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.|
|ClinicalTrials.gov Identifier: NCT00073671|
Recruitment Status : Completed
First Posted : December 3, 2003
Last Update Posted : February 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Cognitive-behavioral prevention program Other: Usual care||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||316 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcome assessor were unaware of condition assignment|
|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|
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
- 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 ]
- Number of depression-free days [ Time Frame: Measured continuously through Month 33 ]
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 ClinicalTrials.gov identifier (NCT number): NCT00073671
|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|
|Nashville, Tennessee, United States, 37203-5721|
|Principal Investigator:||Judy Garber, PhD||Vanderbilt University|