Randomized trial of the effects of Cognitive behavioral therapy and Brief relational therapy for depressed adolescents
Purpose and aims
Depression is a serious disorder with a prevalence of 5-6% for adolescents (Costello et al.,
2006) and a point prevalence of 5% (Essau & Chang, 2009). Contrary to findings for adult patients, not more than 60% of the adolescent patients respond to SSRI medication (Brent et al., 2008, Kennard et al., 2009). Often the adolescent and sometimes his or her parents may be hesitant about medication. There are thus reasons to study other treatment alternatives, primarily psychological. Cognitive behavior therapy (CBT) has strong support as evidence based treatment (National Health Board, 2010). Several recent studies do, however raise doubts concerning its effects. In the Treatment of Adolescent Depression Study (TADS,
2004) CBT had limited effect (43% responders, 16% remitted at end of therapy; Vitiello, et al., 2006). Also the combination of CBT and fluoxetine gave modest results: about 65% of the patients had remaining symptoms and interpersonal difficulties at the end of the therapy. In another American study, the “Treatment of SSRS-resistant depression in adolescents”
(TORDIA; Brent et al., 2008; Kennard et al. 2009), patients who did not respond on SSRImedication had more effect from CBT than from another drug, but still only 56% of the patients were responders post treatment. Similar results were found in the ADAPT study
(Goodyer, 2008). These results get support from a recent meta-analysis of the results of psychotherapy for adult depression. In an overview of the eleven studies of high quality, the mean effect size was .22 and NNT was 8. (Cuijpers, van Staten, Bohlmeyer, Hollon &
Andersson, 2010). In ten of these studies, variants of CBT were one of the therapies. There is thus reason to study alternative psychological treatments against adolescent depression, and particularly to study patient moderators, thus clarifying for whom different therapies work
(Brent, 2006; Hollon & Garber, 2005; Jensen, 2006). Some aspects of this issue merit particular attention One is that CBT therapies tend to have more drop-outs than other psychological therapies (Cuijpers, et al., 2008).. We thus need to study therapies that focus on hard-to-treat patients and those that tend to leave treatment prematurely. Another aspect is that the family relationships of the young person seem to moderate treatment outcome
(Asarnow, 2009; Brent at al., 2008). We thus need to test therapies that take relational aspects into account. A third aspect is that of medication compliance. In treatment of adults with depression it has been found that 21 % were noncompliant or partially noncompliant (Reis et al., 2010). In the present study, we intend to compare psychodynamic therapy, manualized and detailed as Brief Relational Therapy with Cognitive Behavior Therapy and a Treatment as usual group as effective treatments for adolescent depression. The study has three objectives:
1) to analyze whether CBT and/or BRT are effective therapies in the treatment of depression in adolescence, 2) to analyze whether there are patient factors that moderate the effects of these treatments, and 3) to analyze if these two treatments, if they are effective, function through the same or different treatment mediators.
Survey of the field
Several psychological treatments have shown positive effects in the treatment of depression
(Cuijpers et al., 2008) and also in treatment of depression in adolescents (Miller, Wampold &
Varhely 2008; National Institute for Mental Health, 2006; Spielmans, Pasek & McFall, 2007).
Several different, systematic treatments seem to have comparable effects for this patient group
(Cuijpers et al., 2008). CBT is the treatment that has been most studied as a treatment for adolescent depression. CBT has strong empirical support for this patient group (Dimidjian,
Hollon, Dobson, et al., 2006; Gloaguen, Cottraux, Cucherat, & Blackburn, 1998). This is so also for depression in young people (Birmaher et al., 2007; Clarke, Debar, Lynch, Powell et al., 2005; David-Ferdon et al., 2008). Several recent studies have, however, raised doubts
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about the effects that have been found in previous studies. As mentioned above, Cuijpers at al.
(2010) found moderate effects in their meta-analysis. Recent findings from the TORDIA study indicate that approximately one third of the patients in this study, defined as SSRIresistant, were remitted by week 24, irrespective of treatment method (CBT or alternative
SSRI). A recently published meta-analysis (Dubicka et al. 2010) found that addition of CBT only marginally increased the effects of medication treatment of depression in young people.
Psychodynamic treatment for depression has been studied in only a few studies. Some studies indicate that this treatment might have moderate effects (Driessen et al., 2010; Leichsenring,
2009; Lewis, Dennerstein & Gibbs, 2008) and also as treatment for children and adolescents
(Fonagy and Target, 1996; Horn, et al., 2005; Trowell, et al., 2007). Some studies have also indicated that the effect might remain and even increase at follow-up (Muratori, 2002, 2003;
Trowell, et al., 2002, 2007; Kennedy, 2004; Kennedy et al, 2007). In contrast to CBT, psychodynamic treatments focus on the patient’s interpersonal problems, and could thus be an alternative or a complement to CBT.
Moderators
Several moderators have attracted attention in the treatment of adult depression, e. g. the personality dimensions Relatedness and Self-definition (Blatt, 2008, Luyten et al., 2007) and the patient’s attachment pattern (McBride et al., 2006). In the NIMH-TDCRP (Elkin, Shea,
Watkins, Imber, et al., 1989), where CBT was compared with IPT, depressed patients with self-criticism and perfectionism (which could be seen as an expression for a strong need for independence) had weaker outcome, irrespective of treatment form (Blatt et al., 1998).
Another patient moderator that has attracted some research is the patient’s attachment pattern.
McBride et al. (2006) found that depressed patients with avoidant attachment style responded better to CBT treatment than to the alternative treatment. There are, however, few studies on patient moderators in adolescent therapies (Stefini et al., 2009). Brent (2009) suggested emotional abuse as a potential moderator for CBT: “Since CBT focuses in part on negative emotions, it may be less effective in abused patients and in other emotionally avoidant, depressed youth” (p. 873). Ravitz et al. (2008) found, in a series of case descriptions, that adolescents with an avoidant attachment style had better results with CBT than with IPT.
Similar results were found by Cyranowski et al. (2002).
Mediators
Change mechanisms in psychological treatment have been studied to a quite limited extent
(Blatt & Zuroff, 2005; Johansson & Höglend, 2007; Kazdin, 2006; Kazdin & Nock, 2003), although the question is highly important for the understanding of effects of psychological treatment. In studies using quantitative method, this question is usually analyzed as a mediation question (Kazdin, 2010), where the question is whether a certain change in behavior or mind comes before a change in symptoms (Connolly, 2009). Different therapy methods hypothesize, based on their theoretical assumptions, that change in symptoms is promulgated by the change mechanism that the theory focuses on. An analysis of mediators requires a time line design, where symptoms and changes in the mediator are measured at several time points (Baron & Kenny, 1986; Kraemer, Wilson, Fairburn & Agars, 2002). Many studies have argued for mediator results, although the time line requirement was not fulfilled, thus making analysis of mediator results impossible (Weisz, McCarty & Valeri, 2006;
Kennard et al., 2009). Another problem in mediation analyses is that the analysis method requires that there should be main effects differences between methods. Kolko et al. (2000), compared cognitive therapy, family therapy and a supportive therapy, but as there were no significant differences between the methods, no mediation analysis could be made.
In sum, there are no valid studies of mediation in treatment of adolescence depression. A possible hypothesis is that problem solving and behavior activation is a more potent mediator variable than cognitive restructuring (Asarnow et al., 2002). This finding gets some support
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from Dimidjian et al. (2006), where it was found, in treatment of adult depressed patients, that activation but not cognitive restructuring influenced depressive symptoms (at follow-up, however, the cognitive interventions indicated effects, Dobson et al., 2008). Spielmans et al.
(2007), in a meta-analysis of CBT for depressed adolescents, came to the following conclusions: ”(a) CBT was more efficacious than non-bona fide therapies; (b) CBT was no more efficacious than bona fide non-CBT treatments (c) the differences between bona fide treatments were homogenously distributed around zero; and (d) full CBT treatments offered no significant benefit over their components. The results strongly suggest that the theoretically purported critical ingredients of CBT are not specifically ameliorative for child and adolescent depression and anxiety” (s. 642). SBU came to similar conclusions: ”At follow-up of different lengths (long in studies with patients with major depression, short in studies with of children with depressive symptoms), no study has found any difference between CBT and any other active intervention. The analyses of purported cognitive mechanisms which have been made in a few studies do not support the notion that effects of
CBT treatments should be theory/therapy specific” (SBU, 2004, s. 130).
The knowledge about mediating mechanisms in psychodynamic therapy is even more limited, if not non-existent. The traditional idea is that insight should mediate symptom relief, but no quantitative studies of this purported relation have been made. In modern psychoanalytic/relational theory building, improvement in mentalizing is regarded as a potential mechanism of change (Safran & Muran, 2000; Holmqvist, 2007). Mentalization
(operationalized as Reflective functioning) implies that the individual has the ability to recognize that her own and other persons’ behavior are influenced a number of more or less conscious motives. Particularly in emotionally loaded situations, individuals mentalization capacity is reduced (Allen & Fonagy, 2006). Several studies have indicated that depressed patients may have a reduced mentalizing capacity (Fischer-Kern et al., 2008). The question of whether increased mentalization competence mediates depression reduction has never been studied (although our own ongoing study of BRT and IPT for adult depressed patients does study it). Harpaz-Rotem and Blatt (2009) found that a more nuanced image of the therapist mediated for changed self-image as outcome in a study of depressed adolescent in-patients, a finding that might suggest that mentalization could be a mediator.
Project description
In this study, patients will be randomized to three treatment alternatives: CBT (according to the TADS model, which we consider as giving benchmark figures for outcome), BRT, and treatment as usual (TAU). The design will be rather close to the TADS design, in order to make results comparable.
Treatment models
Cognitive behavior therapy (CBT) is a heterogeneous family of interventions, based on the idea that patients need to restructure their thoughts or their behavior in order to decrease symptoms. In depression treatment, the emphasis may be on cognitive restructuring
(Lewinsohn et al., 1990; Brent & Poling, 1997) or on aspects of activation and skills training
(Curry, 2000). In the study that we plan, CBT will be delivered according to the TADS protocol (Curry et al., 2000; Wells & Curry, 2000). This treatment was, however, criticized by leading proponents for CBT as being too rigid, thus inhibiting the therapists’ creative abilities.
We intend to teach it in the modified form that was used in the TORDIA (Brent et al., 2009).
The manual comprises cognitive restructuring, behavior activation, social skills training and problem solving. Gerhard Andersson, a leading CBT researcher, will be responsible for the
Swedish adaptation. Parent contacts will usually be done by the primary therapist.
Brief Relational Therapy (BRT; Safran & Muran, 2000, Holmqvist 2010) is a manualized variant of relationally based psychoanalytic treatment. Similarly to other forms of psychodynamic therapy, the focus is on the systematic exploration of the relationship between
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therapist and patient with the aim of understanding and changing dysfunctional interpersonal patterns. BRT has been especially created in order to handle and make therapeutic use of problems in the therapy alliance. We have for several years trained therapists in this method, and have extensive experience in training and supervision. In Holmqvist (2010), there are guidelines for therapy for depressed patients. Parent therapy will be held by another therapist at less frequent intervals.
These two therapies will go over 16 sessions. Kennard et al. (2009) found that CBT therapies shorter that 9 sessions were two and a half times less successful than therapies going over more than 9 sessions. The adherence to the therapies will be checked by adherence tests on two sessions from each therapy. They will be analyzed according to the adherence manuals for TADS and BRT (Beijnoff et al., 2010; Safran et al., 2002).
Treatment as usual (TAU) will not be controlled or influenced with respect to treatment content. We will, however, register very closely how it is performed, according to a special treatment form. Parent contacts will be held as the TAU method recommends.
Therapists
We have established contacts with the Youth Psychiatry Clinics in Linköping, Norrköping, and Nyköping, and we have preliminary contacts with other clinics. We need 18 therapist treating 10 patients each in the two study treatments, giving a margin of 20 patients with missing data. During their therapies, therapists will be provided with adequate supervision.
When the project starts, they will get a short training in the specific treatment protocol.
Patients
Inclusion criteria are that the patients fulfill the criteria for Major depressive disorder or depressive episode, and that they are between 12 and 18 years of age. Exclusion criteria are psychosis, ongoing substance abuse, autism or serious autism spectrum disorder, mental retardation, suicide risk that psychiatrist considers will need other treatment or management.
The patients will be randomized to the three treatment conditions, with ten patients for each therapist. The randomization will be stratified for sex (because we expect to get more girls) and level of depression as studies have indicated that CBT might work better especially for patients with severe depression. All patients will be patients at Youth Psychiatric clinics and be evaluated by psychiatrists with respect to the need of other forms of treatment.
Pharmacological treatment with antidepressants will be registered and compliance controlled by measures of serum concentration of prescribed medication at steady state (parent drug and/or metabolite(s)), by collection of cubital vein blood taken as trough value (between 10 to
27 hours after dose). Blood samples will be taken at least one month after medication start and when the therapy forms will be evaluated, i.e. six months and two months after therapy or before antidepressant medication is finished. Blood samples will be analysed at Clinical
Pharmacology, University Hospital, Linköping (Chermá et al., 2011). As in the clinical praxis, the prescribed physician can do dos-adjustment if it is necessary but the recommendation will be not to change medication during the treatment period, neither dose nor type, and that those who do not have medication do not start during the project time.
Moderators and mediators
Besides the issue of treatment effects, we will also study moderators and mediators. The patient moderators that we will study are: 1) the patient’s self-rated need for autonomy and relatedness (Blatt, 2008), and 2) the patient’s self-rated relational style, and 3) the patient’s mentalization capacity (Fonagy et al., 1998; Main, 1985). We hypothesize that patients with a stronger need for autonomy will have better effects with CBT, whereas patients with stronger need for relatedness will make better use of BRT. As the findings are divergent, but the issue is important, we will also analyze the importance of relational style and history of abuse, but without making directed hypotheses. Finally, we hypothesize that patients with a lower mentalization capacity (RF) will have more use of BRT, whereas patients with a higher
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mentalizing ability will have more use of CBT (based on results from Höglend and colleagues
(2008). In order to rate RF, we will make whole AAI (or CAI) interviews. Although it is possible to rate RF from abridged interviews, we want to retain the possibility to make attachment codings, albeit in this stage we only plan to rate RF (and relational style with
ECR).
The following mediating mechanisms will be studied, based on previous studies and on the therapies’ theoretical assumptions: a) the patient’s behavior activation (including problem solving), b) changes in dysfunctional thoughts, c) changes in the patient’s metacognitive capacity, 4) changes in the patient’s reflective functioning (RF) and 5) compliance with medication (if prescribed). Finally, 6) we will also use patient rated measures of the alliance for studying mediation. This is based on a recent, not yet published finding, where positive alliance was found to predict symptom change both to the next session and to therapy end, already from the first sessions, and even when symptom change was controlled for
(Falkenström & Holmqvist, 2011).
In addition to these moderators and mediators, we will also, based on recent studies, analyze potential predictors such as depression severity at therapy start, hopelessness, suicidal ideation, family conflict, dysthymic traits, and anxiety (Emslie et al., 2010).
The following hypotheses will be tested:
1.
CBT and BRT have better effect that TAU at reducing depressive symptoms
2.
CBT and BRT have the same effect at symptom reduction
3.
Patients rating high on Relatedness (DEQ) will have better use of BRT, and patients rating higher on Autonomy will have better use of CBT
4.
Patients with an avoidant relationship style (ENR) will have better use of CBT.
Patients with an anxious relationship style will have better use of BRT
5.
Patients with lower RF ratings (AAI) will have better use of BRT, and patients with higher RF rating will have better use of CBT.
6.
In CBT, increased activation and problem solving mediates for symptom change
7.
In CBT, less negative thoughts mediate for symptom reduction
8.
In BRT, increased RF mediates for symptom change
9.
In both therapy forms, increased metacognitive competence (PBRS and NBRS) and positive alliance ratings (WAI) mediate for symptom reduction
10.
Measures of pharmacological compliance (full or partial) will mediate for symptom reduction
It is probable that the mediation mechanisms interact with each other. We have no grounds for making hypotheses about this, but we will study the issue with HLM models.
The study has effectiveness character in the sense that there are few exclusion criteria. On the other hand, the design will fulfill the eight quality criteria required by Cuijpers et al. (2010) for a high quality RCT: a) the patients will be diagnosed with depression (MDD or depressive episode), b) the therapists will use treatment manuals, c) the therapists will be trained in the method they use, d) adherence will be controlled, e) intention-to-treat analyses will be made, f) the number of patients is larger than 50, g) randomization is made by an independent researcher, and h) outcome rating are made by uninformed raters.
The power analysis is based on the assumptions that the effect size between the study treatments will be d = .40 and between them and TAU d = .50, a significance level of .05 and the power .80, which implies 100 patients in CBT and BRT and 64 in TAU (Kazdin, 2003).
The primary outcome measures are the psychiatric evaluation of presence or absence of diagnosis, and the evaluation of depression severity. Secondary outcome measures are selfrated depression, self-rated general psychiatric symptom level and self-rated view of family relationships. Moderators and mediators will be measured with established instruments and in
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some cases with newly created instruments. Outcome will be measured before each session, after therapy, six months after therapy and two years after therapy.
We have in several studies, both RCTs and naturalistic studies, primarily with depressed adult patients, included self-ratings of symptoms and alliance before and after each session. We will use the same procedure in this study, using short forms for symptom rating and alliance.
The following measurement instruments will be used:
Primary outcome measures:

Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS; Puig-Antich &
Chambers, 1978, Kaufman et al., 1997) is a semi-structured interview developed for research purposes in order to diagnose depressed adolescents. For clinics where they do not have clinicians who are trained in the method, we will arrange training. K-
SADS will be used to establish the diagnosis of major depression according to DSM-
IV.
 Children’s Depression Rating Scale-Revised
(CDRS-R; Poznanski & Mokros, 1996,
Olsson & von Knorring 1997) is an interview-based rating scale for rating depression severity, with 14 interview items administered first to the youth and then to the parent, and three observational items.
Secondary outcome measures

Beck Depression Inventory-II (BDI-II; Beck et al., 1996, Olsson & von Knorring
1997)

Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997; Smedje et al., 1999)
 Children’s global assessment scale
(CGAS; Shaffer et al., 1983)
Moderator measures

Adult Attachment Interview (AAI; Main, Caplan & Cassidy, 1985) or Child
Attachment Interview (CAD; Schmueli-Goetz et al., 2008) are well established interviews for rating attachment patterns and Reflective Functioning (RF). We will primarily use them to rate RF

Experiences in Close Relationships (ECR; Brennan, Clark, & Shaver, 1998; Broberg and Zahr (2003)is used to measure self-rated relationship style

The Inventory of Parent and Peer Attachment (IPPA; Armsden & Greenberg, 1987;
Hwang 2001) assesses positive and negative affective and cognitive aspects of the adolescent’s relationships with their mothers, fathers, and peers.

Depressive Experiences Questionnaire (DEQ, adolescent version; Blatt et al., 1992)
 Linkoping’s Youth Life Experience Scale (LYLES ) is a trauma history inventory, which includes questions about adverse childhood circumstances
Mediator measures, at session 4 and 9

Children's Automatic Thoughts Scale (CATS; (Schniering & Lyneham 2007, Floxner et al 2009) is a developmentally sensitive, general measure of negative self-statements across both internalizing and externalizing problems. The CATS is designed for children and adolescents aged between 8 and 17 years of age and contains 40 items

Positive Beliefs about Rumination Scale (PBRS) and Negative Beliefs about
Rumination Scale (NBRS), Roelofs, Huibers, Peeters, Arntz et al., (2010)

Depression Specific Reflective Functioning (DSRF; Jones et al., 2009) uses five questions to rate the patient’s capacity to reflect openly about his or her symptoms

Behaviour rating by patient and therapist
Before every session

Patient Health Questionnaire-9 (PHQ-9; Spitzer, Kroenke & Williams, 1999) is a selfrated questionnaire about depression symptoms that follow the DSM criteria
After every session
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
Working alliance Inventory , short version (WAI; Horvath, 2001), both patient and therapist
All therapies will be video recorded in order to make it possible to rate treatment integrity.
The project will start during the spring 2012. At the participating clinics, the patients fulfilling the inclusion criteria and their patients will be asked consecutively about participation. The study will be performed by a researcher group that performs similar studies with adult depressed patients. In one RCT, we compare outcome for 60 patients receiving BRT with 60 patients receiving IPT. We have also just recently started an RCT where we compare 45 patients getting CBT with 45 patients getting CBT. In these projects, we use similar procedures, including adherence checks.
Ethical considerations
The specific characteristic with this study is that it concerns adolescents. They and their parents will be informed and have the possibility to abstain from participation, and still receive adequate treatment. As the study is made at Youth Psychiatry clinics, there are good resources to give evaluation and treatment. The study will follow Good Clinical Guidelines, and we will rely on Linköping Academic Research Center for this.
Significance
Depression, in adults and adolescents, is a growing problem throughout the world (Kessler &
Walters, 1998). The emotional, social, and economic costs of not giving adolescents adequate and sufficient treatment are very large. Among adolescents who suicide, 60% have a depression. There are several established treatments for adolescent depression, but their results have in recent studies underperformed in relation to expectations. It is important to analyze treatment methods that have some credibility and could help those patients who do not respond to CBT or medication. Several methods have shown promising results. We are presently, in different ways, involved in the training of therapists in methods that focus on the adolescent’s interpersonal and family problems. In this study, we test a manualized form of psychodynamic therapy. There are quite a number of therapists trained in this method, and it is thus feasible to make this trial.
Implementation
The results will give precious knowledge about which patients to treat with which method, and whether BRT is a therapy that can be used for depressed adolescents. The study will be performed at several clinics, and treatment competence will be strengthened at these.
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