Prevention of Depression in At-Risk Adolescents

Sponsor
Vanderbilt University (Other)
Overall Status
Completed
CT.gov ID
NCT00073671
Collaborator
National Institute of Mental Health (NIMH) (NIH)
316
4
2
70.1
79
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive-behavioral prevention program
  • Other: Usual care
N/A

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
Actual Enrollment :
316 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcome assessor were unaware of condition assignment
Primary Purpose:
Prevention
Official Title:
Prevention of Depression in At-Risk Adolescents
Study Start Date :
Mar 1, 2003
Actual Primary Completion Date :
Mar 1, 2006
Actual Study Completion Date :
Jan 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: Cognitive-behavioral prevention program
Cognitive-behavioral prevention program includes 8 weekly and 6 monthly group sessions.

Active Comparator: 2 = Usual care

Participants receive usual care, which involves any type of treatment (e.g., psychotherapy, counseling, pharmacotherapy).

Other: Usual care
Participants receive usual care

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 17 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Harvard University Medical School Boston Massachusetts United States 02115-5794
2 Kaiser Permanente Center for Health Research Portland Oregon United States 97227
3 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213-2593
4 Vanderbilt University Nashville Tennessee United States 37203-5721

Sponsors and Collaborators

  • Vanderbilt University
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Judy Garber, PhD, Vanderbilt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Judith Garber, Professor, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00073671
Other Study ID Numbers:
  • R01MH064735
  • R01MH064735
  • DSIR 84-CTP
  • R01MH064503
  • R01MH064541
  • R01MH064717
First Posted:
Dec 3, 2003
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022
Keywords provided by Judith Garber, Professor, Vanderbilt University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2022