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Prevention of Depression in At-Risk Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00073671
Recruitment Status : Completed
First Posted : December 3, 2003
Last Update Posted : February 7, 2020
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Judith Garber, 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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Cognitive-behavioral prevention program Other: Usual care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : March 2003
Actual Primary Completion Date : March 2006
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
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
Participants receive usual care, which involves any type of treatment (e.g., psychotherapy, counseling, pharmacotherapy).
Other: Usual care
Participants receive usual care

Primary Outcome Measures :
  1. Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4) [ Time Frame: Measured continuously through month 33 ]

Secondary Outcome Measures :
  1. Number of depression-free days [ Time Frame: Measured continuously through Month 33 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00073671

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United States, Massachusetts
Harvard University Medical School
Boston, Massachusetts, United States, 02115-5794
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213-2593
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37203-5721
Sponsors and Collaborators
Vanderbilt University
National Institute of Mental Health (NIMH)
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Principal Investigator: Judy Garber, PhD Vanderbilt University
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Judith Garber, Professor, Vanderbilt University Identifier: NCT00073671    
Other Study ID Numbers: R01MH064735 ( U.S. NIH Grant/Contract )
R01MH064735 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2003    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Keywords provided by Judith Garber, Vanderbilt University:
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders