Prevention of Depression in At-Risk Adolescents

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Cognitive-behavioral prevention program; Other: Usual care

• Registration Number: NCT00073671
• Lead Sponsor: Vanderbilt University

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 Timeline

• Study Start: 2003-03
• Study First Submitted: 2003-12-02
• Study First Submitted QC: 2003-12-02
• Study First Posted: 2003-12-03
• Primary Completion: 2006-03
• Study Completion: 2009-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-25
• Last Update Posted: 2022-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1= Cognitive behavioral prevention of depression program	Cognitive-behavioral prevention 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.
2 = Usual care	Usual care	Participants receive usual care, which involves any type of treatment (e.g., psychotherapy, counseling, pharmacotherapy).

Primary Outcome Measures

Name	Time	Method
Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4)	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 Outcome Measures

Name	Time	Method
Number of depression-free days	Measured continuously through Month 33	Using the depression symptom ratings (DSR) (1-6), each week is given a score of 1 to 6; depression-free days are those with ratings of 1 or 2 on the DSR.

Trial Locations

Locations (4)

Kaiser Permanente Center for Health Research; 🇺🇸 Portland, Oregon, United States

Harvard University Medical School; 🇺🇸 Boston, Massachusetts, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States