Prevention of Depression in At-Risk Adolescents - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00073671

Purpose

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	Intervention
Depression	Behavioral: Cognitive-behavioral prevention program Other: Usual care

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Prevention of Depression in At-Risk Adolescents

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4) [ Time Frame: Measured continuously through month 32 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of depression-free days [ Time Frame: Measured continuously through Month 32 ] [ Designated as safety issue: No ]

Enrollment:	316
Study Start Date:	March 2003
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants receive a group cognitive-behavioral prevention program	Behavioral: Cognitive-behavioral prevention program Cognitive-behavioral prevention program includes 8 weekly and 6 monthly group sessions.
2: Active Comparator Participants receive usual care	Other: Usual care Participants receive usual care

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.

Eligibility

Ages Eligible for Study:	13 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 CES-D

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073671

Locations

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

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Judy Garber, PhD

Vanderbilt University

More Information

Publications:

Clarke GN, Hornbrook M, Lynch F, Polen M, Gale J, Beardslee W, O'Connor E, Seeley J. A randomized trial of a group cognitive intervention for preventing depression in adolescent offspring of depressed parents. Arch Gen Psychiatry. 2001 Dec;58(12):1127-34.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Garber J, Clarke GN, Weersing VR, Beardslee WR, Brent DA, Gladstone TR, DeBar LL, Lynch FL, D'Angelo E, Hollon SD, Shamseddeen W, Iyengar S. Prevention of depression in at-risk adolescents: a randomized controlled trial. JAMA. 2009 Jun 3;301(21):2215-24.

Responsible Party:	Vanderbilt University ( Judy Garber )
Study ID Numbers:	R01 MH64735, DSIR 84-CTP
Study First Received:	December 2, 2003
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00073671 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Adolescent

Additional relevant MeSH terms:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on February 08, 2010