Prevention of Depression in At-Risk Adolescents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vanderbilt University
- Enrollment
- 316
- Locations
- 4
- Primary Endpoint
- Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4)
Study Overview
Brief Summary
This study examines the impact of a group cognitive behavioral program aimed at preventing depressive disorders and symptoms in adolescents at risk for developing depression.
Detailed Description
Depression is a prevalent, chronic, and impairing condition that is often undetected and becomes more difficult to treat as chronicity increases. There is an increasing need to conduct large-scale depression prevention studies in adolescents. This study evaluates a cognitive-behavioral prevention (CBP) program to determine its effectiveness in preventing depressive disorders in at-risk adolescents. The study also will ascertain the costs this intervention to inform attempts at future dissemination of the program in "real world" settings.
Participants in this study are randomly assigned to receive either CBP for eight weekly and 6 monthly continuation sessions or usual care. Depressive symptoms and disorders, levels of functioning, and medical and mental health care utilization are assessed at baseline and again at 2, 8, 20, and 32 months after intake.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessor were unaware of condition assignment
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A parent has had a depressive disorder during child's life
- •Adolescent has had a past depressive episode or has current subsyndromal depressive symptoms measured on the Center for Epidemiological Studies Depression Scale (CES-D)
Exclusion Criteria
- •adolescent or parent ever diagnosed with bipolar I or schizophrenia;
- •adolescent has a current DSM-IV mood disorder diagnosis
Arms & Interventions
1= Cognitive behavioral prevention of depression program
Participants receive a group cognitive-behavioral prevention program, which involved 8 weekly sessions and 6 monthly sessions of CBT skills such as cognitive restructuring, problem-solving, assertivenss, and behavioral activation. Participants in this arm also were able to seek the same kinds of nonstudy treatments as described in the usual care arm.
Intervention: Cognitive-behavioral prevention program (Behavioral)
2 = Usual care
Participants receive usual care, which involves any type of treatment (e.g., psychotherapy, counseling, pharmacotherapy).
Intervention: Usual care (Other)
Outcomes
Primary Outcomes
Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4)
Time Frame: Time to a score of 4 or higher between baseline and 9 months using survival analysis
a score of 4 or greater is considered an onset
Secondary Outcomes
- Number of depression-free days(Measured continuously through Month 33)
Investigators
Judith Garber
Professor
Vanderbilt University