Status:
ACTIVE_NOT_RECRUITING
Clinical Effectiveness of TARA Compared to Standard Treatment for Adolescents and Young Adults With Depression
Lead Sponsor:
Umeå University
Collaborating Sponsors:
Västerbotten County Council, Sweden
Västernorrland County Council, Sweden
Conditions:
Depression in Adolescence
Depressive Disorder
Eligibility:
All Genders
15-22 years
Phase:
NA
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 pr...
Detailed Description
The primary aim of this study is to investigate the clinical effectiveness of TARA in treating depression in adolescents and young adults by using a Randomized Controlled Trial (RCT)-design, with an a...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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
- 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:
- 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.
Key Trial Info
Start Date :
March 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2029
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT04747340
Start Date
March 12 2021
End Date
January 1 2029
Last Update
April 11 2025
Active Locations (3)
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1
Ungdomshälsan/primary care
Umeå and Skellefteå, Västerbotten County, Sweden, 90328
2
Barn och Ungdomspsykiatriska kliniken
Umeå, Skellefteå, and Lycksele, Västerbotten County, Sweden, 90364
3
Barn och Ungdomspsykiatriska kliniken
Örnsköldsvik and Sundsvall, Västernorrland County, Sweden, 89135