Testing the Effectiveness of Adolescent Depression Prevention Programs (The OregonBlues Study)

Depression Clinical Trial

Official title:

Effectiveness Trial of an Adolescent Depression Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00904891
• Other study ID #: R01MH080853
• Secondary ID: R01MH080853DSIR
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 19, 2009
• Last updated: March 10, 2014
• Start date: January 2009
• Est. completion date: November 2013

Study information

• Verified date: March 2014
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will test the effectiveness of two programs for preventing depression in adolescents.

Description:

Major depression is one of the most common psychiatric disorders experienced by adolescents. Even adolescents with depressive symptoms below the level of diagnosis are at increased risk of a range of future problems, such as psychiatric disorders, impaired social functioning, and substance abuse.

Depression prevention therapies have had mixed results. Those that are implemented universally have shown little efficacy, although those that specifically target adolescents at risk of depression have shown greater efficacy. A large scale effectiveness trial—one that applies treatments outside of a lab in "real world" settings—of a targeted depression prevention therapy has not been conducted. This study will test the effectiveness of two therapies for preventing depression in adolescents. The first is a brief, group cognitive-behavioral depression prevention program, and the second is bibliotherapy, which involves giving participants a self-help book for depression. Bibliotherapy has shown efficacy in previous research but has not been examined in an effectiveness trial.

Participation in this study will last 24 months. Participants will be randomly assigned to one of three conditions: a six-session, cognitive-behavioral depression prevention group; a bibliotherapy group; and an assessment only group. Participants in the cognitive-behavioral group will meet with a study therapist and other group members to learn strategies for preventing depression. Participants in the bibliotherapy group will be given a self-help book titled "Feeling Good" with information on preventing depression. Participants in the assessment only group will receive a pamphlet on depression symptoms and treatment. All participants will complete assessments at baseline; after the cognitive-behavioral group has been completed; and at 6-, 12-, 18-, and 24-month follow-ups. These assessments will include an interview about depression symptoms and a survey about thoughts, feelings, actions, depression, and substance abuse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: November 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 19 Years

Eligibility

Inclusion Criteria:

• High school student

• Subthreshold depressive symptoms

Exclusion Criteria:

• Meets criteria for major depression or dysthymia

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Cognitive-behavioral group
Six sessions of cognitive-behavioral depression prevention group intervention
• Cognitive-behavioral bibliotherapy
Cognitive-behavioral bibliotherapy, delivered from the book "Feeling Good"

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Research Institute	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms obtained from Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS)		Measured at baseline; post-treatment; and after 6, 12, 18, and 24 months	Yes
Secondary	Score on Beck Depression Inventory (BDI)		Measured at baseline; post-treatment; and after 6, 12, 18, and 24 months	No