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Clinical Effectiveness of Training for Awareness Resilience and Action Online Compared to Standard Treatment for Adolescents and Young Adults With Depression: Study Protocol and Analysis Plan for a Pragmatic, Multi-Center Randomized Controlled Superiority Trial
Umeå University, Faculty of Medicine, Department of Clinical Sciences, Child and Adolescent Psychiatry.ORCID iD: 0000-0003-0496-7158
Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine.
Umeå University, Faculty of Medicine, Department of Clinical Sciences, Child and Adolescent Psychiatry.
Umeå University, Faculty of Medicine, Department of Clinical Sciences, Child and Adolescent Psychiatry.ORCID iD: 0000-0003-0487-5552
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2021 (English)In: Frontiers in Psychiatry, E-ISSN 1664-0640, Vol. 12, article id 674583Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
Frontiers Media S.A., 2021. Vol. 12, article id 674583
Keywords [en]
adolescent depression, antidepressant drugs, biomarkers, psychotherapy, randomization, yoga, young adults
National Category
Psychiatry
Research subject
Psychiatry
Identifiers
URN: urn:nbn:se:umu:diva-189121DOI: 10.3389/fpsyt.2021.674583ISI: 000713179300001PubMedID: 34707516Scopus ID: 2-s2.0-85117953482OAI: oai:DiVA.org:umu-189121DiVA, id: diva2:1610974
Funder
The Kempe Foundations, LVNFOU933598Swedish Medical Products Agency, SLS-935854Available from: 2021-11-12 Created: 2021-11-12 Last updated: 2024-03-27Bibliographically approved
In thesis
1. Depression in teenagers and young adults: foundational studies of the new treatment paradigm TARA: Training for Awareness, Resilience, and Action
Open this publication in new window or tab >>Depression in teenagers and young adults: foundational studies of the new treatment paradigm TARA: Training for Awareness, Resilience, and Action
2024 (English)Doctoral thesis, comprehensive summary (Other academic)
Alternative title[sv]
Depression bland tonåringar och unga vuxna : grundläggande studier av det nya behandlingsparadigmet TARA: Training for Awareness, Resilience and Action
Abstract [en]

Introduction: Depression in adolescents and young adults is an increasing global health concern and available treatments are not convincingly effective. It is therefore important to develop and test novel treatments to improve treatment outcomes. This dissertation lays the foundation for the evaluation of a Swedish version of the treatment program Training for Awareness, Resilience, and Action (TARA), and tests the psychometric properties of the primary outcome measure for that evaluation.

Objectives: This dissertation aims to 1. Translate and pilot test TARA in Swedish medical students, 2. Evaluate the psychometric properties of the Swedish version of the Reynolds Adolescent Depression Scale second edition (RADS-2) in a clinical sample, 3. Perform a single arm multicenter clinical pilot study of the feasibility and safety of TARA and 4. Design a randomized controlled trial to test the clinical effectiveness of TARA.

Methods: The TARA manual was translated into Swedish and 23 self-selected medical students, with or without mental disorders, received TARA. Self-rating as well as qualitative evaluation was performed. Patients (N = 536 individuals) with a variety of psychiatric diagnoses completed RADS-2 and other questionnaires for psychometric evaluation of RADS- 2. Thirty-five adolescents and young adults with depression received TARA either face-to-face or online, with data collection before, during, and after the treatment. The study design and statistical analysis plan for the randomized controlled trial was conceived and developed.

Results: It was feasible and acceptable to give TARA to Swedish medical students and they described the program as an uncommon meeting ground for personal empowerment. Support was found for the four-factor structure of RADS-2, and the scale demonstrated good validity and acceptable to good reliability. The clinical pilot study further supported the feasibility and clinical safety of TARA, and preliminary signs of effectiveness were seen. A detailed description of the pragmatic, multicenter, randomized controlled superiority trial that will evaluate the clinical effectiveness of TARA compared to standard treatment for depression was outlined, peer reviewed, and published in a study protocol with a statistical analysis plan.

Conclusions: The present results indicate that TARA is feasible and safe in Swedish clinical and non-clinical contexts. RADS-2 is a suitable outcome measure to use in routine clinical practice as well as in the present and future trials of depression. The initiated randomized controlled trial will be an important next step logically following the studies and results presented in this dissertation.

Place, publisher, year, edition, pages
Umeå: Umeå University, 2024. p. 114
Series
Umeå University medical dissertations, ISSN 0346-6612 ; 2294
Keywords
Depression, adolescents, young adults, medical students, mental health, anxiety, psychological stress, qualitative research, randomization, yoga, mindfulness, psychotherapy, antidepressant drugs, biomarkers, clinical trial, feasibility studies, online intervention, reliability, validity, confirmatory factor analysis, measurement invariance
National Category
Other Clinical Medicine
Research subject
Child and Youth Psychiatry
Identifiers
urn:nbn:se:umu:diva-222788 (URN)978-91-8070-281-2 (ISBN)978-91-8070-282-9 (ISBN)
Public defence
2024-04-26, Umeälven, byggnad 28, Norrlands universitetssjukhus, Umeå, 09:00 (English)
Opponent
Supervisors
Funder
Swedish Research CouncilRegion VästerbottenRegion VästernorrlandThe Kempe FoundationsFredrik och Ingrid Thurings StiftelseSwedish Society of Medicine
Available from: 2024-04-05 Created: 2024-03-27 Last updated: 2024-04-02Bibliographically approved

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Ekbäck, ErikGranåsen, GabrielSvärling, RachelBlomqvist, IdaHenje Blom, Eva

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