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| Descriptive Information Fields | |||||
| Brief Title † | Social Cognition and Interaction Training for Improving Social Functioning in People With Schizophrenia | ||||
| Official Title † | Social Cognition and Interaction Training for Schizophrenia | ||||
| Brief Summary | This study will determine the effectiveness of social cognition and interaction training, a manual-based group therapy program, in helping people with schizophrenia improve their social cognition and social functioning. |
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| Detailed Description | Schizophrenia is a serious mental condition that affects approximately 1.1% of adults in the United States. People with schizophrenia experience reality perception impairments, which most commonly manifest as hallucinations, extreme paranoia, social withdrawal, and disordered thinking. Deficits in social functioning are a core feature of schizophrenia. In an effort to improve social functioning, there has been growing interest in identifying factors that underlie psychosocial impairments. One such identified factor has been neurocognition, but treatments that target solely cognitive processes do not always help overall social functioning. Social cognition and interaction training (SCIT), a group-based treatment that aims to improve both processing social information and functioning, may be an effective treatment for enhancing the social skills of people with schizophrenia. This study will compare the effectiveness of SCIT versus treatment as usual (TAU) in helping people with schizophrenia improve their social cognition and social functioning. Participation in this single-blind study will last 11 months. All potential participants will undergo initial screening, involving the completion of a few brief tasks testing social functioning. Eligible participants will then be randomly assigned to receive SCIT plus TAU or TAU alone. Participants assigned to receive SCIT will attend twenty 1-hour weekly group sessions over 5 months. During these sessions, participants will learn ways to manage emotions, work through problems, and integrate into social situations. Participants assigned to TAU alone will meet with their case managers and healthcare provider on an as-needed basis. All participants will undergo assessments of social cognition, social functioning, and psychotic symptoms prior to treatment, immediately post-treatment, and 6 months after treatment. Each assessment will last 3 hours and will include interviews, questionnaires, and a variety of tasks testing social skills. Researchers will also contact a family member or significant other about the participant's social functioning at the same three assessment times noted above. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment | ||||
| Primary Outcome Measure † | Face Emotion Identification Task (FEIT) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ] Face Emotion Discrimination Task (FEDT) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ] The Hinting Task [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ] The Awareness of Social Inference Test (TASIT) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ] Ambiguous Intentions Hostility Questionnaire(AIHQ) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | "Beads in the Jar" Task [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ] Quality of Life Scale (QLS) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ] Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ] Social Skills Performance Assessment (SSPA) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ] Schizophrenia Cognition Rating Scale (SCoRS) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ] Overt Social Cognition: A Rating Scale (OSCARS) [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ] Lecomte Self-Esteem Scale [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: No ] Number of Hospital Admissions [ Time Frame: Measured at baseline, post-treatment, and 6-month follow-up ] [ Designated as safety issue: Yes ] |
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| Condition † | Schizophrenia | ||||
| Intervention † | Behavioral: Social cognition and interaction training (SCIT) Behavioral: Treatment as usual (TAU) |
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| MEDLINE PMIDs | |||||
| Links | Click here for more information on Social Cognition and Interaction Training (SCIT) in this study ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 64 | ||||
| Start Date † | June 2007 | ||||
| Completion Date | June 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00601224 | ||||
| Organization ID | R34 MH80010 | ||||
| Secondary IDs †† | DATR A2-AISZ | ||||
| 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 † | January 15, 2008 | ||||
| Last Updated Date | February 7, 2008 | ||||