Abstract
BackgroundBoth depressive disorder and subclinical depressive symptoms during adolescence are a major public health concern. Therefore, it is important that depression is detected at an early stage and is treated preventively. Prevention based on the principles of Cognitive Behavioural Therapy (CBT) has proven to be the most effective, however research has mainly focused on the effectiveness of “prevention packages” consisting of multiple CBT-components, rather than on the distinct CBT-components. This study will evaluate the relative effectiveness of four core components of CBT (cognitive restructuring (CR), behavioural activation (BA), problem solving (PS) and relaxation (RE)). In addition the relative (cost-)effectiveness of four different sequences of these components will be evaluated: (1) CR – BA – RE – PS, (2) BA – CR – RE – PS, (3) PS – GA – CR – RE and (4) RE – PS – BA – CR.MethodsWe will perform a non-blinded multisite cluster randomized prevention microtrial with four parallel conditions consisting of the four sequences. The four sequences of components will be offered in groups of high school students with elevated depressive symptoms. For each CBT-component a module of three sessions is developed. Assessments will be conducted at baseline, after each CBT-component, prior to each session, at post-intervention and at 6-month follow-up. Potential moderators and mediators will be evaluated exploratively to shed light on for whom the (sequences of) CBT-components are most effective and how effects are mediated.DiscussionThe potential value of the study is insight in the relative effectiveness of the four most commonly used CBT-components and four different sequences, and possible moderators and mediators in the prevention of depression among adolescents. This knowledge can be used to optimize and personalize CBT-programs.Trial registrationThe study is registered in the Dutch Trial Register (Trial NL5584 / NTR6176) on October 13, 2016.
Highlights
Both depressive disorder and subclinical depressive symptoms during adolescence are a major public health concern
Programs based on the principles of Cognitive Behavioural Therapy (CBT) have proven to be the most effective and most applied in preventing depression among adolescents (e.g., [13])
The planned study is aimed at dismantling the relative effectiveness of core components of CBT and its sequencing in the prevention of depression among adolescents
Summary
The study methods and results will be reported in accordance with the CONSORT 2010 statement for reporting parallel group randomized trials [48] and the extension to cluster randomized trials [49]. In all conditions an indicated prevention program will be offered consisting of four modules based on the four most commonly used CBT-components (cognitive restructuring (CR), behavioural activation (BA), problem solving (PS) and relaxation (RE)). Sample size The trial is well powered with n = 64 in each of the four conditions (n = 256 in total) to detect a clinically relevant effect (mean standardized difference, d) of d ≥ 0.33 as statistically significant (at α ≤ 0.05, 2-tailed) with a power of (1-β) ≥ 0.80 when the primary outcome (depressive symptoms) is evaluated in a baseline adjusted analysis of variance (ANCOVA) while taking into account the nesting in the data owing to the cluster randomized trial. Screening measures To assess the eligibility to participate, adolescents will be screened for depressive symptoms using a self-report questionnaire, the CDI-2 [50] which includes 28 items.
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