Prevention of Depression in At-Risk Adolescents

January 25, 2022 updated by: Judith Garber, Vanderbilt University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

316

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115-5794
        • Harvard University Medical School
    • Oregon
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Center for Health Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-2593
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203-5721
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time to a score of 4 or higher between baseline and 9 months using survival analysis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of depression-free days
Time Frame: 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.
Measured continuously through Month 33

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Institute of Mental Health (NIMH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

December 2, 2003

First Submitted That Met QC Criteria

December 2, 2003

First Posted (Estimate)

December 3, 2003

Study Record Updates

Last Update Posted (Actual)

January 31, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH064735 (U.S. NIH Grant/Contract)
  • DSIR 84-CTP (NIH)
  • R01MH064503 (U.S. NIH Grant/Contract)
  • R01MH064541 (U.S. NIH Grant/Contract)
  • R01MH064717 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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