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Clinical Trials in Sweden / NCT04747340
Active, not recruiting Not applicable

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

NCT04747340 · tracked via the Priya Life Science Sweden tracker
Sponsor
Umeå University
Phase
Not applicable
Started
2021-03-12
Last updated
2025-04-11

Condition(s) studied

Depression in AdolescenceDepressive DisorderDysthymia and Chronic Depression

Investigational drug(s) / intervention(s)

Training for Awareness Resilience and Action (TARA)Standard treatment

Training for Awareness Resilience and Action (TARA): See arm-description

Standard treatment: See arm-description

Study 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.

Eligibility

Sex
ALL
Min age
15 Years
Max age
22 Years
Healthy volunteers
No
Inclusion Criteria: * Outpatient at the CAP or YC unit * The criteria for a diagnosis Major Depressive Disorder (MDD) or Persistent Depressive disorder (PDD)/dysthymia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM) IV or 5 are fulfilled. The clinical diagnosis will be validated during the screening process using the Mini International Neuropsychiatric Interview (M.I.N.I.)/Mini-International Neuropsychiatric Interview for Children and Adolescents (M.I.N.I-kid). If a diagnosis of MDD or PDD/dysthymia is not conclusive a cut-off of 40 or above on the Children's' Depression Rating Scale - Revised will be used for inclusion. * For patients in specialist child- and adolescent psychiatry clinics below the age of 18 one parent/ legal guardian must be available and agree to participate in parts of the sessions in case the individual is randomized to the TARA-arm. Exclusion Criteria: 1. 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. 2. One or several psychiatric symptoms or behavioral problems that may interfere with or hinder group participation including: * Severe self-harming behavior * Acute suicidality, including a reported suicide attempt in the last 6 months or hospitalization for suicidality in the last 6 months * Disabling dissociative symptoms or \> 6 points as mean item score on the Adolescent Dissociative Experiencing Scale. * Frequent use of recreational drugs (a urine drug screen will be performed at baseline and if positive a second test has to be negative for inclusion) * Reports of manic or hypomanic symptoms during the last year 3. 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). 4. On-going trauma, neglect, abuse or domestic violence or destabilizing legal process. 5. Pregnancy 6. Non-fluency in oral and written Swedish since the TARA groups are held in Swedish and assessment forms are in Swedish Note: Other psychiatric comorbidities such as attention deficit hyperactivity disorder (ADHD), anxiety, high functioning autism spectrum disorder and mild to moderate eating disorders are not considered exclusion criteria. Accidental findings of biochemical anomalies will not be considered exclusion criteria and medical conditions will be referred for appropriate treatment.

Primary outcome measure(s)

  • Reynold's Adolescent Depression Scale 2nd edition — 3 month follow-up
    Self report. Total raw-score. Raw score range is 30-120 and higher scores mean a worse outcome.

Trial sites (3)

FacilityCityRegionStatus
Ungdomshälsan/primary care Umeå and Skellefteå Västerbotten County
Barn och Ungdomspsykiatriska kliniken Umeå, Skellefteå, and Lycksele Västerbotten County
Barn och Ungdomspsykiatriska kliniken Örnsköldsvik and Sundsvall Västernorrland County

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04747340 on ClinicalTrials.gov ↗ ← All trials in Sweden