Active — Not RecruitingNot Applicable

Clinical Effectiveness of TARA Compared to Standard Treatment for Adolescents and Young Adults With Depression

Sweden136 participantsStarted 2021-03-12

Plain-language summary

Depressive Disorders constitute an increasing global health concern and available treatments for young people have not been sufficiently effective in haltering this trend. The novel group treatment program "Training for Awareness, Resilience, and Action" (TARA) was developed to target 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 adolescents with depression. In this study, young people (age: 15-22) with depression will be recruited from specialized Child and Adolescent Psychiatry and Youth Clinics and randomized to receive either TARA or Standard Treatment (ST) until n=67 is reached in each arm. Outcome measures will be obtained before randomization (T0), 6 weeks after treatment start (T0.5), at 3- and 6 months follow-up (T1, T2). The primary outcome measure is Reynold's Adolescent Depression Scale (RADS-2) score at T1. Secondary outcome measures are RADS-2-score at T2, clinician depression rating with Children's Depression Rating Scale, Revised at T1,and self-rated anxiety with Multidimensional Anxiety Scale for Children, 2nd ed. at T1 and T2. Other outcomes include heart rate variability and systemic bioindicators for depression from blood and hair. Data collected from subgroups within the study will include: brain magnetic resonance imaging and accelerometry. Qualitative interviews will be performed to reach a more comprehensive understanding of the subjective experience of being depressed and to what extent treatment adequately addresses this experience. A 2-year follow-up (T3) will be performed and presented separately. The study will be the first Randomized Controlled Trial to examine the clinical effectiveness of TARA compared to ST for young people with depression. The investigators hypothesize that (1) TARA will result in greater reduction of depression symptoms compared to ST and that group differences will be maintained or increased at T2, (2) the treatment effect of TARA will be mediated by improved emotion regulation, sleep, and psychological flexibility, (3) bioindicators for depression will improve more in the TARA-arm compared to the ST-arm, (4) it will be possible/meaningful to explore the contextual factors perceived to drive the depression onset and maintenance, and the extent to which the different treatments address these factors.

Who can participate

Age range

15 Years – 22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. One or several severe psychiatric co-morbid diagnoses that may interfere with or hinder group participation, including: intellectual development disorder, severe autism spectrum disorder, psychotic disorder, bipolar disorder, severe anorexia nervosa, substance use disorders, acute posttraumatic stress disorder (PTSD) and severe dissociative syndromes.
. One or several psychiatric symptoms or behavioral problems that may interfere with or hinder group participation including:
. A first degree relative with bipolar disorder (a first episode of MDD may be an incipient bipolar disorder which is not the treatment target for TARA).
. On-going trauma, neglect, abuse or domestic violence or destabilizing legal process.
. Pregnancy
. Non-fluency in oral and written Swedish since the TARA groups are held in Swedish and assessment forms are in Swedish

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reynold's Adolescent Depression Scale 2nd edition

Timeframe: 3 month follow-up

Trial details

NCT IDNCT04747340

SponsorUmeå University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-20

View on ClinicalTrials.gov More Depression in Adolescence trials