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

Primary Purpose

Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive-behavioral group
Cognitive-behavioral bibliotherapy
Sponsored by
Oregon Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Adolescents, Prevention, Bibliotherapy

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • High school student
  • Subthreshold depressive symptoms

Exclusion Criteria:

  • Meets criteria for major depression or dysthymia

Sites / Locations

  • Oregon Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

1

2

3

Arm Description

Participants will receive a cognitive-behavioral group intervention.

Participants will receive cognitive-behavioral bibliotherapy.

Participants will only complete study assessments.

Outcomes

Primary Outcome Measures

Depressive symptoms obtained from Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS)

Secondary Outcome Measures

Score on Beck Depression Inventory (BDI)

Full Information

First Posted
May 19, 2009
Last Updated
March 10, 2014
Sponsor
Oregon Research Institute
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00904891
Brief Title
Testing the Effectiveness of Adolescent Depression Prevention Programs (The OregonBlues Study)
Official Title
Effectiveness Trial of an Adolescent Depression Prevention Program
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Adolescents, Prevention, Bibliotherapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
390 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive a cognitive-behavioral group intervention.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive cognitive-behavioral bibliotherapy.
Arm Title
3
Arm Type
No Intervention
Arm Description
Participants will only complete study assessments.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral group
Intervention Description
Six sessions of cognitive-behavioral depression prevention group intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral bibliotherapy
Intervention Description
Cognitive-behavioral bibliotherapy, delivered from the book "Feeling Good"
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Score on Beck Depression Inventory (BDI)
Time Frame
Measured at baseline; post-treatment; and after 6, 12, 18, and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: High school student Subthreshold depressive symptoms Exclusion Criteria: Meets criteria for major depression or dysthymia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul D. Rohde, PhD
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

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

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