STARr-project: Preventing depression in youth|
|- candidate number||25398|
|- NTR Number||NTR6176|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-okt-2016|
|- Secondary IDs||NL59152.041.16 16/653 METC|
|- Public Title||STARr-project: Preventing depression in youth|
|- Scientific Title||Core elements of Cognitive Behavioral Therapy in preventing depression in youth: Does the type and sequence of elements matter?|
|- ACRONYM||STARr: Solve, Think, Act, Relax and repeat|
|- Healt Condition(s) or Problem(s) studied||Depression, Depressive symptoms|
|- Inclusion criteria||- age between 12-18 years old|
- sufficient knowledge of the Dutch language
- (sub)clinical levels of depressive symptoms
|- Exclusion criteria||- absence of adolescents’ or parental permission (for subjects aged younger than 18)|
- currently receiving treatment for psychological problems
- acute and severe suicidal thoughts and/or intentions
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2017|
|- planned closingdate||1-jun-2018|
|- Target number of participants||240|
|- Interventions||The prevention program will be developed by the researchers themselves, in close collaboration with therapists and experts in the field. The program will be designed as a Cognitive Behavioral Therapy, a therapy which has proven to be most effective and most applied in the prevention of depression among adolescents (e.g., Cuijpers et al., 2009). It will consist of twelve sessions, each 45-60 minutes long. For each of the four most commonly used CBT-elements a module of three sessions will be developed; one module with three sessions cognitive restructuring, one module with three sessions behavioral activation, one module with three sessions relaxation and one module with three sessions problem solving skills. The modules will be developed based on current Dutch CBT-protocols (e.g., Doepressie and Op Volle Kracht) and on MATCH-ADTC (Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems; Chorpita & Weisz, 2009). In each step of this developing process, a group of certified CBT-therapists and experts in the field will be consulted. |
To investigate whether the type of element is relevant for the positive effect of CBT-programs on the level of depressive symptoms in adolescents, we distinguish four conditions, all of which start with a different module; condition A starts with the module cognitive restructuring, condition B starts with the module behavioral activation, condition C starts with the module problem solving and condition D starts with the module relaxation. To investigate whether the sequence of elements is relevant for the positive effect of CBT-programs on the level of depressive symptoms in adolescents, the sequence of the four modules will differ per condition (see Table 1). As it is impossible to test all combinations, because of limited time and budget, three theoretically most logical variants (condition A, B and C) and one theoretically least logical variant (condition D) are chosen in close consultation with mental health professionals.
Table 1: Sequence of CBT-modules per condition.
Condition A CR BA RE PS
Condition B BA CR RE PS
Condition C PS BA CR RE
Condition D RE PS BA CR
Note. CR = cognitive restructuring; BA = behavioral activation; PS = problem solving; RE = relaxation.
The prevention program will be given in same-sex groups consisting of six to eight participants. It will take place at the participating schools directly after school. Group sessions take place one to two times a week, depending on holidays. The prevention program will be provided by certified alumni pedagogy/psychology, who will be trained and supervised by certified CBT therapists.
|- Primary outcome||The primary outcome is the level of self-reported depressive symptoms which will be measured with the CDI-2 (Bodden et al., 2016).|
|- Secondary outcome||Secondary study parameters are depressive symptoms according to the parent, depression diagnosis, top three problems, suicide risk, quality of life and care costs. Other study parameters are depression severity, comorbidity and demographic variables (possible moderator variables); negative automatic thoughts, behavioral activation, relaxation and problem solving skills (possible mediator variables); and expectancy of treatment, current and previous treatments, satisfaction with treatment and treatment integrity (treatment characteristics). |
|- Timepoints||In all conditions assessments will take place at baseline (T0), during the intervention phase after session 3 (T1), during the intervention phase after session 6 (T2), during the intervention phase after session 9 (T3), at post-intervention (T4) and at 6-months follow-up (T5). |
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Marieke van den Heuvel|
|- CONTACT for SCIENTIFIC QUERIES|| Marieke van den Heuvel|
|- Sponsor/Initiator ||Trimbos-institute - Netherlands Institute of Mental Health and Addiction, Utrecht University (UU)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background: Depression during adolescence is a major public health concern, because of its high prevalence, association with suicide, comorbid psychiatric diagnoses and high treatment costs. Even subclinical levels of depressive symptoms put adolescents at risk for several negative outcomes. Therefore, it is important that depression is detected at an early stage and is treated preventively. Prevention programs based on the principles of Cognitive Behavioral Therapy (CBT) have proven to be the most effective and most applied in preventing depression among adolescents. Thus far, research has mainly focused on effectiveness of “prevention packages” consisting of multiple CBTelements. Most common CBT-elements in existing programs are cognitive restructuring, behavioral activation, relaxation and problem solving skills. lt is unclear which of these elements contribute to the positive prevention outcomes and how these elements should be offered (i.e., what their optima! sequencing is). This study proposes to evaluate the differential (cost-)effectiveness of different types and sequences of CBT-elements in the prevention of depression among adolescents. The potential value of the study is that we gain insight in the differential effectiveness of the four most commonly used CBT elements in the prevention of depression among adolescents, and in their most optimal sequence. This knowledge can be used for recommendations to optimize CBT-programs in the prevention of adolescents with depressive symptoms.
Objectives: The primary objective is to investigate whether (and if so, which) type of CBT-element (cognitive restructuring (CR), behavioral activation (BA), relaxation (RE) and problem solving skills(PS)) is relevant for the positive effect of CBT-programs on the level of depressive symptoms in adolescents. The secondary objective is to investigate whether (and if so, which) sequence of CBT-elements is relevant for the positive effect of CBT-programs on the level of depressive symptoms in adolescents. In addition, it will be explored tor whom (i.e., moderation) and how (i.e., mediation) a given element, or set of elements, is most effective. Besides, the cost-effectiveness of the prevention of depression will be investigated.
Study design: A Randomized Controlled Trial with four conditions (all prevention programs).
Study population: Adolescents between 12 and 18 years old with elevated levels of depressive symptoms. They will be recruited via secondary schools (from vocational training up to pre-university level) and ROC's around the Netherlands. Adolescents who meet the inclusion criteria will be randomly assigned to one of the tour conditions.
Adolescents who are identified with acute and severe suicidal thoughts and/or intentions will be excluded from the study and redirected to mental health care.
lntervention: The prevention program will be developed by the researchers themselves in close collaboration with experts and CBT-therapists. The program will be designed as a Cognitive Behavioral Therapy, a therapy which has proven to be effective. lt will consist of twelve weekly sessions, each 45-60 minutes long. For each of the tour CBT-elements a module of three sessions will be developed . Each condition starts with a different module and contains a different sequence of modules (condition 1: CR, BA, RE, PS; condition 2 : BA, CR , RE, PS; condition 3: PS, BA, CR, RE; condition 4: RE, PS, BA, CR).
The prevention program will be given in same-sex groups consisting of six to eight participants. lt will be provided by certified alumni pedagogy and psychology, who will trained and supervised by certified CBT- therapists.
|- Main changes (audit trail)|
|- RECORD||13-okt-2016 - 19-mei-2017|
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