Cognitive-Behavioral Therapy in Veterans With Schizophrenia
| Tracking Information | |||||
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| First Received Date ICMJE | May 28, 2008 | ||||
| Last Updated Date | December 6, 2012 | ||||
| Start Date ICMJE | April 2009 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
BPRS, SAS, distress from symptoms [ Time Frame: post-treatment and 6 month follow-up ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
BPRS, SAS [ Time Frame: post-treatment and 3 month follow-up ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00688259 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 | Cognitive-Behavioral Therapy in Veterans With Schizophrenia | ||||
| Official Title ICMJE | Cognitive-Behavioral Therapy in Veterans With Schizophrenia | ||||
| Brief Summary | This is a study comparing the benefits of two types of individual psychotherapy (cognitive-behavioral therapy for psychosis and supportive therapy) in outpatients with schizophrenia or schizoaffective disorder. Treatment lasts 6 months and there are multiple assessment points. |
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| Detailed Description | This is a randomized controlled trial comparing 6 months of participation in one of two active treatments, cognitive-behavior therapy for psychosis or supportive therapy. Assessments of clinical status and social functioning will be obtained at baseline, mid-treatment, end of treatment, and 6 month follow-up. We hypothesize that participation in the cognitive-behavioral therapy will lead to greater reductions in symptoms and improvements in social functioning. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 122 | ||||
| Estimated Completion Date | September 2013 | ||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: outpatients with schizophrenia or schizoaffective disorder in proximity to the West Los Angeles VAMC at least one month since last hospitalization stable antipsychotic medication persisting psychotic symptoms with at least minimal distress competent to sign informed consent. Exclusion Criteria: in other individual psychotherapy presence of organic brain disease mental retardation or illness that would prohibit regular attendance in therapy substance dependence diagnosis in the past 6 months. |
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| Gender | Both | ||||
| Ages | 18 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00688259 | ||||
| Other Study ID Numbers ICMJE | MHBB-016-07S | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | December 2012 | ||||
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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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