Prevention of Depression in At-Risk Adolescents

Depression Clinical Trial

Official title:

Prevention of Depression in At-Risk Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073671
• Other study ID #: R01MH064735
• Secondary ID: R01MH064735DSIR
• Status: Completed
• Phase: N/A
• Start date: March 2003
• Est. completion date: January 2009

Study information

• Verified date: January 2022
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: January 2009
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Other:
• Usual care
Participants receive usual care

Locations

Country	Name	City	State
United States	Harvard University Medical School	Boston	Massachusetts
United States	Vanderbilt University	Nashville	Tennessee
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Kaiser Permanente Center for Health Research	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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: 10.100 — View 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 Adol — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Measured continuously through Month 33