [431], fluvoxamine CR [499], and venlafaxine XR [456] have demonstrated continued improvement compared with placebo over approximately six months. Additional open follow-up data support the long-term efficacy of moclobemide over six to 24 months [464,500]. Biological and alternative therapies Biological therapies: In an open-label study, neuro psycho physical optimization-radio electric asymmetric conveyor (NPPO-REAC) (a brain stimulation technique) was as effective as sertraline for the treatment of SAD (Level 3) [501]. Alternative therapies: St John’s wort failed to demonstrate superiority over placebo, and is not recommended for the treatment of SAD (Level 2, negative) [502]. Summary SAD is one of the most common anxiety disorders, occurring more often in women than men. SAD has a negative impact on QoL, functional and occupational Page 21 of 83 outcomes, and is often associated with other comorbid disorders, including MDD and other anxiety and related disorders. SAD is characterized by intense fear or anxiety relating to social or performance situations where the individual is exposed to scrutiny by others. These situations are often actively avoided. CBT and exposure therapy alone are effective first-line options for the treatment of SAD, although limited data suggest that CBT may be more effective in maintaining benefits during follow-up. VRE and internet-based programs have also demonstrated efficacy. The benefits of CBT are maintained over one to five years of follow-up. CBT and pharmacotherapy appear to have similar efficacy for the acute treatment of SAD, but after treatment discontinuation, gains achieved with CBT appear to persist longer than those achieved with pharmacotherapy. In most studies, adding pharmacotherapy has not been shown to increase the benefits of CBT. Pharmacotherapeutic approaches should begin with a first-line antidepressant such as escitalopram, fluvoxamine, fluvoxamine CR, paroxetine, paroxetine CR, sertraline, or venlafaxine XR, or the anticonvulsant pregabalin. If response to optimal doses is inadequate or the agent is not tolerated, therapy should be switched to another first-line agent before considering a second-line medication. Second-line choices include the benzodiazepines alprazolam, bromazepam, and clonazepam, as well as citalopram, gabapentin, and phenelzine. Pregabalin has also been shown to maintain benefits and prevent relapse in a six-month study. Patients who do not respond to several medication trials and/or CBT are considered to have treatmentrefractory illness. In such patients it is important to reassess the diagnosis and consider comorbid medical and psychiatric conditions that may be affecting response to therapy. Third-line agents and adjunctive therapies may be useful when patients fail to respond to optimal treatment trials of first- and second-line therapies used alone and in combination. Generalized anxiety disorder Epidemiology The estimated 12-month prevalence of GAD ranges from 1-4%, and the lifetime prevalence is approximately 6% [2,3,16,503]. GAD is more frequent in Caucasians compared to other groups [504]. The usual age of onset varies and may be bimodal with the median age of onset being approximately 31 years [2] and mean age of onset being 32.7 years [505]. The prevalence of GAD is estimated to be 3% in children and 10.8% in adolescents [506], with the age of onset for children and adolescents being between ages 10 and 14 [507]. Some data suggest that women may be two to three times more likely to suffer from GAD than men [16,508], and GAD may be more Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 common in older adults [509,510]. This disorder is reportedly frequently under-recognized with less than one-third of patients being adequately treated [511,512]. This is further complicated in children because of the previous designation of Overanxious Disorder of Childhood and its possible differentiation of childhood GAD from GAD in adults. GAD is associated with functional [15,511,513], occupational [511], and QoL impairments [16,511], as well as substantial economic costs [511,514]. In addition, in primary care 60-94% of patients with GAD report painful physical symptoms [515,516], and these were the main reason for initial presentation to a physician in 72% of cases [516]. Comorbidity GAD is associated with high rates of comorbid psychiatric conditions including other anxiety or related disorders and MDD [16]. The risk of medical conditions is also elevated [16], including pain syndromes [16,517], hypertension [16], as well as cardiovascular and gastric conditions [16,518]. The presence of comorbid depression increases the severity of illness, functional impairment [519], and economic costs [514]. Diagnosis GAD is characterized by excessive anxiety and worry about multiple events or activities such as school or work difficulties, which is apparent on a majority of days over the previous six months (Table 22) [26]. In addition, GAD is associated with restlessness, muscle tension, fatigue, concentration difficulties, irritability, and sleep issues [26]. The diagnostic criteria for GAD underwent one minor revision in the DSM-5 [26] compared to the DSM-IVTR [144], the requirement that the disturbance not occur exclusively during a mood, psychotic, or pervasive developmental disorder was removed. However, it remains important to note that most of the treatment data described within this section are based on patients meeting DSM-IV criteria (or older). Psychological treatment Meta-analyses clearly demonstrate that CBT significantly reduces GAD symptoms and is markedly more effective Table 22 DSM-5 diagnosis of GAD • Excessive anxiety and worry (apprehensive expectation) about a number of events or activities (e.g., school/work performance) • The individual finds it difficult to control the worry • Excessive anxiety and worry are associated with ≥3 of the following symptoms (with at least some occurring more days than not for ≥6 months): ○ Restlessness or feeling keyed-up or on edge, being easily fatigued, difficulty concentrating, irritability, muscle tension, or sleep disturbance • The disturbance causes clinically significant distress or functional impairment Adapted from DSM-5 [26]. Page 22 of 83 than placebo or wait-list control conditions for GAD (Level 1) [55,64,65,70,520]. Few studies have compared CBT and pharmacotherapy alone in the same trial, but the magnitude of benefits appear to be comparable for both groups [521-523]. Individual and group therapy appear to be equally effective in terms of anxiety symptom reduction, but individual therapy may lead to earlier improvement in worry and depression symptoms [65,520]. The intensity of therapy was assessed in a meta-analysis of 25 studies [65]. Regimens including fewer than eight sessions were as effective as those of eight or more for anxiety symptoms, but the more intense regimens were more effective in improving symptoms of worry and depression compared with fewer sessions [65]. Several studies have demonstrated the utility of internetbased or computer-based CBT programs [79,524-526]. ICBT has been shown to be significantly more effective than wait-list control [79,524,525], with benefits being maintained at long-term follow-up [525]. In addition, a peer-to-peer cognitive self-therapy program was as effective as treatment-as-usual, with a decreased need for therapist contact [527]. A meta-analysis of five trials found no significant differences between CBT and relaxation therapy [55]. However, more recent studies suggest that applied relaxation has limited efficacy [528-530]. One RCT found little evidence that patients with GAD can learn to relax in therapy or that a decrease in activation is associated with a reduction in anxiety [529]. Balneotherapy, a relaxation therapy involving spa-related treatments, demonstrated potential advantages over SSRI pharmacotherapy in improving anxiety scores and response rates in patients with GAD in a large RCT [531]; however, while this study may be interesting, concerns pertaining to blinding and potential bias indicate further study is needed [531]. Several research-based variables have been specifically identified among individuals with GAD in order to generate evidence-based CBT protocols for GAD, including: intolerance of uncertainty, poor problem-solving confidence, as well as positive and negative metacognitive beliefs about the function or utility of worry [532]. Specific psychotherapeutic protocols based upon models of the disorder that target variables underlying GAD have been developed to individualize therapy. Acceptance-based behavior therapy [533], meta-cognitive therapy [528,534], CBT targeting intolerance of uncertainty [530], and adjunctive MBCT [184] have demonstrated efficacy for the treatment of GAD. Targeting worry and relaxation [535], as well as looming vulnerability (the tendency to generate and maintain internal scenarios of increasing risk and danger) [536], may also be beneficial. Psychodynamic therapy may also be of benefit, however the research findings to date are unclear. A RCT Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 found that short-term psychodynamic psychotherapy was as effective as CBT in improving anxiety scores, but CBT was superior on measures of worry and depression [537]. Another study found no significant differences between brief psychodynamic therapy, pharmacotherapy, or the combination [523]. No significant benefits were found with the addition of interpersonal and emotional processing therapy to CBT when compared with CBT plus supportive listening [538]. However, pretreatment motivational interviewing as an adjunct to CBT was shown to help reduce resistance to therapy, improve homework compliance, and improve worry outcomes — this strategy may be particularly useful in more severe cases [539,540]. In clinical practice, the approach may need to be individualized to the problems experienced by the patient. Psychological and pharmacological treatment Few data are available on the use of combined psychological and pharmacological treatment. A meta-analysis concluded that combination pharmacotherapy and CBT was more effective than CBT alone at posttreatment but not at six-month follow-up [83]. While large effect sizes were found for GAD, data were available from only two studies, and these compared CBT plus diazepam or buspirone with CBT alone [83]. Compared to pharmacotherapy alone, the few studies that have assessed the benefits of adjunctive psychotherapy have been conflicting [184,523,541,542]. One study suggested benefits of the combination [184], while two other studies did not [523,541]. However, adjunctive CBT was shown to facilitate benzodiazepine tapering in patients with GAD [542]. There is no current evidence to support the routine combination of CBT and pharmacotherapy. However, as in other anxiety and related disorders, when patients do not benefit from CBT or have a limited response, a trial of pharmacotherapy is advisable. Similarly, patients who show limited benefit from pharmacotherapy may benefit from CBT. Long-term effects of psychological treatment Long-term follow-up data from a meta-analysis [520] and RCTs [523,525,535,543] suggest that benefits of psychological treatments are maintained at one to three years follow-up after treatment. Pharmacological treatment The management of patients with GAD should follow the principles discussed in Section 2. Pharmacological interventions that have good evidence for efficacy in treating GAD include SSRIs, SNRIs, TCAs, benzodiazepines, pregabalin, quetiapine XR, and other therapies. Treatments that have been investigated for use in GAD have been assessed according to the criteria for strength of evidence (Tables 1 and 2) and are summarized in Tables 23 and 24. Page 23 of 83 First-line agents Antidepressants (SSRIs & SNRIs): Evidence from RCTs supports the use of SSRIs including escitalopram [544-552] and sertraline [556,559-561], as well as the SNRIs duloxetine [566-571] and venlafaxine XR [548,553,570-580] (all Level 1) for the first-line treatment of GAD. Similar evidence exists for paroxetine [546,547,553-558] supporting its use as a first-line option. Paroxetine CR has a similar active ingredient, and although there are less data supporting its use, it is likely interchangeable with paroxetine as a first-line agent (Level 3) [564,565]. In head-to-head comparisons, the efficacy of SSRIs and SNRIs appear to be similar [546,547,549,556,558,570,571]. Some data suggest that escitalopram may be less effective than venlafaxine XR [548] or quetiapine XR [551]. Efficacy of venlafaxine was similar to pregabalin in one RCT [576], but less effective in another [577]. Other antidepressants: In two 12-week, double-blind RCTs, agomelatine was found to be more effective than placebo (Level 1) [584,585], and as effective as escitalopram [585]. Pregabalin: The anticonvulsant pregabalin was more effective than placebo in RCTs [576,577,592,593,597,613] and as effective as benzodiazepines [592,593,597] in patients with GAD (Level 1). Pregabalin was more effective than venlafaxine XR in one RCT [577], but equivalent in another [576]. Second-line agents Benzodiazepines: Alprazolam [589-593], bromazepam [589,594], diazepam [583,589,595,596], and lorazepam [589,593,597-601] all have demonstrated efficacy for the treatment of GAD (all Level 1). While these agents have level 1 evidence for efficacy, they are recommended as second-line therapy, and usually only for short-term use, because of side effects, dependence, and withdrawal issues. TCAs and other antidepressants: In RCTs, imipramine was superior to placebo and as effective as benzodiazepines for the treatment of GAD (Level 1) [553,581-583]. However, because of side effects and potential toxicity in overdose, imipramine is recommended as a secondline option. While there are little data on bupropion XL (Level 2), in a 12-week RCT in patients with GAD it was as effective as escitalopram (a first-line option), supporting its use as a second-line option [549]. Vortioxetine is a so-called “serotonin modulator” because of its activity in a variety of serotonin receptors. Results from two similar, eight-week, placebo-controlled RCTs with vortioxetine were conflicting, with one trial being positive [587] and the other negative (Level 1, conflicting) [586]. The differences in outcomes may be related to differences in recruitment between the two studies [623], and data suggest that vortioxetine may be useful in GAD. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 24 of 83 Table 23 Strength of evidence for pharmacotherapy for GAD Agent Level of evidence Agent Level of evidence Antidepressants SSRIs TCAs Escitalopram [544-552] 1 Imipramine [553,581-583] 1 Paroxetine [546,547,553-558] 1 Other antidepressants Sertraline [556,559-561] 1 Agomelatine [584,585] 1 Citalopram [562] 3 Vortioxetine [586,587] 1* Fluoxetine [563] 3 Bupropion XL [549] 2 Paroxetine CR [564,565] SNRIs 3 Trazodone [583] Mirtazapine [588] 2 3 Duloxetine [566-571] 1 Venlafaxine XR [548,553,570-580] 1 Other therapies Anxiolytics Atypical antipsychotics Benzodiazepines Alprazolam [589-593] Bromazepam [589,594] 1 1 Quetiapine XR [551,557,602,603] 1 Adjunctive quetiapine [565,604,605] Adjunctive risperidone [606,607] 1* 1* Diazepam [583,589,595,596] 1 Adjunctive olanzapine [608] 2 Lorazepam [589,593,597-601] 1 Adjunctive aripiprazole [269,609] 3 Adjunctive quetiapine XR [610] Adjunctive or monotx ziprasidone [611,612] Anticonvulsants 3 2 (-ve) Other treatments Pregabalin [576,577,592,593,597,613] Divalproex chrono [614] Tiagabine [615,616] Adjunctive pregabalin [617] 1 2 1 (-ve) 2 Buspirone [108,561,572,589,598,618,619] Hydroxyzine [594,619,620] Pexacerfont [552] 1 1 2 (-ve) Propranolol [621] 2 (-ve) Memantine [622] 4 (-ve) *Conflicting data. SNRI = serotonin–norepinephrine reuptake inhibitor; SSRI = selective serotonin reuptake inhibitor; TCA = tricyclic antidepressant; XL = extended release; XR=extended release; (-ve) = negative. Quetiapine XR: There is good evidence for the efficacy of quetiapine XR for the management of GAD (Level 1) [551,557,602,603]. Two meta-analyses [115,116] concluded that quetiapine was significantly superior to placebo and equivalent to antidepressants [115] for the treatment of GAD. However, quetiapine was associated with more weight gain and sedation, and higher dropout rates due to adverse events compared with placebo or antidepressants [115,116]. Due to tolerability and long-term safety concerns with atypical antipsychotics, this treatment is recommended as a second-line option for patients who cannot be provided antidepressants or benzodiazepines. Other treatments: Buspirone was more effective than placebo and as effective as benzodiazepines in several Table 24 Recommendations for pharmacotherapy for GAD First-line Agomelatine, duloxetine, escitalopram, paroxetine, paroxetine CR, pregabalin, sertraline, venlafaxine XR Second-line Alprazolam*, bromazepam*, bupropion XL*, buspirone, diazepam*, hydroxyzine, imipramine, lorazepam*, quetiapine XR*, vortioxetine Third-line Citalopram, divalproex chrono, fluoxetine, mirtazapine, trazodone Adjunctive therapy Second-line: pregabalin Third-line: aripiprazole, olanzapine, quetiapine, quetiapine XR, risperidone Not recommended: ziprasidone Not recommended Beta blockers (propranolol), pexacerfont, tiagabine CR = controlled release; XL = extended release; XR=extended release. *Note: These have distinct mechanisms, efficacy and safety profiles. Within these second-line agents, benzodiazepines would be considered first in most cases, except where there is a risk of substance abuse, while bupropion XL would likely be reserved for later. Quetiapine XR remains a good choice in terms of efficacy, but given the metabolic concerns associated with atypical antipsychotic, it should be reserved for patients who cannot be provided antidepressants or benzodiazepines. Please refer to text for further rationale for the recommendations. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 RCTs (Level 1) [108,561,572,589,598,618,619]. There are limited data comparing buspirone to antidepressants, with it being less effective than venlafaxine XR in one study [572], but as effective as sertraline in another [561]. Limited effectiveness in clinical practice relegates buspirone to a second-line agent. Hydroxyzine has demonstrated efficacy superior to placebo and similar to benzodiazepines and buspirone in RCTs (Level 1) [594,619,620]; however, clinical experience with this agent in the treatment of GAD remains limited. Third-line agents The following agents are recommended as third-line options because of limited data, side effects, or lack of clinical experience as a primary therapy for the treatment of GAD. Antidepressants: In open-label studies or case series, the antidepressants citalopram [562], fluoxetine [563], paroxetine CR [564,565], and mirtazapine [588] have demonstrated efficacy in patients with GAD (all Level 3). In a RCT, trazodone was as effective as diazepam (Level 2) [583]. Other treatments: Divalproex chrono was superior to placebo for the treatment of GAD (Level 2) [614], however this formulation is not widely available. Adjunctive therapy Adjunctive strategies have generally been studied in patients who have had an inadequate response to SSRI therapy, and can be considered for patients with treatment-resistant GAD. Second-line adjunctive therapies: Adjunctive pregabalin demonstrated good efficacy in a large RCT in patients with GAD who had an inadequate response to prior treatments (Level 2) [617]. Third-line adjunctive therapies: A meta-analysis of five RCTs of adjunctive atypical antipsychotics found no significant improvement in response rates but higher discontinuation rates versus placebo in patients with refractory GAD [116]. Two RCTs suggest that adjunctive risperidone (Level 1, conflicting) [606,607] may be useful in some patients, but in the larger RCT it demonstrated superiority over placebo only in patients with moderate to severe residual symptoms at baseline [607]. Similarly, data on adjunctive quetiapine have been inconsistent (Level 1, conflicting) [565,604,605], with one RCT being negative [565], while another, unblinded RCT showed some, but limited benefits [605]. Adjunctive olanzapine demonstrated efficacy in a small RCT in patients who remained symptomatic after six weeks of SSRI therapy [608]. Adjunctive treatment with quetiapine XR [610] or aripiprazole [269,609] (both Level 3) also had some benefit in open trials. Because of the limited evidence for efficacy and their potential for weight gain and metabolic side effects, atypical antipsychotics should be reserved for highly Page 25 of 83 treatment-refractory cases of GAD, and other than quetiapine XR, used only as an adjunctive treatment. Not recommended adjunctive therapies: Ziprasidone does not appear to be effective as adjunctive therapy (Level 2, negative) [611]. Not recommended Propranolol [621] and pexacerfont [552] (both Level 2, negative) have not demonstrated efficacy and are not recommended in the treatment of GAD. While a small randomized, open-label trial suggested that tiagabine was as effective as paroxetine, the results of three placebocontrolled RCTs do not support the efficacy of tiagabine in patients with GAD (Level 1, negative) [615,616]. Memantine also does not appear to be effective in this disorder (Level 4, negative) [622]. Maintenance pharmacological treatment Long-term therapy has been evaluated in relapse prevention and naturalistic follow-up studies. Relapse-prevention studies are those in which responders to SSRI therapy are randomized to continued active treatment or placebo. A meta-analysis of three relapse prevention studies included 1342 patients with GAD and found a highly significant reduction in relapse rates with continued SSRI treatment compared with placebo over six to 12 months (odds ratio for relapse was 0.20) [497]. In RCT discontinuation studies, duloxetine [624], escitalopram [625], paroxetine [626], and venlafaxine XR [627] have demonstrated significantly lower relapse rates over six to 18 months in the range of 10-20% with active treatment compared to 40-56% with placebo. Pregabalin [628] and quetiapine XR [629] have also demonstrated significantly lower relapse rates over six to 12 months of continued treatment in discontinuation trials. In long-term RCT studies, escitalopram [546], paroxetine [546], and venlafaxine XR [578,579] have demonstrated continued improvement compared with placebo over approximately six months. Biological and alternative therapies In general, these therapies may be useful for some patients; however, more data are needed. Biological therapies: In a small open trial, rTMS was effective as monotherapy or as an adjunct to SSRIs in patients with GAD (Level 3) [630], and improvements were largely maintained six months after treatment [631]. Alternative therapies: Several herbal preparations have demonstrated efficacy comparable to lorazepam for the treatment of GAD including silexan (lavender oil) (Level 1) [600,632] and Galphimia glauca extract (Level 2) [601]. Cochrane meta-analyses found two studies of passiflora (passion flower) indicating it was as effective as benzodiazepines (Level 2) [633], and one study of valerian which found no significant differences between placebo, valerian, or diazepam (Level 2, negative) [634,635]. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Unfortunately, because these preparations are poorly standardized and have substantial variation in proportion of the active ingredient in different products, they cannot be widely recommended. A RCT of adjunctive resistance training (weightlifting) or aerobic exercise found significant symptomatic improvements compared to a wait-list condition (Level 2) [636]. A systematic review included four studies of acupuncture in GAD or anxiety neurosis, and while all trials reported positive findings, methodological details were lacking and the authors concluded that there was insufficient evidence to determine efficacy (Level 2) [637]. Open-label studies suggest that adjunctive meditation and yoga-based treatments may be useful in patients with GAD (Level 3) [638,639]. Not recommended alternative therapy: In a RCT, there were no significant improvements with bright light therapy compared with placebo (Level 2, negative) [640], and this treatment is not recommended. Summary The lifetime prevalence of GAD is approximately 6%, it is more frequent in women than in men, with age of onset reflecting a bimodal distribution (onset in lateteens to early-twenties, and again in the 30s and 40s). GAD is associated with substantial functional impairment and a high prevalence of comorbid psychiatric and medical disorders. According to DSM-5 criteria, GAD is characterized by excessive anxiety and worry about multiple situations and is associated with restlessness, muscle tension, and behavioral changes. CBT is an effective first-line option for the treatment of GAD and is as effective as pharmacotherapy. Internetbased and computer-based CBT have also demonstrated efficacy. Evidence does not support the routine combination of CBT and pharmacotherapy, but when patients do not benefit from CBT, a trial of pharmacotherapy is advisable, and vice versa. Pharmacotherapeutic approaches should begin with one of the first-line options including an SSRI such as escitalopram, paroxetine, or sertraline, an SNRI such as duloxetine or venlafaxine XR, or other antidepressant such as agomelatine. The anticonvulsant pregabalin is also a recommended first-line therapy. If response to optimal doses is inadequate or the agent is not tolerated, therapy should be switched to another firstline agent before considering second-line medications. Second-line choices include bupropion XL, buspirone, hydroxyzine, imipramine, quetiapine XR, vortioxetine, as well as the benzodiazepines, alprazolam, bromazepam, diazepam, and lorazepam. Patients who do not respond to multiple courses of therapy are considered to have treatment-refractory illness. In such patients it is important to reassess the Page 26 of 83 diagnosis and consider comorbid medical and psychiatric conditions that may be affecting response to therapy. Third-line agents, adjunctive therapies, as well as biological and alternative therapies may be useful when patients fail to respond to an optimal treatment trial of first- and second-line therapies used alone and in combination. Obsessive-compulsive disorder Epidemiology OCD is a relatively uncommon, yet severe, mental disorder, with an estimated lifetime and 12-month prevalence of 1.0-2.3% and 0.7%-1.2% in adults, respectively [2,3,641,642]. Mean age of onset of OCD is ~20 years of age, but symptoms can occur below the age of 10, with few new cases after the early 30s [2,641,643]. Rates of treatment-seeking have been estimated to be only about 14-56% of patients, suggesting that OCD may be underrecognized and under-treated [644,645]. Social isolation, history of physical abuse, and negative emotionality are risk factors for the development of OCD [646]. OCD is associated with a substantial negative impact on QoL for both patients [647,648] and their caregivers [649]. Patients experience cognitive, social, and occupational impairments [642,645,650,651]. In addition, up to one-quarter of patients with OCD have attempted suicide [645,652]. OCD symptoms are associated with increased rates of health care utilization compared to those without OCD symptoms [642], with health care costs estimated at $10.6 billion/year (2005) in the US [653]. Comorbidity About 60-90% of patients with OCD also have a comorbid disorder [641,645]. Patients with OCD or OCD symptoms have a three-times higher rate of comorbidity compared to those without OCD symptoms [642]. Common comorbidities include mood, anxiety, and somatoform disorders, as well as SUDs, psychotic disorders, and bipolar disorders [641,642,645]. Diagnosis A diagnosis of OCD requires the presence of obsessions and/or compulsions (Table 25) [26]. Obsessions are defined as recurrent, persistent, and intrusive thoughts, images, or urges that cause marked anxiety, and compulsions are defined as repetitive behaviors or mental acts that the patient feels compelled to perform to reduce the obsession-related anxiety [26]. The obsessions or compulsions are time consuming and cause significant impairment in social or occupational functioning. In the DSM-5, OCD has been moved from the “anxiety disorders” [144] to a new diagnostic category called “obsessive-compulsive and related disorders.” In addition to OCD, this new category also includes diagnostic criteria for body dysmorphic disorder, hoarding disorder, Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Table 25 DSM-5 diagnosis of OCD • Presence of either obsessions, compulsions, or both ○ Obsessions are defined by the following: • Recurrent and persistent thoughts, urges, or images that are experienced as intrusive and unwanted and that cause marked anxiety or distress • The individual attempts to ignore or suppress such thoughts, urges, or images, or to neutralize them with other thoughts or actions ○ Compulsions are defined by the following: • Repetitive behaviors (e.g., hand washing, ordering, checking) or mental acts (e.g., praying, counting, repeating words silently) that the individual feels driven to perform in response to an obsession or according to rigid rules • Compulsions are aimed preventing or reducing anxiety or preventing some dreaded situation or event; however, they are not connected in a realistic way with what they are designed to neutralize or are clearly excessive • The obsessions or compulsions are time-consuming (e.g., take >1 h/day) or cause clinically significant distress or functional impairment • Specify patient’s degree of insight as to reality of OCD beliefs: ○ Good or fair insight (i.e., definitely or probably not true) ○ Poor insight (i.e., probably true) ○ Absent insight (i.e., completely convinced beliefs are true) • Specify if “tic-related” OCD Adapted from DSM-5 [26]. hair-pulling disorder (trichotillomania), and skin picking disorder [26]. Most of the other modifications to the OCD diagnostic criteria in the DSM-5 were minor wording changes designed to enhance clarity or further operationalize concepts that were considered too vague [26]. In particular, the definitions of obsessions and compulsions were clarified and simplified [26,654]. The requirement that the patient recognizes that the obsessions or compulsions are “excessive or unreasonable” has been deleted, since these terms are subject to interpretation and patients can have varying levels of insight. As a result, the previous DSMIV-TR specifier of “poor insight” has been expanded to include: good or fair, poor, and absent insight [26]. Finally, a specifier of “tic-related” OCD has been added [26]. While the most up-to-date DSM-5 diagnostic criteria are presented here, it is important to note that most of the treatment data described within this section are based on patients meeting DSM-IV criteria (or older). Psychological treatment Meta-analyses support the beneficial effects of psychological treatment for OCD, mainly CBT, generally including exposure with response prevention (ERP) [60-63,70,71, 655-657]. CBT is equivalent or superior to pharmacotherapy [71,658-660]. Results with CBT were generally similar in comparisons of interventions with an emphasis on ERP and those with an emphasis on cognitive elements [60,63,655]. A treatment specifically designed to address fear of contamination with infectious substances, using a cognitive intervention that includes no direct exposure Page 27 of 83 (“danger ideation reduction therapy, DIRT”), was found to be more efficacious than ERP [661,662]. Cognitive interventions may be important in patients who do not have overt compulsions, which can make ERP more difficult. One meta-analysis found that exposure in vivo combined with imaginal exposure was better than exposure in vivo alone [60]. Several meta-analyses have demonstrated no significant differences in efficacy between group and individual CBT [60,62,663]. However, results of head-to-head trials are conflicting, with some RCTs finding no significant differences in efficacy between group and individual therapy [663,664], and others showing individual therapy to be superior [665-667]. Differences in results may be explained by the fact that in individual therapy the therapist may have the advantage of being more aware of the patient’s dysfunctional beliefs, however, the group therapy setting may offer the advantages of group encouragement, reciprocal support, imitation, and interpersonal learning which may result in an increased motivation and reduced discontinuation of treatment [62]. An important practical question concerns the intensity and duration of treatment. The intensive ERP program described by Foa’s group involves 15 two-hour sessions scheduled five days a week over three weeks [658,668]. A similar program administered twice-weekly (a more practical approach for many patients and therapists) was as effective at the end of follow-up as the intensive fivedays/week strategy [669]. A step-care approach in which patients received six weeks of low-intensity counseling with ERP bibliotherapy followed by standard ERP for non-responders only was found to be as effective as initial therapy with standard ERP (17 sessions twice weekly), but was significantly less costly [670]. Other techniques that may be useful include acceptance and commitment therapy (ACT) [671], modular cognitive therapy (CT) addressing OCD beliefs [672,673], CT addressing obsessional doubt [674], organizational training [675,676], and mindfulness training [677]. RCTs on the benefits of adding motivational interviewing to CBT have been conflicting, with one showing no additional benefits [678], while another demonstrated improved symptom reduction and remission rates compared with CBT alone [679]. While EMDR was more effective than an SSRI in a RCT [680], data are limited and this technique is not generally recommended for patients with OCD. Data suggest that therapist-guided exposure is better than self-exposure [60]. While both treatment conditions showed significant symptom reduction, therapistadministered ERP was superior to self-administered ERP in improving OCD symptoms and self-reported functional impairment [681]. Other data suggest that ERP Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 28 of 83 delivered by telephone is equivalent to face-to-face ERP [682]. Bibliotherapy in the form of self-help manuals delivered to patients via email has demonstrated significantly greater improvements in OCD symptoms compared with wait-list control groups in two RCTs [683,684]. ICBT is an easily accessible treatment that has the potential to reach untreated patients and motivate them for face-to-face psychotherapy if necessary [684,685]. Several RCTs have demonstrated that ICBT programs are significantly more effective than supportive therapy or relaxation control strategies [685-687]. ICBT was as effective as therapist-led CBT only when patients completed at least one self-exposure session [687]. ICBT was associated with significantly better outcomes when it included brief, scheduled, therapist-initiated telephone support compared with on-demand phone support [688]. Family accommodation (i.e., family members taking part in the performance of rituals, avoidance of anxietyprovoking situations, or modification of daily routines to assist a relative with OCD) has been associated with poorer response to both behavioral and pharmacological treatments [689]. Clinicians may want to consider targeting family accommodation in order to improve treatment outcomes for some patients. Although hoarding disorder is now a separate diagnosis [690], the limited data available on the treatment of hoarding will be mentioned in this section on OCD. One RCT found that group CBT significantly reduced hoarding and depression symptoms while bibliotherapy alone was associated with very limited improvements [691]. The addition of posttreatment, nonclinician, home assistance did not significantly improve outcomes. Pharmacological treatment Combined psychological and pharmacological treatment Clomipramine: There is good evidence to support the use of clomipramine in the treatment of OCD (Level 1) [658,711,713,714,716-718,720,724,740,741]. Clomipramine has efficacy similar to SSRIs, but SSRIs are generally better tolerated [711,713,714,716-718,720,724]. Side effects and safety are issues with clomipramine and therefore it is recommended as a second-line choice. Common adverse effects include anticholinergic effects such as dry mouth, constipation, and blurred vision, as well as urinary retention, orthostatic hypotension, weight gain, and sedation [813,814]. The major safety concerns are cardiac arrhythmias, seizures, drug interactions, and toxicity in overdose [813,814]. Antidepressants: In RCTs, citalopram was more effective than placebo but less effective than psychotherapy (Level 2) [680,726]. Additional data from augmentation studies support the efficacy of citalopram for the treatment of OCD [727,728]. However, given that other SSRIs have much stronger evidence, citalopram was designated a second-line option. The only RCT data on The combination of psychological and pharmacological treatment has been shown to be superior to medication alone [657,658,692-694], but not to CBT alone [83,658, 692,694,695]. These findings suggest that if pharmacotherapy is required or preferred, adding CBT to pharmacological treatment of OCD may enhance response rates and reduce relapse rates. Unlike in some anxiety and related disorders, there does not appear to be any contraindication to combining CBT with medications in patients with OCD [696], and combined treatment may improve relapse prevention [697]. Adding d-cycloserine may hasten the onset of improvements with ERP, with significant benefits over placebo during the first four or five ERP sessions [698-700], but this effect has not been seen in all studies [701]. Long-term effects of psychological treatment Follow-up studies suggest that the benefits of CBT are maintained at one to five years of follow-up [664,695, 702-704]. The management of patients with OCD should follow the principles discussed in Section 2. SSRIs are recommended first-line pharmacological interventions for OCD, while SNRIs, clomipramine, and other antidepressants are recommended second- and third-line treatments. Treatments that have been investigated for use in OCD have been assessed according to the criteria for strength of evidence (Tables 1 and 2) and are summarized in Tables 26 and 27. First-line agents SSRIs: Evidence from RCTs and meta-analyses support the use of SSRIs, including escitalopram [705-709], fluoxetine [660,710-716], fluvoxamine [711,713,714,717-719], paroxetine [705,720-722], and sertraline [659,710,711, 713,714,723-725] (all Level 1), in the treatment of OCD. In meta-analyses, response rates with SSRIs are generally twice those of placebo [809], at 40-60% with treatment versus <20% with placebo [711,713,714,740,741]. Pooled response rates are not significantly different between SSRIs [809]. In meta-analyses and head-to-head trials, compared with clomipramine, the SSRIs fluoxetine, fluvoxamine, paroxetine, and sertraline had similar efficacy but better tolerability [711,713,714,716-718,720,724]. Dimensional analyses have suggested that symmetry/ hoarding symptoms may be associated with a poorer response to SSRI therapy [810,811], while aggressive/ religious/sexual symptoms may predict better outcomes [810,812]. It has been hypothesized that the symmetry/ hoarding symptom dimension may be mediated by the dopamine system and aggressive behaviors by the serotonin system [810,812]. Second-line agents Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 29 of 83 Table 26 Strength of evidence of pharmacotherapy for OCD Agent Level of evidence Agent Level of evidence Antidepressants SSRIs MAOIs Escitalopram [705-709] 1 Phenelzine [737,738] 2* Fluoxetine [660,710-716] 1 Tranylcypromine [739] 4 Fluvoxamine [711,713,714,717-719] 1 TCAs Paroxetine [705,720-722] 1 Clomipramine [658,711,713,714,716-718,720,724,740,741] 1 Sertraline [659,710,711,713,714,723-725] 1 IV clomipramine [742-744] 2 Citalopram [680,726-728] IV citalopram [729] 2 3 Desipramine [723,745] Adjunctive clomipramine [746,747] Adjunctive citalopram [730] 3 Other antidepressants Mirtazapine [748] 2 Venlafaxine XR [721,731-733] 2 Bupropion [749] 3 (-ve) Duloxetine [734-736] 4 Adjunctive mirtazapine [727] Antipsychotics Adjunctive aripiprazole [750-755] 1 Anxiolytics Benzodiazepines Adjunctive risperidone [755-761] 1* Clonazepam [771] 2 (-ve) Adjunctive olanzapine [760,762,763] 1* Adjunctive clonazepam [772] 2 (-ve) Adjunctive quetiapine [728,746,747,764-768] 1* Adjunctive haloperidol [758,769] 2 Clonidine [773] Adjunctive amisulpride [770] 3 Adjunctive pindolol [774-776] 1* Adjunctive ziprasidone [767] 4 Adjunctive celecoxib [777] 2 1* Adjunctive granisetron [778] Adjunctive IV ketamine [779,780] 2 2 SNRIs 2 (-ve) 2 (-ve) 3 Other therapies Anticonvulsants Adjunctive topiramate [795-798] Other treatments 2 (-ve) Adjunctive lamotrigine [799,800] 2 Adjunctive memantine [622,781-783] 2 Adjunctive pregabalin [801,802] 3 Adjunctive ondansetron [784,785] 2 Adjunctive gabapentin [803,804] 3 (-ve) Adjunctive N-acetylcysteine [786,787] 2 Opioids Tramadol [805,806] 4 Naltrexone [807] Adjunctive morphine [808] 3 (-ve) 2 Adjunctive riluzole [788,789] 3 Adjunctive lithium [790,791] 1 (-ve) Adjunctive buspirone [792,793] Adjunctive minocycline [794] 2 (-ve) 4 (-ve) *Conflicting data. IV = intravenous; MAOI = monoamine oxidase inhibitor; SNRI = serotonin–norepinephrine reuptake inhibitor; SSRI = selective serotonin reuptake inhibitor; TCA = tricyclic antidepressant; XR = extended release; (-ve) = negative. the use of mirtazapine in OCD are from a discontinuation study in which continued mirtazapine was associated with continued improvement (Level 2) [748]. There is some evidence to support the use of venlafaxine XR for the treatment of OCD (Level 2) [721,731-733]. In RCTs, venlafaxine XR was more effective than placebo [732], and as effective as paroxetine [721] and clomipramine [731]. In a double-blind extension of a RCT [721], Table 27 Recommendations for pharmacotherapy for OCD First-line Escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline Second-line Citalopram, clomipramine, mirtazapine, venlafaxine XR Third-line IV citalopram, IV clomipramine, duloxetine, phenelzine, tramadol, tranylcypromine Adjunctive therapy First-line: aripiprazole, risperidone Second-line: memantine, quetiapine, topiramate Third-line: amisulpride, celecoxib, citalopram, granisetron, haloperidol, IV ketamine, mirtazapine, N-acetylcysteine, olanzapine, ondansetron, pindolol, pregabalin, riluzole, ziprasidone Not recommended: buspirone, clonazepam, lithium, morphine Not recommended Clonazepam, clonidine, desipramine IV = intravenous; XR = extended release. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 paroxetine was more efficacious than venlafaxine in the treatment of non-responders to previous treatment with the alternate antidepressant [733]. Third-line agents Intravenous clomipramine: In a RCT, intravenous (IV) clomipramine was more effective than placebo in patients with OCD (Level 2) [742]. Initiating therapy with IV then switching to oral therapy does not appear to be associated with greater benefit compared with oral therapy alone [743,744]. Other agents: IV citalopram [729] (Level 3), as well as duloxetine [734-736], tramadol [805,806], and tranylcypromine [739] (all Level 4) have demonstrated some efficacy in open trials or case reports. Results with phenelzine have been inconsistent. In one RCT, phenelzine was not significantly better than placebo [738], but in another it was as effective as clomipramine (Level 2) [737]. In the placebo-controlled trial, post-hoc analysis suggested that phenelzine may be beneficial in patients with symmetry or other atypical obsessions [738]. These agents are recommended as third-line options, and may be useful in refractory patients after first- and second-line monotherapies and adjuncts have been unsuccessful. Adjunctive therapy Adjunctive strategies have generally been studied in patients who have had an inadequate response to SSRI therapy, and can be considered for patients with treatment-resistant OCD. A meta-analysis demonstrated that response rates with adjunctive medication were twice those of placebo, however these were still quite low (31.8% versus 13.6%) [815]. Meta-analyses of RCTs found that adding risperidone (and possibly quetiapine) to antidepressants increased efficacy but decreased tolerability, while adjunctive olanzapine did not improve response rates [816,817]. First-line adjunctive therapies: In RCTs, adjunctive aripiprazole was significantly more effective than placebo (Level 1) [750,754], and may be as effective as risperidone [755]. Additional open-label data also support the beneficial effects of adjunctive aripiprazole [751-753]. As adjunctive therapy for treatment-resistant OCD, risperidone was more effective than placebo (Level 1) [756-759] and as effective as olanzapine [760] and aripiprazole overall [755]. Compared with aripiprazole, risperidone may provide greater improvement in obsessions [755]. Risperidone was also as effective as haloperidol for obsessions, but less so for compulsions, however it was better tolerated [758]. More recently an open, randomized study found that while augmentation with ERP was superior to risperidone or pill placebo, risperidone was not significantly more effective than placebo [761]. However, patients in this study had some response to SSRI therapy and may have been less refractory compared to those in Page 30 of 83 other studies. Considering the tolerability concerns of atypical antipsychotics, these data reinforce that this augmentation strategy should be reserved for patients with treatment-resistant OCD. Second-line adjunctive therapies: RCT evidence demonstrated that adjunctive memantine was superior to placebo (Level 2) [783]. Additional open-label data also support this therapy [622,781,782]. Another option which may be useful as an adjunctive therapy in those with refractory OCD is the atypical antipsychotic quetiapine (Level 1, conflicting) [728,746,747,764-766,768]. Data from small RCTs suggest that topiramate may be a useful adjunctive therapy, but data are conflicting (Level 1) [796,797]. In one RCT, adjunctive topiramate significantly improved Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores compared with placebo [797], while in another trial, adjunctive topiramate significantly improved compulsions but not obsessions [796]. Additional open-label data support the use of adjunctive topiramate [795,798]. Third-line adjunctive therapies: The agents discussed below are recommended as third-line adjunctive options, since some data are available to suggest they may be useful but there is conflicting or inadequate evidence to warrant stronger recommendations. These agents may be useful for some patients, but more data are needed. Other atypical antipsychotics have been assessed as adjunctive therapies in patients with refractory OCD, including olanzapine (Level 1, conflicting) [760,762,763], amisulpride (Level 3) [770], and ziprasidone (Level 4) [767]. There is level 2 evidence to support the use of adjunctive haloperidol in patients with refractory OCD [758,769], and although it may be as effective as adjunctive risperidone, it is a third-line choice because it was less well tolerated [758]. Adjunctive mirtazapine was associated with an earlier onset of response of OCD symptoms compared with citalopram alone, but there was no advantage of the combination over time (Level 2) [727]. Some data also support the efficacy of adjunctive citalopram for treatmentresistant OCD (Level 3) [730]. Adjunctive anticonvulsants may be useful for some patients with refractory illness [799-802]. In a small RCT, adjunctive lamotrigine improved both obsessions and compulsions compared to SSRI therapy (Level 2) [799]. Open-label data also suggest that adjunctive pregabalin may be useful (Level 3) [801,802]. Other agents that have been studied as adjunctive therapy for treatment-resistant OCD include celecoxib [777], granisetron [778], IV ketamine [779,780], ondansetron [784,785], N-acetylcysteine [786,787] (all Level 2), and riluzole (Level 3) [788,789]. There is little clinical experience with these agents for refractory OCD, Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 therefore they are recommended as third-line adjunctive options only. Results with pindolol augmentation have been inconsistent, with significant improvements in one small RCT [774], but not in other randomized or open trials (Level 1, conflicting) [775,776]. In two randomized, quetiapine-controlled trials, adjunctive clomipramine was not superior to SSRI therapy (Level 2, negative) [746,747]. Clinical experience suggests that some patients may benefit from adjunctive clomipramine; however, plasma levels should be monitored because of the risk of drug interactions with SSRIs [747,813]. Not recommended Clonazepam [771], clonidine [773], and desipramine (all Level 2, negative) [723,745] have not demonstrated efficacy and are not recommended in the treatment of OCD. Bupropion [749] and naltrexone (both Level 3, negative) [807] also do not appear to be effective in this disorder. Adjunctive buspirone [792,793], clonazepam [772] (Level 2, negative), or lithium [790,791] (Level 1, negative) have not demonstrated efficacy for the treatment of OCD. There is currently no evidence for the efficacy of adjunctive gabapentin (Level 3, negative) [803,804] or minocycline (Level 4, negative) [794], but there are insufficient data to make recommendations at this time. In a RCT, adjunctive once-weekly oral morphine was effective in patients who had failed six SSRI trials (Level 2) [808], however, morphine is not generally recommended because of its potential for abuse. Maintenance pharmacological treatment Long-term therapy has been evaluated in relapse prevention and naturalistic follow-up studies. Relapse-prevention studies are those in which responders to SSRI therapy are randomized to continued active treatment or placebo. A meta-analysis of six relapse prevention studies included 951 patients with OCD and found a highly significant reduction in relapse rates with continued SSRI treatment compared with placebo over six to 12 months (odds ratio for relapse was 0.38) [497]. In RCTs, escitalopram [818], paroxetine [722], sertraline [819], and high-dose fluoxetine [820] have demonstrated reductions in relapse rates. In RCT discontinuation studies, mirtazapine [748] and clomipramine [821] have demonstrated continued improvement compared with placebo over approximately six to 12 months. Additional data support the long-term efficacy of fluoxetine, fluvoxamine XR, and sertraline over six to 24 months [710,822-824]. Biological and alternative therapies Biological therapies: Biological therapies may be useful in patients with OCD who have not responded to CBT and multiple medication trials. Open trials have Page 31 of 83 suggested that rTMS may be a promising adjunctive therapy in patients with treatment-refractory OCD [825,826]. However, results of sham-controlled trials are conflicting, with some trials finding significant improvements [827,828] and others concluding that rTMS was ineffective for treatment-resistant OCD (Level 1, conflicting) [829-831]. Some data suggest that rTMS may improve comorbid depressive symptoms in patients with OCD [829,830]. Several very small studies have suggested that deep brain stimulation may improve symptoms and functionality in up to two-thirds of patients with highly treatment-refractory OCD (Level 4) [832-834]. Open trials suggest that capsulotomy (Level 3) [835-839] or cingulotomy (Level 3) [840-842] may be effective in reducing symptoms in patients with severe, treatment-refractory OCD, however these treatments are usually considered last resorts. Alternative therapies: A meta-analysis of meditation therapies found only two small studies and showed that transcendental meditation and Kundalini yoga were likely no more effective than other kinds of relaxation therapies in treating OCD (Level 3, negative) [843]. Open studies suggest that adjunctive moderate-intensity aerobic exercise may help improve OCD symptoms (Level 3) [844,845]. Small RCTs and open trials have suggested that herbal therapies such as milk thistle (Silybum marianum L. Gaertn.) (Level 2) [715], valerian root (Valeriana officinalis L.) (Level 2) [846], and St John’s wort (Hypericum perforatum) (Level 3) [847] may be useful in patients with OCD. Unfortunately, because these preparations are poorly standardized and have substantial variation in the proportion of the active ingredient in different products, they cannot be widely recommended. These therapies may be useful for some patients; however, more data are needed. Summary OCD is a relatively rare, yet severe, mental disorder, with an onset in the 20s or earlier. It is characterized by the presence of obsessions (persistent, intrusive thoughts) and/or compulsions (repetitive behaviors the individual feels compelled to perform). OCD is associated with substantial functional impairment and a high prevalence of comorbid disorders. CBT, and notably ERP, are effective first-line options for the treatment of OCD, being equivalent or superior to pharmacotherapy. CBT can be effectively delivered in both individual and group settings, as well as via self-exposure, self-help books, telephone, and internet-based programs. The benefits of CBT are maintained over one to five years of follow-up. The combination of psychotherapy and pharmacotherapy appears to be superior to pharmacotherapy Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 alone, but not to CBT alone, and data suggest that adding CBT to pharmacological treatment may yield better longterm outcomes. Pharmacotherapeutic approaches should begin with a first-line SSRI such as escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline. If response to optimal doses is inadequate or the agent is not tolerated, therapy should be switched to another first-line agent before considering second-line medications. Second-line choices include citalopram, clomipramine, mirtazapine, and venlafaxine XR. OCD can be difficult to treat; therefore, in order to preserve any benefits of a therapy, adjunctive strategies may be important early in treatment. Patients who do not respond to multiple courses of therapy are considered to have treatment-refractory illness. In such patients it is important to reassess the diagnosis and consider comorbid medical and psychiatric conditions that may be affecting response to therapy. Third-line agents, adjunctive therapies, as well as biological and alternative therapies may be useful when patients fail to respond to optimal treatment trials of first- and second-line therapies used alone and in combination. Posttraumatic stress disorder Epidemiology The lifetime prevalence of PTSD in Canada was estimated to be 9.2%, and current (1-month) rates were 2.4% [848]. Over 76% of Canadians reported exposure to a significantly traumatic event [848]. US and European community studies report lifetime prevalence rates of 6.4-6.8% and 12-month rates of 1.1-3.5% [2,849,850]. The most common forms of trauma resulting in PTSD included unexpected death of someone close, sexual assault, serious illness or injury to someone close, having a child with serious illness, and being beaten by a partner or caregiver [848-850]. Onset is generally in the mid to late 20s [2], and the prevalence is about twice as high among women versus men [849,851]. PTSD was associated with significant QoL [852] and functional impairments [848,853-855], which increase with increasing severity of symptoms [855]. In addition, PTSD is associated with high rates of chronic pain [856-859], sleep problems [860], and sexual dysfunction [861], as well as cognitive dysfunction [862,863] and alexithymia [864]. The risk of suicide attempts is increased two- to three-fold by the presence of PTSD [20,849,865]. In primary care, PTSD was associated with more and longer hospitalizations as well as a greater use of mental health care [866]. Among Canadian military personnel, greater use of mental health care was associated with cumulative lifetime trauma exposure, index trauma type, PTSD symptom interference, suicidal ideation, female gender, and comorbid MDD [867,868]. Page 32 of 83 Comorbidity An estimated 75% of patients with PTSD have another comorbid psychiatric disorder [3,848]; and rates are particularly high for other anxiety and related disorders [3,849,859,869,870], MDD [3,849,859,871,872], oppositional defiant disorder [3], ADHD [3], SUD [849], alcohol dependence [3,873], and borderline personality disorder (BPD) [874]. Comorbid panic or mood disorders have been associated with greater functional impairment than PTSD alone [870,871]. Patients with comorbid PTSD and BPD had a poorer QoL, more comorbidity with other psychiatric conditions, and increased odds of a lifetime suicide attempt versus patients with either condition alone [20,874]. Diagnosis By definition PTSD requires exposure to trauma, including actual or threatened death, serious injury, or sexual violation [26]. It is characterized by intrusive and distressing memories or dreams, dissociative reactions, and substantial psychological or physiological distress related to the event (Table 28) [26]. A diagnosis of PTSD requires the disturbances to be present for longer than one month; symptoms of >3 days but less than one month may be diagnosed as acute stress disorder (ASD), if the required ASD criteria are met [26]. Compared to the DSM-IV-TR [144], changes to the diagnostic criteria for PTSD in the DSM-5 include adjusting the symptom clusters, adding some new symptoms, and re-classifying PTSD as a ‘‘trauma- and stressor-related disorder’’ instead of an anxiety disorder [26,875]. In addition to PTSD, this new category also includes diagnostic criteria for reactive attachment disorder, disinhibited social engagement disorder, ASD, and adjustment disorders [26]. The DSM-5 diagnostic criteria for PTSD sharpens the definition of “traumatic event,” and there are now four symptom clusters rather than three with the “avoidance” and “numbing of responsiveness” being separated (Table 28). The DSM-5 also eliminated the acute and chronic PTSD specifiers. The PTSD diagnostic criteria apply to adults, adolescents, and children >6 years of age. A subtype has been added for children ≤6 years of age, as well as a dissociative symptoms specifier for patients of all ages [26]. While the most up-to-date DSM-5 diagnostic criteria are being presented here, it is important to note that the treatment data described within this section are based on patients meeting DSM-IV criteria (or older). PTSD is frequently comorbid with other psychiatric disorders, including other anxiety and related disorders, MDD, and SUDs, which may complicate diagnosis and management [849,859]. In addition, patients with PTSD frequently present with somatic symptoms and pain [859]. It is important to ask patients with psychological or somatic symptoms about trauma [32,859]. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 33 of 83 Table 28 DSM-5 diagnosis of PTSD • The person has been exposed to actual or threatened death, serious injury, or sexual violation in ≥1 of the following ways: ○ Directly experienced or witnessed the traumatic event, learned that trauma occurred to close family member or friend (actual or threatened death must have been violent or accidental), experienced repeated exposure to aversive details of trauma • Presence of ≥1 of the following intrusion symptoms associated with the trauma: ○ Recurrent, involuntary, and intrusive distressing memories, distressing dreams, dissociative reactions (e.g., flashbacks), psychological or physiological distress at reminders of trauma • Persistent avoidance of stimuli associated with the trauma, including ≥1 of the following: ○ Avoidance of distressing memories or feelings and external reminders (e.g., people, places) of the trauma • Negative alterations in cognitions and mood associated with the trauma, including ≥2 of the following: ○ Inability to recall important aspect of the trauma, diminished interest or participation in activities, feeling of detachment or estrangement from others, persistent negative beliefs, distorted blame, and negative emotional state • Marked alterations in arousal and reactivity associated with the trauma, including ≥2 of the following: ○ Irritable or aggressive behavior, reckless or self-destructive behavior, hypervigilance, exaggerated startle response, problems with concentration, sleep disturbance • Duration of disturbance >1 month • Symptoms cause clinically significant distress or impaired functioning • Specify whether with dissociative symptoms (depersonalization or derealization) or with delayed expression (full criteria not met until at least 6 months after the event) Adapted from DSM-5 [26]. Prevention and early intervention A number of studies have assessed early intervention with psychological and pharmacological strategies for the prevention of PTSD. Meta-analyses do not support the efficacy of wide spread use of single-session [876,877] or multiple-session [878] psychological debriefing after trauma in preventing or reducing the intensity of PTSD in individuals who have been exposed to a traumatic event but have not been identified as suffering from any specific psychological difficulties. In fact, these interventions may have an adverse effect on some individuals [876,878]. These findings pertain to individual debriefings only; there is insufficient evidence to comment on the utility of group debriefings. Conversely, meta-analyses have demonstrated the benefit of multisession trauma-focused-CBT (TF-CBT) in patients with ASD or PTSD [879,880]. Therefore, debriefing of all trauma victims is not recommended, rather, screening and treating appropriate individuals is preferred [876]. For the prevention of chronic PTSD in patients with ASD or acute PTSD, brief TF-CBT was more effective than both wait-list and supportive counseling interventions, but there was no evidence of the effectiveness of structured writing compared to minimal intervention [880]. There are few data on the use of pharmacotherapy for the prevention of PTSD. In a cohort study and a RCT, the early use of benzodiazepines following trauma was not beneficial, and may increase the risk of developing PTSD [881,882]. Similarly, retrospective data suggested that gabapentin or pregabalin had no effect on PTSD development [883]. Data from cohort studies on the use of the beta-blocker propranolol have been conflicting [884-888], but one small RCT did show a significant decrease in the severity of PTSD symptoms and lower likelihood of developing subsequent PTSD [889]. SSRI therapy was significantly more effective than placebo in preventing PTSD symptoms according to parent reports but not child reports in a RCT in children [890]. Cohort studies suggest that the early use of morphine during trauma care may reduce the risk of the subsequent development of PTSD in children and adults [891-894]. Psychological treatment Psychological therapies for PTSD generally include education about the disorder and its treatment, as well as exposure to cues relating to the traumatic event. Psychotherapy has demonstrated significant efficacy, although a metaanalysis suggested it may be less effective than pharmacotherapy in improving PTSD and comorbid depression symptoms [895]. Meta-analyses of over 30 RCTs of psychological interventions provide evidence of the efficacy of several CBT approaches for the management of chronic PTSD compared with wait-list or usual care control groups [66,67]. There was evidence that individual TF-CBT, EMDR, stress management, and group TF-CBT were effective, while other nontrauma focused psychological treatments (supportive therapy, nondirective counseling, psychodynamic therapy, and hypnotherapy) did not reduce PTSD symptoms as significantly [66,67]. Individual TF-CBT and EMDR appeared to be equally effective, but superior to stress management in the treatment of PTSD [66]. Another meta-analysis also found EMDR and TF-CBT were equally effective [68]. However, in a head-to-head RCT, EMDR resulted in faster recovery compared with the more gradual improvement with brief TF-CBT [896]. Cognitive therapy approaches have been used effectively in treating PTSD following sexual or interpersonal violence [897-901], civilian trauma [902-908], and military trauma [909-914]. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Cognitive processing therapy (CPT) is an effective protocol that combines cognitive therapy and written accounts [899-901,910-913]; however, an analysis of the components found no differences in outcomes with either component alone or the combined protocol [899]. Prolonged exposure (PE) is a widely studied CBT approach. A meta-analysis of 13 RCTs concluded that PE therapy was more effective than wait-list or psychological placebo control conditions, and as effective as other active treatments (e.g., CBT, CPT, EMDR) [69]. One study found that 30-minute imaginal exposure sessions were as effective as 60-minute sessions [915]. Imaginal appears to be as effective as in vivo exposure [69,916]. Data are conflicting as to the benefits of adding cognitive restructuring to exposure therapy; several studies suggest that exposure alone is superior to the combination [917-919], however, another large RCT found the combination to be significantly better than imaginal or in vivo exposure alone [916]. When used as an adjunct to exposure therapy, cognitive restructuring may improve non-fear problems like anger and guilt, and may be a useful adjunct in patients in which these emotions predominate [920,921]. Similarly, the addition of social emotional rehabilitation to exposure therapy did not improve PTSD symptoms but did improve social functioning in male combat veterans with chronic PTSD [922]. Meta-analyses and systematic reviews reveal two current limitations of CBT for PTSD. The first is that about one-third to one-half of patients experience substantial residual symptoms and functional impairments posttreatment, still report symptoms meeting diagnostic criteria at follow-up, or relapse and require booster sessions [923-925]. The second issue pertains to external validity. While CBT for PTSD has been shown to be efficacious in RCTs, there is a dearth of effectiveness studies to suggest that CBT can be generalized to many patients commonly found in clinical practice. Many RCTs have excluded patients with complex clinical profiles including childhood abuse histories, current SUDs, personality disorders, suicidality or self-injurious behavior, homelessness, refugees, intimate partner violence, and significant dissociative symptoms among others [926,927]. In this regard, Bradley et al. [923] found a positive association between the number of exclusion criteria and the strength of effect sizes, such that studies with stricter inclusion criteria tended to report larger treatment effects. Additionally, numerous studies fail to report whether patients experience any adverse effects from psychological treatments [66], or whether dropout rates (ranging between 0-50%) result from treatment demands. Dialectical behavior therapy (DBT), which was developed to reduce self-harm behavior in patients with BPD, was shown to be useful in patients with PTSD [928-930]. When used as a pretreatment, DBT reduced self-harm Page 34 of 83 behaviors allowing over half of patients to become suitable candidates for PTSD treatment [929]. Another study [931] demonstrated some success with PE treatment of PTSD and comorbid substance abuse. Results of a recent expert clinician survey on best practices suggests that CBT is useful for fear-based PTSD, while this treatment approach may require an additional treatment module targeting affective regulation for patients presenting with a diagnosis of Disorders of Extreme Stress (DESNOS) or complex PTSD [932]. Internet-based treatments are being increasingly investigated, in part because they can be administered remotely and anonymously to under-served or disaster-stricken areas at a relatively low-cost [933]. RCTs have shown that therapist-assisted ICBT is more effective than wait-list or supportive care control strategies in improving PTSD symptoms, depression, anxiety, and disability [934-940]. In addition, a strong therapeutic relationship can be established through the internet, which improved the treatment process [936]. VRE therapy has also demonstrated some utility in improving PTSD symptoms [941-943]. Compared to face-to-face CBT, video-conference CBT was equally effective [944] but telehealth CBT was less effective [914]; however, both were effective compared with pre-treatment. Combined psychological and pharmacological treatment Research evaluating combined treatment in PTSD is limited; a meta-analysis found only four small trials [945]. Combination SSRI plus psychotherapy was not superior to psychotherapy alone in two RCTs [946,947], but was superior to pharmacotherapy alone in the other two trials [948,949]. In contrast, a more recent RCT found that combination therapy was superior to psychotherapy alone [950]. The role of combining psychotherapy and medication requires further study. Adjunctive propranolol with trauma reactivation therapy was found to help prevent reconsolidation of the traumatic memory and thus decreased physiological responses and PTSD symptoms during subsequent follow-up in randomized and open trials [951,952]. Two RCTs have found that use of d-cycloserine did not enhance the overall treatment effects of exposure therapy [953,954], and may in fact decrease response to psychotherapy [954]. Long-term effects of psychological treatment Open follow-up data of psychological treatments suggest that benefits are maintained at six- to 18-month assessments after treatment [923,955-958]. Longer-term follow-up of patients treated with EMDR showed that benefits were maintained at three years, with the majority of patients who had initially remitted being at full working capacity [959]. Very long-term follow-up showed that improvements in PTSD and related symptoms achieved with CPT and PE were maintained over an extended five to 10 year period [901]. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 35 of 83 Pharmacological treatment The management of patients with PTSD should follow the principles discussed in Section 2. Pharmacological interventions that have good evidence for efficacy in treating PTSD include fluoxetine, paroxetine, sertraline, and venlafaxine XR. Treatments that have been investigated for use in PTSD have been assessed according to the criteria for strength of evidence (Tables 1 and 2) and are summarized in Tables 29 and 30. First-line agents Antidepressants (SSRIs & SNRIs): Evidence from metaanalyses [895,1060] and RCTs supports the use of the SSRI paroxetine [966-970] and the SNRI venlafaxine XR [975,989] (both Level 1) for the first-line treatment of PTSD. Data with fluoxetine are mixed, with both positive [960-962] and negative [963-965] RCTs (Level 1, conflicting). Similarly, RCTs with sertraline have yielded both positive [971,972,975,976,978] and negative [973,974,977] results (Level 1, conflicting). However, there appear to be sufficient data from the larger RCTs to suggest that these agents can be effective first-line options. Conflicting results may be related to the types of traumas, symptom clusters, and comorbidities included in the various studies. Second-line agents Antidepressants: The efficacy of mirtazapine was demonstrated in one small RCT (Level 2) [1000] and three open trials [999,1001,1002]. In a randomized, open-label Table 29 Strength of evidence of pharmacotherapy for core symptoms of PTSD Agent Level of evidence Agent Level of evidence Antidepressants SSRIs TCAs Fluoxetine [960-965] 1* Imipramine [992,993] Paroxetine [966-970] 1 Amitriptyline [994] 2 Sertraline [971-978] 1* Desipramine [970,995] 2* Fluvoxamine [979-984] Escitalopram [985] Citalopram [974,986,787,988] 2 3 2 (-ve) SNRIs 1 MAOIs and RIMAs Phenelzine [992,993,996] Moclobemide [997,998] 1* 3 Other antidepressants Venlafaxine XR [975,989] 1 Mirtazapine [999-1002] 2 Duloxetine [990,991] 3 Reboxetine [984] 2 Bupropion SR [1003] 3 Tianeptine [997,1004] 3 Adjunctive bupropion SR [1005] 2 (-ve) Other therapies Anxiolytics Anticonvulsants Benzodiazepines Topiramate [1009,1010] 1* Alprazolam [1006] 2 (-ve) Lamotrigine [1011] 2 Clonazepam [881,1007,1008] 3 (-ve) Carbamazepine [1012,1013] Atypical antipsychotics 3 Divalproex [1014-1017] 1 (-ve) 2 (-ve) Risperidone [1030] 2 Tiagabine [1018] Aripiprazole [1031-1033] Quetiapine [1034,1035] 3 3 Adjunctive gabapentin [1019,1020] Adjunctive levetiracetam [1021] 4 4 Olanzapine [1036-1038] 2 (-ve) Adjunctive pregabalin [1022] 4 Adjunctive risperidone [1039-1044] 1* Adjunctive tiagabine [1023-1025] Adjunctive olanzapine [1045] 2 Adjunctive topiramate [1026-1029] 4 2 (-ve) Adjunctive aripiprazole [1033,1046,1047] 3 Other treatments Adjunctive quetiapine [1048-1050] 3 Buspirone [1051,1052] 4 Trazodone [1053] 4 Memantine [1054] Adjunctive eszopiclone [1055] 4 2 Adjunctive clonidine [1056] 3 Adjunctive guanfacine [1057,1058] 1 (-ve) Adjunctive zolpidem [1059] 2 (-ve) *Conflicting data. MAOI = monoamine oxidase inhibitor; RIMA = reversible inhibitor of monoamine oxidase A; SNRI = serotonin–norepinephrine reuptake inhibitor; SR = sustained release; SSRI = selective serotonin reuptake inhibitor; TCA = tricyclic antidepressant; XR=extended release; (-ve) = negative. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 36 of 83 Table 30 Recommendations for pharmacotherapy for core symptoms of PTSD First-line Fluoxetine, paroxetine, sertraline, venlafaxine XR Second-line Fluvoxamine, mirtazapine, phenelzine Third-line Amitriptyline, aripiprazole, bupropion SR, buspirone, carbamazepine, desipramine, duloxetine, escitalopram, imipramine, lamotrigine, memantine, moclobemide, quetiapine, reboxetine, risperidone, tianeptine, topiramate, trazodone Adjunctive therapy Second-line: eszopiclone, olanzapine, risperidone Third-line: aripiprazole, clonidine, gabapentin, levetiracetam, pregabalin, quetiapine, reboxetine, tiagabine Not recommended: bupropion SR, guanfacine, topiramate, zolpidem Not recommended Alprazolam, citalopram, clonazepam, desipramine, divalproex, olanzapine, tiagabine SR = sustained release; XR = extended release. trial, response rates were significantly higher with mirtazapine than sertraline [1001]. Fluvoxamine demonstrated efficacy for PTSD in open trials [979-983], and in a RCT was as effective as reboxetine (Level 2) [984]. Phenelzine was more effective than placebo in two RCTs [992,993], but not significantly different from placebo in a RCT crossover study (Level 1, conflicting) [996]. Caution is needed when using MAOIs because of the dietary restrictions and potential for drug interactions. Third-line agents The following agents are recommended as third-line options because of limited data, side effects, or lack of clinical experience as a primary therapy for the treatment of PTSD. Antidepressants: In small RCTs, imipramine (Level 1) [992,993] and amitriptyline (Level 2) [994] demonstrated some efficacy in patients with PTSD. Data with desipramine are mixed, with one RCT showing significant benefit, which were comparable to paroxetine [970], and the other showing improvements in depression only [995]. While RCTs with the TCAs suggest some benefit with these agents, it appears to be limited. Reboxetine and fluvoxamine were equally effective in a small RCT (both Level 2) [984], and open-label studies suggest that bupropion SR [1003], duloxetine [990,991], escitalopram [985], moclobemide [997,998], and tianeptine [997,1004] (all Level 3) may be useful in PTSD. Anticonvulsants: Data on topiramate are mixed, with one RCT finding significant benefits over placebo [1010], while the other did not [1009] (Level 1, conflicting). There are also limited data suggesting efficacy of other anticonvulsants, including lamotrigine (Level 2) [1011] and carbamazepine (Level 3) [1012,1013]. Atypical antipsychotics: Some data suggest that the atypical antipsychotics, risperidone (Level 2) [1030], aripiprazole (Level 3) [1031,1032], and quetiapine (Level 3) [1034,1035] may be a useful alternative to SSRIs for some patients with PTSD. A meta-analysis of seven RCTs using atypical antipsychotics, either as monotherapy or adjunctively, concluded that these agents may be beneficial in the treatment of PTSD, particularly for the symptom of “intrusion” [1061]. Other therapies: Small, open case series have suggested benefits with trazodone [1053], buspirone [1051,1052], and memantine [1054] (all Level 4). Adjunctive therapies Adjunctive strategies have generally been studied in patients who have had an inadequate response to adequate antidepressant therapy, and can be considered for patients with treatment-resistant PTSD. Second-line adjunctive therapies: In a RCT, adjunctive eszopiclone was significantly more effective than placebo in improving PTSD and sleep symptoms (Level 2) [1055]. There is RCT evidence for the use of adjunctive atypical antipsychotics, including risperidone (Level 1, conflicting) [1039-1044] and olanzapine (Level 2) [1045], for patients with treatment-resistant PTSD. While a number of small RCTs demonstrated benefits with adjunctive risperidone [1039-1042], a large, six-month trial in approximately 250 patients failed to show improvements in PTSD symptoms compared with placebo [1043]. Third-line adjunctive therapies: Open-label trials and case series suggest that adjunctive quetiapine [1048-1050] or aripiprazole [1033,1046,1047] (both Level 3) are useful in patients with refractory PTSD. Similarly, there are some data suggesting adjunctive anticonvulsants including: gabapentin [1019,1020], levetiracetam [1021], pregabalin [1022], or tiagabine [1023-1025] (all Level 4), as well as the alpha-adrenergic agonist clonidine (Level 3) [1056], can improve symptoms in patients with treatment-resistant PTSD. Not recommended adjunctive therapies: Small RCTs failed to show the superiority of adjunctive therapy with guanfacine (Level 1, negative) [1057,1058], bupropion SR [1005] (Level 2, negative), or zolpidem [1059] (Level 2, negative). While case series suggested that adjunctive topiramate [1026,1027,1029] may be effective in treatment-resistant PTSD, a RCT failed to show superiority over placebo [1028] (Level 2, negative). Treatments for specific PTSD-associated symptoms Several agents have been used to target particular symptoms associated with PTSD. Prazosin has demonstrated significant efficacy for reducing trauma nightmares and improving sleep quality in patients with PTSD compared Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 with placebo (Level 1) [1035,1062-1066]. Some openlabel data suggest that naltrexone may help reduce flashbacks (Level 3) [1067-1070], and fluphenazine may improve trauma re-experiencing symptoms (Level 3) [1037]. Cyproheptadine was not effective for nightmares or sleep problems in patients with PTSD and may actually exacerbate sleep disturbance (Level 2, negative) [1071]. Not recommended In general, data do not currently support the use of divalproex [1014-1017] (Level 1, negative), alprazolam [1006], citalopram [974,986-988], olanzapine [1036-1038], tiagabine [1018] (all Level 2, negative), or clonazepam (Level 3, negative) [881,1007,1008]. Maintenance pharmacological treatment Long-term therapy has been evaluated in relapseprevention and naturalistic follow-up studies. Relapseprevention studies are those in which responders to SSRI therapy are randomized to continued active treatment or placebo. A meta-analysis of three relapseprevention studies included 272 patients with PTSD, and found a highly significant reduction in relapse rates with continued SSRI treatment compared with placebo over approximately six months (odds ratio for relapse was 0.25) [497]. In RCT discontinuation studies, fluoxetine [1072,1073] and sertraline [1074] have demonstrated significantly lower relapse rates over six months in the range of 5-22% with active treatment compared to 16-50% with placebo [1072-1074]. However, in a small discontinuation RCT, tiagabine was not superior to placebo in preventing relapse [1075]. Open follow-up studies with paroxetine [1076] and sertraline [1077] have demonstrated sustained and continued improvement over six to 12 months of continued SSRI therapy. Biological and alternative therapies In general, these therapies may be useful for some patients; however, more data are needed. Biological therapies: In RCTs, rTMS was effective as monotherapy or as an adjunct to SSRIs in patients with PTSD (Level 1) [1078-1080], and at least some improvements were maintained at two to three months after treatment [1078,1079]. Open prospective and retrospective data suggest that adjunctive electroconvulsive therapy may be helpful in patients with refractory PTSD (Level 3) [1081,1082]. Alternative therapies: In a RCT, acupuncture was more effective than a wait-list control and as effective as group CBT (Level 2) [1083]. Adjunctive use of symptom-oriented hypnotherapy [1059] or mantra repetition [1084] (both Level 2) improved PTSD symptoms in small trials; and in a small case series, patients with Page 37 of 83 PTSD benefited from transcendental meditation (Level 4) [1085]. Summary The lifetime prevalence of PTSD is around 6-9%; it is more frequent in women than in men, with an onset generally in the mid to late 20s. PTSD is associated with high rates of functional impairment, somatic complaints, suicide risk, and comorbid psychiatric disorders. A diagnosis of PTSD requires evidence of exposure to trauma, and is characterized by intrusive and dissociative symptoms. Evidence does not support the wide spread use of early intervention with psychological strategies for the prevention of PTSD. Debriefing of all trauma victims is not recommended, rather, screening and treating appropriate individuals is preferred. In general, there is little evidence supporting the use of pharmacotherapy for the prevention of PTSD, with most studies suggesting no preventive benefits. CBT is an effective first-line option for the treatment of PTSD. Effective approaches include TF-CBT, EMDR, PE, and stress management therapy. ICBT and VRE have also demonstrated efficacy. Benefits are maintained during long-term follow-up of up to one to 10 years after treatment. Research evaluating combined psychological and pharmacological treatments in PTSD is limited, and this requires further study. Pharmacotherapeutic approaches should begin with one of the first-line options which include SSRIs such as fluoxetine, paroxetine, or sertraline, or the SNRI venlafaxine XR. If response to optimal doses is inadequate or the agent is not tolerated, therapy should be switched to another first- or second-line agent, or a second-line agent should be added. Patients with PTSD may make few gains during treatment, and it is important to preserve even small gains achieved with initial therapy. Therefore, augmentation with second- or third-line agents may be important early in treatment. Patients who do not respond to multiple courses of therapy are considered to have treatment-refractory illness. In such patients it is important to reassess the diagnosis and consider comorbid medical and psychiatric conditions that may be affecting response to therapy. Third-line agents, adjunctive therapies, as well as biological and alternative therapies may be useful when patients fail to respond to an optimal treatment trial of first- and second-line therapies used alone and in combination. Special populations Women during pregnancy and the postpartum period Epidemiology Women have been found to be at higher risk for anxiety and related disorders than men [2]. Anxiety disorders during the perinatal period are increasingly gaining Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 research attention. Although further investigation is needed, data from a large national survey suggest the overall prevalence of anxiety and related disorders is unchanged in women during pregnancy [1086]; however, other data have found an increased risk for individual disorders, such as GAD [1087,1088]. Similarly, some data suggest that anxiety disorders are also not more prevalent during the postpartum period [1086], but other studies suggest higher rates of OCD and GAD during this period [1089,1090]. In addition, PTSD can develop as a result of pregnancy complications that are experienced as traumatic [1091,1092]. Anxiety and related disorders during pregnancy or postpartum may have a negative impact on the pregnancy, the child, or the mother. While studies report that maternal anxiety disorders are associated with adverse pregnancy outcomes such as a shorter gestational age, premature delivery, or elective cesarean delivery [1093-1095], a meta-analysis found no relationship between anxiety symptoms per se and adverse perinatal outcomes [1096]. Anxiety symptoms during pregnancy have been associated with depressive symptoms, substance use, and anemia, as well as decreased use of prenatal vitamins [1093,1097-1099]. Parenting may also be affected by maternal anxiety and related disorders. Mothers with anxiety disorders have been found to be less promoting of psychological autonomy than those mothers without anxiety [1100]. Maternal anxiety has been found to be predictive of child cognitive development [1101], associated with behavioral/emotional problems in childhood [1101,1102], and maternal anxiety and related disorders have been found to be related to subsequent development of an anxiety disorder in the child [1103]. Treatment issues Psychosocial treatments, with CBT specifically, have strong empirical support for the treatment of anxiety and related disorders [63,70,71,1104], but evidence of their efficacy in perinatal women with anxiety disorders is lacking. Cohort studies have shown beneficial effects of group CBT in pregnant women with B-I-I phobia [1105], and individual CBT in women with OCD in the postnatal period [1106]. Arch et al. argued that although exposurebased CBT or behavioral therapy may have been avoided in the past because of concerns of potential harm, they likely can be viable, safe alternatives in pregnancy [1107]. The lack of data on the use of structured psychosocial interventions for anxiety and related disorders during the perinatal period is a significant gap in the literature. It is important to consider the risks and benefits of pharmacotherapy during pregnancy and while breastfeeding during the postpartum period. Risks to the fetus and newborn should be weighed against that of the potential harm of untreated anxiety and related disorders, an area Page 38 of 83 that is gaining increasingly more research attention. Treatment decisions should attempt to optimize outcomes for both mother and baby. Detailed recommendations on the use of psychiatric medications during pregnancy and lactation are available from the American Congress of Obstetricians and Gynecologists (ACOG) Practice Bulletin [1108]. Although it is over five years old, risks associated with various psychotropic medications are summarized [1108]. The FDA pregnancy risk category system has been criticized as being insufficient [1109] and is currently under the process of revision. The Canadian Hospital for Sick Children Motherisk website (http://www.Motherisk.org) is also a useful resource. Antidepressants: There appears to be little evidence of an association between maternal antidepressant use and increased risks of congenital malformations in general, and major congenital malformations in infants [1110-1113]. The exception is a statistically increased risk of cardiac defects with antidepressants, and with paroxetine specifically, although the clinical significance of this has been questioned [1108,1113-1117]. There have been reports of increased rates of spontaneous abortion following antidepressant use during pregnancy; in the most recent metaanalysis, this was not supported using data from studies with higher study quality but found by others who included all studies [1118-1120]. In terms of delivery outcomes, a recent meta-analysis found a statistically increased risk for preterm birth, lower gestational age, birth weight, and APGAR scores – but the effects were small, generally in the normal range, and of questionable clinical significance [1118]. However, data support an increased risk for poor neonatal adaptation syndrome (PNAS) [1121-1123], while findings of increased risk for persistent pulmonary hypertension in the antenatally exposed infant have not been consistent [1124-1127]. Systematic reviews suggest that overall prenatal exposure to antidepressants does not appear to be associated with changes in long-term neurocognitive or behavioral development in children [1128-1130] and that illness itself appears to play a role in negative outcomes (although this study examined the effects of maternal depression) [1131]. Two reports link prenatal antidepressant use to childhood autism spectrum disorders [1132,1133] and two others link bupropion exposure to childhood ADHD [1134,1135]. These studies have limitations and further research is required. In terms of breastfeeding, potential risks of antidepressant use during lactation must be weighed against the recognized benefits for the infant. Antidepressants are excreted into breast milk and although data are limited, the majority are found in very low amounts with few isolated instances of adverse signs [1108]. If antidepressant treatment is indicated, sertraline or paroxetine is preferred [1136]. Long-term data on potential neurobehavioral Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 39 of 83 effects are lacking. Clinicians can consult LactMed at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT for the latest information available. Benzodiazepines: The data on benzodiazepines remain more limited. A recent meta-analysis did not find an increased risk of major malformations or cardiac defects following prenatal benzodiazepine exposure, but concluded the significant increase in risk of oral cleft remains based on data derived from case-control studies [1137], although another meta-analysis reported the absolute risk is small (<1%) [1138]. A case-control study published in 2002 examining exposure to five benzodiazepines (including clonazepam) and not included in the above meta-analyses, with over 60,000 infants, did not find an association with various congenital malformations or oral clefts [1139]. Although there are a lack of meta-analytic data, neonatal withdrawal or toxicity syndrome has been described with antenatal benzodiazepine exposure and close monitoring of the infant has been recommended [1108]. The neurobehavioral effects on the child over the long-term due to antenatal exposure have been topics of debate and remain uncertain [1108]. Benzodiazepines are excreted into breast milk at low levels generally. A recent study with 124 mothers documented low levels of adverse effects (sedation in particular) and supported the initiation of breastfeeding [1140]. Caution may be advised regardless however in infants who poorly metabolize benzodiazepines [1108]. Atypical antipsychotics: Data on the use of antipsychotics during pregnancy continue to be limited [1141]. Thus far, there does not appear to be an increased risk for malformations although inconsistent data have been reported with some suggesting the data are inconclusive [1141-1143]. These drugs have been found to be associated with both increased and decreased birth weight as well as increased risk for preterm birth [1144-1149]. The second-generation antipsychotics can increase the risk of complications given the risk of metabolic syndrome, and thus diabetes, in the mother. Monitoring has been recommended [1150]. Both the FDA and Health Canada have issued safety alerts advising of the potential risk for abnormal muscle movements and withdrawal symptoms in infants exposed to antipsychotic medications during the 3 rd trimester of pregnancy [1151-1153]. Data on breastfeeding are more limited, but levels in breast milk have typically been shown to be low although adverse effects have been reported [1154]. be counseled about PNAS and its management. Less is known about the risk of benzodiazepine and atypical antipsychotic exposure during pregnancy as the data are more limited. Treatment must be individualized and decisions should be made with the most up-to-date information with the best course of action decided upon with the patient. Poorly or untreated psychiatric illness carries its own risks, both in the short- and long-term. Summary The management of anxiety and related disorders in women who are pregnant or lactating requires careful consideration of both the potential risks of any treatment option as well as risks of an untreated anxiety disorder. Antidepressants are generally associated with low teratogenic risk and adverse delivery outcomes. Patients should Children and adolescents Epidemiology Anxiety and related disorders were the most common psychiatric disorders noted in the National Comorbidity Survey-Adolescent supplement (NCS-A) (age 13-18 years), with a lifetime and 12-month prevalence of 31.9% and 24.9%, respectively [1155,1156]. Prevalence rates for individual anxiety and related disorders are shown in Table 31 [1155,1156]. Specific phobias are very common in children. However, although most adolescents reported at least one fear (77%), lifetime prevalence rates are in the range of 10-35% [308,1156]. A study including children as young as five years of age found lower rates of diagnosed specific phobias (1%) [1157]. B-I-I and animal fears are the most common types reported in pediatric populations [308,1157]. The prevalence of OCD is only 0.25% in children [1158], but is 1-2% in adolescents, which is comparable to the rate seen in adults [2,1159,1160]. In the adolescent population, anxiety and related disorders were found to have the earliest median age of onset (six years), compared to other psychiatric disorders (11-15 years) [1156]. Similarly, in the adult population, the median age of onset was earliest for anxiety and related disorders (11 years) compared to other psychiatric disorders (20-30 years) [2]. Separation anxiety disorder and the phobias (seven to 14 years) have much earlier median ages of onset compared to OCD, GAD, panic disorder, or PTSD (20-30 years) [1,2,1161]. Anxiety and related disorders can have a substantial long-term impact, putting children at elevated risk for Table 31 Prevalence estimates of anxiety and related disorders among youths in the NCS-A (age 13-18 years) Anxiety and related disorder Estimated prevalence (%) 12-month Lifetime Any anxiety disorder 24.9 31.9 Separation anxiety disorder 1.6 7.6 Specific phobia Social anxiety disorder 15.8 8.2 19.3 9.1 Posttraumatic stress disorder 3.9 5.0 Panic disorder 1.9 2.3 Generalized anxiety disorder 1.1 2.2 Adapted from references [1155,1156]. NCS-A = National Comorbidity SurveyAdolescent supplement Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 MDD, other anxiety disorders, and SUD in adulthood [11,12]. Anxiety and related disorders among younger patients are associated with high rates of comorbid psychiatric conditions [1162-1165], SUD [1166-1169], sleep problems [1170-1173], somatic symptoms [1174], and suicidality [1175], as well as problems with cognition/ attention [1164,1176,1177], academic performance [1178,1179], and peer relationships [1180]. Diagnostic issues Diagnostic evaluation of pediatric patients should be based on DSM-5 criteria, but use developmentally appropriate language, and consider collateral information from parents and teachers. Children may express anxiety through crying, tantrums, freezing, or clinging, as well as through play. The DSM-5 provides some modifications to adult criteria to assist in the diagnosis of anxiety and related disorders in children (Table 32) [26]. In particular, a separate subtype for patients ≤6 years of age has been added to the criteria for PTSD to make it more developmentally sensitive to young children [26]. Prevention strategies Psychoeducational programs for children and adolescents aimed at preventing the development of an anxiety or related disorder have shown small, but significant effects [1181]. Both universal (administered to all children within target population) [1182] and indicated prevention programs (administered to children demonstrating highly Page 40 of 83 anxious symptoms) [1183,1184] demonstrate benefits, but indicated programs are associated with larger effect sizes than universal programs [1181]. Both psychological and pharmacological strategies have been assessed for the prevention of PTSD. An early psychological intervention with children involved in road traffic accidents failed to result in any significant benefits over a control group [1185]. In a RCT in burn victims, sertraline was more effective in preventing PTSD symptoms than placebo according to parent report but not child report [890]. Data do not support the use of propranolol in preventing PTSD [1186] or ASD [886] in pediatric injury patients. Treatment issues Psychological treatment Psychological therapies for children often need to be adapted to suit the chronological and developmental ages of young patients and to include parental involvement. Meta-analyses support the efficacy of CBT for the treatment of anxiety and related disorders in children and adolescents [1187-1191]. A meta-analysis of 24 clinical trials showed that almost 70% of youths who received CBT no longer met diagnostic criteria for their anxiety disorder compared to only 13% of wait-list controls [1189]. Meta-analyses and RCTs have confirmed the efficacy of CBT in children with SAD [1192-1197], panic disorder [1198], OCD [1199-1204], PTSD [946,1205-1211], school refusal [1212-1215], and separation anxiety disorder [1216]. Table 32 DSM-5 diagnostic criteria for anxiety and related disorders specific to children Anxiety or related disorder DSM-5 diagnoses specific to children Separation anxiety disorder • Developmentally inappropriate and excessive fear or anxiety concerning separation from those to whom the individual is attached, as evidenced by ≥3 of the following: ○ Distress when separation occurs, worry about loss or separation, reluctance to leave home, be alone, or go to sleep because of fear of separation, nightmares involving separation, or complaints of physical symptoms (e.g., headaches, upset stomach) when separation occurs • Duration of at least 4 weeks • Onset before 18 years of age • The disturbance causes clinically significant distress or impairment in social, academic (occupational), or other important areas of functioning Selective mutism • Consistent failure to speak in specific social situations in which there is an expectation for speaking (e.g., at school) despite speaking in other situations Anxiety or related disorder Changes to adult DSM-5 diagnostic criteria specific to children Specific phobia • The fear or anxiety may be expressed by crying, tantrums, freezing, or clinging • Other specifiers: loud sounds or costumed characters SAD (social phobia) • The anxiety must occur in peer settings, not just during interactions with adults • The fear or anxiety may be expressed by crying, tantrums, freezing, clinging, shrinking, or failure to speak in social situations OCD, panic disorder • No pediatric specific criteria PTSD • Qualifiers in children ○ Intrusion symptoms: repetitive play may occur in which themes or aspects of the traumatic event(s) are expressed; there may be frightening dreams without recognizable content; trauma-specific re-enactment may occur in play • Specific subtype for children ≤6 years of age GAD • Less stringent criteria for symptoms than in adults Adapted from DSM-5 [26]. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 CBT has demonstrated efficacy in both group and individual formats [1189,1190,1194,1217,1218], as well as in computer- or internet-based formats [1219,1220]. One commonly used pediatric CBT protocol is the “Coping Cat” program [1221,1222], which has demonstrated efficacy in RCTs [1221,1223,1224] and in longterm follow-up studies [1222,1225]. In a RCT, Coping Cat CBT was as effective as pharmacotherapy with an SSRI, but less effective than combination therapy [1223,1224]. Additional specific psychological approaches that have demonstrated efficacy in treating anxiety in children and adolescents include: attention bias modification (ABM) [1226], MBCT [1195], and social effectiveness therapy (SET) [1227,1228] for SAD; ERP [1229,1230], family-based CBT [1231,1232], and meta-cognitive therapy [1229] for OCD; cognitive behavioral writing therapy (CBWT) [1233], spiritual-hypnosis assisted therapy (SHAT) [1234], emotion regulation therapy [1235], exposure therapy [1236], and EMDR [905,1237,1238] for PTSD; and exposure therapy for specific phobias [313]. Approaches that include parental or family involvement may have some additional benefit over strategies that include children only [1239-1245], especially when parents suffer from an anxiety or related disorder themselves [1246]. Parental training only has also demonstrated beneficial effects on children with an anxiety disorder [1247,1248]. The presence of comorbidities may have a negative impact on the efficacy of CBT in pediatric patients [1249]. However, integrated CBT protocols designed to target both conditions have demonstrated efficacy in youths with anxiety and related disorders and comorbid ADHD [1250], aggression [1251], or comorbid SUD [1252]. Long-term follow-up studies have shown sustained benefits of CBT over two to seven years posttreatment [1218,1225,1228,1253,1254]. Pharmacological treatment Complete treatment recommendations for the management of anxiety and related disorders in youths are beyond the scope of these guidelines and the reader is referred to specific guidelines for the assessment and treatment of children and adolescents with anxiety disorders, such as those developed by the American Academy of Child and Adolescent Psychiatry (AACAP) [1255-1258]. For children and adolescents, psychological treatments are generally preferred over pharmacotherapy, or if warranted combination therapy may be an option. RCTs comparing combined pharmacological and psychological treatments in younger patients with anxiety have demonstrated efficacy equal or superior to either treatment alone [1199,1223,1224,1259]. In the pediatric population, safety concerns associated with antidepressants (see “Safety Issues”) should be weighed against the potential benefits of therapy. Medication may be warranted in children and adolescents with severe impairment or those Page 41 of 83 who are unlikely to respond to CBT due to cognitive or other issues. A “start low and go slow” approach is advised when using medications in this patient population. The strength of evidence for pharmacotherapeutic agents in the treatment of pediatric patients is shown in Table 33. When pharmacotherapy is felt to be warranted, SSRIs are generally preferred for children and adolescents with anxiety and related disorders. Antidepressants: SSRIs and TCAs have been well studied in pediatric patients with anxiety and related disorders (Table 33) [1260-1262], although these agents should be used with caution in youths as discussed in the section on safety issues below. Most of the data in pediatric patients are in those with OCD [1204,1261,1263] or SAD [1197]. There is good evidence for the efficacy of SSRIs in children and adolescents with OCD, including fluoxetine (Level 1) [1264-1269], citalopram (Level 2) [1264,1270], fluvoxamine (Level 2) [1271], paroxetine (Level 2) [1272], and sertraline (Level 2) [1273], as well as for the TCA clomipramine (Level 1) [1274-1276]. Similarly, there is good evidence for the efficacy of SSRIs in SAD, including fluoxetine (Level 1) [1227,1277], fluvoxamine (Level 2) [1278], paroxetine (Level 2) [1279], escitalopram (Level 3) [1280], and sertraline (Level 3) [1281], as well as for the SNRI venlafaxine XR (Level 2) [1282], and some evidence for mirtazapine (Level 3) [1283]. There is level 2 evidence for the efficacy of fluoxetine [1277] and fluvoxamine [1278] in separation anxiety disorder, and for fluoxetine [1277], fluvoxamine [1278], and sertraline [1284] in GAD. In school-refusing children and adolescents, a small case-series suggested benefit with citalopram (Level 4) [1285], and a RCT demonstrated that imipramine as an adjunct to CBT was more effective than CBT alone (Level 2) [1259]. In pediatric PTSD, sertraline alone [1286] or as an adjunct to CBT [946] was not more effective than placebo or CBT (both Level 2, negative) and cannot be recommended at this time. Benzodiazepines: There are little data demonstrating the efficacy of benzodiazepines in children and adolescents with anxiety and related disorders (Table 33) [1287-1292]. In fact, the few RCTs have demonstrated no significant improvements in anxiety symptoms with alprazolam over placebo in overanxious or avoidant disorders (Level 2, negative) [1290] or school-refusal (Level 2, negative) [1291], or with clonazepam in separation anxiety disorder (Level 2, negative) [1292]. Benzodiazepines have limited utility in youths, although they may be useful for short-term therapy in specific situations where there is a need to achieve rapid reduction in severe anxiety symptoms to allow exposure-related psychotherapy (e.g., panic disorder, school refusal behavior). Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Page 42 of 83 Table 33 Strength of evidence of treatments for anxiety and related disorders in children and adolescents Disorder Antidepressants Benzodiazepines and other treatments OCD Fluoxetine (Level 1) [1264-1269] Antipsychotics Clomipramine (Level 1) [1274-1276] Adjunctive aripiprazole (Level 3) [1293] Citalopram (Level 2) [1264,1270] Other Fluvoxamine (Level 2) [1271] Riluzole (Level 4) [1294] Paroxetine (Level 2) [1272] Sertraline (Level 2) [1273] Panic disorder Anxiolytics Clonazepam (Level 4) [1287,1288] Alprazolam (Level 4) [1289] SAD Fluoxetine (Level 1) [1227,1277] Anxiolytics Fluvoxamine (Level 2) [1278] Alprazolam (Level 2, -ve) [1290] Paroxetine (Level 2) [1279] Venlafaxine XR (Level 2) [1282] Escitalopram (Level 3) [1280] Sertraline (Level 3) [1281] Mirtazapine (Level 3) [1283] Separation anxiety disorder GAD Fluoxetine (Level 2) [1277] Anxiolytics Fluvoxamine (Level 2) [1278] Clonazepam (Level 2, -ve) [1292] Fluoxetine (Level 2) [1277] Anxiolytics Fluvoxamine (Level 2) [1278] Alprazolam (Level 2, -ve) [1290] Sertraline (Level 2) [1284] School-refusal PTSD Citalopram (Level 4) [1285] Anxiolytics Adjunctive imipramine (Level 2) [1259] Alprazolam (Level 2, -ve) [1291] Sertraline (Level 2, -ve) [1286] Adjunctive sertraline (Level 2, -ve) [946] XR = extended release; (-ve) = negative. Other treatments: In open trials in pediatric patients with treatment-resistant OCD, the atypical antipsychotic aripiprazole (Level 3) [1293] and the glutamate antagonist riluzole (Level 4) [1294] have demonstrated some efficacy. Combination psychological and pharmacological therapies The combination of sertraline and CBT was significantly superior to both monotherapies in a large RCT in pediatric patients with separation anxiety disorder, GAD, or SAD [1223]. In pediatric patients with OCD, the addition of CBT in those with a partial response to SSRIs resulted in significantly greater response rates compared with the SSRI alone [1199], while the addition of d-cycloserine to CBT was not superior to placebo [1295]. Alternative therapies There is currently little evidence supporting the efficacy of exercise in reducing anxiety symptoms in pediatric populations [1296], although some open data suggest it may have a small beneficial effect in pediatric PTSD [1297,1298]. Safety issues An important consideration when using antidepressant medications in children and adolescents is the potential for an increased risk of suicidality. Clinicians should be aware of the potential activating side effects of SSRIs (insomnia, agitation, tremor, and anxiety), especially in young children [1299-1301]. Regulatory bodies in many countries have issued black-box warnings about suicidal ideation/suicide attempts with the use of antidepressants in patients younger than 19 years. However, in a comprehensive analysis, the pooled absolute risk difference for suicidal thinking or behavior between SSRI- and placebotreated youth with anxiety and related disorders was nonsignificant (0.5-0.7%), and lower than the risk for youth treated for MDD (0.9%) [1302]. Anxiety and related disorders also increase the risk of suicidality — nearly eight times for suicidal ideation and six times for suicide attempts compared with not having an anxiety disorder [1175]. Therefore, risks and benefits of treatment should be discussed with both children and their parents. The most common antidepressant adverse events are generally activation and vomiting in children, and somnolence in adolescents [1303]. More conservative dosing strategies may be needed especially in younger children or those with low body weight [1301]. Summary The management of anxiety and related disorders in children and adolescents can be challenging. Diagnostic evaluation of pediatric patients should use developmentally appropriate language and consider collateral information Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 from parents and teachers. Children may express anxiety through crying, tantrums, freezing, or clinging, as well as through play. For children and adolescents, psychological therapies are generally preferred over pharmacotherapy, or if warranted combination therapy may be an option. Psychological therapies often need to be adapted to suit the chronological and developmental ages of young patients and to include parental involvement. When pharmacotherapy is warranted, SSRIs are generally preferred, although antidepressants should be used with caution in pediatric patients. Elderly Epidemiology The lifetime and 12-month prevalence of any anxiety or related disorder among those age 65 or older is estimated to be 13.6% and 7.0%, respectively, compared with 27.8% and 17.8% in the overall adult population [1304]. Including subthreshold anxiety increases the 12-month prevalence from about 6% to over 26% in older adults [1305]. The prevalence rates of anxiety and related disorders have generally been shown to decline with age, and as in younger age groups, the prevalence is higher in women than in men [509,1304,1306,1307]. The decline in prevalence may be related to age biases in the assessment of anxiety and the masking effect of other risk factors that increase with aging [1308]. Under-diagnosis is common, with one study finding that only 34% of older patients with GAD had previously had anxiety symptoms documented [1309]. Among older adults (≥55 years) with mood or anxiety and related disorders, 60-70% do not use mental health care services [1310,1311], although use is higher among those with comorbid disorders [1312]. Older adults with anxiety and related disorders have higher rates of sleep disturbances [1313-1315] and greater impairment in cognitive functioning [1316-1319] compared to those without anxiety disorder. In addition, anxiety negatively impacts physical functioning and mobility [1320,1321], and health related QoL [1321,1322]. Comorbidities Depression is among the most common comorbid disorders among older adults with anxiety and related disorders [1323-1325], and is associated with poorer outcomes of both disorders [1326]. Approximately 80% of adults ≥65 years of age have at least one chronic medical condition, and this may be even higher among those with anxiety disorders [1327]. Older patients with anxiety and related disorders report higher rates of diabetes, gastrointestinal conditions, and dementia [1325,1327,1328]. Chronic urinary incontinence, hearing impairment, hypertension, respiratory disease, and poor sleep were associated with elevated rates of anxiety symptoms or disorders [1315,1329]. Comorbid anxiety in patients with medical illnesses, particularly cardiovascular disease, has been associated with an increased risk of mortality Page 43 of 83 [1330,1331]. Furthermore, the relationship between anxiety and related disorders in the elderly and cognitive impairment remains largely neglected [1332]. Diagnostic issues The recognition and accurate diagnosis of anxiety and related disorders in older patients can be challenging [1333]. Modifications to the DSM-5 diagnostic criteria may assist clinicians in more accurately recognizing and diagnosing anxiety and related disorders in the elderly [1333]. Older patients with anxiety often present differently than younger patients [1327,1334]. Avoidance and excessive anxiety may be difficult to detect in older patients [1333]. Older adults may describe symptoms differently; for example, they may discuss concerns rather than worries [1327,1333]. They are less likely to attribute symptoms to anxiety and related disorders, but rather may attribute them to physical illness and they may have difficulty remembering symptoms [1327,1335]. Obtaining information from collateral sources may be useful. Assessing impact on work or social functioning may also be complicated by changes in responsibilities associated with aging (e.g., retirement) [1333]. It may be helpful to ask about activities relevant to older adults, such as visiting grandchildren. Similarly, avoidance may be harder to detect because of limitations in physical mobility or visual problems, leading to a decline in activities outside the home [1336]. Chronic medical illness or the use of medications can also complicate the diagnosis of anxiety and related disorders [1333]. Determining which came first, the physical illness or the anxiety symptoms can be helpful. However, when a medical illness is chronic, this precludes the likelihood that the anxiety would resolve when the medical condition resolves. Late-onset anxiety and related disorders are relatively unusual [2], therefore older patients with new onset anxiety should be investigated for potential causative factors (e.g., physical illness, medication side effects). Psychological treatment Relaxation training, CBT, supportive therapy, and CT have support for the treatment of anxiety symptoms and disorders in older patients [1337]. Meta-analyses suggest the efficacy of psychological treatment is similar to that of pharmacotherapy for the treatment of anxiety and related disorders in older patients [1338,1339]. In meta-analyses, CBT was an effective option in reducing anxiety symptoms among older patients compared to wait-list or active controls [1340-1342]. Some data suggest that CBT may be less effective for anxiety and related disorders in older patients than in working-age adults [1337,1342]. Older patients may benefit from the inclusion of learning- and memory-aids with standard CBT [1343,1344]. In RCTs in older patients, CBT demonstrated Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 efficacy for the treatment of GAD [1337,1343,1345-1347] and panic disorder [1348,1349]. Exposure therapy, with or without CBT, demonstrated efficacy in case-controlled studies in patients with PTSD [1350] or specific phobias [1351]. CBT may also be effectively delivered via telephone, although improvements may not be long lasting [1352]. In a case-control study, regular physical exercise reduced the risk of developing anxiety disorders among older adults [1353]. Pharmacological treatment Data suggest that pharmacotherapy including antidepressants or anticonvulsants is likely as effective in older adults as it is in younger patients [575]. Most of the studies in older patients include those ≥60 or 65 years and have been conducted in patients with GAD or panic disorder. The most robust data in elderly patients with GAD are from a large RCT (n=273), which demonstrated significant improvements and good tolerability with pregabalin compared with placebo [1354]. Pregabalin was also effective as adjunctive therapy in an open trial in older patients with comorbid GAD and depression [1355]. Pooled analyses of subsets of older patients from multiple RCTs demonstrate that duloxetine [1356] and venlafaxine [575] were effective for the treatment of GAD. Citalopram was effective in an eight-week RCT [1357] and in an open study over six months of treatment [1358]. Some data suggest that escitalopram may be useful in older patients with GAD [550,1359]; although in one RCT, response rates were not significantly different than placebo in the intention-to-treat analysis [550]. Sertraline was more effective than CBT [1349], particularly at a one-year follow-up assessment [1360], and was as effective as buspirone [561] in older adults with GAD. In older patients with panic disorder, paroxetine was as effective as CBT and more effective than a wait-list control, and results were sustained at a six-month follow-up [1348]. Escitalopram [1361] and citalopram [1361] were equally effective in a small, open trial. A small, open trial also showed fluvoxamine to be effective in older patients with GAD, panic disorder, or OCD [1362]. Data in patients with MDD, suggest that mirtazapine may have beneficial anxiolytic effects in the elderly [1363,1364]. Data show that 45-60% of older patients (>55 years) with anxiety and related disorders are prescribed a benzodiazepine, which is higher than the rate of antidepressant use [1365-1367]. The very high use of these agents is a cause for concern since they are not a preferred longterm treatment strategy and elderly patients may be more sensitive to their negative effects [1365,1366]. Safety issues The elderly maybe more susceptible to adverse drug events and drug-drug interactions (DDIs) due to gradual age-related physiologic changes that affect the pharmacokinetic and pharmacodynamic properties of Page 44 of 83 many medications [1368,1369]. Factors which may alter drug metabolism and plasma concentrations among elderly patients include frailty, reduced homoeostatic mechanisms, and psychosocial issues [1368]. Age-related changes in body composition can result in increases or decreases of drug volume distribution, and hepatic or renal dysfunction can impair drug metabolism and drug clearance [1369,1370]. All of these changes are highly variable in elderly patients, further complicating use of medications in this population [1368,1369]. A review of the literature found that almost half of available antidepressants are associated with age-related clearance changes and identified at least 45 medications that could interact with specific antidepressants [1371]. DDIs may be more common in older adults because of the greater number of concomitant medication they may be taking to treat multiple comorbid conditions. In one study of US community-dwelling older adults, almost 30% used at least five prescription medications, 80% used at least one prescription medication, and almost half used over-the-counter and dietary supplements [1372]. Psychotropic medications have been associated with an increased risk of fractures [1369,1373,1374]. In a metaanalysis, the RR of fractures was 1.34 for benzodiazepines, 1.60 for antidepressants, 1.54 for anticonvulsants, and 1.59 for antipsychotics [1373]. In a prospective cohort study (The Rotterdam Study) of subjects over 55 years of age, the risk of non-vertebral fractures was 2.35 for current SSRI use versus non-use [1375]. The increased risk for hip fracture associated with benzodiazepines was further increased with increasing dose and the use of concomitant interacting drugs [1369,1374]. There does not appear to be any difference between atypical antipsychotic agents in the increased risk of falls or fractures [1376]. An increased mortality risk has been associated with the use antipsychotics in older patients with dementia [1377-1379], which appears to be greater with conventional compared to atypical antipsychotics [1378-1380]. Antidepressants are frequently used to treat symptoms of anxiety in older adults who suffer from comorbid medical conditions such as heart disease. In a meta-analysis of SSRIs versus placebo or no antidepressant therapy in patients with coronary heart disease (CHD) and depression, SSRIs were associated with lower rates of all-cause mortality and readmissions for CHD, indicating that treatment may improve CHD prognosis [1381]. Clinicians should weigh the risks associated with antidepressants against the potential benefits when making prescribing decisions. Summary While onset of anxiety and related disorders in late-life is uncommon, they do persist into older age and can have substantial impact on QoL and functionality. Older Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 patients can present differently compared to younger patients, and diagnosis can be complicated by communication barriers, changes in role functioning, memory difficulties, and comorbid medical conditions. Few treatment studies are conducted in older patients; however, data suggest that psychological treatment and pharmacotherapy appear to be similarly effective in older patients. Using pharmacotherapy in elderly patients can be challenging, and should consider patient factors such as body mass, hepatic and renal function, comorbid conditions, and use of concomitant medications. Anxiety with comorbid conditions Overview Anxiety and related disorders often present together with other psychiatric or medical conditions [3,16,43, 1382,1383]. About 60-80% of patients with an anxiety disorder have at least one other comorbid psychiatric condition, which most commonly include another anxiety or related disorder, MDD, bipolar disorder, ADHD, and SUD [3]. The presence of comorbid disorders has a negative impact on most aspects of care. Patients with psychiatric comorbidities have more severe symptoms [46,1384], poorer treatment outcomes for both disorders [47,1385-1387], greater functional impairment [46,871,1384], poorer QoL [1388,1389], and an increased risk of suicide [652]. Medical conditions and pain disorders are also common comorbidities in patients with anxiety and related disorders. Medical conditions frequently reported in patients with anxiety and related disorders include cardiovascular disease, gastrointestinal disease, arthritis, respiratory disease, thyroid disease, migraine, and allergic conditions [16,52]. Patients with both anxiety disorders and medical conditions experience elevated disability, including more psychiatric comorbidity and depressive symptoms, as well as poorer interpersonal and physical functioning [52,142]. Patients with chronically painful conditions such as arthritis, back pain, or migraine are at a two- to four-fold higher risk of having an anxiety or related disorder, particularly panic disorder or PTSD [1390]. The high probability of comorbid disorders should be considered when diagnosing and treating patients with anxiety and related disorders. In patients with comorbid psychiatric conditions, such as another anxiety disorder or mood disorder, consider therapies that are effective for both disorders [32]. Benzodiazepines should be prescribed with additional caution in patients with comorbid SUDs. In patients with comorbid medical conditions, the clinician must weigh the benefits and risks of medication for the anxiety or related disorder, but should also consider the impact of untreated anxiety [32]. Page 45 of 83 Major depressive disorder (MDD) Q. What is the prevalence and impact of comorbid MDD and anxiety/related disorders? MDD is very common in patients with anxiety, being reported in 20-36% of patients [121,310,360,1382]; and conversely, about 60% of patients with MDD will have a comorbid anxiety or related disorder [44]. In patients with anxiety, comorbid depression has been associated with more severe symptoms [46,1384], lower likelihood of remission [47], greater functional impairment [46,871,1384], an increased risk of suicide [652], and a greater risk of having another comorbid anxiety disorder [360]. Similarly, in patients with MDD, comorbid anxiety and related disorders were associated with poorer treatment outcomes including higher recurrence rates [1385-1387], poorer QoL [1391], and an increased risk of suicide [24,1387,1392,1393]. Q. What pharmacological treatment may be useful for patients with an anxiety/related disorder and comorbid MDD? Guidelines generally recommend antidepressants (most commonly SSRIs and SNRIs) as first-line treatments in patients with both anxiety and depressive symptoms [32,1394]. SSRIs and SNRIs in patients with anxiety and related disorders, including panic disorder, GAD, OCD, or PTSD, with comorbid MDD have been shown to be effective in improving both disorders [224,723,1359,1395]. Among the atypical antipsychotics, quetiapine has been found to have efficacy as monotherapy in both MDD [1396] and GAD [1397], as well as MDD with anxiety [1398], while case series suggest that aripiprazole augmentation of antidepressants [496], and risperidone monotherapy [267] may also reduce comorbid depressive and anxiety symptoms. Bipolar disorder or psychoses Q. What is the prevalence and impact of comorbid bipolar disorder or psychoses with anxiety/related disorders? Among patients with anxiety and related disorders, almost 14% also met criteria for bipolar I or II disorder [121]. However, among patients with bipolar disorder the rates of comorbid anxiety disorders are very high compared to the general population, and the DSM-5 notes anxiety disorders as the most common comorbidities in patients with bipolar disorder [26]. In epidemiological surveys, the lifetime comorbidity rates for any anxiety or related disorder among patients with bipolar disorder was 52% in Canada [43] and 60-75% in the US [1389,1399]. In a clinic population, the rate of anxiety and related disorders was 22% in patients with bipolar disorder, compared to 17% in patients with schizophrenia, and 30% in those with schizoaffective disorder [1400]. A meta-analysis of prevalence studies found that the rates of various anxiety disorders in patients with schizophrenia and related psychotic disorders ranged from 10-15% [1401]. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Comorbid anxiety and related disorders in patients with bipolar disorder were associated with a greater risk of MDD and drug use disorders, a poorer bipolar course, lower QoL, and lower psychosocial functioning [1388,1389]. Data are conflicting on the impact of anxiety and related disorders on suicidal tendencies in patients with bipolar disorder, with some analyses finding an increased risk [1389,1402], but not all [1403]. Similar findings have been reported in patients with schizophrenia, where comorbid anxiety and related disorders have been associated with more past SUDs, lower social adjustment and overall QoL, and greater suicidality [1404,1405]. Q. What pharmacological treatment may be useful for patients with an anxiety/related disorder and comorbid bipolar disorder or psychoses? The management of patients with anxiety and related disorders and comorbid bipolar disorder, schizophrenia, or other psychosis should consider therapies that are effective for both disorders [32]. Atypical antipsychotics are recommended treatments for bipolar disorder and schizophrenia [111,1406], while the long-term use of antidepressants may destabilize patients with bipolar I disorder [111,1394]. Data in patients with a diagnosed anxiety or related disorder and comorbid bipolar disorder or psychosis are limited. In a RCT, risperidone monotherapy was shown to be no more effective than placebo for patients with bipolar and comorbid panic disorder or GAD [1407]. However, in a single-blind trial, olanzapine or lamotrigine when added to lithium demonstrated improvements in anxiety disorder symptoms in patients with remitted bipolar disorder [1408]; and in an open trial, switching to aripiprazole significantly improved social anxiety and psychosis in patients with SAD and schizophrenia [379]. In addition, atypical antipsychotics have demonstrated efficacy in RCTs in patients with anxiety and related disorders (see specific disorder sections for evidence), and data show that these agents can significantly reduce anxiety symptoms in patients with bipolar disorder [1409-1413]. Taken together, these data suggest these agents may be useful in comorbid patients. Anticonvulsants have also demonstrated efficacy in the treatment of some anxiety and related disorders (see specific disorder sections for evidence) and are often used for the treatment of bipolar disorder [111]. In patients with bipolar disorder, adjunctive valproate and gabapentin have demonstrated efficacy for the treatment of panic disorder [281,1414] and resulted in reductions in anxiety symptoms [1415,1416]. ADHD Q. What is the prevalence of comorbid ADHD and anxiety/ related disorders? It is estimated that the lifetime rate of ADHD in children is 6-9%, with 70% persistence into adolescence and Page 46 of 83 50-60% into adulthood [45,1417,1418]. In a communitybased survey, the estimated prevalence of current selfreported adult ADHD was 4.4% [45]. While ADHD has long been known to persist into adulthood [1419,1420], it has only recently become the focus of widespread clinical attention [1421-1423]. Of adults identified with ADHD in the National Comorbidity Survey-Replication (NCS-R), only one in 10 had received treatment within the previous year [45]. Of these individuals, it is estimated that approximately 47% meet criteria for an anxiety or related disorder within 12 months of assessment, with the most common being SAD (29.3%), followed by specific phobia (22.7%), PTSD (11.9%), panic disorder (8.9%), and GAD (8.0%) [45]. Patients with an anxiety or related disorder were reportedly four times more likely to meet criteria for ADHD than the general population [45]. Similar results were found in a Canadian survey of patients in an anxiety disorders clinic, where the rate of adult ADHD was 28% [378]. Q. What factors should be considered when treating patients with an anxiety/related disorder and comorbid ADHD? When managing a patient with ADHD, it may be important to differentiate ADHD with anxious symptoms from comorbid ADHD and anxiety/related disorders. This can be challenging, as anxiety symptoms are frequently related to a sense of being overwhelmed or to compensatory skills in patients with ADHD. Stimulants may play a larger role in managing ADHD in patients with anxiety symptoms [1424,1425]; however, in an open trial, atomoxetine improved ADHD and comorbid symptoms of depression and anxiety [1426]. Treatment of patients with comorbid ADHD and an anxiety or related disorder may be more complicated. Generally, in patients with comorbid anxiety disorders and ADHD the diagnostic and treatment priority should be determined by the relative severity of symptoms and risks of each disorder [1427]. There are limited data on the role of stimulants in patients with ADHD and an anxiety disorder. In a RCT, atomoxetine significantly improved ADHD and SAD symptoms compared with placebo [487]. In separate open trials, adjunctive atomoxetine [1428] and adjunctive extended release mixed amphetamine salts [1429] significantly improved anxiety symptoms in patients with ADHD and GAD refractory to antidepressants alone. Medical comorbidities Q. What is the prevalence and impact of comorbid medical conditions and anxiety/related disorders? Medical conditions are also common comorbidities that must be considered when prescribing medication for patients with anxiety and related disorders. Medical conditions are reported in over 60% of patients with anxiety Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 and related disorders including cardiovascular diseases, gastrointestinal diseases, arthritis, respiratory diseases such as asthma, thyroid disease, migraine headaches, back pain, and allergic conditions [16,52,1430-1432]. Comorbidities are particularly common among patients with GAD, panic disorder, and PTSD [16,140,515, 517,1390,1433]. Patients with anxiety and related disorders and medical conditions experience more psychiatric comorbidity, depressive symptoms, and more severe anxiety disorder symptoms, as well as poorer interpersonal and physical functioning [52,140,142,515]. Q. What factors should be considered when treating patients with an anxiety/related disorder and comorbid chronic pain? Chronically painful conditions (i.e., arthritis, back pain, and migraine) are commonly associated with anxiety [515,1390,1430,1434]. Patients with anxiety and related disorders are twice as likely to have painful physical symptoms compared to of those without, 45-60% versus 28% [515,1433]. About 60-70% of patients with anxiety disorders report migraine headaches [140,141]. For the management of anxiety and related disorders in patients with pain it may be helpful to consider treatments that have demonstrated efficacy in both anxiety disorders as well as pain. While there are few data available, duloxetine has demonstrated efficacy for both GAD and pain symptoms in RCTs [1435-1437]. TCAs, and to a lesser extent SSRIs, have been shown to reduce headache attacks in patients with migraine [1438], and provide moderate relief of neuropathic pain [1439]. Q. What factors should be considered when treating patients with an anxiety/related disorder and comorbid cardiovascular disease? Although panic attacks can sometimes be mistaken for cardiovascular symptoms, it is important to be aware that patients with anxiety and related disorders do have a twoto three-times greater risk of cardiovascular disease compared to the general population [1431,1432]. In addition, anxiety disorders have been associated with increased risk of cardiovascular hospitalization rates and mortality risk [1440-1442]. In patients with cardiovascular or cerebrovascular comorbidity, it is important to consider the impact of treatments used for anxiety on heart rate, blood pressure, and lipid measures [1443-1445]. Q. What factors should be considered when treating patients with an anxiety/related disorder and comorbid diabetes and metabolic syndrome? Patients with anxiety symptoms have an elevated risk of type 2 diabetes [1446]. While glycemic measures do not appear to be affected by anxiety symptoms [1447], some treatments, particularly some atypical antipsychotics, alter glucose parameters, lipid levels, and cause weight Page 47 of 83 gain [109-116,1443]. Some antidepressants, including amitriptyline, mirtazapine, and paroxetine have also been associated with weight gain [1448]. Canadian Anxiety Guidelines Initiative Group Additional authors Martin M. Antony1, Stéphane Bouchard2, Alain Brunet3, Martine Flament4, Sophie Grigoriadis5, Sandra Mendlowitz6, Kieron O’Connor7, Kiran Rabheru4, Peggy M.A. Richter5, Melisa Robichaud8, John R. Walker9 1 Department of Psychology, Ryerson University, Toronto, M5B 2K3, Canada; 2Department of Psychoeducation and Psychology, University of Québec in Outaouais, Gatineau, J9A 1L8, Canada; 3 Department of Psychiatry, McGill University, Montreal, H3A 1A1, Canada; 4 Department of Psychiatry, University of Ottawa, Ottawa, K1Z 7K4, Canada; 5 Department of Psychiatry, University of Toronto, Toronto, M5S 1A1, Canada; 6Department of Child Psychiatry, University of Toronto, Toronto, M5S 1A1, Canada; 7Department of Psychiatry, University of Montreal, Montreal, H3C 3J7, Canada; 8 Departments of Psychiatry and Psychology, University of British Columbia, Vancouver, V6T 2A1, Canada; 9 Department of Clinical Health Psychology, University of Manitoba, Winnipeg, R3E 3N4, Canada Email: Martin M. Antony - mantony@psych.ryerson.ca; Stéphane Bouchard - stephane.bouchard@uqo.ca; Alain Brunet - alain.brunet@mcgill.ca; Martine Flament - martine.flament@theroyal.ca; Sophie Grigoriadis - sophie.grigoriaidis@sunnybrook.ca; Sandra Mendlowitz - sandra. mendlowitz@sickkids.on.ca; Kieron O’Connor - kieron. oconnor@umontreal.ca; Kiran Rabheru - kiranrabheru@hotmail.com; Peggy M.A. Richter - peggy.richter@sunnybrook.ca; Melisa Robichaud - robichau@mail.ubc.ca; John R. Walker - jwalker@cc.umanitoba.ca Additional contributors to the comorbidity section Gordon Asmundson10, Larry J. Klassen11, Raymond W. Lam12, Roger S. McIntyre13, Isaac Szpindel14 10 Department of Psychology, University of Regina, Regina, S4S 0A2, Canada; 11Department of Psychiatry, Faculty of Medicine, University of Manitoba, Winnipeg, R3T 2N2, Canada; 12Department of Psychiatry, University of British Columbia, Vancouver, V6T 2A1, Canada; 13 Departments of Psychiatry and Pharmacology, University of Toronto, Toronto, M5S 1A1, Canada; 14Attention and Learning Related Disorders, START Clinic, Toronto, M4W 2N4, Canada Email: Gordon Asmundson - gordon.asmundson@uregina.ca; Larry J. Klassen - larryjklassen@hotmail.com; Raymond W. Lam - r.lam@ubc.ca; Roger S. McIntyre roger.mcintyre@uhn.ca; Isaac Szpindel - iszpindel@startclinic.ca Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Additional material Additional file 1: Suggested dosing ranges Dosing ranges of various psychiatric medications List of abbreviations used AACAP: American Academy of Child and Adolescent Psychiatry; ABM: attention bias modification; ACOG: American Congress of Obstetricians and Gynecologists; ADHD: attention-deficit/hyperactivity disorder; APA: American Psychiatric Association; ASD: acute stress disorder; B-I-I: blood-injection-injury; BPD: borderline personality disorder; CBT: cognitive behavioral therapy; CBWT: cognitive behavioral writing therapy; CCHS: Canadian Community Health Survey; CHD: coronary heart disease; CPT: cognitive processing therapy; CR: controlled release; DBT: dialectical behavioral therapy; DDI: drugdrug interactions; DIRT: danger ideation reduction therapy; DSM-5: Diagnostic and Statistical Manual of Mental Disorders, 5th Edition; EMDR: eye movement desensitization and reprocessing; ERP: exposure with response prevention; FDA: Food and Drug Administration; GAD: generalized anxiety disorder; HARS: Hamilton Anxiety Rating Scale; HDL: high-density lipoprotein; ICBT: internet-based CBT; IPT: interpersonal therapy; IV: intravenous; LDL: lowdensity lipoprotein; MAOI: monoamine oxidase inhibitor; MBCT: mindfulnessbased cognitive therapy; MBT: mindfulness-based therapy; MDD: major depressive disorder; Mini-SPIN: Mini-Social Phobia Inventory; MRI: magnetic resonance imaging; N/A: not available; NaSSA: noradrenergic and specific serotonergic antidepressant; NCS-A: National Comorbidity Survey – Adolescent supplement; NCS-R: National Comorbidity Survey – Replication; NMDA: N-methyl-D-aspartate; NNT: number needed to treat; NPPO-REAC: neuro psycho physical optimization-radio electric asymmetric conveyor; NSAID: nonsteroidal anti-inflammatory drug; OCD: obsessive-compulsive disorder; ODT: orally disintegrating tablet; PNAS: poor neonatal adaptation syndrome; PTSD: posttraumatic stress disorder; QoL: quality of life; RCT: randomized controlled trial; REAC: radioelectric asymmetric conveyor; RIMA: reversible inhibitors of monoamine oxidase A; RR: relative risk; rTMS: repetitive transcranial magnetic stimulation; SAD: social anxiety disorder; SET: social effectiveness therapy; SHAT: spiritual-hypnosis assisted therapy; SNRI: serotonin–norepinephrine reuptake inhibitor; SR: sustained release; SSRI: selective serotonin reuptake inhibitor; SUD: substance use disorder; TC: total cholesterol; TCA: tricyclic antidepressant; TF-CBT: trauma-focused-CBT; TG: triglycerides; vLDL: very-low-density lipoprotein; VRE: virtual reality exposure; XL: extended release; XR: extended release; Y-BOCS: Yale-Brown Obsessive Compulsive Scale. Competing interests Unrestricted educational grants for the development of these guidelines were provided by Astra Zeneca Canada, Eli-Lilly Canada, Janssen Inc., Lundbeck Canada, Pfizer Canada, Purdue Canada, Servier Canada Inc., Shire Canada, and Valeant Canada. None of the members received payment for participating in the development of these guidelines. The following authors do not have any competing interests to declare: AB, GA, JRW, KO, MMA, MF, LK, MR, SM. Advisory board/speaker’s bureau: Astra Zeneca (KK, KR, MK, P. Bleau, P. Blier, RWL, RSM), Biovail (RWL), Boehringer Ingelheim (MK), BMS (KK, KR, MK, P. Bleau, P. Blier, PC, RWL, RSM), Canadian Institutes of Health Research (CIHR) (RWL), Canadian Network for Mood and Anxiety Treatments (CANMAT) (RWL), Canadian Psychiatric Association (CPA) Foundation (RWL), Eli Lilly Canada (MK, P. Bleau, P. Blier, PC, SG, RWL, RSM, IS), France Foundation (RSM), GlaxoSmithKline (MK, P. Blier, RSM, SG), Janssen Ortho (KK, MK, P. Blier, PC, RSM), Labopharm (P. Blier), Litebook Company (RWL), Lundbeck (KK, KR, MK, P. Bleau, P. Blier, PC, RWL, RSM, SG), Lundbeck Institute (RWL), Organon (MK, RSM), Merck (P. Blier, RSM), Mochida (RWL), Otsuka (KK), Pfizer (P. Bleau, P. Blier, PC, RWL, RSM, SG), Pierre Fabre (P. Blier), Purdue (IS), Servier (P. Blier, RWL, SG), Shire (MK, RSM, IS), Solvay (MK), St. Jude’s Medical (RWL), Sunovion (KK, P. Blier), Takeda (P. Blier, RWL), UBC Institute of Mental Health/Coast Capital Savings (RWL), Valeant (P. Blier, IS), Wyeth (P. Bleau, MK, SG) Consultation fees: AstraZeneca (MK), BMS (MK), Boehringer Ingelheim (MK), Clinique et Développement In Virtuo Inc. (SB), Eli Lilly Canada (MK, SG), Page 48 of 83 GlaxoSmithKline (MK, SG), Janssen Ortho (MK), Lundbeck (MK, PR, SG), Organon (MK), Pfizer (SG), Servier (SG), Shire (MK), Solvay (MK), Wyeth (MK, SG) Educational support: Astra Zeneca (RSM), BMS (RSM), CME Outfitters (RSM), Eli Lilly Canada (RSM, IS), France Foundation (RSM), I3CME (RSM), Merck (RSM), Optum Health (RSM), Pfizer (RSM), Physicians’ Postgraduate Press (RSM), Shire (IS) Research grants/clinical trial funding: AstraZeneca (KK, MK, P. Bleau, RSM, RWL), Biovail (RWL), BMS (KK, P. Bleau, RWL), Canadian Foundation for Innovation (MK), Canadian Institutes of Health Research (CIHR) (MK, RWL, SG), Canadian Network for Mood and Anxiety Treatments (CANMAT) (RWL), Canadian Psychiatric Association (CPA) Foundation (MK, RWL), Centre for Addiction and Mental Health Foundation (MK), CR Younger Foundation (SG), Eli Lilly Canada (MK, P. Bleau, PR, RSM, RWL), Genuine Health (MK), GlaxoSmithKline (MK), Janssen Ortho (MK, RSM), Litebook Company (RWL), Lundbeck (KK, MK, P. Bleau, RSM, RWL), Lundbeck Institute (RWL), Mochida (RWL), National Alliance for Research on Schizophrenia and Depression (NARSAD) (RSM), National Institutes of Mental Health (NIMH) (RSM), Ontario Ministry of Health (SG), Ontario Mental Health Foundation (SG), Organon (MK), Pfizer (P. Bleau, RSM, RWL), Roche (PR), Servier (RWL), Sick Kids Foundation (MK), Solvay (MK), St. Jude’s Medical (RWL), Shire (MK, RSM), Stanley Medical Research Institute (RSM), Takeda (RWL), UBC Institute of Mental Health/Coast Capital Savings (RWL), Wyeth (MK, P. Bleau) Unrestricted grants: Astra Zeneca Canada (MK), Eli Lilly Canada (MK), Janssen Inc. (MK), Lundbeck Canada (MK), Pfizer (MK), Purdue Pharma (MK), Servier Canada (MK), Shire Canada (MK), Valeant Canada (MK) Reimbursements, fees, funding, or salary: In the past five years, MVA received reimbursements, fees, funding, or salary from: Astra Zeneca, Biovail, Canadian Foundation for Innovation (CFI), Cephalon, Eli Lilly, Forest Laboratories, GlaxoSmithKline, Hamilton Academic Health Sciences Organization (HAHSO) Innovation Grant (AFP Innovation Grant), Janssen Ortho, Labo Pharm, Lundbeck, National Institutes of Health (NIH), Novartis, Pfizer Inc., Servier, Shire, Sunovion, Valeant, Wyeth-Ayerst Stock/share ownership: Clinique et Développement In Virtuo Inc. (SB) Authors’ contributions We thank all co-authors for their considerable expertise in generating these guidelines. Authors who were members of the executive committee (MK, PB, PB, PC, KK, MVA) took part in teleconferences and a meeting in December 2012 to reach consensus on the strength of evidence and treatment recommendations. Draft guidelines were then developed by the core committee and revised by all co-authors. The entire content was subsequently circulated to all members of the Canadian Anxiety Guidelines Initiative Group for additional comments and approval during 2013. GA, LJK, RWL, RSM, and IS provided additional reviews of the comorbidity section. The final manuscript was then circulated to external reviewers (MP, DS, LDM) and revisions were made based on input from the core committee. Acknowledgements The consensus group would like to thank Astra Zeneca Canada, Eli-Lilly Canada, Janssen Inc., Lundbeck Canada, Pfizer Canada, Purdue Canada, Servier Canada Inc., Shire Canada, and Valeant Canada for their generous support of the guideline process with unrestricted educational grants. Funds were used for editorial assistance and meeting logistics; none of the members received payment for participating in the guideline development process. The consensus group would also like to thank Pauline Lavigne and Steven Portelance who provided medical writing services on their behalf. Declarations The development and publication of these guidelines was supported by unrestricted educational grants provided by Astra Zeneca Canada, Eli-Lilly Canada, Janssen Inc., Lundbeck Canada, Pfizer Canada, Purdue Canada, Servier Canada Inc., Shire Canada, and Valeant Canada. None of the members received payment for participating in the development of these guidelines. This article has been published as part of BMC Psychiatry Volume 14 Supplement 1, 2014: Canadian Anxiety Disorders Guidelines Initiative: Clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders. The full contents of the supplement are available online at http://www.biomedcentral.com/bmcpsychiatry/ supplements/14/S1. Katzman et al. BMC Psychiatry 2014, 14(Suppl 1):S1 http://www.biomedcentral.com/1471-244X/14/S1/S1 Authors’ details 1 Department of Psychiatry, University of Toronto, Toronto, ON, M5S 1A1, Canada. 2Department of Psychiatry, McGill University, Montreal, QC, H3A 1A1, Canada. 3Department of Psychiatry and Cellular/Molecular Medicines, University of Ottawa, Ottawa, ON, K1Z 7K4, Canada. 4Department of Psychiatry, University of Alberta, Edmonton, AB, T6G 2R7, Canada. 5 Department of Psychiatry, University of British Columbia, Vancouver, BC, V6T 2A1, Canada. 6Department of Psychiatry and Behavioural Neuroscience, McMaster University, Hamilton, ON, L8N 3K7, Canada. Page 49 of 83 18. 19. 20. 21. Published: 2 July 2014 References 1. 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Serretti A, Mandelli L: Antidepressants and body weight: a comprehensive review and meta-analysis. J Clin Psychiatry 2010, 71:1259-1272. doi:10.1186/1471-244X-14-S1-S1 Cite this article as: Katzman et al.: Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessivecompulsive disorders. BMC Psychiatry 2014 14(Suppl 1):S1. 525674 research-article2014 JOP0010.1177/0269881114525674Journal of PsychopharmacologyBaldwin et al. BAP Guidelines Evidence-based pharmacological treatment of anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder: A revision of the 2005 guidelines from the British Association for Psychopharmacology Journal of Psychopharmacology 1–­ 37 © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0269881114525674 jop.sagepub.com David S Baldwin1,2, Ian M Anderson3, David J Nutt4, Christer Allgulander5, Borwin Bandelow6, Johan A den Boer7,8, David M Christmas9, Simon Davies10, Naomi Fineberg11, Nicky Lidbetter12, Andrea Malizia13, Paul McCrone14, Daniel Nabarro15, Catherine O’Neill12, Jan Scott16, Nic van der Wee17 and Hans-Ulrich Wittchen18 Abstract This revision of the 2005 British Association for Psychopharmacology guidelines for the evidence-based pharmacological treatment of anxiety disorders provides an update on key steps in diagnosis and clinical management, including recognition, acute treatment, longer-term treatment, combination treatment, and further approaches for patients who have not responded to first-line interventions. A consensus meeting involving international experts in anxiety disorders reviewed the main subject areas and considered the strength of supporting evidence and its clinical implications. The guidelines are based on available evidence, were constructed after extensive feedback from participants, and are presented as recommendations to aid clinical decision-making in primary, secondary and tertiary medical care. They may also serve as a source of information for patients, their carers, and medicines management and formulary committees. Keywords Anticonvulsants, antidepressants, antipsychotics, anxiety disorders, anxiolytics, benzodiazepines, cognitive behaviour therapy, evidence-based guidelines, generalised anxiety disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, pregabalin, separation anxiety disorder, serotonin-noradrenaline reuptake inhibitor, social anxiety disorder, specific phobia, selective serotonin reuptake inhibitor, treatment. 1. Introduction The British Association for Psychopharmacology (BAP; www. bap.org.uk) aims to advance education and research in the science and practice of psychopharmacology by arranging scientific meetings, fostering research and teaching, encouraging publication of research results, and providing guidance and information on matters relevant to psychopharmacology. As part of this 1Faculty 11Postgraduate 2Department 12Anxiety of Medicine, University of Southampton, Southampton, UK of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa 3Neuroscience and Psychiatry Unit, University of Manchester, Manchester, UK 4Division of Experimental Medicine, Imperial College London, London, UK 5Karolinska Institutet, Stockholm, Sweden 6Department of Psychiatry and Psychotherapy, University of Goettingen, Goettingen, Germany 7Department of Nuclear Medicine and Molecular Imaging, University Medical Centre Groningen (UMCG), Groningen, The Netherlands 8PRA International Zuidlaren,The Netherlands 9Cambridge and Peterborough NHS Foundation Trust, Cambridge, UK 10Centre for Addiction and Mental Health, University of Toronto, Toronto, ON, Canada Medical School, University of Hertfordshire, Hatfield, UK UK, Manchester, UK 13North Bristol NHS Trust, Bristol, UK 14Institute of Psychiatry, Kings College London, London, UK 15OCD Action, London, UK 16Newcastle University, Newcastle, UK 17Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands 18Institute of Clinical Psychology and Psychotherapy, Technical University Dresden, Dresden, Germany Corresponding author: David Baldwin, University Department of Psychiatry, University of Southampton, College Keep, 4-12 Terminus Terrace, Southampton, SO14 3DT, UK. Email: dsb1@soton.ac.uk 2 process the BAP has developed and periodically revised a series of consensus statements on the use of psychotropic drugs in patients with psychiatric and other disorders, with an emphasis on making concise and realistic recommendations based on a review of the evidence [IV] (Anderson et al., 2000, 2008; Barnes and Schizophrenia Consensus Group of British Association for Psychopharmacology, 2011; Burns and O’Brien., 2006; Goodwin, 2003, 2005; Goodwin et al., 2008; Lingford-Hughes et al., 2004, 2012; National Institute for Health and Clinical Excellence, 2011; O’Brien and Burns, 2010; Nutt et al., 2006; Wilson et al., 2010). Anxiety symptoms and disorders are common in community settings, and in primary and secondary medical care. The personal and societal burden associated with anxiety disorders is considerable, but many people who might benefit from treatment are not recognised or treated. Likely factors in this sub-optimal management include the range of different anxiety disorders, their co-morbidity with other disorders (particularly mood disorders), a widespread lack of awareness of anxiety disorders by affected individuals and health practitioners, and the low confidence of many practitioners in their management. Conversely, some patients with only mild or transient anxiety symptoms receive unnecessary or inappropriate treatment. Given the considerable room for improvement, the BAP previously produced evidence-based guidelines for the pharmacological treatment of anxiety disorders [IV] (Baldwin et al., 2005): this revision of those guidelines provides an update on key steps in diagnosis and treatment. 2. Caveats Clinical guidelines are systematically derived statements that aim to inform treatment decisions in clinical care. Recommendations are graded according to the strength of evidence, and whenever possible are derived from the findings of systematic reviews and randomised controlled trials. Principal recommendations apply to the management of ‘typical’ patients and hence apply much of the time: we therefore use expressions such as ‘clinicians should consider…’ in the summary boxes. But there are many patients and many clinical decision points where slavish adherence to guideline recommendations may be unhelpful and possibly harmful. In situations where the evidence is weaker we summarise potential management options, recognising that their implementation depends upon clinician experience, patient clinical features and preference, and local circumstance [IV] (Haynes et al., 2002). Some of our recommendations may be regarded as standards of clinical care that are largely driven by custom and practice: these are ‘standards’ which are intended to be applied routinely. There is often a tension between existing established clinical practice and the possible implications of new research findings for changing practice. Existing practice may be accepted on the basis of prolonged clinical experience but limited good quality evidence: new treatments may have proven superiority to placebo in methodologically robust randomised controlled trials, but lack comparator data against ‘established’ treatments. We attempt to strike a balance between the risks of advocating specific novel treatment recommendations that may prove premature and adhering to established routines when the evidence supporting them is questionable. Journal of Psychopharmacology 3. Process for achieving consensus The revision of the original BAP guidelines started in February 2011, with a consensus meeting attended by experts in the field and representatives of patient groups (all who attended are named in the acknowledgments). Brief presentations were made on key areas, with an emphasis on systematic reviews and randomised controlled trials. Each presentation was followed by discussion, to identify areas of consensus or uncertainty. A literature review was then performed to ascertain the validity of the consensus points. Logistical factors made it impossible to perform a systematic review of all possible data from primary sources. Existing systematic reviews and randomised controlled trials were identified from MEDLINE and EMBASE searches and from the Cochrane Database, as well as from recent previous guidelines and reviews [IV] (Baldwin et al., 2011b; Bandelow et al., 2008a; Batelaan et al., 2012; Blanco et al., 2013; Fineberg et al., 2012; Ipser and Stein, 2012), through cross-referencing, and through discussion with experts in the field. We also drew on recent guidelines for generalised anxiety disorder, panic disorder, social anxiety disorder, post-traumatic stress disorder and obsessive-compulsive disorder developed by the National Institute for Health and Clinical Excellence (2005, 2011a, 2011b, 2013). Particular attention was paid to research findings which had appeared since 2005, the year of publication of the original guidelines. Draft versions of the consensus statement, with recommendations based on the level of supporting evidence, were circulated repeatedly to the presenters and other participants and their comments were incorporated into the final version of the guidelines. Given the range and depth of the subject area it was not possible for all participants in the wider group to achieve full consensus on all points. 4. Levels of evidence and strength of recommendations The categories of evidence for causal relationships and the grading of recommendations have their origin in the methodology of the North of England Evidence-Based Guideline Development Project undertaken by the Centre for Health Services Research, University of Newcastle upon Tyne and the Centre for Health Economics, University of York [IV] (Shekelle et al., 1999). Given current debates about their competing merits, we have accorded a similar ‘level’ (‘I’) in the hierarchy of evidence to the findings of systematic reviews and to the results of randomised controlled trials, noting the evidence source which is available for each statement and recommendation (Table 1). Weaker levels of recommendations do not necessarily imply a reduced level of clinical importance. As in some previous guidelines we have included a category denoted as ‘S’ (representing a standard of care), for a recommendation that reflects important consensus on good clinical practice rather than on empirical evidence. 5. Aim and scope of the guidelines We hope the guidelines will prove relevant to most doctors treating patients with anxiety and related disorders, in primary, secondary and tertiary medical care settings. Each of the principal disorders – generalised anxiety disorder, panic disorder, specific 3 Baldwin et al. Table 1. Levels of evidence and strength of recommendations. Categories of evidence relevant to treatment I [M] Evidence from meta-analysis of randomised double-blind placebo-controlled trials I [PCT] Evidence from at least one randomised double-blind placebo-controlled trial II Evidence from at least one randomised double-blind comparator-controlled trial (without placebo) III Evidence from non-experimental descriptive studies IV Evidence from expert committee reports or opinions and/or clinical experience of respected authorities Categories of evidence relevant to observational findings and associations I Evidence from large representative population samples II Evidence from small, well designed but not necessarily representative samples III Evidence from non-representative surveys, case reports IV Evidence from expert committee reports or opinions and/or clinical experience of respected authorities Strength of recommendations A Directly based on category I evidence (either I [M] or I [PCT]) B Directly based on category II evidence or an extrapolated recommendation from category I evidence C Directly based on category III evidence or an extrapolated recommendation from category I or II evidence D Directly based on category IV evidence or an extrapolated recommendation from other categories S Standard of clinical care (or simple) phobia, social anxiety disorder (also known as social phobia), post-traumatic stress disorder, and obsessive-compulsive disorder – is considered in turn, following key steps in management (acute treatment; longer-term treatment; combination with psychological approaches; treatment resistance). The continued inclusion or otherwise of obsessive-compulsive disorder within the broad category of anxiety disorders is the subject of continuing debate, given evidence of its dissimilarity from other anxiety disorders and its resemblance to other conditions characterised by compulsivity and impulsivity: but the principles of pharmacological treatment of anxiety disorders and obsessive-compulsive disorder share many common features, and so we have chosen to retain obsessive-compulsive disorder within these guidelines. We also include separation anxiety disorder, given its inclusion within anxiety disorders in the Diagnostic and Statistical Manual (DSM5) (American Psychiatric Association, 2013), though evidence relating to its treatment in adults is at present very sparse. We also summarise the evidence for treatment of patients with health anxiety (‘illness anxiety disorder’), partly because of the overlap in clinical features with those of generalised anxiety disorder. We expect the guidelines will be most useful in informing decisions in primary and secondary care, regarding pharmacological treatment in patients aged between 18–65 years. The nature and prevalence of anxiety disorders changes during childhood and adolescence and the mean age of onset in adult patients varies between anxiety disorders. Most adults with anxiety disorders report an onset of symptoms in childhood or adolescence (Jones, 2013; Kessler et al., 2005), and some recommendations (for example those pertaining to obsessive-compulsive disorder and social phobia) will therefore be potentially applicable to adolescent patients. Similarly the recommendations are also likely to be pertinent to elderly patients although we did not specifically review evidence in those aged over 65 years. 6. Epidemiology of anxiety symptoms and disorders Anxiety symptoms are common in the general population and in primary and secondary medical care. Symptoms may be mild, transient and without associated impairment in social and occupational function, but many patients are troubled by severe and persistent symptoms that cause significant personal distress, impair function and reduce quality of life. To meet the diagnosis of an anxiety disorder, patients have to experience a certain number of symptoms for more than a minimum specified period, the symptoms causing significant personal distress, with an associated impairment in everyday function. Most research in the field has been based on the diagnostic categories for anxiety disorders in the fourth edition of the Diagnostic and Statistical Manual (DSM-IV) [IV] (American Psychiatric Association, 1994) which are broadly similar to those in the tenth edition of the International Classification of Diseases (ICD-10) [IV] (World Health Organisation, 1992). The DSM system has recently been revised, and it is uncertain whether the approach to anxiety disorders within ‘ICD-11’ will differ substantially from ICD-10 or DSM-5. We give simplified versions of the principal clinical features of the anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder in Table 2: a simple algorithm for initial delineation of anxiety and depressive symptoms into disorders is suggested in Figure 1. Epidemiological studies in the general population indicate that when taken together anxiety disorders have a 12-month period prevalence of approximately 14% [I] (Wittchen et al., 2011) (see Table 3), and a lifetime prevalence of approximately 21% [I] (Wittchen and Jacobi, 2005). Individual disorders are less frequent, with estimated 12-month prevalence rates ranging between 0.7% (obsessive-compulsive disorder) and 6.4% (specific phobia), and estimated lifetime prevalence rates between 0.8% (obsessive-compulsive disorder) and 13.2% (specific phobia). The age and sex distribution of individual disorders varies: for example, specific phobias are markedly more common in women than men across all age bands, whereas panic disorder is almost as frequent in men and women in middle age. Despite this variation within individual anxiety disorders, the pattern for all disorders taken together is fairly constant with an overall female: male ratio of approximately 2:1 across the age range. 4 Journal of Psychopharmacology Table 2. Principal clinical features of the anxiety disorders, post-traumatic stress disorder, and obsessive-compulsive disorder. Generalised anxiety disorder Generalised anxiety disorder is characterised by excessive and inappropriate worrying that is persistent (lasting more than a few months) and not restricted to particular circumstances. Patients have physical anxiety symptoms and key psychological symptoms (restlessness, fatigue, difficulty concentrating, irritability, muscle tension and disturbed sleep). Generalised anxiety disorder is often co-morbid with major depression, panic disorder, phobic anxiety disorders, health anxiety and obsessive-compulsive disorder. Panic disorder (with or without agoraphobia) Panic disorder is characterised by recurrent unexpected surges of severe anxiety (‘panic attacks’), with varying degrees of anticipatory anxiety between attacks. Panic attacks are discrete periods of intense fear or discomfort, accompanied by multiple physical or psychological anxiety symptoms. Panic attacks typically reach their peak within 10 min and last around 30–45 min. Most patients develop a fear of having further panic attacks. Around two-thirds of patients with panic disorder develop agoraphobia, defined as fear in places or situations from which escape might be difficult or in which help might not be available, in the event of having a panic attack. These situations include being in a crowd, being outside the home, or using public transport: they are either avoided or endured with significant personal distress. Social phobia (social anxiety disorder) Social phobia is characterised by a marked, persistent and unreasonable fear of being observed or evaluated negatively by other people, in social or performance situations, which is associated with physical and psychological anxiety symptoms. Feared situations (such as speaking to unfamiliar people or eating in public) are either avoided or are endured with significant distress. Specific phobia Specific, simple or isolated phobia is characterised by excessive or unreasonable fear of (and restricted to) single people, animals, objects, or situations (for example, dentists, spiders, lifts, flying, seeing blood) which are either avoided or are endured with significant personal distress. Separation anxiety disorder Separation anxiety disorder is characterised by fear or anxiety concerning separation from those to whom an individual is attached: common features include excessive distress when experiencing or anticipating separation from home, and persistent and excessive worries about potential harms to attachment figures or untoward events that might result in separation. Post-traumatic stress disorder Post-traumatic stress disorder is characterised by a history of exposure to trauma (actual or threatened death, serious injury, or threats to the physical integrity of the self or others) with a response of intense fear, helplessness or horror; with the later development of intrusive symptoms (such as recollections, flashbacks or dreams), avoidance symptoms (for example efforts to avoid activities or thoughts associated with the trauma), negative alterations in cognitions and mood, and hyper-arousal symptoms (including disturbed sleep, hypervigilance and an exaggerated startle response). Obsessive-compulsive disorder Obsessive-compulsive disorder is characterised by recurrent obsessive ruminations, images or impulses, and/or recurrent physical or mental rituals; which are distressing, time-consuming and cause interference with social and occupational function. Common obsessions relate to contamination, accidents, and religious or sexual matters; common rituals include washing, checking, cleaning, counting and touching. Illness anxiety disorder A somatic symptom related disorder characterised by excessive or disproportionate preoccupations with having or acquiring a serious illness, with excessive health-related behaviours and high levels of alarm about personal health status. 6.1. Course of anxiety symptoms and disorders Significant anxietyrelated symptoms and impaired function, Also moderate/ severe depression? Yes Treat depression No Predominant symptom focus Trauma history and flashbacks? Obsessions + compulsions Uncontrollable worry about several areas intermittent panic/anxiety attacks and avoidance Fear of social scrutiny Check for PTSD Check for OCD Check for GAD Check for social phobia Discrete Some object/ uncued/ situation spontaneous Check for specific phobia Check for panic disorder Figure 1. Suggested scheme for exploring a suspected anxiety disorder. GAD: generalised anxiety disorder; OCD: obsessive-compulsive disorder; PTSD: post-traumatic stress disorder. Longitudinal studies in community samples indicate that many individuals with anxiety symptoms that are below the threshold for an anxiety disorder diagnosis experience an episodic condition with prolonged periods of remission: reappearance or worsening of symptoms being associated with adverse life events and other psychosocial stressors. By contrast, follow-up studies in patient groups demonstrate that anxiety disorders tend to run a chronic course, often over many years, with symptoms fluctuating in severity between periods of remission and relapse, the course of illness varying between disorders [II] (Bruce et al., 2005). Generalised anxiety disorder tends to run a waxing and waning course in non-clinical samples [I] (Angst et al., 2009), and a prolonged course in primary care [I] (Rodriguez et al., 2006): but may also ‘switch’ to other diagnoses particularly depression and somatoform disorders [II] (Rubio and Lopez-Ibor, 2007a). Social anxiety disorder tends to run a chronic course in primary [I] (Beard et al., 2010) and secondary medical care settings [II] 5 Baldwin et al. Table 3. Twelve-month prevalence of anxiety disorders within the European Union. Diagnosis (DSM-IV) Inter-quartile range (%) Best estimate (%) Number affected (millions)a Anxiety disorders Panic disorder Agoraphobia Social anxiety disorder Specific phobias Generalised anxiety disorder Obsessive-compulsive disorder Post-traumatic stress disorder Not applicableb 0.4–2.0 0.4–2.0 1.1–4.4 3.4–7.1 0.6–2.2 0.5–1.1 0.7–2.5 14.0 1.8 2.0 2.3 6.4 1.7–3.4c 0.7 1.1–2.9d 61.5 7.9 8.8 10.1 22.7 8.9 2.9 7.7 aAccording to Eurostat Directorate General of European Commission (Eurostat 2010) for the age groups used. data from single study. 95% confidence interval, 13.4–15.6%. cAge range 14–65 years, 1.7%; age 65+ years, 3.4%. dAge range 14–34 years, 2.9%; age range 35–65 years, 1.3%; age 66+ years, 1.1%. Best estimates represent consensus view of experts on most probable estimate from identified range. Full data available in Wittchen et al. (2011). DSM-IV refers to the Diagnostic and Statistical Manual of Mental Disorders, American Psychiatric Association (1994). bAggregate (Bruce et al., 2005; Ramsawh et al., 2009). For panic disorder, prospective studies reveal high degrees of symptom chronicity [I] (Batelaan et al., 2010b), relapse after remission [I] (Batelaan et al., 2010a), and ‘switching’ to other diagnoses [II] (Rubio and Lopez-Ibor, 2007b). Childhood separation anxiety disorder often resolves with entry into adolescence [I] (Copeland et al., 2014). Retrospective longitudinal studies in obsessive-compulsive disorder suggest a very poor outcome, though prospective studies in non-clinical [I] (Fineberg et al., 2013) and clinical samples [II] (Eisen et al., 2010; Kempe et al., 2007) indicate a more favourable prognosis. Cohort studies which have examined the course of symptoms following traumatic experiences suggest that posttraumatic stress disorder emerges in only a minority of affected individuals (for example, [II] Mayou et al., 2001) the course of established post-traumatic stress disorder is not established, though a chronic course was seen in almost one-half of adolescents and young adults [I] (Perkonigg et al., 2005). Recommendations: increased awareness of anxiety disorders ● Become familiar with the main features of the anxiety disorders, post-traumatic stress disorder and obsessivecompulsive disorder: and with the main symptoms which distinguish between them [S] ● Develop systematic questions to ask about the nature, severity, duration, distress and associated impairment in patients with anxiety symptoms, to decide whether an anxiety disorder, post-traumatic stress disorder or obsessive-compulsive disorder is present [S] ● Become familiar with the fluctuating nature of symptoms in patients with anxiety disorders, and with the tendency for symptoms to change in nature over time [S] 6.2. Co-existing psychological symptoms and co-morbid mental disorders Anxiety symptoms often co-exist with other psychological symptoms, especially depressive symptoms, which are particularly frequent among those individuals with more severe anxiety symptoms. Cross-sectional studies in European community and clinical settings [I] (Fehm et al., 2005; Goodwin, 2005; Lieb et al., 2005) and in UK primary medical care [I] (Nease and Aikens, 2003) reveal a significant correlation between measures of anxiety and depressive symptom severity. Many patients with anxiety disorders also simultaneously fulfil diagnostic criteria for another disorder, this pattern typically being named ‘co-morbidity’. High levels of co-morbidity are seen between the anxiety disorders, and with major depression [I] (Wittchen and Jacobi, 2005), bipolar disorder [II] (Gaudiano and Miller, 2005; Henry et al., 2003), schizophrenia (IV) (Buckley et al., 2009) substance misuse (Castle, 2008; Crippa et al., 2009; Robinson et al., 2009; Ziedonis et al., 2008) and physical illness [IV] (Davies et al., 2007; Roy-Byrne et al., 2008). The presence of a comorbid anxiety disorder is associated with both a longer time to recovery and with a greater risk of ending treatment prematurely in patients with major depression [II] (Brown et al., 1996). An early systematic review found that patients with comorbid conditions generally had worse outcomes than those with anxiety disorder or depressive disorder alone [I] (Emmanuel et al., 1998). This is supported by the findings of the US National Comorbidity Survey which demonstrated that individuals with comorbid generalised anxiety disorder and major depression were significantly more likely to remain symptomatic than individuals with depression or generalised anxiety disorder alone [I] (Kessler et al., 2008). Detection of co-morbid depression can sometimes lead to simultaneous recognition of an underlying primary anxiety disorder. For example, a French primary care study of the prevalence, recognition and treatment of social phobia found that detection rates were increased in the presence of comorbid depression (66%, compared with 53% in those without depression) [I] (Weiller et al., 1996). However the presence of a seemingly more pressing comorbid condition can result in sub-optimal treatment for the anxiety disorder. Data from a United Kingdom general practice cluster randomised controlled trial of the impact of mental health guidelines, which found that only 54% of patients with a ‘common mental disorder’ (depression or anxiety) were offered active treatment, revealed that patients with anxiety or mixed anxiety-depression were significantly less likely to be offered 6 Journal of Psychopharmacology treatment than patients with depression alone [I] (Hyde et al., 2005). Analysis of a Dutch primary care database involving patients with a newly diagnosed anxiety disorder found that benzodiazepines were significantly more frequently prescribed in patients with psychiatric comorbid conditions, and antidepressants significantly more frequently prescribed in patients with comorbid physical illness: in both forms of comorbidity, the prescription pattern of benzodiazepines was inconsistent with current guideline recommendations [I] (Smolders et al., 2007). The presence of marked co-existing depressive symptoms is an important consideration in treatment decisions. Where anxiety symptoms are present within the context of a depressive disorder, antidepressant drug treatment is often effective in reducing anxiety (IV) (Anderson et al., 2008). Where depression follows or is comorbid with an anxiety disorder it is generally indicative of greater severity and associated with poorer prognosis (II) (Albus and Scheibe, 1993; Brown et al., 1995; Cowley et al., 1996; Erwin et al., 2002; Martinsen et al., 1998; Rief et al., 2000; Shalev et al., 1998). Clinical practice has usually been to direct treatment towards the depressive disorder in the first instance, choosing treatments that also have action against the symptoms of the anxiety disorder: though some guidance notes that when a patient has an anxiety disorder and comorbid depression or depressive symptoms, treating the anxiety disorder first should also be considered, as effective treatment of the anxiety disorder will often improve the depression or depressive symptoms (National Institute for Health and Clinical Excellence, 2011). Recommendations: enquiring about coexisting symptoms and comorbid disorders ● Check for anxiety symptoms in patients presenting with symptoms of other mental disorders, including depression, bipolar disorder, psychosis and substance misuse [A] ● Remember that coexisting depressive symptoms in patients with anxiety disorders are associated with greater functional impairment and a longer duration of illness [B] ● Assess for comorbid depression and treat if depressive symptoms are of more than mild intensity [S] 7. Detection of anxiety symptoms in primary medical care settings Within the setting of primary medical care (general practice), most patients with anxiety or depression have relatively mild and transient symptoms, which tend to resolve without the need for intervention: but many have severe, persistent and disabling symptoms, which are likely to benefit from psychological or pharmacological treatment. However, many patients with anxiety and depressive symptoms do not present to primary medical care services [I] (Andrews and Carter, 2001; Roness et al., 2005). Even when patients do consult their general practitioner, anxiety symptoms are usually not their presenting complaints. The general practitioner therefore faces a significant challenge, in detecting the sample of patients most in need of treatment, from among the wider group, in many of whom intervention may be unnecessary. The limited detection of anxiety disorders in primary care has been observed in multiple countries over many years. A Dutch study found a low (47%) rate of detection of anxiety and depression, recognition being more likely in anxiety disorders of shorter duration [I] (Ormel et al., 1991). A German study, in which 5.3% of patients fulfilled diagnostic criteria for generalised anxiety disorder, and 1.6% for comorbid major depressive episode and generalised anxiety disorder, found that whilst the majority (over 70%) of affected individuals were recognised as having clinically significant emotional problems, accurate diagnosis was less common (34.4% for generalised anxiety disorder) [I] (Wittchen et al., 2002). A United States investigation of older patients with generalised anxiety disorder found low rates of recording of anxiety symptoms (34%) or anxiety disorder (9%) despite much use of health services [I] (Calleo et al., 2009). A Canadian study found the majority of ‘cases’ of anxiety disorder diagnosed through a structured clinical interview did not have a recorded diagnosis (generalised anxiety disorder, 71.0%; panic disorder, 85.8%; social anxiety disorder, 97.8%) [I] (Vermani et al., 2011). Limited recognition is partly related to difficulty in discussing emotional difficulties: many patients do not express emotional symptoms and many doctors find it hard to raise concerns about potential psychological distress. A United Kingdom general practice survey involving patients whose questionnaire scores indicated likely psychiatric ‘caseness’ found the vast majority had not mentioned emotional problems in the consultation, mainly through fears of either being unable to cope with the ensuing distress or of embarrassment, or through not wishing to trouble their doctor: but many also felt there would be either insufficient time, or the doctors could do nothing to help [II] (Cape and McCulloch, 1999). A United States primary care study found that doctors who were more sensitive to non-verbal communications were more likely to make diagnoses; but those who tended to ‘blame’ patients made fewer psychological assessments, and were less accurate in detecting distress [II] (Robbins et al., 1994). Fortunately general practice is structured in such a way that many patients present repeatedly, which provides an opportunity for recognition of symptoms at subsequent consultations, if an anxiety disorder is not detected at the first visit. In a United Kingdom longitudinal study of the detection of depression and anxiety which found that many ‘cases’ were not detected at the initial appointment, the vast majority of undetected cases of depression or anxiety were recognised at follow-up [I] (Kessler et al., 2002). A Dutch primary care practice survey found that patients with an anxiety disorder were less likely to be diagnosed than patients with a depressive episode, but the likelihood of diagnosis in both conditions increased with the number of consultations, and the expression of more severe psychological symptoms [I] (Verhaak et al., 2006). Recommendations: increasing skills in detecting anxiety symptoms ● Remember that many patients are either reluctant to present with psychological symptoms or find it hard discuss emotional problems [A] 7 Baldwin et al. ● Be sensitive to non-verbal expression of psychological distress [B] ● Use the opportunity provided by repeated consultations in primary care to ask follow-up questions about possible anxiety symptoms when these were suspected but not established at earlier appointments [A] ● Routine screening of all patients for the presence of anxiety symptoms is not recommended [A] 8. Screening for anxiety disorders in primary care settings In theory, patients and health professionals might benefit from the use of screening tools for detecting anxiety disorders, which can lead to discussion of psychological symptoms at both the index and subsequent appointments. A Danish primary care study of the potential value of screening for common mental disorders found that disclosure of scores on screening questionnaires increased the recognition of mental disorders by doctors with moderate or low recognition rates; and also resulted in increased discussion of psychological concerns and planned follow-up consultations in patients who had ‘screened positive’ [I] (Christensen et al., 2005). However, use of screening questionnaires needs to be accompanied by other changes in practice structure, and it is uncertain whether routine screening and disclosure of ‘screened positive’ patients with anxiety disorders leads to improved clinical outcomes. An educational intervention involving this design, among United States primary care patients found no evidence for an improvement in patient outcomes [I] (Mathias et al., 1994). The criteria for diagnosing psychiatric disorders are mainly from clinical observations in psychiatric outpatients and inpatients and so may not be appropriate for routine use in screening for common mental disorders, among the more mildly ill patients in primary care. Primary care doctors often have reservations about the usefulness of DSM-IV criteria for diagnosis in primary care, and many of their patients are reluctant to accept any offered diagnoses or undergo psychotropic drug treatment [II] (Van Rijswijk et al., 2009). Although general practitioners sometimes find using screening questionnaires to be troublesome within a standard consultation, patients do not object to completing them [II] (Leydon et al., 2011). The use of questionnaires for detecting and following up patients with depressive symptoms has become part of routine primary care practice in the United Kingdom, suggesting that use of a similar questionnaire for detecting anxiety disorders is feasible in practice [IV] (Buszewicz and Chew-Graham, 2011). 9. Increasing awareness of anxiety disorders in particular patient populations When compared with the general population, anxiety disorders are more common among patients with other mental disorders, with chronic physical illness, and in certain demographic groups. Patients with long-standing socioeconomic problems, and those from certain ethnic populations, may be at greater risk of receiving sub-optimal care and treatment. A Dutch primary care investigation, which included a nested case-control study of care received by patients with or without psychosocial problems, found that individuals with associated problems were significantly more likely to receive benzodiazepines and less likely to receive antidepressants: which may have contributed to their poorer outcomes [I] (Van Rijswijk et al., 2006). A crosssectional study of anxiety and depressive symptoms in Australian family practices found that unemployed patients, when compared to employed patients, were significantly more likely to report affective symptoms, to have greater symptom severity, to have previously undergone treatment and to be prescribed psychotropic medication: but were no more likely to be referred to mental health services than were employed patients [I] (Comino et al., 2000). Data from the United States indicate that black and Hispanic patients were less likely than white patients to receive care for depression and anxiety, or to receive antidepressant prescriptions (and for Hispanic patients, to undergo counselling) in primary care; and black patients were less likely than white patients to receive antidepressant prescriptions from a psychiatrist [II] (Lagomasino et al., 2011). Similar discrepancies were seen in a treatment review among United States primary care patients with anxiety disorders, where ‘non-white’ individuals were significantly less likely to receive treatment [II] (Weisberg et al., 2007). This situation may not necessarily apply in all countries, as a Dutch general practice study of the quality of care for anxiety and depression across ethnic minority groups found that all groups (with the exception of individuals originating from Surinam and the Antilles) were as likely to receive guideline-concordant medical care [I] (Fassaert et al., 2010). Recommendations: paying particular attention to certain patient groups ●Remember that anxiety symptoms tend to persist longer in patients who are experiencing long-standing socioeconomic difficulties [B] ● Ensure that the presence of socioeconomic disadvantage or membership of a minority ethnic group among patients in your practice is not associated with a reduced chance of their undergoing evidence-based pharmacological or psychological treatment [S] 10. Identifying which patients with anxiety disorders should undergo treatment Many anxious individuals have mild symptoms of recent onset that are associated with stressful life events or troublesome situations, which will often improve without needing specific treatment. However, the chronic nature and significant associated disability of anxiety disorders means that most patients who fulfil the diagnostic criteria for an anxiety disorder – in terms of severity, duration, distress and impairment – are likely to benefit from some form of treatment, whether this is psychological or pharmacological. The need for treatment is influenced by the intensity and duration of illness, the impact of symptoms on everyday life, the presence of co-existing depressive symptoms and comorbid 8 Journal of Psychopharmacology disorders, and the presence of concomitant medication; together with other features such as a good response to, or poor tolerability of, previous treatments. The choice of a particular treatment should be influenced by the supporting evidence base, by patient characteristics (such as co-morbid physical illness, previous response, or treatment contraindications), the preferences of patients and experience of doctors, and the local availability of any proposed intervention [IV] (Haynes et al., 2002). However, many patients with anxiety disorders who might benefit from treatment do not receive it. A United States longitudinal primary care study of the use of health services by patients with panic disorder found that 64% had undergone some form of intervention over 4–10 months, but only 22% had been given appropriate pharmacological treatment, and only 12% had received appropriate psychological treatment [II] (Roy-Byrne et al., 1999). The quality of treatment in those who do receive it may be enhanced through making an accurate diagnosis and by regular monitoring of progress. Another United States primary care study of the treatment of patients with panic disorder found that inadequate dosage and insufficient duration of treatment were both common, and suggested that enhanced patient education and an increased frequency of appointments would be more likely to facilitate adequate treatment than would physician education [II] (Roy-Byrne et al., 2002). A study of adherence to evidence-based guidelines for depression and anxiety disorders within the setting of Dutch primary medical care found that only 27% of patients with anxiety disorders received guidelineconsistent care: symptom severity had no influence on adherence, but documentation of a diagnosis by the general practitioner significantly increased the likelihood of receiving guidelineconsistent care [I] (Smolders et al., 2009). Media reports in many countries have raised concerns about the ‘medicalisation’ of anxiety, shyness, worrying and adjustment to trauma, and about the inappropriate prescribing of psychotropic drugs to patients who are experiencing life stresses or situational problems. This may be a factor in some settings, though most studies find a low level of inappropriate prescribing and a high level of unmet need. For example, a Norwegian primary care study involving over 1300 patients found some of evidence of ‘overtreatment’ (including inappropriate counselling, prescription of psychotropic medication, or specialist referral) in 11% of individuals without a formal psychiatric diagnosis, but also found substantial rates of ‘under-treatment’ for individuals with the diagnoses of major depressive episode (49%) or generalised anxiety disorder (64%) [I] (Olsson et al., 2006). Recommendations: deciding when and which treatment is required ● Assess the severity and duration of anxiety symptoms, and the associated distress and impairment, when deciding which patients should be offered pharmacological or psychological treatment [S] ● Remember to ask about coexisting depressive symptoms and other potential comorbid disorders [S] ● Consider other factors such as the presence of physical illness, current concomitant medication, and a history of good response to, or poor tolerability of, previous treatments [S] ● Record the diagnosis and review this at subsequent appointments [A] ● The choice of a particular treatment should be influenced by the supporting evidence base, by clinical characteristics (such as treatment contraindications and expected impact of potential side effects), the preferences of patients, personal experience, and the local availability of any proposed intervention[S] 11. Anticipating common concerns about potential adverse effects of psychotropic drugs Many patients experience unwanted and distressing adverse effects of psychotropic drug treatment, such as sexual dysfunction with selective serotonin reuptake inhibitors (SSRIs), excessive perspiration with serotonin-noradrenaline reuptake inhibitors (SNRIs), drowsiness with pregabalin and the benzodiazepines, or weight gain with antipsychotic drugs. Others fear developing a tolerance or becoming dependent on medication, and so are reluctant to start, let alone continue, pharmacological treatment. In addition, many patients and health professionals and some commentators consider pharmacological intervention to be a merely symptomatic and not a definitive treatment. For these reasons, many of those who might benefit from treatment do not receive it, and many of those who do undergo treatment stop it early because of the emergence of unwanted effects. Opinions about the potential value and drawbacks of psychotropic drug treatment vary widely. A United States crosssectional study of patients with panic disorder attending primary care found high levels of willingness to see a psychiatrist or psychotherapist, or to undergo pharmacological treatment [III] (Johnson et al., 2000). However a United Kingdom primary care qualitative study of patients’ views on anxiety and depression found marked preferences regarding their perceived health needs, and much scepticism about the value of pharmacological treatments [II] (Kadam et al., 2001). Certain patient groups may be particularly reticent about starting or continuing psychotropic drug treatment. For example, in a United States study of beliefs about psychotherapy and psychotropic drug treatment for an anxiety disorder which found few differences between diagnostic groups, coexisting depression was associated with more favourable views regarding drug treatment, whereas individuals from black and minority ethnic groups were less favourably inclined towards pharmacological or psychological treatments [II] (Wagner et al., 2005). Adherence to prescribed treatment may be enhanced by providing relevant information about treatment and minimising administrative challenges. A qualitative study of experiences of care among groups of treatment-adherent and non-adherent economically disadvantaged patients with panic disorder found that providing information was empowering and reduced a sense of isolation; that patients used a continuing process to evaluate the benefits and risks of treatment; and that barriers to treatment were primarily logistical [II] (Craske et al., 2005). Another investigation of perceived barriers to care suggested that difficulties in the continuing treatment of panic disorder were primarily administrative, such as being uncertain where to seek help, worrying 9 Baldwin et al. about potential costs, a lack of health insurance cover, and a delay in receiving appointments [II] (Mukherjee et al., 2006). Recommendations: ascertaining attitudes to care and treatment ● Explore attitudes and expectations about pharmacological and psychological treatment and correct any misconceptions with patients prior to making a specific treatment recommendation [S] ● Review patient attitudes and experiences periodically during the course of treatment [B] ● Consider the administrative aspects of practice organisation to see whether these facilitate the care and treatment of patients with anxiety disorders [S] 12. Pharmacological treatments in patients with anxiety disorders It has often proved difficult to demonstrate the benefit of antidepressant drug treatment in patients with mild depressive symptoms and the same difficulty is likely to be seen in patients with milder forms of anxiety disorders. Randomised controlled trials across a range of anxiety disorders also often demonstrate a high placebo response [IV] (Baldwin et al., 2011b; Batelaan et al., 2012; Blanco et al., 2013; Fineberg et al., 2013, 2012; Ipser and Stein, 2012) which suggests that non-specific effects of assessment and monitoring can play a large part in overall improvement. It should be emphasised that treatment response is not immediate; that a transient worsening of symptoms can sometimes occur; that prolonged courses are needed to maintain an initial treatment response; and that psychotropic medications and psychological treatments can have additive effects in some disorders. The selection of a particular drug class (and of a specific drug within that class) should be determined principally by the evidence base supporting its use, and also by whether the patient has previous experience of treatment with that compound. The absence of a licensed indication does not necessarily mean an absence of evidence for the proposed treatment intervention: conversely it should not be assumed that all drugs within a class are likely to be efficacious in the treatment of a particular anxiety disorder, when one member of that class has proven efficacy [IV] (Aquilina et al., 2007; Baldwin and Kosky, 2007; Royal College of Psychiatrists, 2007). The presence of coexisting depressive symptoms of moderate or greater severity should guide treatment choice towards the prescription of antidepressant drugs rather than benzodiazepines. 12.1. SSRIs and SNRIs SSRIs have ‘broad spectrum’ efficacy in both short-term and long-term treatment, and are generally well tolerated; and for these reasons are widely considered to be the first-line pharmacological approach in patients with anxiety disorders or obsessivecompulsive disorder. However SSRIs have potentially troublesome adverse effects, including initial increased nervousness, insomnia, nausea and sexual dysfunction [I (M)] (Gartlehner et al., 2011; Serretti and Chiesa, 2009; Sinclair et al., 2009). Fluoxetine and paroxetine are inhibitors of some cytochrome P450 enzymes and hence may interact with some other psychotropic drugs and treatments for physical illness [IV] (Muscatello et al., 2012). When stopped abruptly, and even when tapered slowly, SSRIs can produce a discontinuation syndrome characterised by dizziness, insomnia and flu-like symptoms [I (M)] (Baldwin et al., 2007; Schatzberg et al., 2006): this seems more likely with paroxetine and least likely with fluoxetine [II] (Tint et al., 2008). The SNRIs duloxetine and venlafaxine have proven efficacy in short-term and long-term treatment of generalised anxiety disorder [IV] (Baldwin et al., 2011b), and placebo-controlled trials indicate that venlafaxine is also efficacious in the acute treatment and prevention of relapse in panic disorder [IV] (Batelaan et al., 2012). Although the tolerability profiles of SSRIs and SNRIs in patients with anxiety disorders are not established fully, systematic reviews of studies in depressed patients suggest that duloxetine and venlafaxine may be less well tolerated than the SSRIs [I (M)] (Cipriani et al., 2012; Schueler et al., 2011). Both duloxetine and venlafaxine have been associated with discontinuation symptoms after abrupt withdrawal [I(M)] (Baldwin et al., 2007; Perahia et al., 2005) in adult patients, data being limited in children and adolescents [IV] (Hosenbocus and Chahal, 2011). Although evidence is mixed (Harrison et al., 2004; Mbaya et al., 2007; Thase, 1998) venlafaxine is sometimes associated with an increase in blood pressure, and monitoring is recommended with higher daily doses [IV] (Joint Formulary Committee, 2012). A systematic review [I (M)] (McIntyre et al., 2008) and the findings of pharmacoepidemiological studies [I (M)] (Strombom et al., 2008; Wernicke et al., 2008a, 2008b) provide no consistent evidence of an increased risk of hepatotoxicity with duloxetine, but it is recommended that duloxetine is avoided in patients with known liver disease and patients considered to be at risk of hepatic dysfunction [IV] (Joint Formulary Committee, 2012). 12.2. Other antidepressant drugs Certain tricyclic antidepressants (TCAs) [IV] (Baldwin et al., 2011b; Bandelow et al., 2008a; Batelaan et al., 2012; Blanco et al., 2013; Fineberg et al., 2012; Ipser and Stein, 2012) are efficacious in some anxiety disorders, but TCAs are associated with a greater burden of adverse effects than either SSRIs or SNRIs [IV] (Anderson et al., 2008), and for this reason should be generally be reserved for use after a non-response to or poor tolerance of initial treatment with an SSRI or SNRI. TCAs should be avoided in patients considered to be at risk of suicide, due to their potential fatal toxicity after overdose [IV] (Thanacoody and Thomas, 2005; Woolf et al., 2007). As with some SSRIs, many possible pharmacokinetic interactions limit their use in patients taking concomitant medication (listed in Appendix 1 of the British National Formulary, Joint Formulary Committee, 2012). As with other antidepressants, stopping TCAs abruptly can cause a discontinuation syndrome [IV] (Schatzberg et al., 2006). The traditional irreversible monoamine oxidase inhibitor (MAOI) phenelzine has proven efficacy in panic disorder and social phobia: but side effects and the need to follow dietary restrictions limit its use, so it should generally be reserved for when patients have not responded to, or proved intolerant of, other treatment approaches. Phenelzine overdose is potentially fatal [III] (White et al., 2008), and it should usually be avoided in patients considered to be at risk of suicide. Interactions involving 10 traditional MAOIs and serotonergic antidepressants such as SSRIs and clomipramine can be hazardous (Lane and Baldwin, 1997). Moclobemide, a reversible inhibitor of mono-amine oxidase A (RIMA) has proven efficacy in social phobia [IV] (Blanco et al., 2013) and some evidence of benefit in panic disorder [I (PCT)] (Ross et al., 2010): the reversibility of its action reduces the need for dietary restrictions at lower daily doses though avoidance of tyramine-containing foods is advisable at higher dosage [I (PCT)] (Dingemanse et al., 1998). Agomelatine has proven efficacy in acute treatment (Stein et al., 2008a) and prevention of relapse (Stein et al., 2012) in generalised anxiety disorder: sexual dysfunction is less likely than with SSRI or SNRI antidepressants [I (M)] (Serretti and Chiesa, 2009), as are discontinuation symptoms [I (PCT)] (Goodwin et al., 2009; Montgomery et al., 2004): elevations of hepatic enzymes occur in more than 1% of treated patients and regular monitoring of liver function tests is required in the early months of treatment [IV] (McAllister-Williams et al., 2010). The evidence for the efficacy of mirtazapine in patients with anxiety disorders is limited and inconsistent (Andrisano et al., 2013; Muehlbacher et al., 2005; Schutters et al., 2010), but in depressed patients treatment-emergent sexual dysfunction is probably less frequent than with SSRIs [I (M)] (Watanabe et al., 2011). 12. 3. Benzodiazepines Some benzodiazepines have proven efficacy in the treatment of patients with panic disorder, generalised anxiety disorder and social anxiety disorder [IV] (Baldwin et al., 2011b; Bandelow et al., 2008b; Batelaan et al., 2012; Blanco et al., 2013). However benzodiazepines can cause troublesome sedation and cognitive impairment in both short-term and long-term treatment, and tolerance and dependence can occur (especially in predisposed patients) with prolonged use: and it is hard to identify those patients at risk of developing long-term problems [IV] (Dell’Osso and Lader, 2012). It is uncertain whether benzodiazepines are efficacious in relieving depressive symptoms in patients with anxiety disorders but there is no evidence of efficacy for benzodiazepines in the acute treatment of patients with minor depression [I (M)] (Barbui et al., 2011) and antidepressants should therefore be preferred in patients with significant coexisting depressive symptoms. Benzodiazepines will usually be reserved for the further treatment of patients who have not responded to at least three previous treatments (such as after non-response to both an SSRI and an SNRI and a psychological intervention); but it has been argued that concerns about potential problems in long-term use should not prevent their use in patients with persistent, severe, distressing, and impairing anxiety symptoms, when other treatments have proved ineffective [IV] (Baldwin and Talat, 2012; Nutt, 2005). 12. 4. Pregabalin Pregabalin has proven efficacy in both acute treatment and prevention of relapse in generalised anxiety disorder [IV] (Baldwin et al., 2011b) and social anxiety disorder. In generalised anxiety disorder, it is efficacious in relieving depressive symptoms of mild to moderate intensity [I (M)] (Stein et al., 2008a), and in reducing the severity of sleep disturbance (Holsboer-Trachsler Journal of Psychopharmacology and Prieto, 2013). Common adverse effects include drowsiness and dizziness though it may be better tolerated than other medications in the acute treatment of generalised anxiety disorder [I (M)] (Baldwin et al., 2011a). Long-term treatment is accompanied by weight gain in approximately 20% of patients [III] (Montgomery et al., 2013). It is not subject to hepatic metabolism and is excreted unchanged in the urine, which is a potential advantage in patients with hepatic impairment and in patients taking other drugs metabolised by the liver, but potentially disadvantageous in patients with renal disease. There is no known untoward interaction with lithium. Spontaneous reports of adverse sexual side effects are uncommon but the incidence of treatment-emergent sexual dysfunction with pregabalin is uncertain [IV] (Baldwin et al., 2013). Discontinuation symptoms after abrupt withdrawal of pregabalin have been reported, as has the abuse of pregabalin generally in individuals with a history of other substance abuse: but the relative potential for developing tolerance and abuse, when compared to with medications, is not established [IV] (Baldwin et al., 2013). 12. 5. Other agents Antipsychotic drugs are often prescribed to patients with anxiety disorders, but the strongest evidence for benefit is restricted to acute treatment and prevention of relapse with quetiapine in generalised anxiety disorder [IV] (Baldwin et al., 2011b), and the augmentation of SSRI antidepressants in patients with obsessivecompulsive disorder [IV] (Fineberg et al., 2012). The tolerability profile of antipsychotic drugs is such that they should generally be reserved for treatment after a non-response to other interventions [IV] (National Institute for Health and Clinical Excellence, 2011). The azapirone drug buspirone is efficacious in the acute treatment of generalised anxiety disorder [I (M)] (Chessick et al., 2006), as is the anti-histamine drug hydroxyzine [I (M)] (Guaiana et al., 2010), though neither has published evidence of efficacy in the prevention of relapse. Recommendations: general aspects of pharmacological treatment ● Discuss the anticipated balance of potential benefits and potential risks of specific psychotropic medications with patients before starting treatment [S] ● Consider a SSRI for first-line treatment, as SSRIs are effective across the anxiety and related disorders, in both the short-term and long-term, and are generally well tolerated [A] ● Remain familiar with the evidence base for other classes of medication, as many patients do not respond to or are intolerant of SSRI treatment, but may respond to other classes of psychotropic drug [S] ● Discuss potential adverse effects early in treatment, including increased nervousness, worsened agitation, and review patient progress carefully over the first few weeks of treatment [A] ● Remember that benzodiazepines can be effective in many patients with anxiety disorders [A], but recognise that their use should generally only be short-term: 11 Baldwin et al. and only considered beyond this in patients who have not responded to a succession of other treatment approaches [S] ● Discuss the potential for experiencing discontinuation or withdrawal symptoms during unforeseen abrupt interruptions to treatment and after the planned end of pharmacological treatment [S] 13. Psychological treatments in patients with anxiety disorders Many patients with anxiety disorders or obsessive-compulsive disorder have a marked preference for psychological treatment approaches [II] (Patel and Simpson, 2010; Zoellner et al., 2009). Certain forms of psychotherapy, such as exposure therapy, cognitive therapy and cognitive behavioural therapy (CBT), have largely consistent evidence of efficacy in the treatment of anxiety disorders [I (M)] (Hofmann and Smits, 2008). An early systematic review of counselling for primary care patients with emotional problems (including anxiety, depression, and ‘stress’) indicates that the short-term (but not long-term) efficacy of counselling was greater than that of standard general practitioner care, with or without antidepressant treatment [I (M)] (Bower et al., 2001): though a subsequent meta-analysis suggests that short-term counselling is less beneficial than longer-term treatment with other psychological interventions [I (M)] (Cape et al., 2010). Some psychological interventions – such as psychodynamic psychotherapy - have not been subject to extensive controlled investigations (Leichsenring, 2005; Lewis et al., 2008). Psychodynamic psychotherapy was reported to be superior to applied relaxation in patients with panic disorder (Leichsenring et al., 2009; Milrod et al., 2007), but has been found less beneficial than CBT in generalised anxiety disorder (Durham et al., 1999) . Many evaluations of the efficacy of psychological treatments have not employed an optimal psychological placebo control treatment: the use of waiting list controls is inadequate to demonstrate potential efficacy. The efficacy of psychological and pharmacological approaches is broadly similar in the acute treatment of anxiety disorders. In some studies, relapse rates are lower after an initial response to cognitive therapy with exposure than after response to drug treatment. For these reasons, patients should be offered a choice of treatment approaches, selection being affected by patient clinical features, needs and preference, and by the local availability of services able to offer evidence-based psychological interventions [IV] (Haynes et al., 2002). In most anxiety disorders (generalised anxiety disorder, social anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder) it is uncertain whether combining psychological and pharmacological treatments is associated with greater long-term benefit than that which is seen with either treatment approach when given alone. However, previous concerns that prescription of psychotropic drugs might reduce the efficacy of psychological treatment are probably unfounded: in some anxiety disorders systematic reviews suggest that psychotropic drug administration can enhance the short-term efficacy of cognitive-behavioural interventions. As with pharmacological approaches, it should be emphasised that response to psychological treatment is not immediate; that transient worsening of symptoms can sometimes occur; that prolonged courses are often needed to maintain an initial treatment response; that dependence on the therapist may occur, with problems when treatment is stopped; and that encouraging short-term outcomes are no guarantee of good outcomes over the longer-term. Given uncertainty about the value of combination treatment and widespread constraints in the availability of mental health services, it may be best to plan sequential steps in patient management [IV] (National Institute for Health and Clinical Excellence, 2005, 2011). When psychological treatment is recommended, it should only be delivered by suitably trained and supervised staff, able to demonstrate that their clinical practice adheres to evidencebased treatment protocols [IV] (National Institute for Health and Clinical Excellence, 2005). The potential effectiveness of initiatives designed to increase the uptake of psychological interventions for patients with common mental health problems – such as the Improving Access to Psychological Therapies programme [IV] (Brown et al., 2010; Clark, 2011) in the United Kingdom – has not been established through formal randomised controlled trials. A general range of 8–20 h of sessions of CBT may be needed in the treatment of anxiety disorders. In generalised anxiety disorder and panic disorder, a typical treatment course consists of approximately 16–20 h, up to half of which can be conducted by the patient in supervised ‘homework’ sessions, over a period of approximately four months [IV] (National Institute for Health and Clinical Excellence, 2011). In social anxiety disorder a standard course should consist of up to 14 sessions of 90 min duration over the course of four months [IV] (National Institute for Health and Care Excellence, 2013). In post-traumatic stress disorder, a standard course of psychological treatment might involve 8–12 sessions of trauma-focused CBT, delivered at weekly intervals [IV] (National Institute for Clinical Excellence (NICE), 2005). In obsessive-compulsive disorder, a typical initial treatment course might include approximately 16 h of intervention based on exposure and response prevention, with longer and more intensive treatment in housebound patients [IV] (National Institute for Health and Clinical Excellence, 2005). Recommendations: general aspects of psychological treatment ● Remember that the efficacy of psychological and pharmacological approaches is broadly similar in the acute treatment of patients with anxiety disorders [A] ● Discuss the anticipated balance of potential benefits and potential risks of specific psychological interventions with patients before starting treatment [S] ● Ensure that psychological treatments are only delivered by suitably trained and supervised staff, able to demonstrate that their clinical practice adheres to evidence-based treatment protocols [A] ● Remind patients that response to psychological treatment is not immediate and that a prolonged course is usually needed to maintain an initial treatment response [S] ● Plan sequential steps in patient management rather than combining treatments from the start, as it is uncertain whether combining is associated with greater longterm benefit [D] 12 14. The role of self-help and complementary approaches in anxiety disorders Patient preference and the often sub-optimal effects of ‘standard’ pharmacological or psychological treatment approaches have encouraged the development of a range of self-help techniques and therapies in anxiety disorders; some undertaken as individuals, often through internet-based resources, and others in groups. Many patients and their carers derive considerable practical and emotional support from local self-help groups and national selfhelp organisations (such as the United Kingdom organisations Anxiety-UK and Obsessive Action): though formal evaluations of the effectiveness of participation in such groups are sparse [I (M)] (Pistrang et al., 2008). There have been relatively few randomised controlled trials of the efficacy and acceptability of self-help approaches undertaken as individuals, and few studies have been conducted in diagnostically homogenous groups, with reliable outcome measures and robust statistical analysis. An early systematic review of six randomised controlled trials found evidence for the efficacy of self-help in primary care patients with mixed anxiety disorders, greater efficacy being seen with more detailed instruction in use of self-help manuals [I (M)] (Van Boeijen et al., 2005). The findings of a systematic review of 21 studies in patients with depression or anxiety disorders suggest that guided self-help has similar effectiveness to face-to-face psychotherapy [I (M)] (Cuijpers et al., 2010): a subsequent systematic review of 31 randomised controlled trials in anxiety disorders indicates that selfhelp interventions are more effective than being placed on a waiting list, but less effective than therapist-administered treatments [I (M)] (Lewis et al., 2012). In addition, the evidence base for self-help approaches in young people with anxiety disorders is limited [IV] (Parslow et al., 2008; Rickwood and Bradford, 2012). In 2006, the UK National Institute for Clinical Excellence concluded that there was insufficient evidence to recommend the general introduction of computerised CBT for anxiety symptoms or disorders (National Institute for Health and Clinical Excellence, 2006): however the findings of a systematic review of 26 studies in individuals with depression or anxiety disorders suggest that internet-based interventions offer promise, in overall management [I (M)] (Griffiths et al., 2010); though there is a need to further investigate factors associated with beneficial outcomes (Andersson, 2012). Many patients with anxiety disorders wonder whether taking herbal preparations or nutritional supplements might prove beneficial, either instead of or in conjunction with standard pharmacological or psychological treatments. Systematic reviews find some evidence for the potential effectiveness of a number of ‘phytomedicines’, including Passiflora species extracts, Kava (Piper methysticum), and combinations of l-lysine and l-arginine (Lakhan and Vieira, 2010; Sarris et al., 2011b; Van der Watt et al., 2008). There is no current convincing evidence for the effectiveness of homoeopathic preparations in the treatment of patients with anxiety disorders [I (M)] (Davidson et al., 2011; Pilkington et al., 2006). Kava preparations appeared to have some beneficial effects in patients with generalised anxiety disorder but have been withdrawn in many countries due to potential hepatotoxic effects [IV] (Sarris et al., 2011a). Journal of Psychopharmacology Other complementary approaches include regular exercise and interventions drawing on meditation techniques. A systematic review indicates that exercise training reduces anxiety symptoms in sedentary patients with long-term medical conditions [I (M)] (Herring et al., 2010); and regular walking may enhance the efficacy of group CBT, across a range of anxiety disorders [II] (Merom et al., 2008). In panic disorder, regular exercise is marginally superior to relaxation [I (PCT)] (Wedekind et al., 2010); but less effective than either the TCA clomipramine [I (PCT)] (Broocks et al., 1998) or group CBT [II] (Hovland et al., 2012). Preliminary evidence suggests that exercise training may be effective in obsessive-compulsive disorder (Abrantes et al., 2009), generalised anxiety disorder (Herring et al., 2012) and social anxiety disorder (Jazaieri et al., 2012). Meditation and yoga practices are often advocated, as part of the overall management of patients with anxiety disorders. Early systematic reviews found only minimal evidence for the effectiveness of meditation therapy [I (M)] (Krisanaprakornit et al., 2006) or mindfulness-based meditation [I (M)] (Toneatto and Nguyen, 2007). However another systematic review indicated that relaxation training (which often includes components of meditation) is effective in reducing anxiety symptoms in nonclinical and clinical groups [I (M)] (Manzoni et al., 2008): and the findings of two recent systematic reviews suggest that meditative therapies are effective in reducing anxiety symptoms (though their effect in anxiety disorders is uncertain) [I (M)] (Chen et al., 2012), and that mindfulness- and acceptance-based interventions are effective in reducing anxiety and co-existing depressive symptoms in patients with anxiety disorders [I (M)] (Vøllestad et al., 2012). Recommendations: approaches self-help and complementary ● Remember that self-help approaches, such as use of internet-based educational resources, are potentially beneficial in patients with mild anxiety and depressive symptoms [A] ● Keep patients who use such resources under review as many will not improve, and so will need to undergo other forms of treatment [S] ● Enquire about the use by patients of herbal preparations or nutritional supplements, but remember that the evidence base for their use is relatively slight, when compared to the substantial evidence supporting the use of pharmacological and psychological interventions [S] 15. Costs of illness and costeffectiveness of treatment Anxiety disorders are associated with a substantial economic burden: both in health care systems (mainly direct costs of assessment, investigation, treatment and care), and in the wider society (including premature mortality, unemployment, reduced productivity losses) [I] (Andlin-Sobcki and Wittchen, 2005; Gustavsson et al., 2011; Wittchen et al., 2011). Using estimates to calculate the size of the population in the European Union that would be affected (69.1 million people), it was estimated that, in 2010, anxiety disorders (excluding post-traumatic stress disorder) cost close to €66 13 Baldwin et al. billion [I] (Gustavsson et al., 2011). Treatment costs account for a small proportion of the overall costs of health care, and it has been argued that the increased costs of strategies to increase the recognition and evidence-based treatment in patients that would otherwise remain undetected and untreated would be small, compared to the saving arising from unemployment and reduced productivity at work [IV] (Baldwin et al., 2010; Issakidis et al., 2004). However there have been relatively few randomised controlled trials or systematic evaluations of the cost-effectiveness of pharmacological, psychological or self-help interventions across the broad range of anxiety disorders (Joesch et al., 2012; Konnopka et al., 2009; Lewis et al., 2012; Poirier-Bisson et al., 2010). Investigations of the costs of illness and cost-effectiveness of individual anxiety disorders are limited. The cost-effectiveness of Improving Access to Psychological Therapies (IAPT) services within the UK is not established [III] (McCrone, 2013; Mukuria et al., 2013). For generalised anxiety disorder, cost-effectiveness studies provide evidence for the value of CBT, certain antidepressants, and pregabalin (Bereza et al., 2009; Heuzenroeder et al., 2004; Iskedjian et al., 2008; Jorgensen et al., 2006; VeraLlonch et al., 2010). Cost-effectiveness studies in panic disorder provide evidence for the value of CBT (Heuzenroeder et al., 2004; Roberge et al., 2008) [II]; SSRI or tricyclic antidepressants (Heuzenroeder et al., 2004; McHugh et al., 2007); lifestyle approaches (Lambert et al., 2010) [III]; computerised interventions (Klein et al., 2009; McCrone et al., 2009; Mihalopoulos et al., 2005) and early intervention (Smit et al., 2009). Brief interventions (Klein et al., 2009), monotherapies (McHugh et al., 2007) and self-directed approaches (McCrone et al., 2009) may be more cost-effective than longer, combination treatment, or clinician-led approaches, respectively. Treatment studies in social anxiety disorder provide some evidence for the cost-effectiveness of internet-delivered approaches [II] (Hedman et al., 2011c; Titov et al., 2009), group CBT [II] (Hedman et al., 2011a), and for long-term treatment with the SSRI escitalopram in the prevention of relapse [I (PCT)] (Francois et al., 2008). The costeffectiveness of treatments for obsessive-compulsive disorder has been investigated only rarely, with limited evidence for the greater cost-effectiveness of ‘stepped care’ compared to standard CBT [II] (Tolin et al., 2011) and group CBT in children and adolescents [III] (Farrell et al., 2012). In post-traumatic stress disorder, there is only modelled or limited evidence, for the cost-effectiveness of trauma-focused CBT in the treatment of sexually abused children, which may be enhanced when combined with an SSRI [III] (Gospodarevskaya and Segal, 2012); and for virtual reality graded exposure therapy in combat-related trauma [III] (Wood et al., 2009). 16. Management of generalised anxiety disorder 16. 1. Recognition and diagnosis Generalised anxiety disorder is amongst the most common of mental disorders in primary medical care, and is associated with increased use of health services. However it is often not recognised, possibly because only a minority of patients present with anxiety symptoms (most present with physical symptoms), and doctors tend to overlook anxiety unless it is a presenting complaint [I] (Munk-Jorgensen et al., 2006). The degree of functional impairment associated with generalised anxiety disorder is similar to that with major depression [I] (Wittchen et al., 2000). Patients with ‘co-morbid’ depression and generalised anxiety disorder have a more severe and prolonged course of illness and greater functional impairment (Tyrer et al., 2004). Patients with co-morbid depression are more likely to be recognised as having a mental health problem, though not necessarily as having generalised anxiety disorder [I] (Weiller et al., 1998; Wittchen et al., 2002). 16.2. Acute treatment The findings of systematic reviews [I (M)] (Baldwin et al., 2011b; National Institute for Health and Clinical Excellence, 2011) and randomised placebo-controlled trials of acute treatment of patients with generalised anxiety disorder together provide substantial evidence for the efficacy of many antidepressant drugs – including SSRIs (citalopram, escitalopram, paroxetine, sertraline), SNRIs (duloxetine, venlafaxine), the tricyclics imipramine and opipramol, trazodone, and agomelatine [IV] (Baldwin et al., 2011a). Other compounds with efficacy in placebo-controlled acute treatment studies include pregabalin [I (M)] (Wensel et al., 2012), some benzodiazepines (alprazolam, diazepam, lorazepam) [I (M)] (Martin et al., 2007), buspirone [I (M)] (Chessick et al., 2006), some antipsychotic drugs (quetiapine, trifluoperazine) [I (M)] (Lalonde and Van Lieshout, 2011) and the antihistamine hydroxyzine [I (M)] (Guaiana et al., 2010). Beta-blockers are often used in primary medical management of physical symptoms of anxiety but placebo-controlled evidence of efficacy in acute treatment of patients with generalised anxiety disorder is minimal [I (PCT)] (Meibach et al., 1987). There have been relatively few randomised comparatorcontrolled studies of acute treatment in generalised anxiety disorder [I (M)] (Baldwin et al., 2011b; National Institute for Health and Clinical Excellence, 2011) and most reveal no significant differences in overall efficacy between active compounds. An early analysis of randomised controlled trials of acute treatment found an overall mean effect size of 0.39: medications with higher effect sizes were pregabalin, hydroxyzine and SNRIs; and with lower effect sizes were benzodiazepines, SSRIs and buspirone [I (M)] (Hidalgo et al., 2007). The tentative findings of a mixed treatment comparison suggest fluoxetine, sertraline and pregabalin have some advantages over other medications: among currently licensed treatments in the United Kingdom, duloxetine, escitalopram and pregabalin may have some advantages over paroxetine and venlafaxine [I (M)] (Baldwin et al., 2011b). It is uncertain whether antidepressant drugs, pregabalin and benzodiazepines differ in their relative efficacy in reducing the severity of psychological or somatic anxiety symptoms [IV] (Baldwin et al., 2011a). The findings of fixed-dose randomised placebo-controlled trials provide some evidence of a dose-response relationship for pregabalin [I (M)] (Bech, 2007; Lydiard et al., 2010), but studies with antidepressant drugs provide no consistent evidence for a dose-relationship [IV] (Baldwin et al., 2011a). Although not an antidepressant, a post hoc pooled analysis of randomised placebo-controlled trials with pregabalin indicate that it is efficacious in reducing depressive symptom severity in patients with mild to moderate intensity of depressive symptoms [I (M)] (Stein et al., 2008b). 14 16.3. Longer term treatment The findings of acute treatment studies indicate that the proportion of responding patients steadily increases over time [IV] (Baldwin et al., 2011a). Continuing with SSRI or SNRI treatment is associated with an increase in overall response rates: from 8–24 weeks with escitalopram or paroxetine [II] (Bielski et al., 2005); from 4–12 weeks with sertraline [I (PCT)] (Allgulander et al., 2004a) and from 8–24 weeks with venlafaxine [I (PCT)] (Montgomery et al., 2002). However, the findings of post hoc analyses of data from randomised double-blind placebo-controlled studies with duloxetine [I (M)] (Pollack et al., 2008), escitalopram [I (M) (Baldwin et al., 2009), and with alprazolam, pregabalin and venlafaxine [I (M) (Baldwin et al., 2011a) all suggest that response is likely only if there is an onset of effect within four weeks of treatment. The findings of randomised placebo-controlled relapseprevention studies in patients who have responded to previous ‘open’ acute treatment of varying lengths reveal a significant advantage for staying on active medication (agomelatine, duloxetine, escitalopram, paroxetine, pregabalin, quetiapine, venlafaxine, vortioxetine), when compared with switching to placebo, for periods of between 6–18 months (Baldwin et al., 2011b, 2012; Katzman et al., 2011; Rickels et al., 2010). Journal of Psychopharmacology treatments with proven efficacy may be helpful [IV] (National Institute for Health and Clinical Excellence, 2011). The addition of pregabalin to SSRI or SNRI antidepressant drugs is superior to continued treatment with antidepressants alone [I (PCT)] (Rickels et al., 2012). The findings of small randomised placebo-controlled augmentation studies suggest that augmentation of antidepressants with antipsychotic drugs (olanzapine, quetiapine, risperidone) may be beneficial [I (PCT)] (Brawman-Mintzer et al., 2005; Pollack et al., 2006; Altamura et al., 2011), but the evidence for quetiapine augmentation is inconsistent [I (PCT)] (Khan et al., 2011; Simon et al., 2008), and uncertain for ziprasidone augmentation [I (PCT)] (Lohoff et al., 2010). Alternative treatments which have been found helpful in some patients include multi-faith spiritually based intervention [II] (Koszycki et al., 2010); Galphimia glauca (‘thyrallis’) [I (PCT)] (Herrera-Arellano et al., 2007), Matricaria recutita extract (chamomile) [I (PCT)] (Amsterdam et al., 2009), ‘Silexa’ lavender oil preparation [I (PCT)] (Woelk and Schlaefke, 2010), ‘relaxing room therapy’ [III] (Sherman et al., 2010), yoga-based breathing programme [III] (Katzman et al., 2012) and ‘balneotherapy’ (hydrotherapy with message) [III] (Dubois et al., 2010): but more investigation of these approaches is needed before they can be recommended. 16.4. Comparative efficacy of psychological, pharmacological, and combination treatments Recommendations: managing patients with generalised anxiety disorder Pharmacological or psychological treatments, when delivered singly, have broadly similar efficacy in acute treatment [I (M)] (Bandelow et al., 2007a; National Institute for Health and Clinical Excellence, 2011). The efficacy of CBT and applied relaxation appears superior to that of other psychological interventions (National Institute for Health and Clinical Excellence, 2011). A randomised controlled trial found that augmentation of venlafaxine with CBT conferred no additional benefit, when compared with venlafaxine alone [II] (Crits-Christoph et al., 2011) but it is uncertain whether combining drug and psychological treatments is associated with greater overall efficacy than is seen with either treatment, when given alone [I (M)] (Bandelow et al., 2007a), and a ‘stepped care’ approach is recommended [IV] (National Institute for Health and Clinical Excellence, 2011). Anxiety symptom severity at follow-up after initial treatment is lower with CBT than with other forms of psychological treatment [III] (Durham et al., 2005): but the comparative efficacy of pharmacological and psychological approaches over the long-term is not established. ● Become familiar with the symptoms and signs of generalised anxiety disorder [S] ● Ask about the presence of coexisting depressive symptoms [A] ●Ask about long-standing anxiety in patients with depressive or unexplained physical symptoms [S] ● Assess any comorbid physical illness and enquire about excess alcohol consumption [S] 16. 5. Further management after nonresponse to initial treatment Many patients do not respond to first-line pharmacological or psychological interventions. There is only inconsistent evidence for a dose-response relationship with antidepressant drugs, but some patients who have not responded to an initial low dosage may respond to a higher daily dose. The efficacy of pregabalin when compared with placebo is more marked at higher daily doses (200 mg or higher) [I (M)] (Bech, 2007; Lydiard et al., 2010). Switching between pharmacological and psychological Detection and diagnosis Acute treatment ● Choose an evidence-based acute treatment [A] ○ pharmacological: most SSRIs (citalopram, escitalopram, paroxetine, sertraline), duloxetine, venlafaxine, pregabalin, agomelatine, quetiapine, some benzodiazepines (alprazolam, diazepam, lorazepam), imipramine, buspirone, hydroxyzine and trazodone [A] ○ psychological: cognitive-behaviour therapy, applied relaxation [A] ● Take account of patient clinical features, needs and preference and local service availability when choosing treatment, as pharmacological and psychological approaches have broadly similar efficacy in acute treatment [S] ● Consider an SSRI for first-line pharmacological treatment [A] ● SNRIs and pregabalin may be considered as alternative initial treatments if SSRIs are judged to be unsuitable [A] ● Remember that higher daily doses of pregabalin may be associated with greater response rates [A] 15 Baldwin et al. ● Advise the patient that treatment periods of up to 12 weeks may be needed to assess efficacy [S] but recognise that an absence of clinical benefit within four weeks warns that a response to unchanged treatment is unlikely [A] Longer-term treatment ● Continue drug treatment for up to 18 more months in patients who have responded to treatment [A] ● Use a treatment approach that is known to be efficacious in preventing relapse [S] ● Recommend CBT over other forms of psychological treatment as it may reduce relapse rates better than other psychological treatments [C] ● Monitor effectiveness and acceptability regularly over the course of treatment [S] ● When stopping treatment, reduce the dose gradually over an extended period to avoid discontinuation and rebound symptoms [A]: in the absence of evidence a minimum of three months is recommended for this taper period [D] Combination of drugs and psychological treatment ● Routinely combining drug and psychological approaches is not recommended for initial treatment [A] When initial treatments fail ● Consider raising the dosage of pregabalin if the current dosage is well tolerated [A] ● Consider switching to another evidence-based treatment [D] ● Consider combining evidence-based treatments only when there are no contraindications [S] ● Consider pregabalin augmentation after a non-response to initial SSRI or SNRI treatment [A] ● Consider use of benzodiazepines after a non-response to SSRI, SNRI, pregabalin and buspirone treatment [S] ● Consider combining drug treatment and cognitivebehaviour therapy [D] ● Consider referral to regional or national specialist services in treatment refractory patients [S] 17. Management of panic disorder 17.1. Recognition and diagnosis Accurate diagnosis of panic disorder is dependent upon establishing the presence of recurring panic attacks (i.e. short-lived periods of severe psychological and physical symptoms of anxiety, typically peaking within 10 min and resolving within 30 min), at least some of which are, or have been, unexpected. There should be intervening periods of comparative freedom from anxiety between attacks; but the presence of associated concern, worry or change in behaviour due to an anticipated risk of having further panic attacks [IV] (Roy-Byrne et al., 2006). There is substantial overlap between panic disorder and agoraphobia, in community and clinical samples [I] (Goodwin et al., 2005; Wittchen et al., 2010). Patients with panic disorder are often not recognised or accurately diagnosed in primary [IV] (National Collaborating Centre for Mental Health, 2011) or secondary medical care [I] (Burton et al., 2011; Deacon et al., 2008), despite their considerable use of emergency, cardiac, gastrointestinal, neurological and mental health services [IV] (Roy-Byrne et al., 2006). There is considerable co-morbidity with other mental disorders, including anxiety disorders, bipolar disorder and major depression [IV] (Roy-Byrne et al., 2006): co-morbid panic and depression is particularly common, and associated with greater disability and impairment, and increased use of health services [I] (Roy-Byrne et al., 2000). 17.2. Acute treatment Systematic reviews demonstrate that a range of pharmacological [IV] (Andrisano et al., 2013, Batelaan et al., 2012;), psychological [IV] (Schmidt and Keough, 2010) and combination [I (M)] (Furukawa et al., 2007; Watanabe et al., 2007) interventions are effective in the acute treatment of patients with panic disorder. Little is known about the efficacy of pharmacological or psychological treatment in patients with agoraphobia but without panic attacks (Perna et al., 2011). The findings of randomised doubleblind placebo-controlled trials of antidepressants indicate that all SSRIs (escitalopram, citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline); the SNRI venlafaxine; the selective noradrenaline reuptake inhibitor reboxetine; some TCAs (clomipramine, desipramine, imipramine, lofepramine); the MAOI phenelzine; some benzodiazepines (alprazolam, clonazepam, diazepam, lorazepam); and some anticonvulsants (gabapentin, sodium valproate) are all efficacious in acute treatment [IV] (Batelaan et al., 2012). The findings of randomised comparator-controlled studies provide some evidence for beneficial effects with mirtazapine [II] (Ribeiro et al., 2001) and moclobemide [II] (Kruger and Dahl, 1999; Tiller et al., 1999). The relative efficacy and tolerability of differing pharmacological treatments is uncertain, but there may be efficacy advantages for venlafaxine, and tolerability disadvantages for fluvoxamine and reboxetine [I (M)] (Andrisano et al., 2013). A post hoc analysis of findings from a randomised placebo-controlled trial suggests that escitalopram is superior to citalopram [I (PCT)] (Bandelow et al., 2007b); and randomised controlled trials suggest that some SSRIs (fluvoxamine, paroxetine) are more effective than some noradrenaline reuptake inhibitors (maprotiline, reboxetine) [II] (Bertani et al., 2004; Den Boer and Westenberg, 1988). Medications with a lack of efficacy in the acute treatment of patients with panic disorder include the antidepressant bupropion [I (PCT)] (Sheehan et al., 1983), the betablocker propranolol [I (PCT)] (Munjack et al., 1989); and buspirone[I (PCT)] (Sheehan et al., 1988). The potential value of antipsychotic drug monotherapy in acute treatment is unknown [I (M)] (Depping et al., 2010). 17.3. Longer term treatment The findings of acute treatment studies indicate that the proportion of responding patients steadily increases over time [IV] (Batelaan et al., 2012). Double-blind studies indicate that continuing SSRI or clomipramine treatment from 12–52 weeks is associated with an increase in overall treatment response rates [I (PCT)] (Ballenger, 1998; Lecrubier and Judge, 1997; Lepola et al., 1998). The relative effectiveness and acceptability of 16 differing medications over long-term treatment is uncertain, but a 12-month comparison of the efficacy and tolerability of differing SSRIs (citalopram, fluoxetine, fluvoxamine, paroxetine) suggests that fluvoxamine is less likely to be associated with weight gain or sexual adverse effects [III] (Dannon et al., 2007); and the findings of a randomised naturalistic parallel-group study of 34 months of continuation treatment with clonazepam or paroxetine suggest that clonazepam is marginally more effective and better tolerated [II] (Nardi et al., 2012). Placebo-controlled and other relapse-prevention studies in patients who have responded to previous acute treatment reveal a significant advantage for staying on active medication (fluoxetine, imipramine, paroxetine, sertraline, venlafaxine), compared to switching to placebo, for periods of up to six months: but the optimal duration of continuation treatment is uncertain [I (M)] (Donovan et al., 2010). 17.4. Comparative efficacy of psychological, pharmacological, and combination treatments The findings of pooled analyses and randomised controlled trials together indicate that pharmacological and psychological treatments, when delivered singly, have broadly similar efficacy in acute treatment [I (M)] (Bandelow et al., 2007b; McHugh et al., 2009). In acute treatment, the combination of psychotherapy with antidepressants is superior to psychotherapy or an antidepressant, when either is given alone (Furukawa et al., 2007; Koszycki et al., 2011; Van Apeldoorn et al., 2010): the advantage over monotherapies persists as long as the antidepressant is continued, but combination treatment is more effective than antidepressant treatment alone, though no different to psychological treatment alone, in preventing relapse [I (M)] (Furukawa et al., 2007). Based on limited data, the combination of psychotherapy with a benzodiazepine is probably superior to a benzodiazepine when given alone during acute treatment, but the relative efficacy of combination treatment and monotherapies in the prevention of relapse is uncertain [I (M)] (Watanabe et al., 2007). However combination treatment appears no more cost-effective than antidepressant or CBT monotherapy [II] (McHugh et al., 2007). Exploratory placebo-controlled studies suggest that the addition of d-cycloserine may hasten the onset of effect [I (PCT)] (Siegmund et al., 2011) or increase overall effectiveness [I (PCT)] (Otto et al., 2010) of CBT in the acute treatment of patients with panic disorder. 17. 5. Further management after nonresponse to initial treatment Many patients do not respond to first-line pharmacological or psychological interventions. The findings of randomised fixeddose placebo-controlled studies suggest that higher daily doses of some antidepressants [I (PCT)] (paroxetine, fluoxetine: Ballenger et al., 1998; Michelson et al., 1998) but not others [I (PCT)] (citalopram, venlafaxine: Pollack et al., 2007; Wade et al., 1997) may be superior in efficacy to lower doses. However, the evidence to support dose escalation after an initial lack of response to lower doses is only limited [I (PCT)] (Michelson et al., 2001) or negative [I (PCT)] (Simon et al., 2009). Journal of Psychopharmacology Switching between pharmacological and psychological treatments with proven efficacy may be helpful [IV] (National Institute for Health and Clinical Excellence, 2011). A single-blind crossover study in non-responders suggests that switching between citalopram and reboxetine may be worthwhile [II] (Seedat et al., 2003). A randomised placebo-controlled study found that pindolol augmentation of fluoxetine was superior to continued fluoxetine alone [I (PCT)] (Hirschmann et al., 2000). A small open study involving the addition of fluoxetine in patients taking a TCA, or vice versa, found some evidence of benefit [III] (Tiffon et al., 1994). Combined treatment with sodium valproate and clonazepam may be beneficial in patients who have not responded to several previous medications [III] (Ontiveros and Fontaine, 1992); as has the addition of olanzapine to other medications [III] (Sepede et al., 2006). Addition of lithium to clomipramine was found successful in a single case report [III] (Cournoyer, 1986). Augmentation of CBT with paroxetine may be superior to continuing with CBT alone, in patients who did not previously respond over 15 sessions [I (PCT)] (Kampman et al., 2002); and addition of group CBT may be beneficial in non-responders to pharmacological approaches [III] (Heldt et al., 2003; Otto et al., 1999; Pollack et al., 1994). However a small study in multiply treatment-resistant patients found no difference in effectiveness between the augmentation of medication with CBT or ‘medication optimisation’ (SSRI plus clonazepam) [I (PCT)] (Simon et al., 2009). Recommendations: managing patients with panic disorder Detection and diagnosis ● Become familiar with the symptoms and signs of panic attacks and panic disorder [S] ● Ask about the presence of coexisting depressive symptoms [A] ● Assess the level of agoraphobic avoidance to help judge the severity of the condition [S] ● Ask about panic attacks and agoraphobia in patients with medically unexplained physical symptoms [D] Acute treatment ● Choose an evidence-based acute treatment [A] ○ pharmacological: all SSRIs, some TCAs (clomipramine, desipramine, imipramine, lofepramine) venlafaxine, reboxetine, some benzodiazepines (alprazolam, clonazepam, diazepam, lorazepam), some anticonvulsants (gabapentin, sodium valproate) [A] ○ psychological: cognitive-behaviour therapy [A] ● Avoid prescribing propranolol, buspirone and bupropion [A] ● Take account of patient clinical features, needs and preference and local service availability when choosing treatment, as pharmacological and psychological approaches have broadly similar efficacy in acute treatment [S] ● Consider an SSRI for first-line pharmacological treatment [S] 17 Baldwin et al. ● Consider increasing the dose if there is insufficient response, but remember that the evidence for a doseresponse relationship with SSRIs and venlafaxine is inconsistent [A] ● Initial side effects can be minimised by slowly increasing the dose or by adding a benzodiazepine for a few weeks [D] ● Advise the patient that treatment periods of up to 12 weeks may be needed to assess efficacy [A] Longer-term treatment ● Continue drug treatment for at least six months in patients who have responded to treatment [A] ● Use an approach that is known to be efficacious in preventing relapse [S] ● Monitor effectiveness and acceptability regularly over the course of treatment [S] ● When stopping treatment, reduce the dose gradually over an extended period to avoid discontinuation and rebound symptoms [A]: in the absence of evidence a minimum of three months is recommended for this taper period [D] Combination of drugs and psychological treatment ● Consider combining cognitive therapy with antidepressants as this has greater efficacy and may reduce relapse rates better than drug treatment alone [A] ● Consider combining cognitive therapy with benzodiazepines (being mindful of potential long-term problems) as this probably has greater efficacy than drug treatment alone [A] When initial treatments fail ● Consider raising the dosage if the current dosage is well tolerated [A] ● Consider switching to another evidence-based treatment [D] ● Consider combining evidence-based treatments only when there are no contraindications [S] ● Consider combining evidence-based pharmacological and psychological treatments [A] ● Consider referral to regional or national specialist services in treatment refractory patients [S] 18. Management of specific phobia (also known as simple or isolated phobia) 18.1. Recognition and diagnosis Specific fears of objects, animals, people or situations are widespread in children, adolescents and adults, but only a minority of affected individuals reach the full diagnostic criteria for specific phobia. Specific (or simple or isolated) phobia has an estimated 12-month prevalence of 6.4% [I] (Wittchen et al., 2011), and had a lifetime prevalence of 9.4% in the United States National Epidemiologic Survey on Alcohol and Related Conditions [I] (Stinson et al., 2007). Many affected individuals have multiple fears, whose presence is associated with an earlier onset, greater severity and impairment, and more frequent psychiatric comorbidity [I] (Burstein et al., 2012; Stinson et al., 2007). Most individuals with specific phobia do not present for treatment of that condition, presentation being more likely with comorbid anxiety or mood disorders [I] (Mackenzie et al., 2012). 18.1 Treatment The effectiveness and acceptability of psychological or pharmacological treatments for specific phobia has been relatively under-researched when compared to other anxiety disorders. The findings of a meta-analytic review of 33 randomised controlled treatment studies indicate that exposure-based therapies (particularly those involving in vivo exposure) are more effective than other psychological interventions: effectiveness being seen regardless of the nature of the specific phobia, and being somewhat greater with multiple rather than single sessions [I (M)] (Wolitzky-Taylor et al., 2008). Most patients respond to psychological approaches, but some may benefit from pharmacological treatment. The findings of small randomised placebo-controlled trials provide evidence for the efficacy of escitalopram [I (PCT)] (Alamy et al., 2008) and paroxetine [I (PCT)] (Benjamin et al., 2000). The findings of small randomised placebo-controlled studies suggest that the efficacy of exposure therapy can be enhanced through prior administration of d-cycloserine [I (PCT)] (Nave et al., 2012; Ressler et al., 2004): but not all evidence is consistent [I (PCT)] (Guastella et al., 2007), and its administration after a session is not associated with enhanced efficacy [I (PCT)] (Tart et al., 2013). Prior administration of naltrexone may reduce the effectiveness of exposure therapy [I (PCT)] (Kozak et al., 2007). It is unclear whether concomitant use of benzodiazepines enhances or reduces the efficacy of behavioural approaches. Recommendations: managing patients with specific (or simple) phobia ● Become familiar with the symptoms and signs of specific phobia [S] ● Assess the number of fears, the level of anxiety, and the degree of impairment to judge severity [A] ● Ask about symptoms of comorbid disorders in treatment-seeking patients [A] ● Use psychological treatments based on exposure techniques as first-line treatment [A] ● Consider SSRI treatment for patients who have not responded to psychological interventions [A] 19. Management of social anxiety disorder (also known as social phobia) 19.1. Recognition and diagnosis Social anxiety disorder is often not recognised in primary medical care [I] (Weiller et al., 1996) but detection can be enhanced through the use of screening questionnaires in psychologically distressed primary care patients [I] (Donker et al., 2010; Terluin 18 et al., 2009). Social anxiety disorder is often misconstrued as mere ‘shyness’ but can be distinguished from shyness by the higher levels of personal distress, more severe symptoms and greater impairment [I] (Burstein et al., 2011; Heiser et al., 2009). The generalised sub-type (where anxiety is associated with many situations) is associated with greater disability and higher comorbidity, but patients with the non-generalised subtype (where anxiety is focused on a limited number of situations) can be substantially impaired [I] (Aderka et al., 2012; Wong et al., 2012). Social anxiety disorder is hard to distinguish from avoidant personality disorder, which may represent a more severe form of the same condition [IV] (Reich, 2009). Patients with social anxiety disorder often present with symptoms arising from comorbid conditions (especially depression), rather than with anxiety symptoms and avoidance of social and performance situations [I] (Stein et al., 1999). There are strong, and possibly two-way, associations between social anxiety disorder and dependence on alcohol and cannabis [I] (Buckner et al., 2008; Robinson et al., 2011). 19.2. Acute treatment The findings of meta-analyses and randomised placebocontrolled treatment studies indicate that a range of approaches are efficacious in acute treatment [IV] (Blanco et al., 2013). CBT is efficacious in adults [I (M)] (Hofmann and Smits, 2008) and children [I (M)] (James et al., 2005): cognitive therapy appears superior to exposure therapy [I (M)] (Ougrin, 2011), but the evidence for the efficacy of social skills training is less strong [IV] (Ponniah and Hollon, 2008). Antidepressant drugs with proven efficacy include most SSRIs (escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline), the SNRI venlafaxine, the MAOI phenelzine, and the RIMA moclobemide: nefazodone is not efficacious and the evidence for mirtazapine is inconsistent [I (M)] (De Menezes et al., 2011). The potential efficacy of tricyclic antidepressants is unknown. Some benzodiazepines (bromazepam and clonazepam, but not alprazolam) and anticonvulsants (gabapentin and pregabalin, but not levatiracetam), and the antipsychotic olanzapine also appear efficacious in acute treatment [IV] (Blanco et al., 2013). Neither the 5-hydroxytryptamine (5-HT1A) partial agonist buspirone, nor the beta-blocker atenolol are efficacious in generalised social anxiety disorder [IV] (Blanco et al., 2013), although a number of small single-dose placebo-controlled cross-over studies together suggest that beta-blockers can be beneficial in reducing anxiety symptoms in individuals with ‘performance anxiety’ (for example, when speaking in public), which overlaps with mild non-generalised social anxiety disorder) [IV] (Blanco et al., 2013). There have been relatively few randomised comparator-controlled studies of acute treatment and most reveal no significant differences in overall efficacy or tolerability between active compounds. In randomised placebo- and comparator- controlled studies, phenelzine was superior to placebo, but atenolol was not [I (PCT)] (Liebowitz et al., 1992); phenelzine was superior to placebo, but alprazolam was not [I (PCT)] (Gelernter et al., 1991); and escitalopram was found superior to paroxetine [I (PCT)] (Lader et al., 2004); venlafaxine and paroxetine had similar overall efficacy in two placebo-controlled studies [I (PCT)] (Allgulander et al., 2004b; Liebowitz et al., 2005). Journal of Psychopharmacology 19.3. Longer term treatment The findings of acute treatment studies indicate that the proportion of responding patients increases steadily over time [IV] (Blanco et al., 2013). Double-blind studies indicate that continuing SSRI or SNRI treatment from 12–24 weeks is associated with an increase in overall treatment response rates [I (M)] (Lader et al., 2004; Stein et al., 2002a, 2003). A post hoc analysis of the clinical trial database for escitalopram indicates that response is unlikely if there is no onset of clinical effect within the first four weeks of treatment [I (PCT)] (Baldwin et al., 2009): however a post hoc analysis of the clinical trial database with paroxetine indicates that many non-responders to treatment at eight weeks become responders with a further four weeks of double-blind treatment [I (PCT)] (Stein et al., 2002a). The findings of randomised placebo-controlled relapse-prevention studies in patients who have responded to previous acute treatment reveal a significant advantage for staying on active medication (clonazepam, escitalopram, paroxetine, pregabalin, sertraline) for up to six months [IV] (Blanco et al., 2013). 19.4. Comparative efficacy of pharmacological, psychological and combination treatments Pharmacological and psychological treatments, when delivered singly, have broadly similar efficacy in acute treatment [I (M)] (Canton et al., 2012). However, acute treatment with cognitive therapy (group or individual) is associated with a reduced risk of symptomatic relapse at follow-up [I (M)] (Canton et al., 2012). It is unlikely that the combination of pharmacological with psychological treatments is associated with greater overall efficacy than with either treatment, when given alone, as only one in four studies of the relative efficacy of combination treatment found evidence for superior efficacy [I (PCT)] (Blanco et al., 2010). The findings of small randomised placebo-controlled studies suggest that the efficacy of psychological treatment may be enhanced through prior administration of d-cycloserine [I (PCT)] (Guastella et al., 2008; Hofmann et al., 2006) or cannabidiol [I (PCT)] (Bergamaschi et al., 2011). 19.5. Further management after nonresponse to initial treatment The findings of fixed-dose randomised controlled trials do not provide consistent evidence of a dose-response relationship with antidepressant drugs: but a fixed-dose study of pregabalin found that only the higher daily dosage was efficacious [I (PCT)] (Pande et al., 2004). A double-blind randomised controlled dosage escalation trial found no advantage for increasing to a higher daily dosage (120 mg) of duloxetine, when compared to continuing treatment with a lower (60 mg) dosage [II] (Simon et al., 2010). Switching between treatments with proven efficacy may be helpful [IV] (Blanco et al., 2013). An uncontrolled study of augmentation of SSRI treatment with buspirone found some evidence of beneficial effects [III] (Van Ameringen et al., 1996); but a placebo-controlled crossoverstudy of the augmentation of paroxetine with pindolol found no evidence of efficacy [I (PCT)] (Stein et al., 2001). A small 19 Baldwin et al. placebo-controlled study of the augmentation of paroxetine with clonazepam found the combination was marginally short of superiority, when compared to paroxetine alone [I (PCT)] (Seedat and Stein, 2004). Recommendations: managing patients with social anxiety disorder Detection and diagnosis ● Become familiar with the symptoms and signs of social anxiety disorder [S] ● Assess the level of distress and disability to help distinguish social anxiety disorder from shyness [A] ● Ask about the presence of coexisting depressive symptoms [A] ● Ask about social anxiety symptoms when patients present with depression, panic attacks restricted to social situations, or alcohol and cannabis misuse [A] Acute treatment ● Choose an evidence-based acute treatment [A] ○ pharmacological: most SSRIs (escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline), venlafaxine, phenelzine, moclobemide, some benzodiazepines (bromazepam, clonazepam) and anticonvulsants (gabapentin, pregabalin), and olanzapine ○ psychological: cognitive-behaviour therapy ● Avoid prescribing atenolol or buspirone in generalised social anxiety disorder [A] ● Take account of patient clinical features, needs and preference and local service availability when choosing treatment, as pharmacological and psychological approaches have broadly similar efficacy in acute treatment [S] ● Consider an SSRI for first-line pharmacological treatment [A] ● Routine prescription of higher doses of SSRIs is not recommended [A], but individual patients may benefit from higher doses [D] ● Advise the patient that treatment periods of up to 12 weeks may be needed to assess efficacy [A] Longer-term treatment ● Use an approach that is known to be efficacious in preventing relapse [S] ● Continue drug treatment for at least six months in patients who have responded to treatment [A] ● Consider cognitive therapy with exposure as this may reduce relapse rates better than drug treatment [A] ● Consider cognitive therapy after response to drug treatment, in patients with a high risk of relapse [D] ● Monitor effectiveness and acceptability regularly over the course of treatment [S] Combination of drugs and psychological treatment ● Routinely combining drug and psychological approaches is not recommended for initial treatment in the absence of consistent evidence for enhanced efficacy over each treatment when given alone [A] When initial treatments fail ● Consider raising the dosage if the current dosage is well tolerated [D] ● Consider switching to another evidence-based treatment [D] ● Consider combining evidence-based treatments only when there are no contraindications [S] ● Consider adding buspirone after partial response to an SSRI [C] ● Consider combining evidence-based pharmacological and psychological treatments [A] ● Consider benzodiazepines in patients who have not responded to other approaches [D] ● Consider referral to regional or national specialist services in treatment refractory patients [S] 20. Management of post-traumatic stress disorder 20.1. Recognition and diagnosis Exposure to potentially life-damaging traumatic events is common, in both genders, during childhood, adolescence and adult life [IV] (Nemeroff et al., 2006): but only a proportion of those exposed to trauma develop psychological sequelae. For example, the US National Comorbidity Survey found that 60.7% of men and 51.2% of women reported exposure to at least one traumatic event, but post-traumatic stress disorder had a lifetime prevalence of 7.8% [I] (Kessler et al., 1995). In the UK, post-traumatic stress disorder was present in only a minority of individuals exposed to motor vehicle accidents, at three-month (11%) and 12-month (5%) follow-up [I] (Mayou et al., 2001). The 12-month prevalence of post-traumatic stress disorder is estimated to be 1.1–2.9%, being more common in younger than older adults [I] (Wittchen et al., 2011). Post-traumatic stress disorder shows considerable co-morbidity with other mental disorders [I] (Loewe et al., 2011). Suicidal thoughts are common but the increased risk of completed suicide is probably due to the presence of comorbid depression [I (M)] (Krysinska and Lester, 2010). Post-traumatic stress disorder is associated with increased use of health services, but is often not recognised in primary or secondary care [I] (Liebschutz et al., 2007). Diagnosis can be established through eliciting the history of exposure to trauma (actual or threatened death, serious injury, or threats to the physical integrity of the self or others); with a response of intense fear, helplessness or horror; and the presence of ‘re-experiencing symptoms’ (such as intrusive recollections, flashbacks or dreams); avoidance symptoms (such as efforts to avoid activities or thoughts associated with the trauma); and hyper-arousal symptoms (including disturbed sleep, hypervigilance and an exaggerated startle response). 20.2. Prevention of post-traumatic disorder after experiencing trauma There is some scope for preventing the emergence of psychological post-traumatic symptoms in people subject to major trauma. Early administration of benzodiazepines after trauma may not 20 prevent the emergence of post-traumatic symptoms [III] (Gelpin et al., 1996). A small randomised placebo-controlled study found that acute administration of propranolol (160 mg/day) was superior to placebo in reducing subsequent post-traumatic symptoms and physiological hyper-activity to reminders of trauma, but not the emergence of post-traumatic stress disorder, at one month [I (PCT)] (Pitman et al., 2002). A naturalistic study suggests acute administration of propranolol (120 mg/day) prevented the emergence of syndromal post-traumatic stress disorder at two months [III] (Vaiva et al., 2003): but not all evidence is consistent [I (PCT)] (Nugent et al., 2010, Stein et al., 2007b). Intravenous administration of hydrocortisone has been found superior to placebo in preventing post-traumatic symptoms, in intensive care adult patients with septic shock (median interval, 31 months) [I (PCT)] (Schelling et al., 2001), in patients undergoing cardiac surgery (interval, six months) [I (PCT)] (Schelling et al., 2004), and in patients experiencing acute stress reactions following a range of traumatic experiences [I (PCT)] (Zohar et al., 2011). The findings of small randomised placebo-controlled treatment studies find evidence for the efficacy for sertraline [I (PCT)] (Stoddard et al., 2011), but not for gabapentin [I (PCT)] (Stein et al., 2007b) or escitalopram [I (PCT)] (Shalev et al., 2012), in preventing post-traumatic symptoms. The findings of systematic reviews suggest that trauma-focused CBT is potentially beneficial in preventing chronic post-traumatic symptoms, when provided within six months of the incident [I (M)] (Roberts et al., 2009); but approaches with limited efficacy include single-session ‘debriefing’ [I (M)] (Van Emmerik et al., 2002) and multiple-session early intervention [I (M)] (Roberts et al., 2009). 20.3. Acute treatment of post-traumatic disorder The findings of randomised placebo-controlled treatment studies indicate that there is evidence for the efficacy of a range of antidepressants including some SSRIs (fluoxetine, paroxetine, sertraline), amitriptyline, imipramine, mirtazapine, nefazodone, phenelzine and venlafaxine (Ipser and Stein, 2011). There is also evidence for the efficacy of the antipsychotics risperidone (Padala et al., 2006), olanzapine (Carey et al., 2012) and the anticonvulsant topiramate; (Yeh et al., 2011). Medications which have not been found efficacious in placebo-controlled trials include citalopram, alprazolam, and the anticonvulsants tiagabine and divalproex. However when 37 randomised placebo-controlled trials are subject to meta-analysis (restricted to comparisons of outcome data using validated scales), only paroxetine, sertraline and venlafaxine were found to have superiority over placebo [I (M)] (Ipser and Stein, 2011). Probably due to the small size of certain patient sub-groups (men vs women, civilians vs military veterans) neither paroxetine nor sertraline have been found consistently beneficial across all patient groups: though a post hoc analysis suggests that venlafaxine is potentially efficacious in reducing post-traumatic symptom severity in men and women, and across all trauma types [I (PCT)] (Rothbaum et al., 2008a). There have been few controlled comparisons of the effectiveness and acceptability of differing medications, though venlafaxine was found superior to placebo, when sertraline was not [I (PCT)] (Davidson et al., 2006b); reboxetine had similar effectiveness but lower overall tolerability than fluvoxamine [II] Journal of Psychopharmacology (Spivak et al., 2006); and mirtazapine had somewhat greater than effectiveness than sertraline, in a randomised but ‘open’ trial [II] (Chung et al., 2004). 20.4. Longer term treatment Although many patients with post-traumatic stress disorder experience a prolonged illness, there is some uncertainty about the course of the condition, as most longitudinal studies in post-traumatic stress disorder are retrospective in design. Few prospective studies have been published, although the findings of a prospective study in adolescents and young adults with post-traumatic stress disorder or sub-threshold post-traumatic stress disorder indicate that around 50% will experience a chronic course of illness [I] (Perkonigg et al., 2005). The findings of acute and continuation treatment studies indicate that the proportion of responding patients increases steadily over time (Davidson et al., 2006a; Ipser and Stein, 2011; Londborg et al., 2001). A small number of randomised double-blind placebo-controlled relapse prevention studies find evidence for the efficacy of longer-term treatment, for fluoxetine [I (PCT)] (Martenyi et al., 2002) and sertraline [I (PCT)] (Davidson et al., 2005), but not tiagabine [I (PCT)] (Connor et al., 2006). 20.5. Comparative efficacy of pharmacological, psychological and combination treatments Meta-analyses demonstrate that trauma-focused CBT and eye movement desensitisation and reprocessing (EMDR) are both efficacious and superior to ‘stress management’ [I (M)] (Bisson and Andrew, 2007), and appear to have similar overall efficacy [I (M)] (Seidler and Wagner, 2006). There have been very few direct comparisons of the efficacy of psychological and pharmacological treatments, in either acute or long-term treatment of patients with post-traumatic stress disorder. A small unblinded 12-week comparison of paroxetine and trauma-focused CBT [III] (Frommberger et al., 2004) suggested that CBT may have certain advantages, in reducing the severity of post-traumatic and depressive symptoms. A systematic review of four studies of the combination of pharmacological with psychological treatments could find insufficient evidence to draw conclusions about the relative efficacy of combination treatment compared to monotherapy [I (M)] (Hetrick et al., 2010), although a more recent randomised placebo-controlled trial found evidence that paroxetine could enhance the effectiveness of prolonged (10 sessions) exposure therapy [I (PCT)] (Schneier et al., 2012). The findings of two randomised placebo-controlled studies of the potential augmentation of exposure therapy through administration of d-cycloserine could find no evidence of increased efficacy [I (PCT)] (De Kleine et al., 2012; Litz et al., 2012). The findings of two small exploratory randomised placebo-controlled trials in patients with treatment-resistant post-traumatic stress disorder suggest that the short-term efficacy of psychological treatment may be enhanced through concurrent administration of 3,4-methylenedioxymethamphetamine (MDMA) [I (PCT)] (Mithoefer et al., 2011; Oehen et al., 2013): with some evidence of persisting improvement at two-year follow-up [III] (Mithoefer et al., 2013). 21 Baldwin et al. 20.6. Further management after nonresponse to initial treatment Many patients with post-traumatic stress disorder do not respond to initial pharmacological or psychological treatment. Switching between treatments with proven efficacy may be beneficial [IV] (National Institute for Clinical Excellence (NICE), 2005). The findings of small randomised placebo-controlled augmentation studies provide evidence for the efficacy of the alpha-adrenergic agonist prazosin in reducing nightmares and other PSTD symptoms [I (PCT)] (Raskind et al., 2003), for olanzapine in reducing post-traumatic and depressive symptoms and sleep disturbance [I (PCT)] (Stein et al., 2002b) and risperidone in reducing comorbid ‘psychotic symptoms’ [I (PCT)] (Hamner et al., 2003), in reducing irritable aggression [I (PCT)] (Monnelly et al., 2003), and in reducing overall post-traumatic symptoms [I (PCT)] (Bartzokis et al., 2005; Rothbaum et al., 2008b). However a large randomised placebo-controlled trial found no evidence of benefit for risperidone augmentation of a range of pharmacological and psychological treatments [I (PCT)] (Krystal et al., 2011). Recommendations: managing patients with posttraumatic stress disorder Detection and diagnosis ● Ask about a history of traumatic events when patients present with psychological symptoms [S] ● Become familiar with the symptoms and signs of posttraumatic stress disorder [S] ● Ask about the presence of coexisting depressive symptoms [A] Prevention of post-traumatic symptoms ● After major trauma, discuss the potential for preventing the emergence of post-traumatic symptoms, and providing there are no contra-indications, consider preventive treatment with propranolol or sertraline [A] or traumafocused CBT [A] ● Do not recommend routine single-session or multiplesession ‘debriefing’ [A] Acute treatment of chronic post-traumatic stress disorder ● Choose an evidence-based acute treatment [A] ○ pharmacological: paroxetine, sertraline, venlafaxine [A] ○ psychological: trauma-focused individual CBT or EMDR [A] ● Consider an SSRI for first-line pharmacological treatment [A] ● Take account of patient clinical features, needs and preference and local service availability when choosing treatment, as the comparative efficacy of drug and psychological approaches is not established [S] ● Advise the patient that treatment periods of up to 12 weeks may be needed to assess efficacy [A]. Longer-term treatment ● Use an approach that is known to be efficacious in preventing relapse [S] ● Continue drug treatment for at least 12 months in patients who have responded to treatment [A] ● Monitor effectiveness and acceptability regularly over the course of treatment [S] Combination of drugs with psychological treatment ● Routinely combining drug and psychological approaches is not recommended for initial treatment in the absence of consistent evidence for enhanced efficacy over each treatment when given alone [A]: but paroxetine may enhance the effectiveness of exposure therapy [A] When initial treatments fail ● Consider raising the dosage if the current dosage is well tolerated [D] ● Consider switching to another evidence-based treatment [D] ● Consider combining evidence-based treatments only when there are no contraindications [S] ● Consider combining evidence-based pharmacological and psychological treatments [A] ● Consider augmentation of antidepressants with olanzapine [A] risperidone [A] or prazosin [A] ● Consider referral to regional or national specialist services in treatment refractory patients [S] 21. Management of obsessivecompulsive disorder 21.1. Recognition and diagnosis Obsessive-compulsive disorder has an estimated 12-month prevalence of 0.7–1.0% [I] (Kessler et al., 2012; Wittchen et al., 2011), and an estimated lifetime morbid risk of 2.7% [I] (Kessler et al., 2012). The female preponderance, early age of onset and typical presence of coexisting obsessions and compulsions are common features across societies, but the content of obsessions varies between cultures [I (M)] (Fontenelle et al., 2004). The disorder usually follows a chronic course, waxing and waning in severity; and has substantial co-morbidity with major depression and anxiety disorders [IV] (Zaudig, 2011), and with tic disorders [I] (Fibbe et al., 2012). Distinguishing obsessive-compulsive disorder from obsessive-compulsive personality disorder is difficult, and patients often fulfil diagnostic criteria for both conditions: their comorbidity is associated with greater illness severity [I] (Coles et al., 2008; Garyfallos et al., 2010; Lochner et al., 2011). Patients often present with symptoms arising from the co-morbid conditions, rather than with obsessional ruminations and compulsive rituals [I] (Torres et al., 2007). 21.2. Acute treatment of obsessivecompulsive disorder The findings of systematic reviews and meta-analyses of randomised double-blind placebo-controlled trials indicate that the TCA antidepressant clomipramine, and the SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) [I (M)] (Soomro et al., 2008) are all efficacious in acute treatment, in reducing symptom severity and in improving health-related quality 22 of life [IV] (Fineberg et al., 2012). Pharmacological approaches are efficacious in treating children and adolescents with obsessivecompulsive disorder [I (M)] (Watson and Rees, 2008). There have been few evaluations of the relative efficacy and tolerability of differing pharmacological treatments. The findings of meta-analysis suggest that the efficacy of clomipramine is on the margins of superiority over that of SSRIs [I (M)] (Ackerman and Greenland, 2002; National Institute for Health and Clinical Excellence, 2005) but in randomised controlled trials the tolerability of SSRIs is generally superior [IV] (Fineberg and Gale, 2005). The findings of a randomised comparator controlled trial suggest that paroxetine and venlafaxine had comparable effectiveness and acceptability [II] (Denys et al., 2003). Fixed-dose randomised controlled studies provide inconsistent evidence for a dose-response relationship with SSRIs, higher doses being associated with greater overall efficacy in some but not all studies: however the findings of meta-analysis of nine treatment studies involving SSRIs finds some evidence for greater efficacy (though poorer tolerability) with higher daily dosages [I (M)] (Bloch et al., 2010). Meta-analyses of controlled studies involving psychological treatment approaches find evidence for the efficacy of behaviour therapy based on exposure with response prevention alone, for cognitive restructuring alone, and for exposure with response prevention plus cognitive restructuring [I (M)] (RosaAlcazar et al., 2008). Internet-delivered CBT is superior to online supportive therapy [I (PCT)] (Andersson et al., 2012), though therapist-led CBT appears more effective than computerised CBT [I (M)] (Tumur et al., 2007). The relative effectiveness of individual and group CBT approaches is uncertain [I (M)] (Jonsson and Hougaard, 2009). Psychological approaches are efficacious in treating children and adolescents with obsessive-compulsive disorder [I (M)] (Watson and Rees, 2008). 21.3. Longer term treatment The findings of acute treatment studies indicate that the proportion of responding patients increases steadily over time. Long-term (up to 12 months) double-blind randomised controlled studies demonstrate an advantage for continuing with medication, in patients who have responded to acute treatment [I (PCT)] (Greist et al., 1995; Katz et al., 1990; Tollefson et al., 1994). A randomised placebocontrolled trial with paroxetine as an active comparator found that a low dosage of escitalopram only became efficacious in the second half of a 24-week study [I (PCT)] (Stein et al., 2007a). Most (but not all) placebo-controlled relapse-prevention studies in patients who have responded to previous acute treatment reveal a significant advantage for staying on active medication (escitalopram, fluoxetine at higher daily doses, paroxetine, sertraline), compared with switching to placebo, for up to 12 months [I (PCT)] (Fineberg et al., 2007), but the optimal duration of continuation treatment is uncertain [I (M)] (Donovan et al., 2010). 21.4. Comparative efficacy of pharmacological, psychological and combination treatments It is probable, but not certain, that the combination of pharmacological and psychological treatment is superior to psychological Journal of Psychopharmacology approaches or medication, when either is given alone. The evidence for enhanced efficacy of exposure therapy with clomipramine compared with exposure alone is inconsistent (Foa et al., 2005; Marks et al., 1988; Rachman et al., 1979), though fluvoxamine has been shown to enhance the efficacy of exposure therapy [I (PCT)] (Cottraux et al., 1990) and multi-modal CBT [I (PCT)] (Hohagen et al., 1998). The combination of exposure and response prevention with varying SSRIs has been found superior to SSRI treatment alone [II] (Simpson et al., 2008); the addition of behaviour therapy after completion of acute treatment was superior to continuing with SSRI treatment alone in another study [II] (Tenneij et al., 2005); and the addition of CBT (but not CBT instructions) to SSRI treatment was found superior to medication management alone, in children and adolescents [II] (Franklin et al., 2011). However the value of combination treatment over psychological or pharmacological treatments given alone over the long term is uncertain. A series of small randomised placebo-controlled studies suggest that administration of d-cycloserine may hasten the response to CBT, but provide no evidence that the overall effectiveness of CBT is enhanced [I (PCT)] (Kushner et al., 2007; Storch et al., 2010; Wilhelm et al., 2008). 21.5. Further management after nonresponse to initial treatment Many patients do not respond to first-line pharmacological or psychological interventions. Switching between pharmacological or psychological treatments with proven efficacy is helpful in some patients. Increasing the dose of an SSRI, sometimes beyond formulary limits, may be beneficial (Ninan et al., 2006; Pampaloni et al., 2010). A placebo-controlled study found that intravenous clomipramine infusion was efficacious after non-response to oral clomipramine, but the necessary arrangements limit its usefulness in practice [I (PCT)] (Fallon et al., 1998). The findings of some, but not all, randomised double-blind placebo-controlled augmentation studies indicate that the addition of the antipsychotics aripiprazole, haloperidol, olanzapine, quetiapine or risperidone to continuing antidepressant treatment can be efficacious in patients who have not responded to initial treatment with clomipramine or SSRIs, the evidence currently being most strong for augmentation with risperidone [I (M)] (Dold et al., 2011). The findings of small randomised placebocontrolled augmentation studies with 5-HT3 antagonists provide evidence for the efficacy of the addition of ondansetron to fluoxetine [I (PCT)] (Soltani et al., 2010) and for the addition of granisetron to fluvoxamine [I (PCT)] (Askari et al., 2012). Three relatively small randomised placebo-controlled anticonvulsant augmentation studies indicate that the addition of topiramate to SSRIs reduces the severity of compulsions [I (PCT)] (Berlin et al., 2011), and of obsessive-compulsive symptoms [I (PCT)] (Mowla et al., 2010); and the addition of lamotrigine to SSRIs reduces the severity of obsessive-compulsive and affective symptoms [I (PCT)] (Bruno et al., 2012). The evidence for augmentation with pindolol is mixed, but placebo-controlled or comparator-controlled augmentation studies find no evidence for the efficacy of augmentation with buspirone, clonazepam, desipramine, inositol, liothyronine, lithium, naltrexone or oxytocin [IV] (Fineberg and Gale, 2005). 23 Baldwin et al. The findings of a randomised comparator-controlled trial of dextroamphetamine or caffeine augmentation of SSRI or SNRI antidepressants suggest both compounds were beneficial in reducing symptom severity [II] (Koran et al., 2009). Other potential but as yet unproven approaches in the management of patients with treatment-resistant obsessive-compulsive disorder include monotherapy with once-weekly morphine [I (PCT)] (Koran et al., 2005); and the glutamate-modulating compounds riluzole [III] (Coric et al., 2005; Pittenger et al., 2008), memantine [III] (Stewart et al., 2010), and glycine [I (PCT)(Greenberg et al., 2009). Some patients with treatment-refractory obsessive-compulsive disorder may benefit from deep brain stimulation and other neurosurgical approaches [IV] (Blomstedt et al., 2012; De Koning et al., 2011; Greenberg et al., 2010). Recommendations: managing patients with obsessivecompulsive disorder Detection and diagnosis ● Become familiar with the symptoms and signs of obsessive-compulsive disorder [S] ● Assess the time engaged in obsessive-compulsive behaviour, the associated distress and impairment, and the degree of attempted resistance to confirm the diagnosis [S] ●Ask about obsessive-compulsive symptoms when patients present with depression [S] ● Ask about the presence of coexisting depressive symptoms [A] Acute treatment ● Choose an evidence-based acute treatment [A] ○ pharmacological: clomipramine and all SSRIs [A] ○ psychological: exposure therapy, cognitive-behaviour therapy, cognitive therapy [A] ● Take account of patient clinical features, needs and preference and local service availability when choosing treatment [S]: drug and psychological approaches have broadly similar efficacy in acute treatment ● Consider an SSRI for first-line pharmacological treatment [D] ● Consider increasing the daily dosage of SSRIs if there is insufficient response at lower dosage [A] ● Advise the patient that initial treatment periods beyond 12 weeks may be needed to assess efficacy [A] Longer-term treatment ● Use an approach that is known to be efficacious in preventing relapse [S] ● Continue drug treatment for at least 12 months in patients who have responded to treatment [A] ● Monitor effectiveness and acceptability regularly over the course of treatment [S] Combination of drugs with psychological treatments ● Consider combining an SSRI or clomipramine with an evidence-based psychological treatment when efficacy needs to be maximised [D] When initial treatments fail ● Consider raising the dosage if the current dosage is well tolerated [A] ● Consider switching to another evidence-based treatment [D] ● Consider combining evidence-based treatments only when there are no contraindications [S] ● Consider combining evidence-based pharmacological and psychological treatments [A] ● Consider augmentation of an SSRI or clomipramine with an antipsychotic drug [A] ● Consider augmentation of an SSRI or clomipramine with a 5-HT3 antagonist [A] ● Consider augmentation of an SSRI with topiramate [A] or lamotrigine [A] ● Consider augmentation of an SSRI with morphine [A] ● Consider augmentation of an SSRI with riluzole [C] ● Consider referral to regional or national specialist obsessive-compulsive disorder services in treatment refractory patients [S] 22. Management of other anxiety disorders 22.1. Marked health anxiety (‘illness anxiety disorder’) The DSM-5 ((American Psychiatric Association, 2013) includes ‘illness anxiety disorder’ within the group of ‘somatic symptom and related disorders’. The condition is characterised by excessive concern over health, constant fear of undiagnosed disease that physicians may have missed, and the characteristic behaviours of repeated checking and need for medical reassurance. Pharmacological treatment is not normally acceptable to patients, as those with marked health anxiety are typically very sensitive to adverse effects of medication: but fluoxetine showed some benefit over placebo, though this was not pronounced and occurred late in treatment (8–12 weeks [I (PCT)] (Fallon et al., 2008). Psychological treatments have been found beneficial [I (M)] (Thomson and Page, 2007), and include behavioural stress management (Clark et al., 1998) ([II]), cognitive behaviour therapy, in both face-to-face and internet format (Hedman et al., 2011b; Seivewright et al., 2008; Sørensen et al., 2011) ([II]), and mindfulness –based CBT (McManus et al., 2012) ([II]). A recent large randomised controlled trial found efficacy for an adapted form of CBT in medical patients, in which significant benefits over standard care were still present two years after therapy had ended [II] (Tyrer et al., 2014). 22.2 Separation anxiety disorder in adults Though traditionally regarded as having an onset in childhood, separation anxiety disorder is now recognised as both continuing into and having an onset during adult life: and as such is grouped with other anxiety disorders within the DSM-5 (American Psychiatric Association, 2013). The efficacy of psychological or pharmacological treatment in adults with separation anxiety 24 Journal of Psychopharmacology disorder has not been studied extensively, and treatment studies in children have often involved mixed diagnostic groups [IV] (Bögels et al., 2013). Psychological treatment studies in children find some evidence of benefit with CBT, parent-child interaction training, and ‘summer camp’ programmes [IV] (Ehrenreich et al., 2008). The findings of randomised placebo-controlled trials of pharmacological treatment in children with separation anxiety disorder provide no convincing evidence of benefit for any medication, although fluvoxamine (Walkup et al., 2001) and sertraline have been found efficacious among the separation anxiety disorder subgroup within mixed diagnostic samples (Walkup et al., 2008). Recommendations: adolescents treatment of children and ● Reserve pharmacological treatments for children and teenagers who have not responded to psychological interventions, and in whom the anticipated benefits are expected to outweigh any potential risks [S] ● Choose from the same range of treatments as considered for adult patients, considering an SSRI for first-line pharmacological treatment: fluoxetine may be the SSRI with the best balance of potential benefit and risk [B] ● Ensure that the daily dosage takes account of the age and weight of the patient, and start with low dosage, recognising that more rapid metabolism may lead to the need for ‘adult’ doses [S] ● Monitor patients carefully, especially for any evidence of increased anxiety and agitation, and remember that many children and adolescents find it hard to describe emotional states and possible psychological adverse effects [D] 23. Special considerations in particular patient groups 23.1. Children and adolescents When compared with investigations in individuals aged between 18–65 years, there have been relatively few randomised placebocontrolled studies of the potential benefits and risks of psychotropic drug treatment in younger people, and little is known about the value of long-term treatment [I (M)] (Ipser et al., 2009). The findings of randomised placebo-controlled trials in children and adolescents indicate that SSRI treatment can be effective in children and adolescents with generalised anxiety disorder, separation anxiety disorder or social anxiety disorder [I (M)] (Dieleman and Ferdinand, 2008), and also in post-traumatic stress disorder [IV] (Strawn et al., 2010), and obsessive-compulsive disorder [IV] (Gentile, 2011). Psychological treatments also have evidence of efficacy [I (M)] (Gillies et al., 2012; James et al., 2005; Kircanski et al., 2011; Kowalik et al., 2011) but the relative efficacy of pharmacological and psychological treatment approaches, alone and in combination, is not established: although combination treatment was found optimal in obsessive-compulsive disorder (March et al., 2004). In 2004, the United Kingdom Committee on Safety of Medicines stated that the balance of risks and benefits for the treatment of depressive illness in people under the age of 18 years was judged to be unfavourable for some SSRIs (escitalopram, citalopram, paroxetine and sertraline), mirtazapine and venlafaxine [IV] (Committee on Safety of Medicines, 2004), and advised caution when treating depressed adults aged 18–30 years with SSRIs. A recent meta-analysis cautiously concluded that the balance of benefit and risk in the treatment of depressed children and adolescents may be most favourable with fluoxetine [I (M)] (Hetrick et al., 2012). The balance of risks of harm and benefit in the treatment of children and adolescents with anxiety disorders, when compared to the treatment of depression, is more favourable [IV] (Holtkamp and Herpertz-Dahlmann, 2008). However careful monitoring is advisable, due to possible diagnostic uncertainty, the presence of co-morbid depression, problems associated with estimating the optimal dosage, and the difficulties young people might have in describing untoward effects of psychotropic drug treatment. It may be preferable to reserve pharmacological treatments for patients who do not respond to evidence-based psychological approaches. 23.2. Elderly patients and patients with cardiac or neurological disease Many elderly patients are troubled by anxiety symptoms, but anxiety disorders in those over 65 years may be less common than in younger age groups [IV] (Wolitzky-Taylor et al., 2010). When compared with investigations in individuals aged between 18–65 years, there have been relatively few randomised controlled studies of the potential benefits and risks of psychological or pharmacological treatment for anxiety disorders in older people [IV] (Oude Voshaar, 2013), and little is known about the relative effectiveness and acceptability of differing treatments, or about the value of long-term treatment [I (M)] (Goncalves and Byrne, 2012; Gould et al., 2012; Pinquart and Duberstein, 2007; Thorp et al., 2009). Clearance of many drugs is slower in the elderly, so lower doses may be required than in younger patients. Tricyclic antidepressants and some antipsychotic drugs are best avoided in patients with cardiac disease, as they can increase heart rate, induce orthostatic hypotension, slow cardiac conduction and have significant quinidine-like effects on conduction within the myocardium [IV] (Vieweg et al., 2009). Other type 1A antiarrhythmics (quinidine, moricizine) carry an increased risk of mortality in patients with ventricular arrhythmias and ischaemic heart disease, and TCAs should be regarded as relatively contraindicated in these situations. SSRIs have relatively minor effects on cardiovascular function and may have potentially beneficial effects on platelet aggregation (Bismuth-Evenzal et al., 2012; Lopez-Vilchez et al., 2009). Higher doses (more than 40 mg per day) of citalopram may be associated with a slightly increased risk of QT interval prolongation on the electrocardiogram, and should be avoided in patients with known cardiac risk factors including hypokalaemia and hypomagnesaemia [IV] (US Food and Drug Administration, 2012): though a recent large pharmacoepidemiological study found no evidence of elevated risks of ventricular arrhythmia or all-cause, cardiac or non-cardiac mortality associated with higher citalopram dosages [I] (Zivin et al., 2013). Anxiety symptoms and disorders have an increased prevalence in patients with common neurological conditions, including migraine [IV] (Buse et al., 2012), epilepsy [IV] (Beyenburg et al., 2005), and in the aftermath of stroke [I (M)] (Campbell Burton 25 Baldwin et al. et al., 2012). SSRI and SNRI antidepressants should be used with caution in patients with migraine undergoing prophylaxis with triptans [IV] (Evans et al., 2010). Despite widespread belief that antidepressant drugs can lower the seizure threshold, systematic review of data from placebo-controlled trials with psychotropic drugs, submitted to the United States Federal Drug Administration, indicates that that the frequency of seizures is significantly lower with most antidepressants than with placebo [I (M)] (Alper et al., 2007). Pharmacokinetic interactions between medications used for treating anxiety disorders and anticonvulsants are not uncommon and it is always advisable to establish the potential for untoward drug-drug interactions when treating epileptic patients with anxiety disorders [IV] (Muscatello et al., 2012). SSRI treatment may improve overall recovery after stroke [I (M)] (Mead et al., 2012), but little is known about the potential efficacy of psychological or pharmacological interventions in the treatment of anxiety disorders in the aftermath of stroke [I (M)] (Campbell Burton et al., 2011). Recommendations: treatment in elderly and physically ill patients ● Remember that anxiety symptoms and disorders are common in elderly and physically ill patients, and that many individuals will benefit from evidence-based pharmacological or psychological treatments [S] ● Manage elderly patients in a broadly similar way to younger patients, being mindful of the possibility of drug interactions, the potential need for lower doses in patients with renal or hepatic impairment, and the risk of worsening any pre-existing cognitive impairment through the use of medications with sedative effects [S] ● Avoid prescribing tricyclic antidepressants to patients with cardiovascular disease [D] 23.3. Pregnant and breastfeeding women Anxiety disorders are not uncommon during pregnancy and in the post-partum period [I (M)] (Ross and McLean, 2006). Symptoms will remit during pregnancy in some women [III] (George et al., 1987). Many doctors consider the scope for withdrawing psychotropic drugs in pregnant women (particularly in the first trimester), and using psychological rather than pharmacological treatments, but in practice it is sometimes necessary to continue pharmacological treatment, in patients with severe anxiety disorders. The findings of a recent systematic review indicate that antidepressant drugs are associated with increased risk of spontaneous abortions, stillbirths, preterm deliveries, respiratory distress, endocrine and metabolic disturbance, with some evidence of a discontinuation syndrome and of an increased risk of cardiac defects; antipsychotics are associated with increased gestational weight and diabetes and with increased risk of preterm birth [I (M)] (Oyebode et al., 2012). However the overall evidence on the balance of risks and benefits of psychotropic drug treatment during pregnancy evolves over time and it is wise to seek advice from respected information sources. The BAP is producing guidance on the management of patients during the perinatal period (McAllister-Williams et al., in development). Recommendations: women of child-bearing age ● Remember that anxiety disorders are common among women who wish to become pregnant [S] ● Keep familiar with the changing evidence base about the potential hazards of treatment of pregnant and breast-feeding women with psychotropic drugs [S] ● Consider carefully the anticipated benefits and risks of pharmacological and psychological treatments of anxiety disorders in pregnant women, including the potential relative and actual risks of harm to a developing child [S] 23.4. Referral to secondary and tertiary care mental health services Despite the availability of many evidence-based pharmacological and psychological treatments, a substantial proportion of patients will not respond fully to initial treatments, provided in primary medical care. The criteria for referral to secondary care mental health services should be sufficiently flexible to ensure that patients with disabling and treatment-resistant anxiety disorders can have equitable access to mental health specialists. Consensus between primary and secondary care about when referral of patients with anxiety disorders is advisable should be an explicit component of service commissioning procedures. Potential criteria for referral to secondary care mental health services include when the primary care practitioner feels insufficiently experienced to manage the patient’s condition; when two or more attempts at treatment have not resulted in sustained improvement; when there are severe coexisting depressive symptoms or a risk of suicide; when comorbid physical illness and concomitantly prescribed treatments could interact with prescribed psychotropic medication; and when proposed interventions are not available within primary care services. Some patients with complex, severe, enduring and treatment-resistant anxiety disorders do not respond to the range of treatment options delivered in secondary care mental health services, and these patients should be referred to tertiary care specialist services for patients with affective disorders. Acknowledgements The authors would like to thank Susan Chandler and Lynne Harmer of the BAP office for organising the logistical aspects of the consensus meeting and for their support during the subsequent consensus process. Secretarial assistance for writing the consensus statement was provided by Magda Nowak (University of Southampton) The consensus group comprised Christer Allgulander, Ian Anderson, Spilios Argyropoulos, David Baldwin, Borwin Bandelow, Alan Bateson, David Christmas, Val Curran, Simon Davies, Hans den Boer, Lynne Drummond, Rob Durham, Nicol Ferrier, Naomi Fineberg, Matt Garner, Andrew Jones, Malcolm Lader, Alan Lenox-Smith, Glyn Lewis, Andrea Malizia, Keith Matthews, Paul McCrone, Stuart Montgomery, Marcus Munafò, David Nabarro, David Nutt, Catherine O’Neill, Jan Scott, David Taylor, Peter Tyrer, Nic van der Wee, Tom Watson, and Sue Wilson. The patient organisations OCD Action and Anxiety UK were represented at the meeting. Observers were also present from the Eli Lilly, Lundbeck, Pfizer and Servier pharmaceutical companies. 26 Conflict of interest All participants were asked to provide information about potential conflict of interest at the time of the consensus meeting Funding This consensus statement received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. References Abrantes AM, Strong DR, Cohn A, et al. (2009) Acute changes in obsessions and compulsions following moderate-intensity aerobic exercise among patients with obsessive-compulsive disorder. J Anxiety Disord 23: 923–927. Ackerman DL and Greenland S (2002) Multivariate meta-analysis of controlled drug studies for obsessive-compulsive disorder. J Clin Psychopharmacol 22: 309–317. Aderka IM, Hofmann SG, Nickerson A, et al. (2012) Functional impairment in social anxiety disorder. J Anxiety Disord 26: 393–400. 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Gross b a b Adult Anxiety Clinic of Temple University, USA Stanford University, USA a r t i c l e i n f o Article history: Received 31 August 2013 Received in revised form 13 April 2014 Accepted 19 May 2014 Available online 14 June 2014 Keywords: Social anxiety disorder Social phobia Depression Implicit associations Cognitive biases a b s t r a c t Implicit associations of the self to concepts like “calm” have been shown to be weaker in persons with social anxiety than in non-anxious healthy controls. However, other implicit self associations, such as those to acceptance or rejection, have been less studied in social anxiety, and none of this work has been conducted with clinical samples. Furthermore, the importance of depression in these relationships has not been well investigated. We addressed these issues by administering two Implicit Association Tests (IATs; Greenwald, McGhee, & Schwartz, 1998), one examining the implicit association of self/other to anxiety/calmness and the other examining the association of self/other to rejection/acceptance, to individuals with generalized social anxiety disorder (SAD, n = 85), individuals with generalized SAD and a current or past diagnosis of major depressive disorder or current dysthymic disorder (n = 47), and nonanxious, non-depressed healthy controls (n = 44). The SAD and SAD-depression groups showed weaker implicit self-calmness associations than healthy controls, with the comorbid group showing the weakest self-calmness associations. The SAD-depression group showed the weakest implicit self-acceptance associations; no difference was found between non-depressed individuals with SAD and healthy controls. Post hoc analyses revealed that differences appeared to be driven by those with current depression. The SAD-only and SAD-depression groups did not differ in self-reported (explicit) social anxiety. The implications of these findings for the understanding of SAD-depression comorbidity and for the treatment of SAD are considered. © 2014 Elsevier Ltd. All rights reserved. 1. Introduction Social anxiety disorder (SAD) and major depressive disorder (MDD) are two of the most common mental disorders in the US (Kessler, Chiu, Demler, Merikangas, & Walters, 2005), with 12month prevalence rates of 6.8% and 6.7%, respectively (Kessler, Berglund, et al., 2005). SAD and MDD often occur together, and SAD precedes MDD in approximately 70% of individuals with both disorders (Kessler, Stang, Wittchen, Stein, & Walters, 1999; Schneier, Johnson, Hornig, Liebowitz, & Weissman, 1992). In one study, individuals with SAD were at 3.5 times higher risk than those without 夽 Portions of this paper were presented at the 2011 and 2012 meetings of the Association for Behavioral and Cognitive Therapies. ∗ Corresponding author at: Adult Anxiety Clinic, Department of Psychology, Weiss Hall, Temple University, 1701 North 13th Street, Philadelphia, PA 19122-6085, USA. Tel.: +1 215 204 7489; fax: +1 215 204 5539. E-mail address: heimberg@temple.edu (R.G. Heimberg). http://dx.doi.org/10.1016/j.janxdis.2014.05.008 0887-6185/© 2014 Elsevier Ltd. All rights reserved. to have a subsequent depressive disorder (Stein et al., 2001). In another study that followed adolescents into adulthood, the risk for depression was 2-fold in individuals with SAD compared to those without SAD and almost 3-fold compared to those with no anxiety disorder (Beesdo et al., 2007). Increasing our knowledge of depression comorbidity among persons with SAD is important because anxiety-depression comorbidity is associated with more chronic distress, greater risk of relapse, and more impaired psychosocial functioning than when the disorders present independently (e.g., Brown, Schulberg, Madonia, Shear, & Houk, 1996; Lewinsohn, Rohde, & Seeley, 1995; Reich et al., 1993; Ruscio et al., 2008). One particular focus is understanding the role of information processing biases in SAD with and without depression. 1.1. Attentional biases in social anxiety disorder Cognitive-behavioral models of SAD (e.g., Clark & Wells, 1995; Heimberg, Brozovich, & Rapee, 2010; Hofmann, 2007; see Wong, Gordon, & Heimberg, 2014, for a review and comparison of 538 J. Wong et al. / Journal of Anxiety Disorders 28 (2014) 537–546 cognitive-behavioral models of SAD) posit that dysfunctional information processing contributes to the etiology and maintenance of the disorder. In fact, a large body of research documents the occurrence of one type of dysfunctional information processing, attentional bias toward social threat stimuli, in SAD (for a review, see Morrison & Heimberg, 2013; for a review of attentional bias toward threat stimuli in the anxiety disorders more generally, see Bar-Haim, Lamy, Pergamin, Bakermans-Kranenburg, & van Ijzendoorn, 2007). However, limited research suggests that the presence of depressive symptoms among individuals with social anxiety/SAD may alter the nature of this response. One study looked at the impact of depressive symptoms on attentional bias among socially anxious individuals using an emotional Stroop task (Grant & Beck, 2006). Socially anxious individuals without depressive symptoms showed greater Stroop interference for threat words relative to neutral and positive words. However, the socially anxious-dysphoric group did not exhibit this bias. To our knowledge, only two other studies have addressed this problem (LeMoult & Joormann, 2012; Musa, Lépine, Clark, Mansell, & Ehlers, 2003). Both administered a dot-probe task to individuals with SAD, SAD and a concurrent depressive disorder, and nonpatient controls. Musa et al. found results largely consistent with Grant and Beck. Patients with SAD showed the expected bias (i.e., vigilance) toward social threat words. Patients with SAD and concurrent depression showed no such bias and appeared similar to controls. In contrast to the 500 ms threat cue presentation duration employed by Musa et al., LeMoult and Joormann presented threat cues for either 7 ms or 1000 ms. They found evidence of attentional avoidance of angry faces in the depressed SAD group compared to the non-depressed SAD group for the supraliminal presentation. However, the meaning of these results is less than clear, given that neither SAD group differed from controls on these trials. In addition, no evidence of attentional bias, either vigilance or avoidance, in either SAD group was detected for subliminally presented angry face cues, nor for positive, sad, or disgust faces at either presentation time. Taken together, the pattern of results suggests that comorbid depression may nullify, or at least dampen, attentional biases associated with social anxiety at relatively brief exposures. When more time is permitted for stimulus processing, biases may be observed in the comorbid depression group, albeit in the opposite direction. Indeed, Mathews and MacLoed (2005) have suggested that early sensitivity to threat cues apparent in anxiety may by inhibited in depression, in which biases toward mood-congruent information are more commonly observed for stimuli that are presented for longer durations, potentially due to slower, more strategically directed processes such as rumination. Therefore, it appears prudent to consider whether concurrent depressive symptoms or depressive disorder have similar effects on other automatic cognitive biases in individuals with SAD. 1.2. Implicit associations and the Implicit Association Test (IAT) Implicit associations are another important type of biased cognitive processing that is receiving attention in research on psychopathology. Implicit associations are thought to represent stable memory constructs developed over time that contribute to schemas about the self (Beevers, 2005; Haeffel et al., 2007). The IAT, developed by Greenwald, McGhee, and Schwartz (1998), examines implicit attitudes that someone holds regarding the relationship between a concept or category (e.g., flowers) and an attribute (e.g., goodness). The IAT has been widely used to examine attitudes regarding different racial groups, genders, and sexual orientations (e.g., Devos & Banaji, 2005; Jellison, McConnell, & Gabriel, 2004; Nosek, Banaji, & Greenwald, 2002). During the typical administration of the IAT, participants make a series of response choices involving a concept discrimination (e.g., flowers/insects) and an attribute discrimination (e.g., good/bad). Participants are instructed to respond rapidly with a right key press to items representing one concept and one attribute (e.g., flowers and good) and with a left key press to items from the remaining two categories (e.g., insects and bad). Participants then complete a second task in which key assignments for one of the pairs is switched. IAT response latencies are interpreted in terms of relative association strengths.1 It is assumed that responses are more rapid when the concept and attribute mapped onto the same key are strongly associated, whereas responses are assumed to be relatively slower when the concept and attribute mapped on the same key are less closely associated. The use of implicit measures, such as the IAT, may be particularly relevant with socially anxious individuals. Given that individuals with SAD experience heightened self-presentational concerns and fears of others’ evaluation, explicit self-report may yield an inaccurate or incomplete picture of their experiences. For example, it is a well-replicated phenomenon that persons with SAD report that they perform more poorly on behavioral tests than do other informants (e.g., Rapee & Lim, 1992; Rodebaugh, Heimberg, Schultz, & Blackmore, 2010; Rodebaugh & Rapee, 2005; Stopa & Clark, 1993). Implicit measures like the IAT may minimize – perhaps even circumvent – self-presentational biases and effects. 1.3. Implicit associations in social anxiety and depression Several studies have used the IAT to study implicit associations in socially anxious individuals. de Jong (2002) administered the IAT to female undergraduates high and low in social anxiety, using concept categories of self (e.g., I, self) and other (e.g., their, them) and attribute categories of low-esteem (e.g., bad, stupid) and highesteem (e.g., smart, valuable). Both high and low socially anxious groups performed faster categorizing self with high-esteem words than the reverse category pairings, although a significant interaction effect suggested that this pattern was stronger in the low socially anxious group. Similarly, another study found that high social anxiety participants did not exhibit negative implicit selfesteem; they responded more quickly to self-positive pairings than to self-negative pairings (Tanner, Stopa, & De Houwer, 2006). However, they did respond more slowly to self-positive pairings than those low in social anxiety. Notably, depressive symptoms did not impact IAT performance. Some researchers have also examined responses to an IAT in which self or other is paired with rejection or acceptance, an area of clear concern to persons with social anxiety. A self-rejection IAT was used by Teachman and Allen (2007) in their study of perceived peer acceptance/rejection and its relationship to implicit and explicit fear of negative evaluation in adolescents. Adolescents more easily associated the self with acceptance than with rejection. Clerkin and Teachman (2010) examined the responses to the same IAT of socially anxious undergraduates to whom they provided training to modify implicit associations. Because all participants were socially anxious, it was not possible to compare their responses to those of a non-anxious sample, but similar to the adolescent sample of Teachman and Allen (2007), they more easily associated the self with acceptance than rejection. However, trained participants demonstrated strengthened self-acceptance 1 As noted by Pinter and Greenwald (2005), it is important to keep in mind that “the standard interpretation of any IAT measure involves relative strengths of associations of the two contrasted concept categories with the two contrasted attribute categories” (p. 75, italics added). Throughout this paper, we will refer to IAT results using simplified descriptors (e.g., flowers-good) to increase readability. However, results are always referring to the relative strength of associations (e.g., flowersgood/insects-bad). J. Wong et al. / Journal of Anxiety Disorders 28 (2014) 537–546 associations and were more likely to complete an impromptu speech than students who had not received the implicit association training. Few studies of implicit attitudes in social anxiety have examined clinical samples. Gamer, Schmukle, Luka-Krausgrill, and Egloff (2008) took a step in this direction when they recruited socially anxious students who completed four weeks of cognitivebehavioral group therapy at a university counseling center and were administered the IAT before and after treatment. Their responses were compared to non-anxious students who received no treatment. Participants were asked to categorize self-other words and anxiety-calmness words. Consistent with previous findings, socially anxious participants and non-anxious controls were faster in the self-calm pairings than in the self-anxiety pairings on both IAT administrations. However, socially anxious participants had weaker self-calm implicit associations than non-anxious controls at baseline. In addition, self-calm implicit associations had strengthened following treatment, as socially anxious participants no longer differed from controls. To date, only one study has used the IAT to examine comorbid anxiety and depression in a diagnosed sample. Glashouwer and de Jong (2010) compared implicit beliefs in a mixed anxiety disorder group, those with a current diagnosis of MDD, those with an anxiety disorder and comorbid MDD, and a healthy control group. Participants were part of the Netherlands Study of Depression and Anxiety (Penninx et al., 2008). An IAT measured implicit self-anxiety associations. As with previous IAT studies, all groups exhibited faster reaction times on self-calm trials than on self-anxiety trials. The anxious group showed weaker self-calm associations than the depressed and control groups. The authors made no hypotheses regarding the effect of comorbidity on IAT scores, but the comorbid group had the weakest self-calm associations, although not significantly different from the anxious group (after Bonferroni correction). Implicit associations have also been studied in relation to depression. For example, in the study by Glashouwer and de Jong (2010), an IAT was also administered in which self versus other words were paired with words representing depression or elation. Although depressed participants exhibited faster reaction times on self-elation trials than on self-depression trials, they also demonstrated weaker self-elation associations than the anxiety and control groups. Several additional studies have examined the implicit associations of persons at cognitive risk for depression (e.g., Haeffel et al., 2007; Steinberg, Karpinski, & Alloy, 2007) or previously depressed persons in reaction to a negative mood induction (e.g., Gemar, Segal, Sagrati, & Kennedy, 2001; Meites, Deveney, Steele, Holmes, & Pizzagalli, 2008). A full review of this literature is beyond the scope of this paper, but see a metaanalysis of implicit cognition in depression by Phillips, Hine, and Thorsteinsson (2010). The general conclusion to be drawn from these studies is that the implicit associations of self to positive attributes of depressed/formerly depressed/at-risk-for-depression persons are weaker than those of non-depressed persons. This is important to the current research because it supports the idea that comorbid depression may confer additional risk for cognitive bias in socially anxious persons, unlike the somewhat mixed findings for attentional bias toward social threat. 1.4. Present study Research has demonstrated the utility of the IAT and provided the groundwork for understanding implicit associations in SAD. However, little is known about implicit associations in those with SAD and comorbid depression. Furthermore, no studies have examined implicit attitudes in a sample of clinically diagnosed, treatment-seeking individuals with SAD and depression. Of the 539 studies reviewed above, the majority have been conducted with analog samples, and only two have examined the impact of depressive symptoms. Tanner et al. (2006) found no effect of depression on the implicit associations of socially anxious persons. Glashouwer and de Jong (2010) examined a mixed anxiety group and did not focus specifically on SAD. Given the high comorbidity of SAD and MDD, and the impairment associated with this comorbidity, it is crucial that we increase our understanding of the associated cognitive processes so that we can expand our theoretical models and enhance our treatment approaches. One step toward this, and a goal of the current study, was to examine implicit associations among treatment-seeking patients with SAD and comorbid depression (i.e., MDD or dysthymia), compared to patients with SAD but no history of depression, and to healthy controls. We used two IATs, one measuring associations of self/other with anxiety/calmness and the other measuring associations of self/other with rejection/acceptance. Based on results from previous studies, we hypothesized that individuals with SAD would exhibit weaker self-calm associations than healthy controls. We also hypothesized that the comorbid group would exhibit weaker self-calm associations than healthy controls. Studies on implicit associations in depression suggest that the comorbid group might have even weaker self-calm associations than the SAD group, but the empirical support for this hypothesis is not strong. The self-rejection IAT used here was similar to the one used by Clerkin and Teachman (2010) and Teachman and Allen (2007) and has yet to be studied in a clinical sample of persons with SAD. Our interest in this IAT comes in part from the literature on interpersonal rejection sensitivity (e.g., Downey & Feldman, 1996; Leary, 2006). Those with high levels of interpersonal rejection sensitivity are thought to have high expectations for rejection by others and to place high value on being accepted (Downey & Feldman, 1996). Rejection sensitivity has been primarily studied as a risk factor for depression (e.g., Ayduk, Downey, & Kim, 2001; Boyce & Parker, 1989), but it may be an underlying personality trait in those with social anxiety as well (Harb, Heimberg, Fresco, Schneier, & Liebowitz, 2002). We sought to explore how a clinical sample would perform on the self-rejection IAT, and whether there would be differences between the SAD and SAD-depression groups, given the potential importance of rejection sensitivity in both social anxiety and depression. 2. Method 2.1. Participants Participants were 136 individuals with a primary diagnosis of generalized SAD and 44 healthy controls (HC group). Among those with SAD, 47 individuals had a current or past diagnosis of major depressive disorder (MDD) or current dysthymic disorder (SAD + Dep group), and 85 individuals had no current or past diagnosis of depression (SAD group). Four individuals with SAD who met criteria for a diagnosis of past dysthymic disorder were not included in the current study due to poor inter-rater reliability on the diagnostic measure (see Section 2.2). All participants with SAD were enrolled in one of two randomized controlled trials for the treatment of SAD. In one trial, participants (n = 74) were randomly allocated to receive individually administered cognitive-behavioral therapy (CBT) for SAD or to a waitlist control condition (see Goldin et al., 2012). In the other trial, participants (n = 62) were randomly assigned to complete either mindfulness-based stress reduction (MBSR) or to an active comparison condition of aerobic exercise (see Jazaieri, Goldin, Werner, Ziv, & Gross, 2012). Measures included in the present analyses were administered prior to randomization. 540 J. Wong et al. / Journal of Anxiety Disorders 28 (2014) 537–546 Participants were included in the treatment studies if they met criteria for a principal diagnosis of generalized SAD according to the Anxiety Disorders Interview Schedule for DSM-IV, Lifetime version (ADIS-IV-L; Di Nardo, Brown, & Barlow, 1994; see below). Additional diagnoses, including MDD and dysthymia, were also assessed with the ADIS-IV-L. Participants were excluded for current pharmacotherapy or psychotherapy; history of medical disorders or head trauma; and current psychiatric disorders other than generalized anxiety disorder, obsessive compulsive disorder (OCD), agoraphobia without a history of panic attacks, specific phobia, MDD, or dysthymic disorder. In Goldin et al. (2012), participants were also excluded for current MDD or OCD, as well as previous CBT treatment. In Jazaieri et al. (2012), participants were excluded for previous completion of an MBSR course or regular meditation practice or exercise regimen. With regard to depression diagnoses in the SAD + Dep group, most met diagnostic criteria for past MDD only (57.4%), current MDD only (21.3%), current MDD and current dysthymia (10.6%), current dysthymia only (8.5%), or past MDD and current dysthymia (2.1%). HC participants had no history of any psychiatric problems assessed by the ADIS-IV-L and were selected to match participants with SAD in the Goldin et al. (2012) study in terms of sex, race, age, and years of education. Participants were recruited via community bulletin boards web-based community listings, and referrals from mental health clinics and providers. 2.2. Materials 2.2.1. Anxiety Disorders Interview Schedule for DSM-IV, Lifetime Version (ADIS-IV-L) The ADIS-IV-L (Di Nardo et al., 1994) is a widely used, semistructured diagnostic interview that assesses current and past episodes of anxiety and related disorders. For each diagnosis, the interviewer provides a Clinician’s Severity Rating (CSR), which is a 9-point, Likert-type rating that ranges from 0 to 8; scores of 4 or greater indicate that the patient has met criteria for a DSMIV diagnosis. In a reliability study of a mixed diagnostic group, the ADIS-IV-L indicated good to excellent inter-rater agreement for current disorders (range of ’s = .67–.86) and lifetime disorders (range of ’s = .58–.83), except dysthymia (e.g., = .36 as a lifetime diagnosis; Brown, Di Nardo, Lehman, & Campbell, 2001). All individuals administering the ADIS-IV-L had satisfied training criteria outlined by Brown et al. (2001) and were experienced clinicians with at least masters-level training in clinical psychology. 2.2.2. Brief Fear of Negative Evaluation Scale (BFNE) The BFNE (Leary, 1983) is a 12-item self-report measure that was designed to assess the degree to which people experience apprehension at the prospect of being evaluated negatively. Participants rate each item using a five-point, Likert scale from 1 (Not at all characteristic of me) to 5 (Extremely characteristic of me). Sample items include “I am afraid that people will find fault with me” and “Sometimes I think I am too concerned with what other people think of me.” Research suggests that the reverse-scored items have inferior validity and that only the eight straightforwardly worded items be used (BFNE-S; Rodebaugh et al., 2004; Weeks et al., 2005). The BFNE-S demonstrated excellent internal consistency in a sample of patients with SAD (˛ = .92) and in a nonanxious control sample (˛ = .90; Weeks et al., 2005). The BFNE-S demonstrated adequate internal consistency in all three of our groups (HC: ˛ = .92; SAD: ˛ = .92; SAD + Dep: ˛ = .77). 2.2.3. Social Interaction Anxiety Scale (SIAS) The SIAS (Mattick & Clarke, 1998) is a 20-item self-report scale designed to measure fears of social interactions. Participants are asked to rate each item using a Likert scale from 0 (not at all characteristic or true of me) to 4 (extremely characteristic or true of me). Sample items include “I feel tense if I am alone with just one person” and “I find it difficult to disagree with another’s point of view.” The SIAS has been widely used in the assessment of social anxiety and has shown good reliability and validity in a number of studies (e.g., Brown et al., 1997; Mattick & Clarke, 1998; Safren, Turk, & Heimberg, 1998). Rodebaugh, Woods, and Heimberg (2007) have reported that the straightforward items of the SIAS are more valid indicators of social interaction anxiety than the reverse-scored items, which appear to be more strongly related to the construct of extraversion, and therefore suggest utilizing only the 17 straightforward items (SIAS-S) to calculate the total score. In the current sample, internal consistency of the SIAS-S was good in all three groups (HC: ˛ = .90; SAD: ˛ = .88; SAD + Dep: ˛ = .88). 2.2.4. Beck Depression Inventory – II (BDI-II) The BDI-II (Beck, Steer, Ball, & Ranieri, 1996; Beck, Steer, & Brown, 1996) is a 21-item self-report instrument which assesses the existence and severity of depressive symptoms. Participants rate the severity of each symptom, such as sadness and loss of interest, over the past two weeks on a 0–3 scale, with higher scores indicating greater severity. The BDI-II has been used extensively and has demonstrated good internal consistency in outpatient and undergraduate populations (e.g., Beck, Steer, Ball, et al., 1996; Beck, Steer, & Brown, 1996; Storch, Roberti, & Roth, 2004), as it did in the three groups in the current sample (HC: ˛ = .73; SAD: ˛ = .91; SAD + Dep: ˛ = .91). 2.2.5. Implicit Association Test Participants completed two IATs administered via computer. In both IATs, the concept discrimination was between self and other. In one IAT, the attribute discrimination was between anxiety and calmness, and in the other IAT, it was between acceptance and rejection. Stimuli from the self category were I, own, my, me, and self. Stimuli from the other category included them, others, you, your, and they. Items from the anxiety category included afraid, anxious, uncertain, nervous, and fearful, and items from the calmness category included calm, restful, balanced, relaxed, and at ease. Items representing the acceptance category were loved, welcomed, admired, included, and respected, and items representing the rejection category included forgotten, alienated, deserted, shunned, and disliked. The IAT procedure was modeled after Egloff and Schmukle’s (2002) “IAT-Anxiety.” Within each IAT, there were five blocks of trials. In the first block, participants completed 20 practice trials categorizing the concept discrimination (i.e., self/other). In the second block, an additional 20 practice trials were completed for categorizing the attribute stimuli. The fourth block was also a practice block of 20 trials for categorizing self/other items with the key assignment switched. The third and fifth blocks were each comprised of 40 critical trials in which participants categorized items into two combined categories. In the third block, items for self and the positive attribute were to be categorized on the left and in the fifth block items for self and the negative attribute were to be categorized on the right. We chose not to counterbalance the order of the pairings to remain consistent with the procedure of Egloff and Schmukle (2002). They argue that the advantages of this type of procedure may outweigh the disadvantages. Specifically, they suggest that, although we cannot interpret the IAT score in absolute terms, this type of consistent ordering optimizes comparison between participants and thus “generates an ordering according to the (relative) size of the IAT effect” (p. 1443). Participants were instructed that they would be asked to make a series of category judgments. On each trial, a stimulus word was presented in the center of the screen and category labels presented in the upper left and right sides of the screen. Participants were J. Wong et al. / Journal of Anxiety Disorders 28 (2014) 537–546 541 Table 1 Demographic information and self-report measures by diagnostic group. Variable SAD SAD + Dep Healthy controls Test statistic % female % Caucasian Age (SD) Years education (SD) BFNE-S (SD) SIAS-S (SD) BDI-II (SD) 52.9 45.9 33.8 (9.1) 16.9 (2.1) 31.5 (5.6) 46.5 (9.8) 11.4 (9.0) 40.4 63.8 32.7 (7.5) 16.2 (2.1) 32.5 (3.8) 48.6 (9.4) 19.4 (10.4) 54.5 40.9 33.5 (9.8) 17.3 (2.0) 13.6 (4.6) 16.4 (6.5) 1.2 (1.8) 2 = 2.4 2 = 5.6 F = 0.2 F = 3.4* F = 204.1** F = 173.9** F = 52.4** Note. SAD – social anxiety disorder; SAD + Dep – SAD with current or past depression; % Caucasian – proportion of individuals who self-identified as Caucasian versus nonCaucasian; BFNE-S – Brief Fear of Negative Evaluation Scale, straightforward item total; SIAS-S – Social Interaction Anxiety Scale, straightforward item total; BDI-II – Beck Depression Inventory – II. * p < .05. ** p < .001. instructed to use the Q key on the left side of the keyboard and the P key on the right side of the keyboard for their responses. They were told to keep their index fingers on the Q and P keys throughout the task and to respond as quickly and accurately as possible. They were also told that if they made an error they would see a red X and that the task would continue. Each of the IATs exhibited excellent reliability overall and within each group (anxiety/calmness IAT: overall ˛ = .94, SAD + Dep ˛ = .94, SAD ˛ = .94, HC ˛ = .94; acceptance/rejection IAT: overall ˛ = .95, SAD + Dep ˛ = .96, SAD ˛ = .95, HC ˛ = .95). 2.3. Procedure Participants first provided written informed consent. Diagnostic status was determined with the ADIS-IV-L. Participants also completed a demographics questionnaire and the BDI-II at this appointment. After leaving the laboratory, participants were emailed a link to complete an online battery of self-report questionnaires, which included the social anxiety questionnaires reported in the current study. At a later appointment, participants completed the two versions of the IAT. Participants always completed the anxiety/calmness IAT prior to the acceptance/rejection IAT. The order of the tasks was kept consistent across participants for the same reason explained above regarding ordering of key assignments. 3. Results endorsed greater depression than the SAD group [BDI-II: t(127) = 4.57, p < .001]; however, they did not differ in self-reported social anxiety [BFNE-S: t(121) = 1.10, p = .27; SIAS-S: t(121) = 1.12, p = .26]. 3.2. IAT data scoring and reduction Response latencies from the IAT were scored according to the algorithm developed by Greenwald, Nosek, and Banaji (2003). Specifically, trials with response latencies greater than 10,000 ms were first deleted. Participants for whom more than 10% of trials had latencies less than 300 ms would then have been deleted, but there were no such individuals in the sample. Then, each error latency was replaced with an error penalty computed as the mean latency of correct responses for that block + 600 ms. These error penalty latencies were used from this point forward. Next, “inclusive” standard deviations for all trials in the critical blocks (i.e., blocks 3 and 5) were calculated. Then the mean latency for responses in each of the critical blocks was calculated. A D score for each IAT was calculated by subtracting the mean latency for selfanxiety and self-rejection associations from the mean latency for self-calmness and self-acceptance associations, respectively, and then dividing this difference by the appropriate inclusive standard deviation. This method of calculating a D score helps to account for overall response latency as well as improve the psychometric properties of the IAT (Lane, Banaji, Nosek, & Greenwald, 2007). Greater IAT scores indicate greater self-calmness or self-acceptance associations. 3.1. Participant characteristics 3.3. IAT results See Table 1 for descriptive statistics and omnibus tests comparing the three groups. Groups did not differ on age or sex; however, there were significant differences among the groups with regard to years of education completed and ethnicity (i.e., Caucasian versus non-Caucasian). Follow-up t-tests revealed the SAD + Dep group reported fewer years of education than the HC group, t(81) = 2.60, p = .01. The SAD group did not differ in years of education from either of the other two groups, ps > .06. The omnibus chi-square test for ethnicity approached significance (p = .06), so we completed follow-up tests, which revealed a greater proportion of Caucasian than non-Caucasian individuals in the SAD + Dep group than the HC group, 2 = 4.79, p = .04. The SAD group did not differ on ethnicity compared with either the SAD + Dep group, 2 = 3.91, p = .07, or the HC group, 2 = 0.29, p = .71. With regard to symptom measures, omnibus tests were all significant (see Table 1). In follow-up tests, the HC group reported significantly lower social anxiety and depression than both the SAD group [BFNE-S: t(114) = 17.14, p < .001, SIAS-S: t(115) = 17.30, p < .001; BDI-II: t(122) = 7.22, p < .001] and the SAD + Dep group [BFNE-S: t(83) = 20.76, p < .001; SIAS-S: t(82) = 17.92, p < .001; BDIII: t(87) = 11.11, p < .001]. As expected, the SAD + Dep group Within-group bivariate correlations between the two IATs and between each of the IATs and self-reports of social anxiety (SIAS-S) and depression (BDI-II) are shown in Table 2. The IAT scores correlated with each other within the SAD group and within the HC group, but not within the SAD + Dep group (p = .06). Only three correlations between IAT scores and self-report measures emerged as significant. In the SAD + Dep group, both IAT scores correlated with depression, with greater self-calmness and greater self-acceptance scores associated with lower depression. In the SAD group, greater self-calmness associations were associated with lower social anxiety. See Fig. 1 for mean IAT scores for each task by group. Because there was a significant difference among the groups for years of education and a near significant difference in ethnicity (i.e., Caucasian versus non-Caucasian), we first examined whether these demographic characteristics were related to implicit associations on either IAT, which would dictate whether they be included as covariates in the IAT data analyses. Bivariate correlations revealed that years of education was not significantly related to either anxiety/calmness IAT scores, r = .09, p = .24, or acceptance/rejection 542 J. Wong et al. / Journal of Anxiety Disorders 28 (2014) 537–546 Table 2 Bivariate correlations of the IATs by diagnostic group. Anxiety/Calmness Implicit Association Test 3.4. Post hoc analyses Acceptance/Rejection Implicit Association Test Social anxiety disorder (SAD) A/R IAT .44*** SIAS-S −.25* BDI-II .20 −.15 −.07 Social anxiety disorder + Depression (SAD + DEP) A/R IAT .28 SIAS-S −.02 BDI-II −.45** −.23 −.35* Healthy control (HC) A/R IAT .66*** SIAS-S −.04 BDI-II −.19 −.20 −.26 Note. SIAS-S – Social Interaction Anxiety Scale, straightforward item total; BDI-II – Beck Depression Inventory – II. Because of the use of listwise deletion, the sample sizes differ from those reported for the primary analyses (SAD = 69, SAD + Dep = 44, HC = 32). * p < .05. ** p < .01. *** p < .001. Self-Calmness/Acceptance IAT Scores IAT scores, r = .11, p = .18, nor was ethnicity related to either anxiety/calmness IAT scores, r = −.03, p = .74, or acceptance/rejection IAT scores, r = .11, p = .16. Therefore, analyses did not control for either years of education or ethnicity. Likewise, we did not control for self-reported social anxiety given that the two SAD groups did not differ on either social anxiety self-report measure. A one-way analysis of variance (ANOVA) comparing the three groups on implicit self-calmness associations was significant, F(2, 173) = 7.30, p < .01, 2 = 0.08. Follow-up t-tests revealed that the SAD + Dep group had the weakest self-calmness associations [compared to the HC group: t(89) = 3.76, p < .001, Cohen’s d = 0.80; compared to the SAD group: t(130) = 2.37, p = .02, Cohen’s d = 0.44]. The SAD group also exhibited weaker self-calmness associations than the HC group, t(127) = 1.99, p < .05, Cohen’s d = 0.36. Results for the acceptance/rejection IAT were similar but not identical. A one-way ANOVA comparing the three groups’ implicit self-acceptance associations was significant, F(2, 173) = 3.13, p < .05, 2 = 0.04. Levene’s test for equality of variances was significant, so reported follow-up t-tests were based on the test that did not assume equal variances. Such t-tests revealed that the SAD + Dep group exhibited weaker self-acceptance associations than the HC group, t(86.54) = 2.75, p < .01, Cohen’s d = 0.59, and the SAD group, t(118.52) = 1.98, p = .05, Cohen’s d = 0.35. The SAD group and HC group did not differ on self-acceptance associations, t(102.48) = 0.91, p = .36, Cohen’s d = 0.17. Given that approximately half of the SAD + Dep group comprised individuals with remitted depression (n = 27), we explored whether the above results differed if the SAD + Dep group was split into its two subgroups (i.e., SAD + Current Dep, SAD + Past Dep). A one-way ANOVA comparing the four groups’ implicit self-calmness associations was significant, F(3, 172) = 5.43, p < .01, 2 = .09. Follow-up t-tests were largely consistent with the previous analysis, in that both of the SAD + Dep groups exhibited weaker self-calmness associations than the HC group, ps < .05. In addition, the two SAD + Dep groups did not differ from one another, t(45) = 1.19, p = .24, Cohen’s d = 0.35. However, whereas the SAD + Current Dep group continued to exhibit weaker self-calmness associations than the SAD group, t(103) = 2.69, p < .01, Cohen’s d = 0.53, the SAD + Past Dep group did not differ from the SAD group, t(110) = 1.23, p = .22, Cohen’s d = 0.23. This final comparison suggests the previously observed differences between the SAD and SAD + Dep groups in self-calmness associations may be driven by those with current depression. With regard to the acceptance/rejection IAT, the omnibus ANOVA was again significant, F(3, 172) = 3.70, p = .01, 2 = .06. Follow-up t-tests revealed significant divergences from previous analyses. Here, the SAD + Current Dep group exhibited weaker selfacceptance associations than the other three groups [compared to the SAD + Past Dep group: t(45) = 2.76, p < .01, Cohen’s d = 0.82; compared to the SAD group, t(103) = 2.69, p < .01, Cohen’s d = 0.53; compared to the HC group, t(62) = 3.73, p < .01, Cohen’s d = 0.95]. In contrast, the SAD + Past Dep group did not differ from the SAD group, t(110) = 0.30, p = .77, Cohen’s d = 0.06, or from the HC group, t(69) = 1.10, p = .28, Cohen’s d = 0.26. Given that the two SAD + Dep groups and the SAD group did not differ from one another on selfreported social anxiety as assessed with the SIAS-S, ps > .30, these results clearly suggest that current depression is driving the difference in self-acceptance associations observed previously. 4. Discussion The current study was the first to examine implicit associations of the self in a clinical, treatment-seeking sample of individuals with generalized SAD with and without comorbid depression. In line with hypotheses, a diagnosis of SAD was associated with the strength of the anxiety-calmness IAT effect. Individuals with SAD exhibited weaker self-calmness associations than non-anxious, non-depressed healthy controls. In addition, those with SAD and comorbid depression showed the weakest self-calmness associations compared to both individuals with SAD without a history of depression and healthy controls. When we looked more specifically at the depression subgroups in post hoc analyses, both the 0.8 0.7 0.6 0.5 0.4 SAD 0.3 SAD+Dep 0.2 Healthy Controls 0.1 0 Calmness/Anxiety Acceptance/Rejecon IAT Fig. 1. Scores on two Implicit Association Tests (IATs) for individuals with social anxiety disorder (SAD), social anxiety disorder and a current and/or past diagnosis of depression (SAD + Dep), and healthy controls (error bars are standard errors). J. Wong et al. / Journal of Anxiety Disorders 28 (2014) 537–546 SAD-past depression and SAD-current depression groups showed weaker self-calmness associations than the healthy controls. However, whereas the SAD-current depression group showed weaker self-calmness associations than the SAD-only group, the SAD-past depression group did not. On the self-rejection/acceptance IAT, the SAD-current depression group showed the weakest self-acceptance associations. However, in this analysis, self-acceptance associations did not differ among individuals with SAD and remitted depression, non-depressed individuals with SAD, and healthy controls. These findings suggest that current depression has a significant effect on both self-calmness and self-acceptance associations in socially anxious individuals. Notably, self-reported (explicit) level of social anxiety did not differ between the SAD-only and SAD-depression groups. Our findings that individuals with SAD demonstrate weaker selfcalmness associations than non-anxious controls replicate results from previous studies using non-clinical samples (e.g., Gamer et al., 2008; Glashouwer & de Jong, 2010). The lack of significant difference between the SAD group and healthy controls on the selfacceptance IAT was unexpected. This implicit association has been far less examined in relation to social anxiety than has the selfcalmness association. Only two studies (Clerkin & Teachman, 2010; Teachman & Allen, 2007) have utilized the self-acceptance IAT, but the nature of these specific studies make predictions based upon them somewhat difficult. Teachman and Allen examined implicit self-acceptance associations among adolescents (ages 13–18) as part of a larger longitudinal investigation of adolescent social development in familial and peer contexts (Allen, Porter, & McFarland, 2006), whereas Clerkin and Teachman focused on the utility of training implicit associations in socially anxious college students. Although the implicit self-acceptance associations of the socially anxious participants improved with training, the authors did not examine the implicit self-acceptance associations of socially anxious participants versus healthy controls. Because fear of negative evaluation and rejection are highly related to SAD (APA, 2013; Harb et al., 2002), we expected to see this difference, which did not appear. It is also of interest that recent research (Mallott, Maner, DeWall, & Schmidt, 2009; Maner, DeWall, Baumeister, & Schaller, 2007) has demonstrated that non-anxious persons react to social rejection with an increase in prosocial behavior and the desire to affiliate with others whereas those with high levels of social anxiety do not show this pattern of response but rather are characterized by social withdrawal in the face of social exclusion. Further research on the implicit self-acceptance associations of persons with SAD appears warranted. 4.1. The impact of comorbid depression In our primary analyses, the SAD-depression group showed the weakest self-calmness associations compared to non-depressed SAD individuals and healthy controls. However, post hoc analyses revealed that the difference between the SAD-depression and SADonly groups was driven by those with current depression; those with remitted depression were no different from socially anxious persons without a history of depression. With regard to rejection/acceptance implicit associations, the impact of current comorbid depressive was robust. Surprisingly, the SAD-only, SAD-past depression, and healthy control groups did not differ on self-acceptance associations. The SAD-current depression group had the weakest self-acceptance associations, weaker than any of the other groups. That comorbid depression should have an effect here follows from the literature on rejection sensitivity as a risk factor for depression (Ayduk et al., 2001; Boyce & Parker, 1989; Downey & Feldman, 1996), although it is unclear why only those with current depression exhibited a difference from the SAD-only group. It is possible that current depression may be more 543 closely linked with the expectation of negative outcomes, or at least greater certainty about such outcomes, than social anxiety with or without past depression, and that this was reflected in our findings. More than two decades ago, Alloy, Kelly, Mineka, and Clements (1990) proposed a cognitive explanation for when and why anxiety and depression co-occur. They theorized that differing degrees of certainty about one’s ability to control important outcomes (i.e., helplessness) and negative-outcome expectancies (i.e., hopelessness) resulted in a pure anxiety, mixed anxiety-depression, or pure depression presentation. They argued that those who experience anxiety are uncertain of their helplessness. Those who are certain of their helplessness and of negative outcomes primarily experience depression. Those in a mixed depression-anxiety state were theorized to be more certain of their helplessness but uncertain about negative outcomes. If we apply this helplesshopelessness theory to explain the self-acceptance IAT results, it could be argued that those with comorbid depression held more negative outcome expectancies and were therefore more likely to expect rejection. Non-depressed individuals with SAD, in contrast, may have had relatively weaker negative outcome expectancies. Social anxiety-relevant implicit associations may be more negative and/or stable among socially anxious individuals when depression is present. Like the attentional bias research reviewed earlier (Grant & Beck, 2006; LeMoult & Joormann, 2012; Musa et al., 2003), this suggests that the presence of depressive symptoms may modify maladaptive cognitive processes in those with social anxiety. Similar to the arguments of Mathews and MacLoed (2005) presented in the introduction, Musa et al. (2003) noted that their findings of nullified attention bias to threat at relatively brief exposure durations suggests that anxiety and depression are associated with biases at different stages of information processing – preattentive and selective attention processes are affected in anxiety, and effortful, controlled processes are more likely to be disrupted in depression. In the IAT, although the processes under study are implicit in nature and thereby outside of conscious awareness, stimuli are presented at durations sufficient for more elaborative processing. As such, our findings that individuals with SAD with current comorbid depression exhibited less positive implicit associations than individuals with SAD with no depression, who themselves exhibited less positive implicit associations than healthy controls (at least in the case of self-calmness associations), appear to converge with this theory. Further, our results suggest that SAD with current comorbid depression may represent a more severe instantiation of social anxiety despite the fact that this was not reflected in our study on explicit self-report measures of social anxiety, nor has it been consistently apparent in the studies on attentional bias. At present, it is unclear why those with SAD and remitted depressed performed similarly to socially anxious individuals without a history of depression, but not to those with current depression, on both IAT tasks. Research on information processing biases comparing currently to formerly depressed individuals is, to our knowledge, scant. A handful of studies suggest that currently and formerly depressed individuals exhibit similar attention biases (Fritzsche et al., 2010; Gupta & Kar, 2012; Joormann & Gotlib, 2007) and memory biases toward sad stimuli (Fritzsche et al., 2010; Gupta & Kar, 2012). However, in the one study that has examined implicit associations found that on a self-esteem IAT, those with remitted depression exhibited higher implicit self-esteem than those with current depression and those without a history of depression (Franck, De Raedt, & De Houwer, 2008). More research is needed to investigate whether implicit biases associated with depression are better characterized as a state marker of a depressive episode, or a trait-like characteristic of people at risk for depression. 544 J. Wong et al. / Journal of Anxiety Disorders 28 (2014) 537–546 4.2. Limitations and future directions It should be noted that there are limitations in using the IAT as a paradigm for examining implicit associations. As mentioned earlier, the IAT was designed to measure relative association strengths and was not meant to measure the difference in evaluative associations with a single target concept (e.g., acceptance versus rejection associations with the self). Karpinski (2004) points out that while some target concepts have obvious and meaningful complementary pairs (e.g., young-old), others do not (e.g., Santa Claus). He contends that in many instances, the unspecified other is not a meaningful complement to the self target concept for the research hypothesis being tested. Pinter and Greenwald (2005) counter by arguing that the other has been found to have a neutral valence. However, given that the other may be perceived by socially anxious individuals as a threatening stimulus, we would likely benefit from examining implicit self associations that are not tied to an other when studying SAD. As an alternative method, Karpinski and Steinman (2006) developed a Single Category IAT (SC-IAT) that eliminates the need for a second contrast category. Preliminary examinations of the SCIAT suggest it shows acceptable reliability and validity (Karpinski & Steinman, 2006). Therefore, a potential next step would be for future studies of social anxiety and implicit associations to compare the SC-IAT to traditional IAT measures. In addition to limitations of the IAT, there were also some methodological limitations to the current study. For one, other stimuli, chosen to be consistent with previous studies, included the words “you” and “your.” Respondents may have potentially confused these words as belonging to the self category, thus adding noise to the IAT results. Also, the order of administration of the IATs used in the study was not counterbalanced, and the acceptancerejection IAT always followed the anxiety-calmness IAT. Practice effects may have weakened the acceptance-rejection IAT effect. In summary, the present results underscore the utility of examining implicit cognitions in our attempts to better understand and treat SAD, alone and when it is comorbid with current depression. The self-calmness and self-acceptance IATs differentiated among groups, but the specific patterns of results differed. Differences between the SAD-only and SAD-current depression groups could reflect differences in specific schema or provide an implicit index of severity of social anxiety that might complement typically employed explicit measures. Future research should look further into the malleability of maladaptive implicit associations and examine the relationship between these associations and behavior. Clerkin and Teachman (2010) demonstrated that selfacceptance associations among socially anxious college students could be strengthened by training and that trained participants were more likely to complete an impromptu speech than untrained participants. Replicating these findings in a clinical sample of persons with SAD could have important implications for treatment. 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Living with Anxiety Understanding the role and impact of anxiety in our lives Mental Health Awareness Week 2014 1 The truth is that anxiety is at once a function of biology and philosophy, body and mind, instinct and reason, personality and culture. Even as anxiety is experienced at a spiritual and psychological level, it is scientifically measurable at the molecular level and the physiological level. It is produced by nature and it is produced by nurture. It’s a psychological phenomenon and a sociological phenomenon. In computer terms, it’s both a hardware problem (I’m wired badly) and a software problem (I run faulty logic programs that make me think anxious thoughts)”.1 1 1. Scott Stossell ‘My Age of Anxiety’. Contents 05 Executive summary 08Introduction 08 What is anxiety? 10 Anxiety and modernity 13 Living with Anxiety: Stephanie 15 Anxiety disorders in the UK 18 Living with anxiety: Ian 20 The state of the nation: Anxiety in the UK 28 Living with anxiety: Jane 30 Managing anxiety 36 A new age of anxiety? 40 Useful resources and information 42References 2 Acknowledgements This report was written by Paul Swift, Dr Eva Cyhlarova, Isabella Goldie and Chris O’Sullivan. Others who contributed to this report include Paul Bristow, Joanna Carson, Hanna Biggs and Jenny Edwards, CBE. Foreword We all experience anxiety; it is a natural human state and a vital part of our lives. Anxiety helps us to identify and respond to danger in ‘fight or flight’ mode. It can motivate to us face up to dealing with difficult challenges. The ‘right’ amount of anxiety can help us perform better and stimulate action and creativity. But there is another side to anxiety. Persistent anxiety causes real emotional distress and can lead to us becoming unwell and, at worst, developing anxiety disorders such as panic attacks, phobias and obsessional behaviours. Anxiety at this level can have a truly distressing and debilitating impact on our lives and impact on our physical as well as our mental health. Some commentators have described this as ‘The Age of Anxiety’. The Mental Health Foundation’s survey, commissioned for this report, backs up this sense of widespread heightened anxiety. Alarmingly, almost 1 in 5 people revealed that they feel anxious ‘nearly all of the time’ or ‘a lot of the time’. More than half of us have noticed that ‘people are more anxious today than they were 5 years ago.’ The survey highlights ‘finance, money and debt’ as the most common source of anxiety, perhaps reflecting the impact of the recession and austerity on public mental health and well-being. Anxiety is one of the most common mental health problems in the UK and it is increasing. Yet it remains under-reported, under-diagnosed and undertreated. A good ability to cope with anxiety is key to resilience in the face of whatever life throws at us. However, experiencing it too much or too often means we risk becoming overwhelmed, unable to find balance in our lives or to relax and recover. Our ability to find some inner peace has never been more important to our well-being. This report is about framing anxiety as an essential aspect of our humanity and part of the natural human emotional response to circumstances in our lives. It is also about challenging the stigma that still gets in the way of our reaching out for help and support when our levels of anxiety become a real problem. As individuals and society we need to understand and engage with anxiety better, recognising when it is helpfully alerting us to pay attention, and ensuring we have coping strategies when its negative impact becomes too great. We need to recognise when the people around us, our friends, family members and colleagues, are experiencing distressing levels of anxiety or at risk of this because of life events and circumstances. Local public health strategies need to identify the points at which people are most likely to experience high anxiety and to offer a range of help that is simple, quick to access and non-stigmatising. We encourage public health commissioners to check the list of the most common sources of anxiety in this survey and 3 use them to help identify the best places and partnerships to reach out to those 1 in 5 people who feel anxious nearly all the time or most of the time. We consider there could be great benefit in public policy becoming “anxiety aware”, adjusting its strategies and styles of interaction with the public in order to prevent and reduce anxiety. If we truly recognised the mounting costs of anxiety distress to people, their children’s futures, to communities and employers, we would act now. In today’s “Age of Apps” where many people are living dual lives, partly online, then we can develop new and innovative digital approaches to living better with anxiety, particularly to invest in the mental and emotional well-being of our children and young people. We hope that this report will act as a catalyst for a growth in self-help resources to enable us all to manage our response to increasingly anxious thoughts. Jenny Edwards CBE Chief Executive Mental Health Foundation 4 Executive summary ―― While 2.6% of the population experience depression and 4.7% have anxiety problems, as many as 9.7% suffer mixed depression Anxiety is a familiar emotion because it is part and anxiety, making it the most prevalent of everyone’s experience. Its natural function is to mental health problem in the population alert us to potential threats, allowing us to evaluate as a whole. and respond to them in appropriate ways. This heightened state of readiness can also help people ―― About 1.2% of the UK population experience perform better and stimulate creative impulses. panic disorders, rising to 1.7% for those Anxiety is often regarded as an artefact of modern experiencing it with or without agoraphobia. societies, one that is increasingly represented in visual arts, music, literature and social media. ―― Around 1.9% of British adults experience a phobia of some description, and women For some people anxiety triggers inappropriate are twice as likely to be affected by this or disproportionate responses to perceived problem as men. threats, leading to persistent and intrusive symptoms associated with anxiety disorders, such as panic, phobias and obsessive behaviours, ―― Agoraphobia affects between 1.5% and 3.5% of the general population in its fully which often have a debilitating effect on their developed form; in a less severe form, up lives. Anxiety is one of the most prevalent mental to one in eight people experience this. health problems in the UK and elsewhere, yet it is still under-reported, under-diagnosed and under―― Post-Traumatic Stress Disorder (PTSD) treated. This report explores the intersection affects 2.6% of men and 3.3% of women. between popular perceptions of anxiety, the experience of anxiety in people’s everyday ―― Obsessive Compulsive Disorders (OCD) lives and the impact of anxiety disorders. affect around 2–3% of the population. The experience of anxiety often involves ―― Generalised Anxiety Disorder affects interconnected symptoms and disorders. It is between 2–5% of the population, yet estimated that one in four people in the UK will accounts for as much as 30% of the experience a mental health problem each year, mental health problems seen by GPs. while one in six experience a neurotic disorder such as anxiety or depression. Anxiety disorders Previous survey evidence suggests that: are also estimated to affect 3.3% of children and young adults in the UK. The prevalence of the ―― Although, on average, women rate their life most common forms of anxiety are given below. satisfaction higher than men, their anxiety levels are significantly higher than men. ―― People in their middle years (35 to 59) report the highest levels of anxiety compared to other age groups. ―― People in the older age groups tend to be happier and less anxious. ―― People with a disability are, on average, more anxious than people without a disability. 5 ―― Unemployed people report significantly higher anxiety levels than those in employment. ―― People in the lowest income groups report significantly higher anxiety levels than those in the higher income groups. ―― On average, all ethnic groups report higher levels of anxiety than people who describe themselves as White British. ―― Young people aged 16–24 are more likely to report lower levels of anxiety compared with adults generally. ―― Women and young adults aged 20–29 are the most likely to seek help for anxiety from their GP. Our specially commissioned survey of over 2,000 members of the public found that: ―― Almost one in five people feel anxious all of the time or a lot of the time. ―― Around a fifth of people who are anxious have a fear of unemployment. ―― Younger people are much more likely to feel anxious about personal relationships. ―― Older people are more likely to be anxious about growing old, the death of a loved one and their own death. ―― The youngest people surveyed (aged 18–24) were twice as likely to be anxious about being alone than the oldest people (aged over 55 years). ―― One-fifth of people who have experienced anxiety do nothing to cope with it. ―― The most commonly used coping strategies are talking to a friend, going for a walk, and physical exercise. ―― Comfort eating is used by a quarter of people to cope with feelings of anxiety, and women and young people are more likely to use this as a way of coping. ―― Only one in twenty people never feel anxious. ―― Women are more likely to feel anxious than men. ―― The likelihood of feeling anxious reduces with age. ―― Students and people not in employment are more likely to feel anxious all of the time or a lot of the time. ―― Financial issues are a cause of anxiety for half of people, but this is less likely to be so for older people. ―― Women and older people are more likely to feel anxious about the welfare of loved ones. ―― Four in every ten employed people experience anxiety about their work. 6 ―― A third of the students in the survey said they cope by ‘hiding themselves away from the world’. ―― People who are unemployed are more likely to use coping strategies that are potentially harmful, such as alcohol and cigarettes. ―― Fewer than one in ten people have sought help from their GP to deal with anxiety, although those who feel anxious more frequently are much more likely to do this. ―― People are believed to be more anxious now than they were five years ago. ―― There is a tendency to reject the notion that having anxious feelings is stigmatising. ―― People who experience anxiety most frequently tend to agree that it is stigmatising. ―― Just under half of people get more anxious these days than they used to and believe that anxiety has stopped them from doing things in their life. We recommend a stepped care approach be adopted to ensure that support for living with anxiety is provided in the least stigmatising and most inclusive way possible including: ―― Most people want to be less anxious in their day-to-day lives. ―― Universal approaches to learning to live well with anxiety should be built into school curriculums from primary 1 onwards, including an understanding of the role of anxiety in our lives, and techniques for managing stresses associated with school (such as peer relationships, exams and transitions). ―― Women and younger people are more likely to say that anxiety has impacted on their lives. Surveys suggest we live in an ‘age of anxiety’ which reflects a shared mood about the defining aspects of modern life: our work, the way we raise children, our attitudes to people who are disadvantaged, the future of public services, the threat of terrorism, and so on. At another level, there is evidence of the hidden impact of more severe forms of anxiety upon the lives of a significant number of people. Our understanding of anxiety disorders has improved in recent years due to research, the development of more sophisticated diagnostics, effective treatments, and the emergence of a genuine voice for people living with anxiety. While these developments are encouraging, our own work suggests that there are still gaps that need to be addressed in the provision of support for people who experience anxiety. ―― Peer-led approaches should be promoted within universal settings such as employment, schools and universities, in recognition of the importance that young people place on support from peers and the unique level of empathetic understanding that can be provided by those with a common experience. ―― Access to good quality self-help approaches should be made available across the UK through quality-assured and co-designed digital platforms to ensure they are fit for purpose for those who choose not to use face-to-face services (young people, people in full time employment). ―― GP training and anxiety-related guidance should be assessed for equalities impact and adapted alongside groups of people who are at highest risk of developing problematic anxiety and least likely to have their needs met by current service provision. ―― A sample of psychological services should be audited to establish how well current referral processes are working, who is accessing these, and who is falling through the gaps. This audit should include IAPT (Improving Access to Psychological Therapies) in England and Wales and initiatives to improve access in Scotland. 7 ―― Agencies offering support to people with anxiety should make greater use of peer mentors and advice and information that is explicitly based on the life experiences of people who live with anxiety. We also recommend that research be commissioned to better understand: ―― The nature and understanding of anxiety for different groups in society (women, people with long-term conditions, older people, people from black and minority ethnic communities), and whether current approaches and interventions can be found to address specific needs. ―― The relationship between unemployment, financial distress, and anxiety. The Department of Work and Pensions should develop strategies to prevent people who are not working from becoming marginalised from the workforce. Processes for accessing social welfare for those unable to work due to disability should be assessed for their impact on anxiety levels. ―― The impact of technological advancements in self-management for anxiety. 8 Introduction In this report we want to get deeper under the skin of ‘anxiety’, one of our most unwelcomed emotional states, and understand the role that it plays in our lives―for better and for worse. It is not our intent to present the case for eradicating anxiety, for being anxious is an important part of what it means to be human. We are often anxious about those aspects of our lives that we care most about: our health; our ability to clothe and feed ourselves and our family; and our ability to be connected and valued by others. Anxiety helps us to get up in the morning and motivates us to step out of our comfort zone. around us, or from professionals. However, as we come to understand anxiety better, there is much that we can do as individuals to take steps to reduce its hold over us, and to learn to appreciate our full range of emotions without fear that they will overtake us. What is anxiety? Everyone has feelings of anxiety at some point in their life, whether it is about preparing for a job interview, meeting a partner’s family for the first time, or the prospect of parenthood. While we associate anxiety with alterations to our mental state, experienced as worry or apprehension perhaps, and physical symptoms such as raised However, we often go to great lengths to avoid heart rate and adrenaline, we also understand being anxious, feeling a sense of failure if we don’t that it is likely to affect us only temporarily until keep our worrying thoughts under tight control. the source of our anxiety has passed or we have There may be times when these thoughts get learnt to cope with it. Anxiety is therefore one away from us and begin to feel overwhelming. of a range of emotions that serves the positive For some they may become habitual, leading function of alerting us to things we might need to to regular uncomfortable, or even distressing, worry about: things that are potentially harmful. physical symptoms. Patterns of avoidance may More importantly, these emotions help us to build up, that can have a limiting effect on our lives. evaluate potential threats and respond to them in an appropriate way, perhaps by quickening Anxiety can also be exhilarating. Putting ourselves our reflexes or focusing our attention. into situations that make us anxious can feel like an ordeal at the time, but getting through to Fear, like anxiety, is a familiar emotion precisely the other side can bring an incredible sense of because it is part of everyone’s experience achievement. Our most important moments in life and we consider it an essential component are usually not achieved without some sleepless of our humanity, yet it is also a psychological, nights. Being a new parent, our wedding days, physiological and behavioural state we share passing exams, and learning to drive bring great with animals when confronted by a threat to our rewards, but it is unlikely that these were achieved wellbeing or survival. Fear increases the body’s without some feelings of apprehension. arousal, expectancy, and neurobiological activity, and triggers specific behaviour patterns designed Anxiety is an emotional state that can work for to help us cope with an adverse or unexpected us as well as against us. It is something we all situation. But how do we distinguish anxiety have in common, but where we often differ is in from fear, given that the two are often how we perceive these feelings of arousal and used interchangeably? how we respond to them. Our life circumstances, our upbringing and our personalities can all be factors in why one person’s exciting fairground ride will leave another person in abject terror. Feeling anxious isn’t a sign of failure and there are times when it is important to ask for help from those 9 “If fear is fearful of something particular and determinate, then anxiety is anxious about nothing in particular and is indeterminate. If fear is directed towards some distinct thing in the world, spiders or whatever, then anxiety is anxious about being-in-the-world as such. Anxiety is experienced in the face of something completely indefinite. It is, Heidegger insists, ‘nothing and nowhere’” (Critchley, 2009). While fear often has a specific, immediate context which provokes classic ‘fight or flight’ reflexes— the automatic fear response occurs faster than conscious thought, releasing surges of adrenaline which can subside quickly once the perceived or actual threat has passed—anxiety connotes lingering apprehension, a chronic sense of worry, tension or dread, the sources of which may be unclear. It can be a vague, unpleasant emotion experienced in anticipation of some ill-defined misfortune. The committee charged with reviewing the diagnostic criteria for the latest version of the Diagnostic and Statistical Manual of Mental Disorders (DSM)2 similarly distinguish anxiety as “a future-oriented mood state associated with preparation for possible, upcoming negative events” from fear which “is an alarm response to present or imminent danger (real or perceived)”; but add “importantly, these descriptions represent prototypes of fear and anxiety that lie at different places upon a continuum of responding. Along such a continuum, symptoms of fear vs. anxiety are likely to diverge and converge to varying degrees” (Craske et al., 2009). Another writer, expressing the distinction in less esoteric terms, suggests “the sudden re-arrangement of your guts when an intruder holds a knife to your back (fear), is different from the mild nausea, dizziness and butterflies in your stomach as you’re about to make a difficult phone call (anxiety).”3 This report is concerned with the way that different types of anxiety, found at various points on the continuum, are experienced by individuals and how they are represented to the wider public. It explores the everyday manifestations as well as what happens when anxiety becomes more than a temporary experience, and instead is experienced as either a series of debilitating episodes or a constant presence in someone’s 10 2. Published by the American Psychiatric Association, the DSM offers standard criteria for the classification of mental disorders for use by clinicians, researchers, pharmaceutical companies, policymakers, etc. The latest version, DSM-V, was published in May 2013. 3. From Harriet Lerner, The Dance of Connection blog October 11th 2009. life. Anxiety disorders such as panic, phobias and obsessive behaviours may be triggered by traumatic memories, irrational hatred of specific objects, proximity to particular situations or physical locations, or a persistent worry that something bad will happen in the future. A defining characteristic of anxiety disorders is that psychological symptoms, such as irritability, difficulties concentrating and depression, become persistent and intrusive. Many people also experience physical symptoms, like heart palpitations, sweating, tensions and pain, heavy and rapid breathing, dizziness, fainting, indigestion, stomach aches, sickness and diarrhoea; in acute cases, people have described how it felt as though they were dying. The lives of those with the most severe forms of anxiety can become completely dominated by their condition, meaning they find it difficult to relax or achieve regular patterns of sleep, becoming stuck in circular patterns of thought that impair their ability to maintain preferred lifestyles, hold down a job or sustain personal relationships. Anxiety and modernity Although it is the most common sign of mental distress in nearly every country in the world, anxiety is often presented as an artefact of modern Western societies; Norman Mailer, for example, suggested that “the natural role of twentiethcentury man [sic] is anxiety”. The concept of anxiety per se was first brought to prominence as a philosophical and psychoanalytic concept in the first part of the twentieth century. Freud was a seminal figure in the development of Western thinking about anxiety, which he conceived of as a state of inner tension from which humans are driven to escape. At a most basic level, anxiety is a signal to the ego (the aspect of personality that deals with reality) that something overwhelmingly awful is about to happen and that it needs to employ a defence mechanism in response. Freud saw this as deriving from an infant’s mental helplessness, which is a counterpart of its biological helplessness. Humans learn to cope with anxiety prompted by ‘real’ threats, such as fear of being bitten by a dog, either by avoiding situations likely to contain the threat, or by physically withdrawing from them. Freud’s typology also included neurotic anxiety arising from an unconscious fear that we will lose control of libidinal impulses, leading to inappropriate behaviour, and moral anxiety, arising from a fear of violating our own moral or societal codes. Moral anxiety, he suggested, manifests itself as guilt or shame. The task of psychoanalysis is therefore to strengthen the ability of the ego to find ways of coping with anxiety such as ‘denial’, ‘rationalisation’, ‘regression’ (to a childhood state) or ‘projection’. Within the existentialist philosophical tradition, ‘angst’, from the German word for anxiety, is held to be a negative feeling arising from the experience of human freedom and responsibility in a world where faith and traditional social bonds have been undermined. Kierkegaard’s classic example of existential angst is of a person standing on the edge of a high cliff or building; 11 along with the fear of accidentally falling, the person feels an irrational impulse to deliberately fling themselves over the edge. The emotion the person feels upon realising that he or she has this option is angst. Kierkegaard described the burden of making moral choices as a consequence of free will “the dizziness of freedom”. Existential psychology therefore proceeds from the presumption that anxiety stems from a crisis in the exercise of free will, which might be manifested in anxiety about one’s mortality, the inevitability of loss, or about accepting personal responsibility for one’s thoughts, feelings and actions. Freudian psychoanalysts would recognise as classical defence mechanisms: “they learn to seal their anxiety off from public view”. According to Daniel Smith, “they learn to cork their anxiety within themselves like acid in a vial. It isn’t pleasant. The human mind isn’t Pyrex, it can corrode. But it works.”6 Perhaps more significantly, the testimony of people living with anxiety affords us a more rounded appreciation of the role that it plays in shaping their lives; as Scott Stossel, author of My Age of Anxiety, puts it, “anxiety can be a spur to achievement as well as a barrier. Picture a bell 4 That anxiety “somehow feels new” may be curve with extreme anxiety on the far right and extreme lack of anxiety on the far left. If you’re explained partly by the fact that anxiety has been the subject of significant scientific research for less too anxious to the point where it’s physically than half a century, while the psychiatric profession and mentally debilitating, then your performance first codified diagnostic criteria for all the different suffers. If you’re not anxious enough, if you’re not disorders as recently as 1980, with the publication engaged and slightly activated by anxiety, as it were, then your performance also suffers.”7 of DSM-III. Subsequent advances in diagnostic techniques, coupled with the development of effective pharmacological treatments and The voices of people living with the more acute psychological therapies, have prompted primary forms of anxiety help us to conceive of anxiety healthcare professionals to more readily identify as something more than simply a condition that anxiety in their patients. requires diagnosis and treatment. How individuals engage with their anxiety, how they manage it and Anxiety is now recognised as one of the most represent it to the wider world lifts anxiety beyond prevalent mental health problems in the UK, the realm of medicine and science and into yet there is good evidence that it is still undera broader sociological and cultural context. reported, under-diagnosed and under-treated. One reason may be that, unlike many other mental health issues, people whose lives are affected have not yet found a voice that articulates the full range of experiences of anxiety, not just those of people living with anxiety disorders. In recent years, this has begun to change, as writers, bloggers and campaigners have provided us with an insight into “Britain’s silent epidemic”5 by describing the lived experience of anxiety, the complexities and nuances of the various disorders, the symptoms that are associated with them, and the effect that anxiety has upon their lives. For example, some people living with anxiety describe feelings of shame and embarrassment 4. Rachel Cooke, The Observer, Sunday 15th September 2013. at their physical symptoms, such as excessive 5. The Observer, Sunday 15th September 2013. perspiration, which lead them to adopt what 6. From Monkey Mind: A Memoir of Anxiety by Daniel Smith, quoted 12 in The Observer, Sunday 15th September 2013. 7. Scott Stossel ‘May Age of Anxiety’. “For as long as I can remember I have suffered from a deep feeling of anxiety which I have tried to express in my art. Without anxiety and illness I should have been like a ship without a rudder” (Edvard Munch). The representation of these more acute forms of anxiety within the arts has long been established as a powerful creative force in a way that fear rarely is.8 From the “dizziness of freedom” has flowed a rich artistic tradition since the beginning of the twentieth century, starting with the close relationship between early modernist artists and psychoanalysis and the rise of art practices within psychiatric hospitals, which in turn had a significant impact on the development of art history. Writers have also recognised anxiety as a “handmaiden to creativity”,9 either as the motivating spirit acknowledged by Graham Greene, for example, or as the animating theme of novels by Virginia Woolf, Franz Kafka and Haruki Murakami. Most notably, the First World War poets, many with the experience of early psychiatric treatments for trauma, brought the subjective experience of severe anxiety disorders into the public realm. In another sphere, musicians as diverse as Leonard Bernstein, Marvin Gaye and Radiohead have represented anxiety in their work, while The King’s Speech demonstrates that a debilitating social anxiety can be the subject matter of a commercially successful film as well as a critically acclaimed one. 13 In 2009, the Mental Health Foundation published In The Face of Fear, which addressed the questions of how fear and anxiety affect our health and society, and what we can do about it. At that time, fear seemed a natural response to the dramatic banking crisis of the previous year and the potential socio-economic consequences that few at the time could predict, except that it was likely to be the deepest recession for a generation. Indeed, research carried out for In The Face of Fear found that “people perceive our world as having become more frightening and frightened”. In 2014, five years on, we are exploring whether and how that mood of fear has translated into a more persistent sense of apprehension and, taking a broader perspective, how that fits into our historical understanding of anxiety. We do this by asking: do we live in age of anxiety? In doing so, we want to draw attention to the way that anxiety affects the lives of the people who live with it and consider the contribution of anxiety to our culture. This report explores the intersection between popular perceptions of anxiety, the experience of anxiety in people’s everyday lives, and the impact of anxiety disorders. In doing so, we have reviewed the research evidence on anxiety disorders, commissioned a survey of public views, and collected people’s stories about their own experiences. The following chapters set out the scale and nature of anxiety in the UK and how it is currently managed, interspersed with case studies describing what it is like to live with anxiety. We hope that the report will contribute to a wider understanding of the role that anxiety plays in our lives and stimulate discussion about the public health implications of learning to live well with anxiety. 8. Later this year, the Anxiety Arts Festival will explore anxiety, its causes, how it affects our lives and how it can act as a motivating force for creativity. 9. Attributed to Aldous Huxley. Living with anxiety: Stephanie, journalist, mid-20s Your greatest strength is also your greatest weakness. I’ve always had a natural tendency to be on edge, to be extremely aware of my surroundings. I’m alert all of the time and, although a predisposition to being quite observant is great for your career, it isn’t always the best for your personal relationships. As a writer, your job is to see the things that other people don’t necessarily see. It’s because of your ability to notice anything and everything that you are able to draw conclusions, notice trends or comment on various social phenomena. I had a brilliant upbringing and a really supportive family. But Mum and Dad were in the process of getting divorced when I went off to university, so there I was, worried about putting on weight while I had a lot going on at home. I started to spend more and more time at the gym because exercise was a great stress relief (and the endorphins didn’t hurt either). I started to see results in weight loss, which made me want to do a bit more and then a bit more. I guess, because I’m a perfectionist, if I was going to do something, I was going to do it well! My weight loss was drastic, but it never got to the stage where I was hospitalised. But I was very well aware that my behaviour was not normal; even then I didn’t lose that logical side of me. Mum and Dad could see what was happening and did encourage me to see a psychologist. It really really helped. When I got the diagnosis (anorexia nervosa/bulimia nervosa with mild anxiety disorder), it was a shock. I was surprised to find out that I had an anxiety disorder, and it was the eating disorder that was the symptom, not the other way around. 14 In my sessions with my psychologist, she used CBT10. Good old CBT, it works every time! I’m a big champion of it. The best techniques for me are the ones that make me separate my emotions from the thoughts; to realise that what I’m feeling inside isn’t necessarily an accurate representation of what the situation is. So, if I’m feeling stressed out of my mind, I take a step back and notice that I’m feeling stressed, then take another step back and notice that I’m having the thought of feeling stressed. That simple dissociation between “I think, therefore I am” really helps. The heightened anxiety I felt during my parents’ divorce lasted for about a year before I got into CBT. Then, within six months I got back to being more like myself. I found that for me, the central issue affecting my anxiety is control; more specifically, the lack of control is what precipitates my anxiety. It definitely flares up when I’m stressed. I used to repress everything to the point where I would become overwhelmed with emotion—I would cut off—but that doesn’t ever help because you eventually explode; it has to come out at some stage. Now I allow myself to feel stressed or anxious for a little period because I know that ultimately it will subside. I let it wash over me, but then stop it because I know that the body can only be in a state of stress for so long; it ultimately calms itself down. People deal with anxiety in different ways. For some, it’s addiction; mine is an eating disorder. Your weight and your food intake is something that will never be out of your control, and that’s why you find comfort with it. I know it will never completely go away—it’s part of my chemistry—but doing CBT helped me and prevented me from going too far and over-thinking things. It helped me to acknowledge that a thought is simply a thought rather than the truth. Now I can gauge where I am in my overall wellbeing by my drive to watch what I eat or how I exercise. Now, if I have dessert, that’s okay. The more that food or weight is in the forefront of my mind, the more I know that I need to change something in my life that is causing me that stress. I’ve had a couple of years now of being more mindful and trying to observe myself from a bird’seye perspective. I know what my limits are now. Having recently moved to London, there were definitely times last year when I fell back into my old patterns of thinking because I was chronically stressed about my job situation and repressed my feelings of loneliness, missing creature comforts, yet wanting to be this strong person. I was too proud to acknowledge that I was having a tough time. I’d never really admit to friends how I was feeling deep down, because that then meant I’d have to admit to myself that I had a problem again. So, I went home and had a couple of booster sessions with my counsellor. 15 10. Cognitive Behavioural Therapy (CBT): is one of a broad range of psychotherapies or ‘talking therapies’ that aims to change the way that you think and behave. Anxiety disorders in the UK The best estimates suggest that: one in four people in the UK will experience a mental health problem each year; one in six will experience a common mental health problem such as anxiety or depression; and that these figures have steadily increased over the past 20 years. Estimates of the number of people who experience anxiety vary because of the different methods for gathering data and the different criteria used in identifying it. Some surveys rely on self-reporting: people’s own assessments of their emotional state. While the results can help us appreciate the general mood of a population and the distribution of anxiety within a population, such surveys lack the consistency of a diagnostic threshold. However, reports based on service data will, by definition, only include those willing and able to seek help for their anxiety and rely on the correct identification by professionals of the presence of a problem. Estimating the prevalence of anxiety problems is further complicated by the fact that, in diagnostic terms, anxiety is the common thread linking a range of disorders, from agoraphobia to obsessive compulsive disorder. Some disorders are linked (for example, agoraphobia and panic disorders), while each displays particular characteristics which themselves impact on people’s lives. What are the most common anxiety disorders? The experience of anxiety often involves a bundle of interconnected symptoms and disorders characterised by confusing circularity between the triggers to anxiety and the responses that it invokes. Scott Stossel’s “bundle” includes emetophobia, a fear of vomiting (especially in public), which is a condition that according to Anxiety UK is not widely diagnosed even though it is fairly prevalent. This is the aspect of his anxiety that is most debilitating, he says, because it is entwined with agoraphobia caused specifically by a fear of being sick far from home as well as nausea, a commonly experienced physical symptom of many forms of anxiety. While the separate elements to the bundle may not, in themselves, have a decisive impact on his life, the effects of their interaction can be devastating. This can be seen more clearly in people diagnosed with co-morbid depression and anxiety, which often results from a downward spiral in which anxiety leads to low mood which in turn intensifies the anxiety. The most recent national survey of mental health in the UK indicates that while 2.6% of the population experience depression and 4.7% have anxiety problems, as many as 9.7% suffer mixed depression and anxiety, making it the most prevalent mental health problem among the population as a whole (McManus et al., 2009). Previous surveys conducted in 1993 and 2000 showed an increase in the prevalence of mixed anxiety and depressive disorders, but only small changes between 2000 and 2007 (Self et al., 2012). Panic is an exaggeration of the body’s normal response to fear, stress or excitement. Panic attacks are a period of intense fear in which symptoms develop abruptly and peak rapidly. Panic attacks have been described as a form of “emotional short-circuiting” (Servian-Schreiber, 2005) whereby the limbic brain suddenly takes over the body’s functioning, leading to overwhelming sensations, which might include 16 a pounding heart, feeling faint, sweating, shaky limbs, nausea, chest pains, breathing discomfort and feelings of losing control. Adrenaline overwhelms the cognitive functions that would normally help the brain assess the real nature of the threat to the body. The effects can be so severe that people experiencing panic attacks believed they were dying. It is estimated that about 1.2% of the UK population experience panic as a separate disorder (Goodwin et al., 2005), rising to 1.7% for those experiencing it with agoraphobia (Skapinakis et al., 2011). developed form; in a less severe form up to one in eight people, i.e. about 7 million in the UK, may be troubled by some agoraphobic symptoms. Post-Traumatic Stress Disorder (PTSD), or syndrome, is a psychological reaction to a highly stressful event outside the range of everyday experience, such as military combat, physical violence, or a natural disaster. The symptoms usually include depression, anxiety, flashbacks, recurrent nightmares, and avoidance of situations that might trigger memories of the event. One study of UK armed forces personnel deployed to Afghanistan found that of 1,431 participants, A phobia is an intense and irrational fear of a 2.7% were classified as having probable PTSD, specific object or situation, such that it compels while a household survey of UK adults estimated the person experiencing it to go to great lengths a prevalence of 2.6% in men and 3.3% in women. to avoid it. Phobias can be about harmful things Whilst a range of studies investigating the health or situations that present a risk, but they can also challenges of asylum seekers and refugees be of harmless situations, objects or sometimes have found that PTSD levels can be as much as animals. Social phobia can include a fear of being 10 times higher than the age-matched general judged, scrutinised or humiliated in some way. It population (Fazel et al., 2005). A range of stressors can show itself with a fear of doing certain things have been identified as impacting adversely on in front of others, such as public speaking. mental health, including those experienced preAccording to the Office for National Statistics, around 1.9% of British adults experience a phobia migration, such as torture, traumatic bereavement and imprisonment, but also post-migration factors of some description, and women are twice as such as discrimination, detention, destitution likely as men to be affected by this problem. and delayed decision making in the asylum process (McColl et al., 2008). One study of women Although agoraphobia is often associated with asylum seekers in Scotland and Belgium found a fear of open spaces, the main feature is intense that 57% were above the cut-point for PTSD anxiety triggering a panic response in situations where escape is perceived as difficult or potentially symptomatology (Scottish Refugee Council et al., 2009). embarrassing, or where help may not be readily available; indeed, such crises often occur in confined spaces. People with agoraphobia appear Obsessive Compulsive Disorder (OCD) affects around 2–3% of the population and is to experience two distinct types of anxiety― characterised by unwanted, intrusive, persistent panic, and the anticipatory anxiety related to fear or repetitive thoughts, feelings, ideas, sensations of future panic attacks. Agoraphobia can have a dramatic limiting effect upon the lifestyle of people (obsessions), or behaviours that makes the sufferer feel driven to do something (compulsions) living with the condition, as they seek to avoid to get rid of the obsessive thoughts. This only situations that make them anxious; for example, provides temporary relief and not performing only using places where exit routes are known or staying close to exits. In extreme cases, individuals the obsessive rituals can cause great anxiety. A are so fearful they become homebound altogether. person’s level of OCD can be anywhere from mild to severe, but if severe and left untreated, it can Onset of agoraphobia is usually between the destroy a person’s capacity to function at work, ages of 18 and 35 and affects between 1.5% at school or even to lead a comfortable existence and 3.5% of the general population in its fully in the home. 17 Generalised Anxiety Disorder (GAD) is the most commonly diagnosed anxiety disorder and usually affects young adults. Women are more likely to be affected than men. While feelings of anxiety are normal, people with GAD find it hard to control them, to such an extent that it impinges upon their daily life. It causes sufferers to feel anxious about a wide range of situations and issues, rather than one specific event. Unlike a phobia, which focuses upon a specific object or situation, generalised anxiety is diffuse and pervades the sufferer’s daily life. Although GAD is less intense than a panic attack, its duration and the mental and physical symptoms, such as irritability, poor concentration and the effects of disrupted sleep patterns, mean that people with the disorder often find it difficult to live the life they would prefer to live. GAD affects 2–5% of the population and has increased slightly since 1993 (Self et al., 2012), yet accounts for as much as 30% of the mental health problems in people seen by GPs, which explains why an analysis of people seeking help through primary care suggests a higher prevalence rate of 7.2% (Martin-Merino et al., 2010). lifestyle choices such as smoking, drinking too much alcohol, and a poor diet (Mental Health Foundation, 2009). Children and young adults Anxiety disorders are estimated to affect 3.3% of children and young adults in the UK (about 290,000) and while we cannot be sure whether children and young adults today are more anxious than previous generations, mental health problems in young people are surprisingly common, disabling and run a chronic course (Cresswell et al., 2010; Hagell et al., 2013). Cohort studies carried out from 1974 show significant increases in emotional problems such as depression and anxiety amongst young people, and in 2004 it was estimated that 4% of children and young people had an emotional disorder (anxiety or depression) (Green et al., 2005). The absence of similar research in the last eight years means that it is difficult to assess the impact of the financial crisis on levels of anxiety amongst young people. Nevertheless, in 2004, children and young people with ‘emotional disorders’ were found to be living in significantly poorer households compared to other children and were more likely Anxiety and health The true impact of anxiety can be masked when it to be educationally disadvantaged (Green et al., is the symptom of other more obvious or treatable 2005). One commentator has concluded that physical problems which are likely to be prioritised such “mental health problems have important implications for every aspect of young people’s in any subsequent medical intervention. Anxiety lives including their ability to engage with problems are common amongst cardiovascular education, make and keep friends, engage in patients; for example, panic disorder is up to 10 times more prevalent amongst people with chronic constructive family relationships and make their obstructive pulmonary disease than in the general own way in the world” (Hagell et al., 2013). population (Livermore et al., 2010, cited by Naylor The results of a major study revealed that et al., 2012). People with GAD have been found children and adolescents with an autistic to be at higher risk of coronary heart disease, spectrum disorder were at particularly high risk while anxiety has also been linked to increased of experiencing problematic levels of anxiety. incidence of gastrointestinal problems, arthritis, Nearly 40% were estimated to have clinically migraines, allergies, and thyroid disease. People elevated levels of anxiety or at least one anxiety with anxiety disorders are four times as likely as disorder, with specific phobia most common others to develop high blood pressure, and many studies have shown a relationship between anxiety at nearly 30%, followed by OCD in 17%, social anxiety disorder and agoraphobia in nearly 17% and reduced white blood cell function, a sign of immune system weakness. There is also emerging and GAD in 15% (Van Steensel et al., 2011). evidence of a link between stress and Alzheimer’s disease. Anxiety is also associated with unhealthy 18 Living with anxiety: Ian, Environmental Trust Manager, mid-30s I heard a psychologist on the radio say that having anxiety is like sticking your head above a trench every day. Mine is not that severe; it is more like getting ready for a job interview, a feeling that I have to perform more highly than in reality I actually have to. Some days it is worse than others, but it is not often that I’m away from thoughts that distract me from letting go or having a good time; there is always something at the back of my mind saying you’ve got to sort this or that out. What we are talking about is GAD. My head says I’m under attack and physically I feel like I’m under attack. I start holding my breath, shallow breathing, my heart starts beating faster, pacing up and down. I get shaking―not like my cup of tea would go everywhere―but more like a buzz, a readiness, as though I’m preparing for something. Maybe I ramble on a bit; that’s a product of it. It’s energysapping although I still manage to find energy. It’s only recently that I’ve realised there is something that needs to be explored a bit more deeply. I’m currently working with a CBT therapist, talking about the time when I first noticed my anxiety, trying to recognise whether it was a particular incident that triggered it or whether I’ve had it from a younger age. My gut feeling is that I’ve always had a tendency to be anxious. My grandmother was anxious and I wonder if there is something genetic there. I was quite shy and reserved at school but it became more pronounced when I went to university. It was less about the stress of moving away from home, although that may have contributed to it, and more uncertainty about me and my place in the world. While I was at university my GP prescribed antidepressants, but I wasn’t comfortable taking them. I didn’t have a diagnosis; I just used to think that I’m not quite hitting the right note, not quite getting satisfaction from what I do, or that I’m flawed in 19 some way. Having experienced life a bit more, I’ve noticed patterns of stress for which I sought counselling. I didn’t really nail down a diagnosis and acceptance of GAD until about 3 years ago. That led to me to get involved with Anxiety UK and they put me in touch with one of their cognitive behavioural therapists and I’m currently looking at ways to change the way I think and instil new behaviours and habits. It has taken me a while to get to that point. Anxiety is always there, but it is heightened when there is a transition or anything new, so at a micro-level it could be a social situation I am not entirely comfortable with. So there are different levels of anxiety. When you hear the word anxiety, classically you think of worry and you would be able to see it, but anxiety can be internalised as well. So when I am there with my family at a social event, it might be the most natural, comfortable thing in the world, but in my mind somewhere I’ve got doubts and worries and anxieties that aren’t showing. I do think that sport is a great medicine. I’d love to do 30 minutes of exercise a day, but the GAD means that I feel I have to do X, Y and Z before I can find time to do some exercise. It’s a form of perfectionism which means that you can’t start something until you’ve lessened the anxious feeling about these things that are pressing because the world will blow up if you don’t do those. Then you can think about exercising. It’s difficult to get a well-rounded routine. I find that taking on responsibilities helps. So I’ve taken on the responsibility to take this seriously. I used to go out and drink and that didn’t help, so now I don’t drink, or very rarely. I haven’t ever stopped and that has been one of the problems. Constantly doing things is something I feel is necessary as a way of preventing things going wrong. But that is actually a negative thing because I haven’t been able to say, ‘hang on Ian look at yourself a little bit more, think some more positive thoughts because it has all been a bit of a rush’. Even if GAD gives me fear-fuelled oomph, I’d definitely swap it for peace My personality is positive by default; however, of mind, clarity, and the yearning to just… be. I’m GAD interrupts my fun and placid temperament often left feeling sad, isolated and frustrated at and replaces positivity with negative thoughts that the difficult task of simply enjoying life. I’m not good enough. Sometimes I wonder what part of it is me and what part of it is GAD. I do get a lot of things done, and then I think: is it good that I have GAD? You know what they say: if you want something done, give it to a busy person. Well, that happens to me. But really I could use the energy in much more productive ways. People have said “You need to learn to say no”, but part of me on the negative side goes, “If I do say no then what will people think of me?” The other part of me says “I really want to get involved in this; I’m going to do it”. And I know, because of the way I am, that if I do agree to do something I’ll worry about it. So I agreed to put on the local carnival alongside holding down my full-time job, as well as juggling a social life. I’m naturally an organised person and I do have a passion for my local community, but my worry about doing a bad job and worry about what people will think of me spurred me on to put on a good schedule of events. 20 The state of the nation: anxiety in the UK ―― People in the older age groups tend to be happier and less anxious (Understanding Society, 2013). To get a picture of the extent and causes of anxiety ―― The anxiety levels of people with a disability amongst the general population of Britain in early are higher, on average, than those of people April 2014, we commissioned a survey of 2,330 11 without a disability (ONS, 2013). adults. The survey complements upon recent large-scale survey evidence about anxiety, which ―― Unemployed people report significantly suggests that: higher anxiety levels than those in employment (ONS, 2013). ―― Although, on average, women rate their life satisfaction higher than men, their anxiety levels are significantly higher than men (Self ―― People in the lowest income groups report significantly higher anxiety levels than those et al., 2012; the Office for National Statistics in higher income groups (ONS, 2014). (ONS), 2013). ―― People in their middle years (35 to 59) report ―― On average, all ethnic groups reported higher levels of anxiety than people describing the highest levels of anxiety compared to themselves as White British (Hicks, 2013). other age groups (Self et al., 2012; ONS, 2013). ―― Young people aged 16–24 are more likely to report lower levels of anxiety compared with adults generally (Potter-Collins & Beaumont, 2012; ONS, 2014). ―― Women and adults aged 20–29 are most likely to seek help from their GP for anxiety. (Martin-Merino et al., 2010). For the purposes of the survey, we defined ‘anxious’ as generally feeling worried, nervous, or uneasy. The survey explored how often people feel anxious, the causes of their anxiety, what they do about it, and the impact of anxiety on their lives. The findings presented an opportunity to map the scale of anxiety across a representative sample of the population, and analyse responses by age, gender, social class and employment status. 21 11. Source: YouGov Plc. April 2014. Total sample size was 2,330 adults. Fieldwork was undertaken between 9th and 10th April 2014. The survey was carried out online. The figures have been weighted and are representative of all GB adults (aged 18+). How often do people feel anxious? ―― Almost one in five people feel anxious nearly all of the time or a lot of the time. ―― Only one in twenty people say they never feel anxious. ―― Women are more likely to feel anxious than men. ―― The likelihood of feeling anxious tends to decline with age. ―― Students and people not in employment are more likely than those who are working or retired to feel anxious all of the time or a lot of the time. In general which ONE, if any, of the following statements do you think BEST describes your experience with anxiety in your everyday life? (n=2,330) I feel anxious nearly all of the time I feel anxious a lot of the time I feel anxious some of the time I rarely feel anxious I never feel anxious Don’t know 4% 14% 41% 34% 5% 1% The frequency of anxious feelings decreased incrementally through the age groups of respondents, while the proportion of those saying they rarely or never feel anxious increased with age, from 25% of 18–24 year olds at the lower end of the scale, to 49% of those aged 55 years When asked to describe how frequently they experience anxiety in their everyday life, our survey or older at the upper end. People not working for other reasons than being unemployed (such as found that 19% of people feel anxious either a lot of the time or all of the time. For this group, anxiety long-term disability) were three times more likely is something that almost two-thirds (61%) of them (12%) to experience anxious feelings all of the time than the survey sample as a whole (4%). experience on a daily basis and a third (33%) Students (26%), people who are unemployed experience it at least once a week. There was a (30%), and people not working for other reasons marked difference between the experiences of men and women however, in that almost a quarter (33%) were more likely to feel anxious a lot of the time or all of the time compared to the of the women surveyed (22%) feel anxious a lot survey sample as a whole (19%). or all of the time, compared to 15% of the men. A further 41% of people in the survey feel anxious some of the time, meaning that six of every ten respondents said they feel anxious at least some of the time. Women were more likely to experience this frequency of anxiety (68%) compared to men (51%). Additionally, 47% of men said they are either rarely or never anxious in their everyday lives, compared to 31% of women. 22 What causes anxiety? ―― Nearly half of the people who said they feel anxious in their everyday life said that financial issues are a cause of anxiety, but this is less likely to be so for older people (those over 55 years). ―― Women and older people are more likely to feel anxious about the welfare of loved ones. ―― Four in every ten people who are currently employed said they experience anxiety about issues to do with their work. ―― Around one-fifth of people who are anxious have a fear of unemployment. ―― Younger people are more likely to feel anxious about personal relationships. ―― Older people are more likely to be anxious about growing old, the death of a loved one, and their own death. ―― The youngest people surveyed (those aged between 18 and 24) were twice as likely to be anxious about being alone than the oldest people (aged 55 and over). 23 We asked people to identify the causes of their anxiety. Almost half of those surveyed (45%) said that financial issues (i.e. money/finance/debt) cause them to feel anxious. The survey highlighted a marked decline in anxiety about finances amongst people aged 55 years and older: nearly one-third (32%) of this age group cited finances as a cause compared to more than half for each of the other age categories. Discounting people who are retired (who are half as likely as others to say financial issues are a cause of their anxiety), this shows that not only are financial issues a significant factor in anxiety for people of working age, but also suggests that people in part-time employment (53%), the unemployed (53%), and people not working for other reasons (55%) are slightly more likely to have anxious feelings about money. The survey findings further suggest that people in social grades C2D&E (49%) may be more likely to feel anxious because of financial issues than people in social grades AB&C1 (42%). Work issues, such as long hours, were identified by just over a quarter of people (27%) as a cause of anxiety and 17% said that the fear of losing their job or unemployment caused them to feel anxious. Anxiety related to work appears to be consistent across working life and then, as one might expect, diminishes sharply as people approach and enter retirement. Indeed, significantly higher proportions of those in either full- or part-time employment cited work issues (39%) and fear of unemployment (22%) as a cause of anxiety compared to the survey sample as a whole. Which, if any, of the following specifically cause you to feel anxious in your everyday life? (n=2,184) Money/finance/debt Welfare of my loved ones/children Other work issues (e.g. long hours etc.) Personal relationships Growing old Death of a loved one Fear of losing my job/unemployment Fear of being alone/isolation My own death Fear of crime/personal safety Other Don’t know/can’t recall 45% 36% 27% 26% 25% 22% 17% 16% 16% 14% 14% 6% Anxiety related to family and relationships featured prominently in the survey. Personal relationships were said to be a cause of anxious feelings for 26% of people who said they feel anxious in everyday life, but significantly more so for people aged 18–24 (44%) and students (46%), and significantly less so for people aged over 55 years (15%). Just over one-third of those surveyed (36%) identified the welfare of a loved one or children as a cause of anxiety, but significantly more women (44%) than men (28%) cited this as a cause, and the likelihood of citing it increased with age so that almost half of people aged over 55 years (47%) said that this was a cause of anxiety. Age was also a factor in anxiety about growing old, with 36% of those aged 55 years and above saying they were anxious about this, compared to just 15% of 18–24 year olds. Similarly, 29% of the people surveyed from the oldest age group felt anxious about the death of a loved one, compared to 13% from the youngest age group, and twice as many from the oldest age group (19%) were anxious about their own death, compared to the youngest age group (10%). However, the survey also threw up an interesting anomaly around fear of being alone/isolation. We might hypothesise that this would be a particular source of anxiety for older people, yet young people aged 18–24 (28%) were twice as likely to mention it than people in the 55 years and over age group whose response (14%) was lower than the survey sample as a whole (16%). This may be suggestive of the importance placed on belonging to a peer group by young people. Women (19%) were slightly more likely than men (13%) to mention this as a cause of feeling anxious, while students (27%), people working part-time (23%) and people not working for reasons other than unemployment (23%) were also more likely to have anxious feelings about being alone. 24 How do people cope with their anxiety? ―― Nearly one-fifth of people who have experienced anxiety do nothing to cope with it. Which, if any, of the following do you do/use to “cope” with your feelings of anxiety in your everyday life? (n=2,184) Talk to a friend or relative 30% Go for a walk 30% Comfort eating 24% Physical activity/exercise 23% Hide away from the world 18% ―― Comfort eating is used by a quarter of people Alcohol 16% (24%) to cope with feelings of anxiety and Relaxation/meditation techniques 13% women and young people are more likely Cigarettes10% to use this as a way of coping. Visit my GP 7% Other 11% ―― Almost one-third of students in the survey Don’t know 2% said they cope by ‘hiding themselves away from the world’. The most common coping strategy was talking ―― People who are unemployed are more likely to a friend or relative, used by 30% of people who to use coping strategies that are potentially feel anxious in their everyday life, although women harmful, such as alcohol and cigarettes, (38%) were more likely to do this than men (21%), than those who are currently employed. and younger people (42%) were more likely to do so than people in older age groups. This may ―― Fewer than one in ten people (7%) have also be an indication of the central role of peer sought help from their GP to deal with relationships in the lives of young people. anxiety, although those who feel anxious more frequently are much more likely The survey explored people’s use of three active to do this. approaches to coping with stress. Almost one-third of all respondents (30%) said they would go for We asked people who have experienced anxiety a walk to cope with anxiety, a little under a quarter in their lives to identify the different ways they said they would undertake a physical activity or do cope with it. Just under one in five (19%) do not some exercise (23%), while fewer (13%) would do, or use, anything to cope with anxiety in their use relaxation or meditation. While these ways everyday lives. The findings revealed an inverse of coping were employed fairly consistently across relationship between the frequency with which all groups, the results suggest that people from people experience anxiety and how active they social grades AB&C1 (27%) may be more likely are in seeking ways to cope with it; so 32% of to undertake physical activities to deal with anxiety people who rarely have anxious feelings said that than people from social grades C2D&E (19%). they do nothing to cope with those feelings, while only 6% of people who live with anxiety all the The survey also included four potentially harmful time do nothing about it. The proportion of men coping strategies. Of these, comfort eating, was not using coping strategies was higher (24%) employed by 24% of those surveyed and women than for women (16%), and older people (28%) (29%) were more likely to cope in this way than are less prone to using coping strategies than men (18%). People in the younger age groups younger people. were much more likely to use comfort eating ―― The most commonly used coping strategies included talking to a friend, going for a walk, and physical exercise. 25 than people in the older age groups. A similar pattern across age and gender emerged in relation to hiding away from the world, which was cited by 18% of respondents. Students were more likely than other groups to hide themselves away; 31% of students in the survey said they use this as a coping strategy. The pattern of usage for alcohol ( just over one in six people) and cigarettes (one in ten people) was not significantly different across age groups or between men and women. The findings suggest that unemployment may be a factor in determining the types of strategies that people use to cope with anxious feelings. Unemployed people were more likely than other groups to use potentially harmful strategies: about a quarter (23%) said they would hide away from the world, use alcohol (27%) and use cigarettes (23%). In contrast, people who are retired are much less likely than any of the other groups to use any of these potentially harmful coping strategies to cope with their anxiety. Visiting a GP to deal with anxiety was an option taken up by just 7% of respondents who had reported anxious feeling at some point in their lives, a proportion that was consistent across gender and age groups. Yet those experiencing anxiety most frequently were over five times more likely to visit their GP than the survey sample as a whole, while those experiencing anxiety a lot of the time were more than twice as likely to visit their GP. Despite this apparently low rate of self-referral usage to GP services, 27% of those surveyed agreed that a problem with anxiety is something they would see a GP about. Agreement amongst women was higher (31%) than amongst men (23%), and more than half (56%) of those experiencing anxiety nearly all of the time agreed that anxiety is something they would visit their GP about. 26 Perceptions of anxiety The impact of anxiety ―― People are believed to be more anxious now than they were 5 years ago. ―― Just under half of people get anxious more often these days than they used to and believe that anxiety has stopped them from doing things in their life. ―― There is a tendency to reject the notion that having anxious feelings is stigmatising. ―― People who experience anxiety most frequently tend to agree that it is stigmatising. The survey found strong agreement with the proposition that people are more anxious now than they were five years ago; as one might expect, agreement is strongest amongst people who experience anxiety most frequently (72%). People were also asked to indicate the extent of their agreement with statements addressing aspects of stigma that may be attached to anxiety. Just over a quarter of respondents (26%) felt that feeling anxious is a sign of not being able to cope, but almost twice as many (50%) disagreed with this sentiment. Slightly more people (29%) agreed that they would be embarrassed to tell someone they have anxieties, but again just under half (46%) indicated that they would not be embarrassed. There was an even stronger rejection of the notion that feeling anxious is something to be ashamed of; just 10% of people agreed with this sentiment, while nearly three-quarters (74%) of them disagreed. However, people experiencing anxious feelings most frequently were much more likely to agree with these stigmatising views of anxiety, while, conversely, respondents who had never experienced anxious feelings were much more likely to disagree with the proposition that they would be embarrassed to tell someone they have anxieties (57%). 27 ―― Most people want to be less anxious in their day-to-day lives. ―― Women and younger people are more likely say that anxiety has impacted on their lives in these ways. We asked three questions of those people who had experienced feelings of anxiety about the impact it has upon their lives. More people agreed (47%) than disagreed (31%) that they get more anxious these days than they used to and there were similar levels of agreement that feelings of anxiety had stopped them from doing things in their lives. There was a more clearly defined tendency for people to agree (57%) than disagree (14%) when asked if they would like to be less anxious in their day-to-day lives. In each of these domains, the tendency for agreement was larger for women compared to men and for people in the younger age groups compared to the older age groups. People experiencing anxiety on a frequent basis were also more likely to agree than disagree with these statements. The state of the nation Our survey provides an important insight into the impact that anxiety has upon people’s everyday lives. The findings suggest that feelings of anxiety are experienced widely and form part of a familiar emotional landscape for people taking part in the survey. The survey highlights those areas of people’s lives most likely to generate feelings of anxiety; stresses and worries about families and personal relationships are a major cause of anxiety, while financial issues and workrelated matters feature prominently in people’s concerns. Overall, people believe that society is more anxious than it was five years ago and many of those who have experienced anxiety in their own lives say that they are more anxious than they used to be. However, the message from people taking part in our survey is that anxiety is not something to be ashamed of or embarrassed about, or that anxious feelings should be interpreted as a sign that someone is unable to cope. This perhaps tells us something about the level of awareness about anxiety that now exists amongst the general public and their potential receptiveness to initiatives to address the problems posed by anxiety. An important message to emerge from the survey is that people find a variety of ways of coping with feelings of anxiety that fall short of seeking professional help. Although we made no attempt to gauge the effectiveness of these strategies, the preferences expressed for simple human interaction and physical activity may suggest that people deal with feelings of anxiety in ways that have proved helpful with other emotional crises. The survey also maps a less positive tendency for some people to use potentially harmful coping strategies, notably comfort eating or social withdrawal. 28 The survey identifies discrete groups within the populations for whom anxiety may be persistent and at times debilitating, or for whom anxiety has a disproportionate impact. It suggests that there is a small but significant group of people for whom anxious feelings are a constant presence that may provoke a heightened sense of stigma, yet they are also more active than most in seeking ways to cope with them and are more likely to call upon primary care services for help. This group will include people who have a recognised anxiety disorder, whether diagnosed or not, as well as those at risk of experiencing acute episodes of anxiety. The survey suggests that gender, age and employment status may be factors in shaping the experience of anxiety in the UK. It reconfirms that anxiety has a disproportionate effect upon the lives of women compared to men in terms of the frequency of anxious feelings, the source of their anxiety and their preferences for coping with it. Women are also more likely to report that their anxiety has had a negative impact upon their lives by, for example, stopping them doing things. Similarly, younger people are more likely to be affected by anxiety than people from older groups, while people in the oldest age group (55 years and over), and especially retired people, are markedly less likely to be affected. Finally, the survey does suggest that people who are not employed are more likely to experience anxiety more frequently than those in work, are more likely to be anxious about financial matters, and be more likely to cope in ways that are potentially harmful. Living with anxiety: Jane, Volunteer, early 50s I was probably considered a shy child, but I didn’t have any major problems in childhood. I had one or two good friends although I wasn’t really comfortable in big groups and I did panic if I was ever invited to parties or if there was a big group thing in class. My anxiety has always been social anxiety, so it has prevented me from doing a lot of things. It really came to a head in my teenage years―that traditional transition stage when I was doing exams. That was when it really started to kick in and I couldn’t go to school, I couldn’t sit my exams, so I left and I got a job through a relative. But I struggled with the work so I had to leave. I tried college and had to leave that too. I felt very ashamed and very embarrassed about having anxiety and it was something I tried desperately to cover up. Of course the more I tried to cover it up, the more anxious I became. I thought there was a real stigma around anxiety at the time; I didn’t realise that young people of my age had similar experiences and feelings. I thought it was just something that affected adults. My father suffered with anxiety and it was something he was ashamed of. He tried to cover it up and wouldn’t talk about it. So I picked up on that as being something to be embarrassed about. My GP diagnosed anxiety―it wasn’t social anxiety then, it was just anxiety―and he gave me valium; I was about 17 at the time. I was also referred to a psychologist at the local hospital, but I really didn’t understand what the psychologist or psychiatrist was telling me; it was very unpleasant. The tablets worked while I was taking them, but once I stopped taking them, all the symptoms came back and I still had all the very negative frightening thoughts―it didn’t help those. I had a lot of physical symptoms, blushing and sweating which people would comment on, so I became more and more withdrawn. Eventually, I stopped going out, so I lost friends, had no social life, no relationships and became quite housebound. My anxiety has meant that I haven’t been able to work 29 for a long time and even looking for a job is really really difficult for me. I wanted to do something because I’m on benefits and I wanted to give something back, also to feel better in myself, to boost my own self-esteem. I am a member of Anxiety UK and I’ve been working as a volunteer on their helpline for about 4 years now. I decided to do some volunteering to help me practise my coping skills. I was always terrified of doing it and then somebody gave me a push and said “You’ve got to make an effort now”. I had a major panic attack the first day I was here, but one of the staff took me outside and had a chat with me; they said, “It’s OK, it’s understandable, we’ve seen this before, it’s not only you that this has happened to”. Just hearing that―that it happens to other people as well― made all the difference. Everybody here has experience of anxiety or, if they haven’t, they have a special interest in it, so I don’t have to hide it. That was the biggest thing: not having to hide it. I could have anxiety attacks with all the symptoms and nobody would make any comments about it. The people here have encouraged me and given me support, and that has really helped me build my self-esteem and confidence. The biggest change has been coming here because it’s such a supportive environment. Peer support is the main thing that helps me cope, but I’ve also done an online CBT course. I’ve seen some therapists, but it may be part of my anxiety, I just feel uncomfortable with therapists being in the room; I feel trapped. I think it’s my social anxiety. So I’ve not been able to concentrate on what they are saying because I’ve been focused on my anxiety and wanting to leave. Doing it online there were no distractions and I really seemed to take that in. I’ve used those CBT techniques and breathing control. There is some excellent self-help online. So it’s been a combination of things. 30 Because it has been there for such a long time, anxiety has taken root. Maybe I have an anxious nature, so it is always going to be a part of my life. But now I understand it a lot better, I know I am not the only one who has it―that helps a lot―and it doesn’t worry me as much because I have some coping techniques and know what I can do to reduce my anxiety. Working here I can give people hope because when they ring up they often think that anxiety is going to ruin their lives and they are never going to get better. I tell them, from my many years’ experience, “You can learn to manage it, it doesn’t have to control you, you can still get on with your life. If you nip it in the bud when it starts, you have a better chance of it not getting really bad. Don’t be frightened of it and don’t bottle it up; share it with someone you feel comfortable with”. I also contribute to a course at a local university, helping to train therapists of the future. The fact that I can use my anxiety in a positive way like this is a massive thing for me because for so many years I felt ashamed and embarrassed about it. So to be able to talk about it openly and for my experience to be embraced―they really want to hear it―that’s been tremendous for me. And in general, I think it makes you a more caring person, I really do. Managing anxiety “A person cannot just simply decide not to be anxious anymore” (Anxiety Care UK). Although anxiety can be a debilitating condition, it is not an illness and therefore is no more susceptible to being ‘cured’ than other emotional states that serve important functions as part of the human survival kit. Our survey illustrates how people experiencing anxiety in their everyday lives often find the personal resources to cope through simple remedies such as talking things through or doing a physical activity, although the finding that people from social grades C2D&E are less likely to engage in a physical activity may suggest an inequality in access to such resources. This gives pause for thought when considering emerging evidence on the benefits of this form of coping strategy on wellbeing more generally (Mental Health Foundation, 2013) and in managing stress levels specifically (Gerber and Puhse, 2009). These self-help strategies are less likely to work for more acute disorders even though most are highly treatable and full recovery is an achievable goal. Medicines can ameliorate the worst symptoms and aid the recovery process, but are less useful in helping people to manage the threat of relapse in the longer term. Lingering symptoms, vulnerability to ‘normal’ anxiety, and stress-related intensification of symptoms and anxiety contribute to a continuous risk of relapse, but these are factors that are directly addressed by psychological therapies which have been shown to improve the long-term outcomes for people who seek this type of help. In 2010 it was estimated that there were 8.2 million diagnosed cases of anxiety disorder in the UK (Fineberg et al., 2013) yet only about one-third to half of sufferers receive treatment (McCrone et al., 2008). One of the problems of tackling anxiety disorders in the UK is the fact that despite the incidence of anxiety symptoms rising between 1998 and 2008, the incidence of GP recorded anxiety diagnoses fell over the same 31 period (Walters et al., 2012). A number of reasons for this apparent under-recording have been suggested, including an increased preference by GPs for recording the symptoms of anxiety rather than specific diagnoses. Others have suggested a preference for broad diagnostic labels, such as ‘anxiety states’, which may reflect a lack of training, a belief that the distinctions in anxiety states are not meaningful in primary care practice, or reluctance to use formal diagnoses which may be perceived as stigmatising for patients (Walters et al., 2012). Others have pointed to structural problems in the pathways that exist between primary and specialist services following implementation of the National Service Framework for Mental Health (Cohen, 2008). This introduced the Improving Access to Psychological Therapies (IAPT) programme, which is designed to provide services for those suffering from anxiety and depression disorders; during the year 2012–13, more than three-quarters of a million people in England were referred to IAPT services nationally. Yet there is evidence that only half of the people referred to IAPT services go on to receive treatment, while for those that remain, about half show significant improvements or recover (Richards and Borglin, 2011). Somewhere along the line a great many people who experience anxiety are either not getting the treatment they require or are choosing not to complete the course of therapy. At the same time, the treatment of co-morbid health and anxiety problems in acute patients appears to be seriously under-developed. For example, while 42% of patients with cardiovascular disease are currently provided with rehabilitation, only 16% of these programmes have a psychological component, despite 31% of these patients experiencing significant anxiety problems (Naylor et al., 2012). New collaborative approaches involving a number of health professionals working together with a patient are likely to help and have been associated with significant improvements in depression and anxiety outcomes compared with usual care (Archer et al., 2012). Several different treatments are available to ease the psychological and physical symptoms of anxiety, including psychological therapies and medication, as well as a range of guided selfhelp strategies and exercise on prescription. The National Institute for Health and Care Excellence (NICE) recommends a ‘stepped care’ approach to treatment, starting with interventions that are the least intrusive of those likely to be effective (NICE, 2012). However, the evidence about the most effective ways of treating anxiety is mixed and we know little about the treatment preferences of those seeking help with anxiety. This is worth further exploration, as one American review found evidence for enhanced outcomes for those receiving the treatment of their choosing and a marked preference for psychotherapeutic support over other forms of treatment (McHugh et al., 2013). Health Foundation (2013) that exercise can be particularly effective in reducing the symptoms of clinical anxiety when combined with CBT, although a review of 7 RCTs found no effect for interventions comprising aerobic exercise only (Bartley et al., 2013). Media link: Gretchen Reynolds ‘How Exercise Can Calm Anxiety’ (New York Times). Cognitive Behavioural Therapy When someone is distressed or anxious, the way they see and evaluate themselves can become negative. Cognitive behavioural therapy (CBT) helps people to understand the link between negative thoughts and mood and how altering their behaviour can enable them to manage anxiety and feel in control. It is the most effective non-pharmacological treatment for reducing the symptoms of almost all mental health Keeping active problems, but especially anxiety and depression Studies on participation in leisure activities have (Stuhlmiller and Tolchard, 2009; Olatunji et al., shown improvements in self and life satisfaction, 2010), for people with anxieties about their health which helps in reducing depression and anxiety (Tyrer et al., 2013), and leads to more general and enhances a person’s sense of wellbeing improvements in the quality of life of people (Haworth, 2010), while the evidence about the experiencing anxiety (Hoffman et al., 2014). effectiveness of exercise alone is mixed. According CBT has also been shown to be effective with to Sport England, participation in physical activity children and young people, although it is not and sport has been shown to be effective in yet clear whether it is more effective than other reducing depression, anxiety, psychological treatments for these younger age groups distress and emotional disturbance. Low to (James et al., 2013). moderate physical exercise can reduce anxiety and have both short and long-term beneficial One feature of CBT is that it is a short-term therapy effects on psychological health. Taking part in and, it is claimed, can be delivered effectively sport and spectating can have a positive impact by primary care therapists either face-to-face on the wellbeing and happiness of young people or as part of a self-help programme (Høifødt et (ONS, 2014). A major limitation in the evidence al., 2011). There is evidence that CBT delivered base is that while numerous studies and metain primary care settings has a moderate effect analyses show that exercise is associated with on reducing symptoms of anxiety (Seekles et reduced anxiety in clinical settings, not enough al., 2013). NICE therefore recommends CBT for research has been done to map the effect of anxiety and panic disorders, and the availability exercise on anxiety in real life (Anderson and of it has expanded rapidly in England under Shivakumar, 2013). A recent systematic review the government-funded Improving Access to of relevant Randomised Controlled Trials (RCTs) Psychological Therapies (IAPT) programme. The concluded that exercise is effective in conjunction Scottish Mental Health Strategy (2012–15) has with other treatments (Jayakody et al., 2014), also committed to improving and monitoring confirming the conclusions of the Mental access to psychological therapies with an 32 important focus on older people, where there remains an equity issue across the UK despite an emerging evidence base of effectiveness in treating anxiety and depression in later life (McMurchie et al., 2013). Media link: Jane Feinmann ‘Coping with anxiety – on the cheap’ (the Daily Telegraph). Mindfulness Mindfulness is a variation of CBT in that it focuses on changing the relationship between the anxious person and his or her thoughts, rather than changing the thoughts themselves. Using meditation and similar techniques, it can help people break out of the ‘automatic pilot mode’ that leads to negative ways of thinking and responding. Instead, it is about helping people to experience the world in the ‘here and now’. It does this by addressing the bodily symptoms experienced when someone is anxious, but rather than avoiding or withdrawing from these feelings, he or she remains present and fully experiences them and in this way is able to observe their reactions in a different way. One guide to mindfulness provides a useful analogy:12 “It may be helpful to think of this approach in terms of a radio. That is, imagine that the negative thoughts that drift into your mind are coming from a loud radio that is tuned to a station where the thoughts are very negative and seem to be shouting at you. The skill in mindfulness is not so much about trying to turn the radio off, but changing the way you listen to the radio. In this way the volume of the radio station can be reduced, and therefore seem less disruptive and distressing.” Reviews of studies into Mindfulness Behavioural Therapy (MBT) have found the approach has a strong positive effect upon mood and symptoms of people with anxiety disorders (Hoffman et al., 2010; Vollestad et al., 2012). Media link: Julie Myerson ‘How mindfulness based cognitive behaviour therapy changed my life’ (the Guardian). 33 12. From the Centre for Interventions’ information sheets. Guided self-help Guided self-help has become an increasingly popular way of offering treatment because of its low cost, adaptability to different forms of digital and social media and its acceptability to people who might otherwise not receive treatment (Andrews et al., 2010) either for reasons connected with their anxiety or because of time pressure from commitments such as caring. Most guided self-help is based on cognitive behavioural approaches and aims to help the person experiencing anxiety achieve a level of recovery whereby they are able to understand the nature of their anxiety and what is happening physiologically to them. They are then helped to develop the necessary skills to tolerate and cope with it, by challenging unhelpful thinking, evaluating their bodily symptoms realistically and managing graded self-exposure to the source of their anxiety. Computerised CBT can be supported by reminders from a non-clinical technician or practice nurse, or guided by a clinician via telephone, email, live links such as Skype, or posts on a private forum. Many areas of the country also have self-help groups that offer peer support. Andrews et al. (2010) point out that a major advantage of this form of CBT is the level of treatment fidelity that can be achieved. Similarly, an evaluation of an online mindfulness course has shown promising results in terms of the acceptability of the means of delivering help to people who might otherwise not receive treatments and its ability to decrease the anxiety experienced by course participants (Krusche et al., 2013). There is good evidence that guided self-help is effective for: ―― Certain types of disorder, such as social phobia and panic disorder (Van’t Hof et al., 2009; Lewis et al., 2012; Mayo-Wilson and Montgomery, 2013). ―― Reducing the symptoms of some anxietyrelated conditions and improving quality of life outcomes (Haug et al., 2013; Stubbings et al., 2013). ―― Children with anxiety disorders (Creswell et al., 2010). ―― People who are motivated (Newman et al., 2011). ―― Those who have lower level anxiety problems (Newman et al., 2011). ―― People who are not able or are not willing to use other services for people with anxiety disorders (Mayo-Wilson and Montgomery, 2013). There are doubts as to the long-term effectiveness of these approaches compared to face-to-face approaches (Coull and Morris, 2011; Haug et al., 2013) and there is a lack of evidence of their usefulness with older people or people with more severe conditions (Newman et al., 2011). Nevertheless, there are good reasons to believe that where face-to-face CBT treatment is not available or where individuals would choose not to use such a service for reasons of control, stigma or convenience, then it makes sense to make self-help treatment widely available. The range and diversity of self-help approaches and methods of engagement means that individuals have the ability to select those that work best for their specific needs. As we engage in more complex ways with technology then it seems probable that we will see more innovation develop in this field of support. More research is 34 needed, but a recent co-production project funded by NHS Greater Glasgow and Clyde et al. found that young people valued digital approaches to self-help and peer support and recommended increased development of digital assets aimed specifically at and co-designed by young people (NHS Greater Glasgow and Clyde et al., 2013). For the past three years, The Mental Health Foundation has worked with the Paul Hamlyn Foundation, Comic Relief and Nominet Trust to deliver the Innovation Labs programme,13 working with technology companies, mental health organisations and young people to co-design and deliver seven tools to support young people address mental health concerns. Throughout the process, the value of technology to young people has been demonstrated, as has their ability to manage risk and challenge in online spaces. Such developments recognise the new ways that people want to access support, but also the importance of providing a safe and quality assured space to do so. At the same time it is critical that digital spaces for mental health don’t merely replicate online what is available offline. A nuanced understanding of the way different audiences use technology is needed to best leverage opportunities. Equally, digital services need to be an opt in for those who are keen to use them, and not an opportunity to remove or ‘reframe’ existing services by forcing people online when they aren’t comfortable with that modality. In time this may create cost-savings, but this should be a collateral benefit and not a driver of digital innovation in mental health. We have also seen the development of scaled technology-based tools for people to self-manage mental ill health, including anxiety. A range of products exist, with many health authorities in the UK having engaged the services of companies like Big White Wall14 to provide a validated, well controlled online community for self-management and self-exploration online. In Scotland, a different approach is being developed with the Scottish Government, NHS 24 and New Media Scotland collaborating on the development of Project Ginsberg. Ginsberg will provide a route for people who use technology to gain insight into their lives, using a range of apps and tools to better self-manage distress. Ginsberg will provide an online platform that will provide a selection of digital products, including access to diagnostic, treatment and monitoring tools that people can access independently of face-to-face services. 35 13. www.innovationlabs.org.uk 14. www.bigwhitewall.com Peer support Peer support is a system of giving and receiving help founded on key principles of respect, shared responsibility, and mutual agreement of what is helpful” (Mead, 2003). The benefits of peer support have been evidenced in a number of studies in relation to supporting individuals to self-manage their mental health problems and for those whose mental health is most at risk, such as isolated older people, people with dementia and young carers. Identified key benefits of peer support are the ability for the peer mentor to provide support based on empathetic understanding and from a position of having previous experience of developing coping skills for the particular set of problems encountered. Most of the research regarding people experiencing mental health problems has not been specific to anxiety. However, there are indications from work in relation to young people during transitions and people adapting to life with long-term conditions that peer support can provide a helpful approach in learning to cope with the anxiety that uncertainty brings. Medication Among patients diagnosed with anxiety, approximately two-thirds are treated with medication, anti-depressants accounting for almost 80% of prescriptions made out to this group (Martin-Merino et al., 2010). Pharmacological interventions have been found to be effective at improving quality of life by reducing the symptoms of anxiety for some patients (Hofmann et al., 2013), although not for a significant number (Ravindran and Stein, 2010). Medication is generally not as effective for older adults as it is for younger adults (Wetherall et al., 2013). NICE suggests that for particular kinds of anxiety, such as panic, social phobia and obsessions, GPs should prescribe anti-depressants, especially certain SSRIs (selective serotonin reuptake inhibitors). SSRIs appear effective in treating social phobia over the short term and the long term (Stein et al., 2004), while augmentative medications appear to be useful in the treatment of GAD, which is a more chronic condition (Chessick et al., 2006). Due to high rates of UK Governments are recognising the benefits of treatment resistance, there is interest in new peer support and over recent years there has been pharmacological treatment options such as a move to embed peer support approaches within second-generation antipsychotics (Depping et al., specialist mental health services as an additional 2010). Additionally, beta-blockers and tranquilisers layer of support. The advancements in digital are sometimes prescribed in the short term to technology may see further innovations in relation treat the physical symptoms without reducing to peer support available online and is an area the psychological symptoms of anxiety. worthy of fuller investigation in relation to anxiety. For fuller consideration of the role of peer support, see the Mental Health Foundation’s Need 2 Know Peer Support Briefing available to download from the Mental Health Foundation website. 36 “The storm has died away, and still we are restless, uneasy, as if the storm were about to break. Almost all the affairs of men remain in a terrible uncertainty. We think of what has disappeared, and we are almost destroyed by what has been destroyed; we do not know what will be born, and we fear the future, not without reason… Doubt and disorder are in us and with us. There is no thinking man, however shrewd or learned he may be, who can hope to dominate this anxiety, to escape from this impre