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Group Treatment for Adolescents With Depression

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ClinicalTrials.gov Identifier: NCT02115737
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : April 16, 2014
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Benjamin Goldstein, Sunnybrook Health Sciences Centre

Brief Summary:
Youth with depressive symptoms are at risk for a range of problems later in life. This includes problematic interpersonal relationships, occupational stress, and the occurrence of adult mental disorders. The main purpose of this study is to test how effective two types of group therapy are at reducing depressive symptoms in youth. A focus on group therapy is important because group therapy allows for many youth to be treated in a short amount of time. Group therapy is also helpful because youth can get social support and feel less alone in their symptoms when they participate in group. This study compares two groups, one that targets skills for managing difficult emotional experiences (dialectical behavior therapy skills group) and another group focuses on psychoeducation and is based on a publicly available treatment manual from the Services for Teens At Risk (STAR) Center at the University of Pittsburgh. The results of this study will provide insights regarding the comparative efficacy of these two treatments, and regarding predictors of treatment response.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Dialectical Behavior Therapy Skills Group Behavioral: Psychoeducation group treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Group Treatment for Adolescents With Depression
Study Start Date : December 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dialectical Behavior Therapy Skills Group
Twelve week skills based group therapy include four modules: mindfulness, emotion regulation, distress tolerance, and walking the middle path
Behavioral: Dialectical Behavior Therapy Skills Group
Experimental: Psychoeducation group treatment
The comparison group used in the present study is based on a publicly available treatment manual from the Services for Teens At Risk (STAR) Center at the University of Pittsburgh
Behavioral: Psychoeducation group treatment



Primary Outcome Measures :
  1. Children's Depression Rating Scale - Revise (CDRS-R) [ Time Frame: Change from baseline to endpoint (assessed at weeks 0, 12, 24) ]
    Measure mood symptom severity. Response is defined as greater than or equal to 50% reduction in CDRS-R score

  2. The Longitudinal Interval Follow-up Evaluation for adolescents (A-LIFE) [ Time Frame: Change from baseline to endpoint (assessed at weeks 0, 12 and 24) ]
    Used to track symptom severity, treatment (both psychosocial and psychotropic), self-injurious/suicidal behavior and psychosocial functioning over time.


Secondary Outcome Measures :
  1. The Adverse Childhood Experiences [ Time Frame: Assessed at baseline ]
    Used to measure adverse events that have happened up until the 18th year of life

  2. The Children's Affective Lability Scale [ Time Frame: Change from baseline to endpoint (assessed at weeks 0, 4, 12 and 24) ]
    Used to ascertain adolescent and parent reported affect regulation, during the preceding year or time since last assessment

  3. The Stressful Life Events Schedule [ Time Frame: Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24) ]
    Used to ascertain 80 adolescent and parent reported negative life events, during the preceding year or time since last assessment

  4. The DBT Ways of Coping Checklist [ Time Frame: Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24) ]
    This is a self-reported questionnaire used to assess adaptive and maladaptive ways to cope with negative emotions or problematic situations

  5. The Life Problems Inventory [ Time Frame: Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24) ]
    This is a self-reported questionnaire (adolescent-reported) used to assess emotion dysregulation in the adolescent.



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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English speaking
  • male or female, ages 14 to 19, all races and ethnicities
  • Current depression as assessed by an ALIFE - PSR score equal to or greater than 4
  • Has a treating psychiatrist at Sunnybrook Health Sciences Centre

Exclusion Criteria:

  • Current manic episode
  • current psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115737


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Benjamin I Goldstein, MD Sunnybrook Health Science Centre

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Responsible Party: Dr. Benjamin Goldstein, Associate Processor, University of Toronto, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02115737     History of Changes
Other Study ID Numbers: 213-2012
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders