Depression Prevention Program for Adolescents

• Sponsor: University of Texas at Austin (Other)
• Overall Status: Completed
• CT.gov ID: NCT00183417
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 350
• Location: 1
• Arms: 4
• Duration (Months): 56
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

This study will compare the effectiveness of two programs designed to prevent depression in adolescents.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Cognitive behavior therapy (CBT); Behavioral: Supportive/expressive (S/E) therapy; Behavioral: Bibliotherapy	N/A

Detailed Description

Major depression is one of the most common psychiatric disorders in adolescents. In many cases, the condition is recurrent and can result in serious psychological impairment. A high number of depressed adolescents never receive treatment; therefore, it is crucial to develop prevention programs for this disorder that are effective and can be easily disseminated. This study will evaluate and compare the effectiveness of cognitive behavior therapy (CBT) and supportive/expressive (S/E) therapy in preventing depressive symptoms in adolescents.

This study will last 2 years. Participants will be randomly assigned to receive six sessions of CBT, S/E therapy, or standard depression education over 2 years. The CBT intervention will focus on reducing negative thoughts and increasing engagement in pleasant activities. S/E therapy is designed to allow adolescents to express their negative emotions and talk about recent stressful events in a supportive environment of their peers. Surveys and psychiatric interviews will be completed by all participants and their parents at the beginning and the end of the study. The surveys and interviews will assess depressive symptoms.

Study Design

• Study Type: Interventional
• Actual Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Depression Prevention Program for High-Risk Adolescents
• Study Start Date: Sep 1, 2004
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Participants will receive cognitive behavioral therapy	Behavioral: Cognitive behavior therapy (CBT); Participants will complete worksheets and group discussion on how to increase positive mood and activity.
Active Comparator: 2 Participants will receive supportive/expressive therapy	Behavioral: Supportive/expressive (S/E) therapy; Participants will be encouraged to express feelings and emotions without advice giving.
Active Comparator: 3 Participants will receive bibliotherapy	Behavioral: Bibliotherapy; Participants will be given a book on how to increase their mood.
No Intervention: 4 Participants in the control condition will receive no treatment

Outcome Measures

Primary Outcome Measures

1. Depressive symptoms [Measured at Year 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Beck Depression Inventory score higher than 10

• Parent or guardian willing to provide informed consent

Exclusion Criteria:

• Diagnosis of depression

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas at Austin	Austin	Texas	United States	78712

Sponsors and Collaborators

• University of Texas at Austin
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Eric M. Stice, PhD, University of Texas at Austin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Texas at Austin
• ClinicalTrials.gov Identifier: NCT00183417
• Other Study ID Numbers: R01MH067183; R01MH067183; DSIR 84-CTP
• First Posted: Sep 16, 2005
• Last Update Posted: Apr 25, 2012
• Last Verified: Apr 1, 2012

• Keywords provided by University of Texas at Austin: Adolescent; CBT
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Apr 25, 2012