NCT00073671

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Mar 2003

Longer than P75 for not_applicable depression

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2003

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

3 years

First QC Date

December 2, 2003

Last Update Submit

January 25, 2022

Conditions

Keywords

Adolescent

Outcome Measures

Primary Outcomes (1)

  • Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4)

    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 Outcomes (1)

  • Number of depression-free days

    Measured continuously through Month 33

Study Arms (2)

1= Cognitive behavioral prevention of depression program

EXPERIMENTAL

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

2 = Usual care

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

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

1= Cognitive behavioral prevention of depression program

Participants receive usual care

2 = Usual care

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • adolescent or parent ever diagnosed with bipolar I or schizophrenia;
  • adolescent has a current DSM-IV mood disorder diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Harvard University Medical School

Boston, Massachusetts, 02115-5794, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213-2593, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203-5721, United States

Location

Related Publications (5)

  • 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. doi: 10.1001/jama.2009.788.

  • Beardslee WR, Brent DA, Weersing VR, Clarke GN, Porta G, Hollon SD, Gladstone TR, Gallop R, Lynch FL, Iyengar S, DeBar L, Garber J. Prevention of depression in at-risk adolescents: longer-term effects. JAMA Psychiatry. 2013 Nov;70(11):1161-70. doi: 10.1001/jamapsychiatry.2013.295.

  • Brent DA, Brunwasser SM, Hollon SD, Weersing VR, Clarke GN, Dickerson JF, Beardslee WR, Gladstone TR, Porta G, Lynch FL, Iyengar S, Garber J. Effect of a Cognitive-Behavioral Prevention Program on Depression 6 Years After Implementation Among At-Risk Adolescents: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Nov;72(11):1110-8. doi: 10.1001/jamapsychiatry.2015.1559.

  • Lynch FL, Dickerson JF, Clarke GN, Beardslee WR, Weersing VR, Gladstone TRG, Porta G, Brent DA, Mark TL, DeBar LL, Hollon SD, Garber J. Cost-Effectiveness of Preventing Depression Among At-Risk Youths: Postintervention and 2-Year Follow-Up. Psychiatr Serv. 2019 Apr 1;70(4):279-286. doi: 10.1176/appi.ps.201800144. Epub 2019 Jan 3.

  • Weersing VR, Shamseddeen W, Garber J, Hollon SD, Clarke GN, Beardslee WR, Gladstone TR, Lynch FL, Porta G, Iyengar S, Brent DA. Prevention of Depression in At-Risk Adolescents: Predictors and Moderators of Acute Effects. J Am Acad Child Adolesc Psychiatry. 2016 Mar;55(3):219-26. doi: 10.1016/j.jaac.2015.12.015. Epub 2016 Jan 18.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Judy Garber, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessor were unaware of condition assignment
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2003

First Posted

December 3, 2003

Study Start

March 1, 2003

Primary Completion

March 1, 2006

Study Completion

January 1, 2009

Last Updated

January 31, 2022

Record last verified: 2022-01

Locations