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

NCT04747340 | Active Not Recruiting DMC

• 1 other identifier: TARA
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Depression in Adolescence; Depressive Disorder; Dysthymia and Chronic Depression

Keywords

young people; RCT; yoga; cognitive behavioural therapy; selective serotonin reuptake inhibitor; psychotherapy; biological markers; antidepressant; meditation; Magnetic resonance imaging; Emotion regulation

Outcome Measures

Primary Outcomes (1)

• Reynold's Adolescent Depression Scale 2nd edition

  Self report. Total raw-score. Raw score range is 30-120 and higher scores mean a worse outcome.

  3 month follow-up

Secondary Outcomes (3)

• Reynold's Adolescent Depression Scale 2nd edition

  6 month follow-up

• Children's Depression Rating Scale - Revised

  3 month follow-up

• Multidimensional Anxiety Scale for Children

  3 month follow-up and 6 month follow-up

Other Outcomes (29)

• Reynold's Adolescent Depression Scale 2nd edition

  2-year follow-up

• Multidimensional Anxiety Scale for Children

  2-year follow-up

• Insomnia Severity Index

  3 month follow-up, 6 month follow-up and 2-year follow-up

Study Arms (2)

Training for Awareness, Resilience and Action (TARA)

EXPERIMENTAL

12 weekly online sessions, each 90 minutes, 6 participants/group. For participants \<18 years at CAP, parents/legal guardians will participate in parts of the sessions. Manual-based: Session 1: Introducing group members; establishing guidelines; investigating attitudes and previous experiences, introducing contemplative practices. All sessions: participants sit on yoga mats. Facilitators open and briefly check-in. Participants are guided through a breathing practice, yoga-based movement (a flow of positions synchronized with the breath) and then a meditation focusing primarily on interoceptive and sensory awareness. After a short break, a psychoeducational presentation is held followed by group exercises and discussions. The sessions conclude with feedback and questions regarding the practice, followed by a description of the home practice for the coming week. Finally, participants gather their attention and have the opportunity to express their reflections and current state.

Behavioral: Training for Awareness Resilience and Action (TARA)

Standard Treatment

ACTIVE COMPARATOR

Standard treatment (ST) as given at each participating study site. ST is based on the health practitioners' knowledge, experience, current guidelines and both the practitioners' and participants' preferences. For young people with depression The Swedish National Board of Health and Welfare recommends social support and psychoeducation (as first priority), Selective Serotonin reuptake inhibitors (as second priority) and cognitive behavioral therapy (as second priority). These recommendations are generally followed and given as stand-alone treatment or in different combinations. In our study we have no control over which of these treatments are given in the ST-arm, nor the combination or timing of them. To obtain data on what treatment has been given in the ST-arm we will go through the individual medical records of all participants at the conclusion of data collection.

Other: Standard treatment

Interventions

Training for Awareness Resilience and Action (TARA) BEHAVIORAL

See arm-description

Training for Awareness, Resilience and Action (TARA)

Standard treatment OTHER

See arm-description

Standard Treatment

Eligibility Criteria

• Age: 15 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Outpatient at the CAP or YC unit
• 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.

You may not qualify if:

• 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:
• 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.
• Reports of manic or hypomanic symptoms during the last year
• 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
• Note:

Sponsors & Collaborators

• Umeå University: lead
• Västerbotten County Council, Sweden: collaborator
• Västernorrland County Council, Sweden: collaborator

Study Sites (3)

Ungdomshälsan/primary care

Umeå and Skellefteå, Västerbotten County, 90328, Sweden

Location

Barn och Ungdomspsykiatriska kliniken

Umeå, Skellefteå, and Lycksele, Västerbotten County, 90364, Sweden

Location

Barn och Ungdomspsykiatriska kliniken

Örnsköldsvik and Sundsvall, Västernorrland County, 89135, Sweden

Location

Related Publications (2)

• Ekback E, Radmark L, Granasen G, Svarling R, Sorlin M, Schonbeck C, Henje E. 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. Front Psychiatry. 2023 Mar 31;14:1130035. doi: 10.3389/fpsyt.2023.1130035. eCollection 2023.

  PMID: 37065894 DERIVED

• Ekback E, Granasen G, Svarling R, Blomqvist I, Henje E. 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. Front Psychiatry. 2021 Oct 11;12:674583. doi: 10.3389/fpsyt.2021.674583. eCollection 2021.

  PMID: 34707516 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Dysthymic Disorder; Emotional Regulation

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Eva Henje, MD, PhD

  Umeå Universitet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization stratified by center.

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 10, 2021
• Study Start: March 12, 2021
• Primary Completion: December 20, 2024
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 11, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)