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Testing the Effectiveness of Adolescent Depression Prevention Programs (The OregonBlues Study)
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), June 2009
First Received: May 19, 2009   Last Updated: June 25, 2009   History of Changes
Sponsor: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00904891
  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 II
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title: Effectiveness Trial of an Adolescent Depression Prevention Program

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment: 390
Study Start Date: January 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants will receive a cognitive-behavioral group intervention.
Behavioral: Cognitive-behavioral group
Six sessions of cognitive-behavioral depression prevention group intervention
2: Active Comparator
Participants will receive cognitive-behavioral bibliotherapy.
Behavioral: Cognitive-behavioral bibliotherapy
Cognitive-behavioral bibliotherapy, delivered from the book "Feeling Good"
3: No Intervention
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00904891

Contacts
Contact: Paul D. Rohde, PhD 541-484-2123 ext 2120 paulr@ori.org
Contact: Eric Stice, PhD 541-483-2123 ext 2199 estice@ori.org

Locations
United States, Oregon
Oregon Research Institute Recruiting
Eugene, Oregon, United States, 97403
Contact: John Santin, MA     541-484-2123 ext 2217     jsantin@ori.org    
Contact: Paul D. Rohde, PhD     541-484-2123 ext 2120     paulr@ori.org    
Principal Investigator: Paul D. Rohde, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Paul D. Rohde, PhD Oregon Research Institute
  More Information

No publications provided

Responsible Party: Oregon Research Institute ( Paul D. Rohde, PhD )
Study ID Numbers: R01 MH080853, DSIR 84-CTP
Study First Received: May 19, 2009
Last Updated: June 25, 2009
ClinicalTrials.gov Identifier: NCT00904891     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Adolescents
Prevention
Bibliotherapy

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

ClinicalTrials.gov processed this record on November 20, 2009