Group Treatment for Adolescents With Depression

Depression Clinical Trial

Official title:

Group Treatment for Adolescents With Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02115737
• Other study ID #: 213-2012
• Status: Terminated
• Phase: N/A
• First received: April 14, 2014
• Last updated: November 16, 2015
• Start date: December 2013
• Est. completion date: November 2014

Study information

• Verified date: November 2015
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Dialectical Behavior Therapy Skills Group

• Psychoeducation group treatment

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline to endpoint (assessed at weeks 0, 12, 24)	Yes
Primary	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.	Change from baseline to endpoint (assessed at weeks 0, 12 and 24)	Yes
Secondary	The Adverse Childhood Experiences	Used to measure adverse events that have happened up until the 18th year of life	Assessed at baseline	Yes
Secondary	The Children's Affective Lability Scale	Used to ascertain adolescent and parent reported affect regulation, during the preceding year or time since last assessment	Change from baseline to endpoint (assessed at weeks 0, 4, 12 and 24)	No
Secondary	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	Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)	No
Secondary	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	Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)	No
Secondary	The Life Problems Inventory	This is a self-reported questionnaire (adolescent-reported) used to assess emotion dysregulation in the adolescent.	Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)	No