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Cognitive Behavioral Social Skills 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  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.

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.

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 ]
Condition  Schizophrenia
Intervention  Behavioral: Cognitive behavioral social skills training (CBSST)
Behavioral: Goal oriented supportive contact (SC)
Behavioral: Social Skills Training
Behavioral: Goal Setting
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:

  • DSM-IV diagnosis of schizophrenia or schizoaffective disorder at any stage of illness

Exclusion Criteria:

  • Level of care required at baseline interferes with outpatient group therapy participation (e.g., partial or inpatient hospitalization for psychiatric illness, substance use, or physical illness)
  • No case manager or care coordinator
  • Medically or psychiatrically unstable for outpatient therapy
  • Exposure to social skills training (SST), cognitive behavioral therapy (CBT), or dialectical behavioral therapy (DBT) within 5 years prior to study entry
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Catherine Loh, PhD     858-552-8585 ext 7386     cloh@ucsd.edu    
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 
Principal Investigator:     Eric L. Granholm, PhD     VA San Diego Healthcare System/University of California San Diego    
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

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




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