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| Tracking Information | |||||||||
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| First Received Date ICMJE | May 19, 2009 | ||||||||
| Last Updated Date | June 25, 2009 | ||||||||
| Start Date ICMJE | January 2009 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Change History | Complete list of historical versions of study NCT00904891 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Testing the Effectiveness of Adolescent Depression Prevention Programs (The OregonBlues Study) | ||||||||
| Official Title ICMJE | Effectiveness Trial of an Adolescent Depression Prevention Program | ||||||||
| Brief Summary | This study will test the effectiveness of two programs for preventing depression in adolescents. |
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| 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. |
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| Study Phase | Phase II, Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment | ||||||||
| Condition ICMJE | Depression | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 390 | ||||||||
| Estimated Completion Date | November 2013 | ||||||||
| Estimated Primary Completion Date | May 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 13 Years to 19 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00904891 | ||||||||
| Responsible Party | Paul D. Rohde, PhD, Oregon Research Institute | ||||||||
| Study ID Numbers ICMJE | R01 MH080853, DSIR 84-CTP | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | June 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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