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Clinical effectiveness of training for awareness, resilience, and action for adolescents and young adults with depression: the pilot phase of a multicenter randomized controlled 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 Clinical Sciences, Child and Adolescent Psychiatry.
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.
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2023 (English)In: Frontiers in Psychiatry, E-ISSN 1664-0640, Vol. 14, article id 1130035Article in journal (Refereed) Published
Abstract [en]

Background: Depression is a top-ranking global health concern increasing in magnitude. Available treatments for adolescents and young adults are not convincingly effective and relapse rates remain high. Training for Awareness, Resilience and Action (TARA) is a group treatment program targeting specific pathophysiological mechanisms of depression in young people. TARA is feasible, acceptable, preliminarily efficacious in depressed American adolescents, and it affects postulated brain-circuitry.

Methods: As an initial step of a multicenter randomized controlled trial (RCT) we performed a single-arm multicenter pilot-study on TARA. Thirty-five depressed individuals (15–21 years old, 28 females) received TARA for 12 weeks face-to-face or online. Data was collected before (T0), during, and after the intervention (T1). The trial was pre-registered at clinicaltrials.gov, NCT Registration: identifier [NCT04747340]. Feasibility outcomes included recruitment, attendance rates, and session ratings. Adverse events were recorded weekly and extracted from medical records at the end of the trial. Primary effectiveness outcome was self-rated depression severity on Reynolds Adolescent Depression scale 2nd ed. at T1. Secondary outcomes were Children’s Depression Rating Scale-revised (CDRS-R) and Multidimensional Anxiety Scale for Children (MASC) at T1.

Results: TARA was feasible and safe in the present trial. No significant RADS-2-change was seen (adjusted mean difference –3.26, 95 % CI –8.35 to 1.83; p= 0.20), however a significant decrease in CDRS-R scores is reported (adjusted mean difference –9.99, 95% CI –14.76 to –5.22; p < 0.001). MASC-scores did not change significantly (adjusted mean difference 1.98, 95% CI –0.96 to 4.91; p=0.18). Additional feasibility aspects are presented and discussed.

Discussion: Limitations include substantial loss-to-follow-up, no randomization to control, and that some participants received concomitant treatment(s). The Coronavirus pandemic complicated both implementation and interpretation of the trial. In conclusion TARA was feasible and safe in depressed adolescents and young adults. Preliminary signs of effectiveness were seen. The initiated RCT will be important and worthwhile to conduct, and several improvements to the design are suggested based on the present results.

Place, publisher, year, edition, pages
Frontiers Media S.A., 2023. Vol. 14, article id 1130035
Keywords [en]
adolescents, clinical trial, depression, feasibility studies, mindfulness, online intervention, yoga, young adults
National Category
Psychiatry
Identifiers
URN: urn:nbn:se:umu:diva-208087DOI: 10.3389/fpsyt.2023.1130035ISI: 000970913600001Scopus ID: 2-s2.0-85153392594OAI: oai:DiVA.org:umu-208087DiVA, id: diva2:1755725
Funder
Swedish Research Council, 2021- 02257Umeå University, 970831Region Västerbotten, RV-939199Region Västerbotten, RV-967045Region Västerbotten, RV-969368Region Västerbotten, RV-941585Region Västerbotten, RV-932919Region VästernorrlandThe Kempe Foundations, LVNFOU933598Swedish Society of Medicine, SLS-935854Available from: 2023-05-09 Created: 2023-05-09 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, ErikRådmark, LinaGranåsen, GabrielSvärling, RachelSörlin, MatildaHenje Blom, Eva

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