Group CBT for Depression and AOD Disorders (BRIGHT2)
| Tracking Information | |||||
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| First Received Date ICMJE | June 29, 2010 | ||||
| Last Updated Date | November 10, 2011 | ||||
| Start Date ICMJE | September 2006 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT01154309 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Group CBT for Depression and AOD Disorders | ||||
| Official Title ICMJE | Group Cognitive Behavioral Therapy for Depression and Alcohol and Other Drug Disorders | ||||
| Brief Summary | The investigators will adapt and test an existing treatment (group CBT for depression) for use in outpatient substance use treatment settings as delivered by trained substance use counselors. The investigators expect that treatment will lead to improved depression and substance use outcomes. |
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| Detailed Description | Aim 1. To adapt an existing group therapy (CBT for depression), creating a manualized treatment and accompanying implementation measures and tools for use with clients with persistent depressive symptoms and AOD disorders and to obtain preliminary assessments of the treatment from patient and provider perspectives. Aim 2. To conduct a pilot test of the revised treatment in which we (a) demonstrate that when the therapy is implemented with fidelity, clinically significant reductions in depressive symptoms and AOD use occur; (b) estimate the likely effect size; and (c) investigate the underlying mechanisms of change, including both cognitive-behavioral and group processes and their relationship to depression and AOD treatment outcomes. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Group CBT for Depression and AOD Disorders
18 sessions of 2-hour group CBT |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 73 | ||||
| Completion Date | September 2009 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01154309 | ||||
| Other Study ID Numbers ICMJE | R01DA020159 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | RAND | ||||
| Study Sponsor ICMJE | RAND | ||||
| Collaborators ICMJE | Behavioral Health Services, Inc. | ||||
| Investigators ICMJE |
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| Information Provided By | RAND | ||||
| Verification Date | November 2011 | ||||
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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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