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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT00904891
First received: May 19, 2009
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Depression
Behavioral: Cognitive-behavioral group
Behavioral: Cognitive-behavioral bibliotherapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effectiveness Trial of an Adolescent Depression Prevention Program

Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Depressive symptoms obtained from Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS) [ Time Frame: Measured at baseline; post-treatment; and after 6, 12, 18, and 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Score on Beck Depression Inventory (BDI) [ Time Frame: Measured at baseline; post-treatment; and after 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]

Enrollment: 390
Study Start Date: January 2009
Study Completion Date: November 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive a cognitive-behavioral group intervention.
Behavioral: Cognitive-behavioral group
Six sessions of cognitive-behavioral depression prevention group intervention
Active Comparator: 2
Participants will receive cognitive-behavioral bibliotherapy.
Behavioral: Cognitive-behavioral bibliotherapy
Cognitive-behavioral bibliotherapy, delivered from the book "Feeling Good"
No Intervention: 3
Participants will only complete study assessments.

Detailed 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.

  Eligibility

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • High school student
  • Subthreshold depressive symptoms

Exclusion Criteria:

  • Meets criteria for major depression or dysthymia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904891

Locations
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
Investigators
Principal Investigator: Paul D. Rohde, PhD Oregon Research Institute
  More Information

No publications provided

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT00904891     History of Changes
Other Study ID Numbers: R01 MH080853, R01MH080853, DSIR 84-CTP
Study First Received: May 19, 2009
Last Updated: March 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Oregon Research Institute:
Adolescents
Prevention
Bibliotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 29, 2014