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| Descriptive Information Fields | |||||
| Brief Title † | Cognitive Behavioral Social Skills Training for Improving Social Functioning in People With Schizophrenia | ||||
| Official Title † | Cognitive Behavioral Skills Training for Schizophrenia | ||||
| Brief Summary | This study will evaluate the effectiveness of cognitive behavioral social skills training versus supportive contact in improving social functioning in people with schizophrenia. |
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| Detailed Description | Schizophrenia is a chronic, severe, and disabling brain disorder. People with schizophrenia sometimes hear voices others don't hear, believe that others are broadcasting their thoughts to the world, or become convinced that others are plotting to harm them. These symptoms make it difficult for people with schizophrenia to interact normally and establish healthy social relationships with others. Cognitive behavioral social skills training (CBSST) is a group behavioral therapy intervention that focuses on improving cognitive and metacognitive impairments and social skills deficits that interfere with normal functioning in people with schizophrenia. Supportive contact (SC) is a group therapy intervention that focuses on helping people with schizophrenia to verbalize their problems or worries and to seek advice from fellow group members. This study will evaluate the effectiveness of CBSST versus SC in improving social functioning in people with schizophrenia. The study will also assess changes in cognition, psychotic symptoms, and use of psychiatric healthcare services. Participants in this open label study will be randomly assigned to one of the following treatment groups: treatment as usual (TAU) plus CBSST or TAU plus SC. Both interventions will hold 2-hour therapy sessions weekly for 36 weeks. Groups receiving each intervention will not exceed ten people. CBSST will integrate cognitive therapy, social skills training, and neurocognitive compensatory aids. Cognitive therapy will help participants challenge unhelpful thoughts and build communication and problem-solving skills. Participants will receive workbooks that describe the skills and contain homework assignments. SC will focus on empowering participants to share problems, worries, or concerns with others who face similar issues. Participants will share advice amongst each other, but therapists will not teach skills. Outcomes will be assessed at Months 4.5, 9, 15, and 21 for all participants. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Social Functioning: Independent Living Skills Survey (ILSS), PSR Toolkit, MASC [ Time Frame: Measured at baseline and Months 15 and 21 ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Neuropsychological functioning: MATRICS (BACS Category & Letter, BACS Symbol Coding, Trails A & B, WAIS letter Number Span, WMS Spatial Span, HVLT, BVMT), D-KEFS (20 questions, Card Sorting, Word Context), [ Time Frame: Measured at baseline and Months 15 and 21 ] [ Designated as safety issue: No ] Cognitive insight: Birchwood Insight Scale, Beck Cognitive Insight Scale [ Time Frame: Measured at baseline and Months 4.5, 9, 15, and 21 ] [ Designated as safety issue: No ] Psychotic symptoms: PANSS, PSY-RATS, Paranoia Scale, Beliefs About Voices Questionnaire (BAVQ-R) [ Time Frame: Measured at baseline and Months 4.5, 9, 15, and 21 ] [ Designated as safety issue: No ] Health services utilization: PSR Toolkit [ Time Frame: Measured at baseline and Months 9 and 21 ] [ Designated as safety issue: No ] |
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| Condition † | Schizophrenia | ||||
| Intervention † | Behavioral: Cognitive behavioral social skills training (CBSST) Behavioral: Goal oriented supportive contact (SC) Behavioral: Social Skills Training Behavioral: Goal Setting |
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| MEDLINE PMIDs | 15741469, 11728848, 10896740, 1389037, 17503982 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 240 | ||||
| Start Date † | June 2005 | ||||
| Completion Date | June 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00338975 | ||||
| Organization ID | R01 MH71410 | ||||
| Secondary IDs †† | DSIR 83-ATAP | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | February 2008 | ||||
| First Received Date † | June 16, 2006 | ||||
| Last Updated Date | February 12, 2008 | ||||