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Cognitive Behavioral Social Skills Training for Improving Social Functioning in People With Schizophrenia
This study is ongoing, but not recruiting participants.
Study NCT00338975   Information provided by National Institute of Mental Health (NIMH)
First Received: June 16, 2006   Last Updated: March 16, 2009   History of Changes

June 16, 2006
March 16, 2009
June 2005
June 2010   (final data collection date for 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 ]
Measured at Months 9, 15, and 21: Social Functioning
Complete list of historical versions of study NCT00338975 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Measured at Months 9, 15, and 21: Neuropsychological functioning
  • Cognitive insight
  • Psychotic symptoms
  • Health services utilization
 
Cognitive Behavioral Social Skills Training for Improving Social Functioning in People With Schizophrenia
Cognitive Behavioral Skills Training for Schizophrenia

This study will evaluate the effectiveness of cognitive behavioral social skills training versus supportive contact in improving social functioning in people with schizophrenia.

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.

 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Schizophrenia
  • Behavioral: Cognitive behavioral social skills training (CBSST)
  • Behavioral: Goal oriented supportive contact (SC)
  • Behavioral: Social Skills Training
  • Behavioral: Goal Setting
  • Experimental: Participants will receive cognitive behavioral social skills training
  • Active Comparator: Participants will receive goal oriented supported contact

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
240
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00338975
Eric L. Granholm, PhD, Veterans Medical research Foundation
R01 MH071410, DSIR 83-ATAP
National Institute of Mental Health (NIMH)
 
Principal Investigator: Eric L. Granholm, PhD VA San Diego Healthcare System/University of California San Diego
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP