PTSD Evidence Based Practice Recommendations Jason's Box Best Practice Group Dr. Sam Moreno, Michelle Schnack Compilation & consolidation of the research and recommendations located in: The VA/DoD Clinical Practice Guideline for the Management of Post-Traumatic Stress (2010) For the full version: http://www.healthquality.va.gov/PTSD-FULL-2010c.pdf For the summary: http://www.healthquality.va.gov/ptsd/ptsd-sum_2010a.pdf The VA’s National Center for PTSD, Clinician’s Guide to Medications for PTSD http://www.ptsd.va.gov/professional/pages/clinicians-guide-to-medications-for-ptsd.asp The International Society for Traumatic Stress Studies Treatment Guidelines for PTSD (2005) For links to the treatment guidelines: http://www.istss.org/TreatmentGuidelines/3337.htm 1 I. First, an explanation of the ratings used in recommendations… Evidence Rating System SR A A strong recommendation that clinicians provide the intervention to eligible patients. Good evidence was found that the intervention improves important health outcomes and concludes that benefits substantially outweigh harm. B A recommendation that clinicians provide (the service) to eligible patients. At least fair evidence was found that the intervention improves health outcomes & concludes that benefits outweigh harm C No recommendation for or against the routine provision of the intervention is made. At least fair evidence was found that the intervention can improve health outcomes but concludes that the balance of benefits and harms is too close to justify a general recommendation. D Recommendation is made against routinely providing the intervention to asymptomatic patients. At least fair evidence was found that the intervention is ineffective or that the harms outweigh benefits. I The conclusion is that the evidence is insufficient to recommend for or against routinely providing the intervention. Evidence that the intervention is effective is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined. SR = Strength of recommendation Level of Evidence (LE) I At least one properly done RCT II-1 Well-designed controlled trial without randomization II-2 Well-designed cohort or case-control analytic study, preferably from more than one source II-3 Multiple time series evidence with/without intervention, dramatic results of uncontrolled experiment III Opinion of respected authorities, descriptive studies, case reports, and expert committees Overall Quality [QE] Good High grade evidence (I or II-1) directly linked to health outcome Fair High grade evidence (I or II-1) linked to intermediate outcome; or Moderate grade evidence (II-2 or II-3) directly linked to health outcome Poor Level III evidence or no linkage of evidence to health outcome Final Grade of Recommendation [SR] The Net Benefit of the Intervention Quality of Evidence Substantial Moderate Small Zero or Negative Good A B C D Fair B B C D Poor I I I I 2 II. Screening Recommendations All new patients should be screened for symptoms of PTSD initially & then annually, or more frequently, if clinically indicated. [B] There is insufficient evidence to recommend one PTSD screening tool versus another. The following screening tools have been validated and should be considered for use: - Primary Care PTSD Screen (PC-PTSD) - Short Screening Scale for DSM IV PTSD 1 2 Evidence Screening all patients for PTSD symptoms. Screening tools: Primary Care PTSD Screen PTSD Brief Screen Short Screening Scale for DSM IV PTSD Checklist (PCL) - PTSD Brief Screen - PTSD Checklist (PCL) Sources Breslau et al., 1999a Leskin & Westrup, 1999 Prins et al., 1999 Taubman et al., 2001 LE II-2 QE Fair SR B II-2 Fair B Breslau et al., 1999a Leskin & Westrup, 1999 Prins et al., 1999 Terhakopian, et al 2008 All patients with PTSD should be assessed for safety & dangerousness including current risk to self or others, and historical patterns of risk: - SI or HI, intent, means, history, behaviors, co-morbidities (substance use, medical conditions) - Family and social environment – including risks to the family - Ongoing health risks or risk-taking behavior - Medical/psychiatric co-morbidities or unstable medical conditions Recommendation Sources LE QE SR 1 Assess for dangerousness including suicidal or homicidal ideation, intent, means, history, behaviors, and comorbidities B Assess family, social environment – including risks for family Assess ongoing health risks or risktaking behaviors III II-2 III II-2 II II II II-2 III II II-2 II II-2 II III III Good 2 Breslau, 2000 Bullman & Kang, 1994 Ferrada-Noli et al., 1998 Kaslow et al., 2000 Marshall et al., 2001 Prigerson & Slimack, 1999 Swanson et al., 2002 Zivin, 2007 Seng, 2002 Swanson, 2002 Acierno et al., 1996 Hutton et al., 2001 Vieweg et al., 2006 Davidson et al., 1991 Farrell et al., 1995; Weisberg et al., 2002 Hoge et al., 2007; Gill et al., 2009 Good B Good B Good B 3 4 Assess medical or psychiatric comorbidities or unstable medical condition LE = Level of Evidence; QE = Quality of Evidence; SR= Recommendation 3 III. Treatment Recommendations A. EARLY INTERVENTIONS TO PREVENT PTSD Early Interventions after Exposure to Trauma (<4 days after exposure) Balance of Benefit and Harm SR Significant Benefit I -- Some Benefit Unknown Benefit Psychological First Aid No Benefit / Potential Harm Spiritual support -- -- Psychological debriefing Psychoeducation & normalization Social support D -- -- Early Interventions after Exposure to Trauma (4-30 days after exposure) Balance of Benefit and Harm SR Significant Benefit A Brief CBT (4-5 sessions) B C Some Benefit Unknown Benefit No Benefit Social support D Individual psychological debriefingW Formal psychotherapy for asymptomatic survivors W Benzodiazepines, Typical Antipsychotics, risperidone* W Atypical antipsychotics as Monotherapy* I Psychoeducation & normalization Imipramine Group psychological debriefing Propranolol, Prazosin Other Antidepressants Anticonvulsants Atypical Antipsychotics as Adjunct (except risperidone)* Spiritual support Psychological First Aid *VA/DoD Clinical Practice Guideline has been revised as follows: 1) atypical antipsychotics are not recommended as mono therapy for PTSD, 2) risperidone is contraindicated for use as an adjunctive agent (potential for harm), and 3) there is insufficient evidence to recommend any other atypical antipsychotic as an adjunctive agent for PTSD (http://www.ptsd.va.gov/professional/pages/clinicians-guide-to-medications-for-ptsd.asp) 4 B. TREATMENT INTERVENTIONS FOR PTSD Providers should explain to all patients with PTSD all available & effective options for PTSD. Patient education is recommended for all patients with PTSD & their family members. [C] Patient and provider preferences should drive the selection of evidence-based psychotherapy and/or evidence-based pharmacotherapy as the first line treatment. Psychotherapies should be provided by practitioners trained in the method of treatment. All clinicians should be trained in trauma-informed care. A collaborative care approach to therapy administration, with care management, may be considered, although supportive evidence is lacking specifically for PTSD. Psychotherapy Interventions for Treatment of PTSD Balance Benefit and Harm SR Significant Benefit A Trauma-focused psychotherapy that includes component of exposure and/or cognitive restructuring (i.e., CBT, EMDR, Exposure Therapy, etc.) ; or, Some Benefit Unknown Benefit Stress Inoculation training B C Patient Education Imagery Rehearsal Therapy Psychodynamic Therapy Hypnosis Relaxation Techniques Group Therapy I Family Therapy Web-based CBT Acceptance and Commitment Therapy Dialectical Behavior Therapy 5 Adjunctive Problem-Focused Method/Services for PTSD If patient: Service/Training Is not fully informed about aspects of health needs & does not avoid high-risk behaviors Provide patient education Does not have sufficient self-care & independent living skills Refer to self-care/independent living skills training services Does not have safe, decent, affordable, stable housing that is consistent with treatment goals Use and/or refer to supported housing services Does not have a family that is actively supportive and/or knowledgeable about treatment for PTSD Implement family skills training Is not socially active Implement social skills training Does not have a job that provides adequate income and/or fully uses his or her training & skills Implement vocational rehabilitation training Is unable to locate & coordinate access to services Use case management services Does not request spiritual support Provide access to religious/spiritual advisors and/or other resources OTHER CONDITIONS Has a borderline personality disorder with parasuicidal behaviors Consider DBT Has concurrent substance abuse problem Integrated PTSD substance abuse treatment (i.e., Seeking Safety) Symptom Response by Drug Class and Individual Drug (based on controlled trials) SSRI SNRI TCAs MAOIs Sympatholytics Other Antidepressants Fluoxetine Sertraline Paroxetine Venlafaxine Amitriptyline/ Imipramine Phenelzine Prazosin Mirtazapine Nefazodone Global Improvement X X X X X Reexperiencing X X X X X Avoidance/ Numbing X X X X X X X X X X X X X X X X X Hyperarousal X X X X *VA/DoD Clinical Practice Guideline has been revised as follows: 1) atypical antipsychotics are not recommended as mono therapy for PTSD, 2) risperidone is contraindicated for use as an adjunctive agent (potential for harm), and 3) there is insufficient evidence to recommend any other atypical antipsychotic as an adjunctive agent for PTSD (http://www.ptsd.va.gov/professional/pages/clinicians-guide-to-medications-for-ptsd.asp) 6 Pharmacotherapy for PTSD Balance of Benefit and Harm SR Significant A SSRIs Some Benefit Unknown No Benefit SNRIs B Mirtazapine Prazosin (for sleep/nightmares) TCAs Nefazodone [Caution] MAOIs (phenelzine) X C Prazosin (for global PTSD) D Benzodiazepines[Harm] Tiagabine Guanfacine Valproate Topiramate Risperidone, as adjunct [Harm] * Atypical antipsychotics, as monotherapy * I Atypical antipsychotic, as adjunct (besides risperidone which is contraindicated)* Typical antipsychotics Buspirone Non-benzodiazepine hypnotics Bupropion Trazodone (adjunctive) Gabapentin Lamotrigine Propranolol Clonidine SR = Strength of recommendation (see Introduction); X= Attention to drug to-drug and dietary interactions *VA/DoD Clinical Practice Guideline has been revised as follows: 1) atypical antipsychotics are not recommended as mono therapy for PTSD, 2) risperidone is contraindicated for use as an adjunctive agent (potential for harm), and 3) there is insufficient evidence to recommend any other atypical antipsychotic as an adjunctive agent for PTSD (http://www.ptsd.va.gov/professional/pages/clinicians-guide-to-medications-for-ptsd.asp) 7 Monotherapy: Strongly recommend that patients with PTSD be offered SSRIs, for which fluoxetine, paroxetine, or sertraline have strongest support, or SNRIs, for which venlafaxine has strongest support. [A] Recommend mirtazapine, nefazodone, TCAs, amitriptyline & imipramine, or MAOIs (phenelzine). [B] Recommend against guanfacine, anticonvulsants (tiagabine, topiramate, valproate) as monotherapy [D] Existing evidence does not support the use of bupropion, buspirone, and trazodone, anticonvulsants (lamotrigine or gabapentin) or atypical antipsychotics as monotherapy in the management of PTSD. [I] There is evidence against the use of benzodiazepines, atypical antipsychotics as monotherapy,*** and risperidone as adjunct*** in management of PTSD. [D] Insufficient evidence to support the use of prazosin as monotherapy in the management of PTSD. [I] Augmented Therapy for PTSD: Recommend adjunctive treatment with prazosin for sleep/nightmares. [B] Insufficient evidence to recommend a sympatholytic, anticonvulsant, or atypical antipsychotic (besides risperidone, which is contraindicated)*** as an adjunct. [I] Treatment Response and Follow-Up Step 1 2 Patient Condition Initial Treatment Non response to initial dose Options • Psychotherapy AND/OR • SSRI/SNRI • Assess adherence Reassess at:* 2 weeks **/ 4 weeks 4-6 weeks • Increase dose • Consider longer duration • Switch to another SSRI or SNRI • Add psychotherapy • Consider referral to specialty care 3 Failed second trial of antidepressant • Switch to another SSRI/SNRI or mirtazapine 8-12 weeks • Add psychotherapy • Augment with prazosin (sleep/nightmare) 4 Failed three trials including augmentation • Re- evaluate diagnosis and treatment > 12 weeks • Switch to TCA • If no response consider nefazodone (monitoring side effects), or phenalzine (with careful consideration of risks) • Consider referral to specialty care * Times are general guidelines and may vary considerably / **If treatment is not tolerable, switch to another antidepressant. ***VA/DoD Clinical Practice Guideline has been revised as follows: 1) atypical antipsychotics are not recommended as mono therapy for PTSD, 2) risperidone is contraindicated for use as an adjunctive agent (potential for harm), and 3) there is insufficient evidence to recommend any other atypical antipsychotic as an adjunctive agent for PTSD (http://www.ptsd.va.gov/professional/pages/clinicians-guide-to-medications-for-ptsd.asp) 8