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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00601224 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Behavioral: Social cognition and interaction training (SCIT) Behavioral: Treatment as usual (TAU) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Social Cognition and Interaction Training for Schizophrenia |
| Estimated Enrollment: | 64 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Participants will receive social cognition and interaction training plus treatment as usual
|
Behavioral: Social cognition and interaction training (SCIT)
SCIT is a group-based treatment that has the goal of improving social cognition and social functioning for individuals with psychotic disorders. SCIT is composed of three phases: emotion training, figuring out situations, and integration. SCIT will be delivered by two therapists in 20 weekly sessions over 5 months.
Behavioral: Treatment as usual (TAU)
TAU will involve routine care and meeting with case-managers and healthcare providers on an as-needed basis.
|
|
Active Comparator: 2
Participants will receive treatment as usual
|
Behavioral: Treatment as usual (TAU)
TAU will involve routine care and meeting with case-managers and healthcare providers on an as-needed basis.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Piper S. Meyer, PhD | 919-843-5262 | psmeyer@email.unc.edu |
| United States, North Carolina | |
| University of North Carolina Hospitals | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: David L. Penn, PhD | |
| Principal Investigator: | David L. Penn, PhD | University of North Carolina, Chapel Hill |
More Information
| Responsible Party: | David L. Penn, PhD, University of North Carolina at Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00601224 History of Changes |
| Other Study ID Numbers: | R34 MH080010, DATR A2-AISZ |
| Study First Received: | January 15, 2008 |
| Last Updated: | March 12, 2009 |
| Health Authority: | United States: Federal Government |
|
Social Cognition Group Therapy Psychosocial Intervention |
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |