Clinical Effectiveness of Training for Awareness Resilience and Action (TARA) Compared to Standard Treatment for Adolescents and Young Adults With Depression, a Pragmatic Multi-center Randomised Controlled Superiority-trial

Plain English Summary

Clinical Effectiveness of TARA Compared to Standard Treatment for Adolescents and Young Adults With Depression is a Not Applicable clinical trial sponsored by Umeå University studying Depression in Adolescence, Depressive Disorder, Dysthymia and Chronic Depression. This trial tests a new group therapy called TARA against standard treatment for depression in young people. It is for adolescents and young adults aged 15-22 diagnosed with depression. Participation involves attending group therapy sessions and completing regular assessments. Standard treatment for depression is the current alternative being compared. The trial aims to enroll 136 participants.

Official 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 S

Who Can Participate

Here is what you need to know about eligibility for this trial. Young people aged 15-22 diagnosed with Major Depressive Disorder or Persistent Depressive Disorder can join. Individuals with severe co-occurring mental health conditions like bipolar disorder, psychosis, or severe autism may not be eligible. Those experiencing severe self-harm, acute suicidal thoughts, or recent suicide attempts are excluded. Participants must be fluent in Swedish, as the therapy and assessments are in Swedish. This trial is studying Depression in Adolescence, Depressive Disorder, Dysthymia and Chronic Depression, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how much depression symptoms improve on a scale called RADS-2 after 3 months, indicating the therapy's effectiveness in reducing depressive feelings. The specific primary outcome measures are: Reynold's Adolescent Depression Scale 2nd edition (3 month follow-up). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial addresses the growing concern of depression in young people by evaluating a novel therapy designed to be more effective than current standard treatments. This research targets Depression in Adolescence, Depressive Disorder, Dysthymia and Chronic Depression, where improved treatment options are needed.

Investor Insight

This trial investigates a new therapeutic approach for a significant mental health issue in a large demographic, potentially offering a more effective treatment and filling a gap in current care.

Is This Trial Right for Me?

Ask your doctor if TARA therapy is suitable for your specific situation and what the potential benefits and risks are. Participation involves attending group sessions and completing questionnaires and possibly biological samples (blood, hair) and scans. Parents or guardians may need to participate in some sessions if the patient is under 18 and assigned to the TARA group. The trial is being conducted at 3 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 136 participants

Interventions

• BEHAVIORAL: Training for Awareness Resilience and Action (TARA) — See arm-description
• OTHER: Standard treatment — See arm-description

Primary Outcomes

• Reynold's Adolescent Depression Scale 2nd edition (3 month follow-up)

Secondary Outcomes

• 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)

Full Eligibility Criteria

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.

Trial Locations

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

Frequently Asked Questions

Related Conditions

• Depression
• Major Depressive Disorder
• Persistent Depressive Disorder
• Dysthymia
• Adolescent Mental Health
• Young Adult Mental Health
• Anxiety Disorders
• Attention Deficit Hyperactivity Disorder (ADHD)
• Eating Disorders
• Autism Spectrum Disorder

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