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| Tracking Information | |||||
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| First Received Date ICMJE | July 3, 2001 | ||||
| Last Updated Date | January 5, 2009 | ||||
| Start Date ICMJE | May 2000 | ||||
| Primary Completion Date | April 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00018629 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cognitive - Behavioral Therapy | ||||
| Official Title ICMJE | Rehabilitation of Older Patients With Schizophrenia | ||||
| Brief Summary | The purpose of this study is to determine if Cognitive - Behavioral Social Skills Training (CBSST) improves functioning in older patients with schizophrenia. |
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| Detailed Description | This is a randomized-control clinical trial. After completion the baseline assessment, subjects will be randomly assigned to either standard pharmacotherapy or SP+CBSST and will be followed for 18 months. The subjects will be 180 outpatients over the age of 45 with a diagnosis of schizophrenia or schizoaffective disorder. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Other: N /A | ||||
| Study Arms / Comparison Groups | |||||
| 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 | Completed | ||||
| Enrollment ICMJE | 76 | ||||
| Completion Date | April 2005 | ||||
| Primary Completion Date | April 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patients must be 45 years of age or older with a diagnosis of schizophrenia or schizoaffective disorder. Exclusion Criteria: |
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| Gender | Both | ||||
| Ages | 45 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00018629 | ||||
| Responsible Party | Granholm, Eric - Principal Investigator, Department of Veterans Affairs | ||||
| Study ID Numbers ICMJE | MHBS-043-99S | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | September 2008 | ||||
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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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