Group Treatment for Adolescents With Depression
Primary Purpose
Depression
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dialectical Behavior Therapy Skills Group
Psychoeducation group treatment
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility 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
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dialectical Behavior Therapy Skills Group
Psychoeducation group treatment
Arm Description
Twelve week skills based group therapy include four modules: mindfulness, emotion regulation, distress tolerance, and walking the middle path
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
Outcomes
Primary Outcome Measures
Children's Depression Rating Scale - Revise (CDRS-R)
Measure mood symptom severity. Response is defined as greater than or equal to 50% reduction in CDRS-R score
The Longitudinal Interval Follow-up Evaluation for adolescents (A-LIFE)
Used to track symptom severity, treatment (both psychosocial and psychotropic), self-injurious/suicidal behavior and psychosocial functioning over time.
Secondary Outcome Measures
The Adverse Childhood Experiences
Used to measure adverse events that have happened up until the 18th year of life
The Children's Affective Lability Scale
Used to ascertain adolescent and parent reported affect regulation, during the preceding year or time since last assessment
The Stressful Life Events Schedule
Used to ascertain 80 adolescent and parent reported negative life events, during the preceding year or time since last assessment
The DBT Ways of Coping Checklist
This is a self-reported questionnaire used to assess adaptive and maladaptive ways to cope with negative emotions or problematic situations
The Life Problems Inventory
This is a self-reported questionnaire (adolescent-reported) used to assess emotion dysregulation in the adolescent.
Full Information
NCT ID
NCT02115737
First Posted
April 14, 2014
Last Updated
November 16, 2015
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT02115737
Brief Title
Group Treatment for Adolescents With Depression
Official Title
Group Treatment for Adolescents With Depression
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment
Study Start Date
December 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dialectical Behavior Therapy Skills Group
Arm Type
Experimental
Arm Description
Twelve week skills based group therapy include four modules: mindfulness, emotion regulation, distress tolerance, and walking the middle path
Arm Title
Psychoeducation group treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Dialectical Behavior Therapy Skills Group
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation group treatment
Primary Outcome Measure Information:
Title
Children's Depression Rating Scale - Revise (CDRS-R)
Description
Measure mood symptom severity. Response is defined as greater than or equal to 50% reduction in CDRS-R score
Time Frame
Change from baseline to endpoint (assessed at weeks 0, 12, 24)
Title
The Longitudinal Interval Follow-up Evaluation for adolescents (A-LIFE)
Description
Used to track symptom severity, treatment (both psychosocial and psychotropic), self-injurious/suicidal behavior and psychosocial functioning over time.
Time Frame
Change from baseline to endpoint (assessed at weeks 0, 12 and 24)
Secondary Outcome Measure Information:
Title
The Adverse Childhood Experiences
Description
Used to measure adverse events that have happened up until the 18th year of life
Time Frame
Assessed at baseline
Title
The Children's Affective Lability Scale
Description
Used to ascertain adolescent and parent reported affect regulation, during the preceding year or time since last assessment
Time Frame
Change from baseline to endpoint (assessed at weeks 0, 4, 12 and 24)
Title
The Stressful Life Events Schedule
Description
Used to ascertain 80 adolescent and parent reported negative life events, during the preceding year or time since last assessment
Time Frame
Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
Title
The DBT Ways of Coping Checklist
Description
This is a self-reported questionnaire used to assess adaptive and maladaptive ways to cope with negative emotions or problematic situations
Time Frame
Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
Title
The Life Problems Inventory
Description
This is a self-reported questionnaire (adolescent-reported) used to assess emotion dysregulation in the adolescent.
Time Frame
Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin I Goldstein, MD
Organizational Affiliation
Sunnybrook Health Science Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Group Treatment for Adolescents With Depression
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