Abstract
Depression in adolescents and young adults is an increasing global health concern. Available treatments are not sufficiently effective and relapse rates remain high. The novel group-treatment program “Training for Awareness, Resilience and Action” (TARA) targets specific mechanisms based on neuroscientific findings in adolescent depression. TARA is framed within the National Institute of Mental Health's Research Domain Criteria and has documented feasibility and preliminary efficacy in the treatment of adolescent depression. Since neurodevelopment continues well into the mid-twenties, age-adapted treatments are warranted also for young adults. Patients 15–22 years old, with either major depressive disorder (MDD) or persistent depressive disorder (PDD) according to the DSM-IV/5 or a rating >40 on the clinician rating scale Children's Depression Rating Scale—Revised (CDRS-R), will be recruited from specialized Child and Adolescent Psychiatry and local Youth-Clinics and randomized to either TARA or standard treatment, including but not limited to antidepressant medication and/or psychotherapy. Outcome measures will be obtained before randomization (T0), after 3 months of treatment (T1) and at 6-months- (T2) and 24-months- (T3) follow-up. Additionally, dose-response measures will be obtained weekly in the TARA-arm and measures for mediation-analysis will be obtained halfway through treatment (T0.5). Primary outcome measure is Reynolds Adolescent Depression Scale (RADS-2) score at T1. Secondary outcome measures include RADS-2 score at T2, Multidimensional Anxiety Scale for Children at T1 and T2, and CDRS-R at T1. Additional outcome measures include self-report measures of depression-associated symptoms, systemic bio-indicators of depression from blood and hair, heartrate variability, brain magnetic resonance imaging, as well as three-axial accelerometry for sleep-objectivization. Qualitative data will be gathered to reach a more comprehensive understanding of the factors affecting adolescents and young adults with depression and the extent to which the different treatments address these factors. In summary, this article describes the design, methods and statistical analysis plan for pragmatically evaluating the clinical effectiveness of TARA. This will be the first RCT to examine the effects of TARA compared to standard treatment for adolescents and young adults with MDD or PDD. We argue that this study will extend the current knowledgebase regarding the treatment of depression.NCT Registration: identifier [NCT04747340].
Highlights
Major depressive disorder (MDD) is a global health concern and is currently the single leading cause of disability worldwide [1]
The primary aim of this study is to investigate the clinical effectiveness of Training for Awareness Resilience and Action (TARA) for adolescents and young adults with MDD/PDD using a Randomized Controlled Trial (RCT)-design, with an active control based on standard treatment in specialized Child and Adolescent Psychiatry (CAP) and local Youth-Clinics (YC)
Protocol non-adherence in the TARA-arm is defined as [1] Facilitators repeatedly not adhering to TARA-manual and not promptly correcting their fidelity to the manual upon receiving feedback, [2] Introduction of concomitant psychotropic medication and/or psychotherapy that is not included in the TARA intervention protocol, [3] Participant missing more than 50% of TARA-sessions, and [4] The monitoring performed by the clinical research center (CRC), for details please see “Data and safety monitoring” below, reveals any major protocol violation, which in such cases will be elaborated in detail
Summary
Major depressive disorder (MDD) is a global health concern and is currently the single leading cause of disability worldwide [1]. MDD is predicted by the World Health Organization to be the single largest contributor to the overall global burden of disease, measured in disability adjusted life years, by 2030 [2]. Traditional treatment methods for adolescent depression such as Selective serotonin reuptake inhibitors (SSRIs) and psychological treatments such as cognitive behavioral therapy (CBT) have not been sufficiently effective to slow down the increasing prevalence of depressive disorders and increased global treatment resources have been warranted [5]. According to repeated Cochrane reviews there is limited evidence upon which to draw conclusions about the relative effectiveness of psychological interventions, antidepressant medication or a combination of these interventions for adolescent depression [6]. Findings from several large meta-analyses conducted since have been consistent with this conclusion [7,8,9,10,11]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
