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Social Cognition and Interaction Training for Improving Social Functioning in People With Schizophrenia

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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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.

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.

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 ]
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 ]
Condition  Schizophrenia
Intervention  Behavioral: Social cognition and interaction training (SCIT)
Behavioral: Treatment as usual (TAU)
MEDLINE PMIDs
Links Click here for more information on Social Cognition and Interaction Training (SCIT) in this study This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  64
Start Date  June 2007
Completion Date June 2010
Eligibility Criteria 

Inclusion Criteria:

  • Meets DSM-IV criteria for schizophrenia or schizoaffective disorder, based on the Structured Interview of DSM-IV patient version (SCID-P)

Exclusion Criteria:

  • Meets current criteria for substance dependence, based on the SCID-P
  • Meets criteria for metal retardation (e.g., has an IQ of less than 80)
  • History of brain injuries
  • Difficulties interacting with others, based on ratings on items from the Social Functioning Scale that tap interactional skills
Gender Both
Ages 18 Years to 65 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Piper S. Meyer, PhD     919-843-5262     psmeyer@email.unc.edu    
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 
Principal Investigator:     David L. Penn, PhD     University of North Carolina    
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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