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Prevention of Depression in At-Risk Adolescents

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-behavioral prevention program
Usual care
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Adolescent

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Harvard University Medical School
  • Kaiser Permanente Center for Health Research
  • University of Pittsburgh Medical Center
  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1= Cognitive behavioral prevention of depression program

2 = Usual care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of depression-free days
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.

Full Information

First Posted
December 2, 2003
Last Updated
January 25, 2022
Sponsor
Vanderbilt University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00073671
Brief Title
Prevention of Depression in At-Risk Adolescents
Official Title
Prevention of Depression in At-Risk Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Adolescent

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessor were unaware of condition assignment
Allocation
Randomized
Enrollment
316 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1= Cognitive behavioral prevention of depression program
Arm Type
Experimental
Arm Description
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.
Arm Title
2 = Usual care
Arm Type
Active Comparator
Arm Description
Participants receive usual care, which involves any type of treatment (e.g., psychotherapy, counseling, pharmacotherapy).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral prevention program
Intervention Description
Cognitive-behavioral prevention program includes 8 weekly and 6 monthly group sessions.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Participants receive usual care
Primary Outcome Measure Information:
Title
Onset of a probable or definite depressive episodes (i.e., Depression Symptom Rating greater or equal to 4)
Description
a score of 4 or greater is considered an onset
Time Frame
Time to a score of 4 or higher between baseline and 9 months using survival analysis
Secondary Outcome Measure Information:
Title
Number of depression-free days
Description
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.
Time Frame
Measured continuously through Month 33

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judy Garber, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard University Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-5794
Country
United States
Facility Name
Kaiser Permanente Center for Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2593
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-5721
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19491183
Citation
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.
Results Reference
result
PubMed Identifier
24005242
Citation
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.
Results Reference
result
PubMed Identifier
26421861
Citation
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.
Results Reference
result
PubMed Identifier
30929618
Citation
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.
Results Reference
derived
PubMed Identifier
26903255
Citation
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.
Results Reference
derived

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Prevention of Depression in At-Risk Adolescents

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