Group Treatment for Adolescents With Depression

NCT02115737 | Terminated DMC

• 1 other identifier: 213-2012
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (5)

• The Adverse Childhood Experiences

  Assessed at baseline

• The Children's Affective Lability Scale

  Change from baseline to endpoint (assessed at weeks 0, 4, 12 and 24)

• The Stressful Life Events Schedule

  Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)

• The DBT Ways of Coping Checklist

  Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)

• The Life Problems Inventory

  Change from baseline to endpoint (assessed at weeks 0, 4, 12, and 24)

Study Arms (2)

Dialectical Behavior Therapy Skills Group

EXPERIMENTAL

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

Psychoeducation group treatment

EXPERIMENTAL

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

Interventions

Dialectical Behavior Therapy Skills Group BEHAVIORAL

Dialectical Behavior Therapy Skills Group

Psychoeducation group treatment BEHAVIORAL

Psychoeducation group treatment

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Current manic episode
• current psychosis

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Benjamin I Goldstein, MD

  Sunnybrook Health Science Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Processor, University of Toronto

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 16, 2014
• Study Start: December 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

CA (1)