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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00904891
First Posted: May 20, 2009
Last Update Posted: March 12, 2014
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.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Oregon Research Institute
  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 (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 ]

Secondary Outcome Measures:
  • Score on Beck Depression Inventory (BDI) [ Time Frame: Measured at baseline; post-treatment; and after 6, 12, 18, and 24 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): NCT00904891


Locations
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Paul D. Rohde, PhD Oregon Research Institute
  More Information

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT00904891     History of Changes
Other Study ID Numbers: R01MH080853 ( U.S. NIH Grant/Contract )
DSIR 84-CTP
First Submitted: May 19, 2009
First Posted: May 20, 2009
Last Update Posted: March 12, 2014
Last Verified: March 2014

Keywords provided by Oregon Research Institute:
Adolescents
Prevention
Bibliotherapy

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


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