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| Sponsor: | Oregon Research Institute |
|---|---|
| Collaborator: |
National Institute of Mental Health (NIMH) |
| Information provided by (Responsible Party): | Oregon Research Institute |
| 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: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Effectiveness Trial of an Adolescent Depression Prevention Program |
| 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 |
|---|---|
|
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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
| 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 | |
| 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: | R01 MH080853, R01MH080853, DSIR 84-CTP |
| Study First Received: | May 19, 2009 |
| Last Updated: | January 12, 2012 |
| Health Authority: | United States: Federal Government |
|
Adolescents Prevention Bibliotherapy |
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |