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Cognitive Behavioral Social Skills Training for Improving Social Functioning in People With Schizophrenia
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), September 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00338975
  Purpose

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


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

MedlinePlus related topics: Psychotic Disorders Schizophrenia
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Cognitive Behavioral Skills Training for Schizophrenia

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: June 2005
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants will receive cognitive behavioral social skills training
Behavioral: Cognitive behavioral social skills training (CBSST)
There are 36 weekly group sessions, each session is 2 hours in length, with a half-hour break after the first hour. The intervention integrates CBT and SST techniques and neurocognitive compensatory aids. All participants are asked to identify a goal. The SST components are based, in part, on a pre-packaged SST intervention available from Psychiatric Rehabilitation Consultants. The CBT components are based on techniques developed for CBT in general and techniques developed specifically for patients with schizophrenia. Cognitive therapy is combined with role-play practice of communication skills and problem-solving training.
Behavioral: Social Skills Training
The SST components are based, in part, on a pre-packaged SST intervention available from Psychiatric Rehabilitation Consultants. Participants engage in role plays and problem solving.
Behavioral: Goal Setting
All participants are asked to identify a personally meaningful goal as soon as possible in therapy. Over the 36 weeks, Participants in CBSST learn skills related to goal attainment, while participants in SC do not recieve skills aimed at goal attainment, but are encouraged to discuss their goals .
2: Active Comparator
Participants will receive goal oriented supported contact
Behavioral: Goal oriented supportive contact (SC)
There are 36 weekly group sessions, each 2 hours in length, with a half-hour break after the first hour. SC has a number of specific goals and interventions, including providing a safe environment where the patient can discuss her/his feelings and concerns; to validate these feelings and concerns; and to provide support and guidance to the client so that she/he can make progress to solving problems or alleviating concerns and worries. Psychotic symptoms and cognition are not directly targeted. The therapists will utilize "non-specific" therapeutic techniques, including providing unconditional positive regard, reflective listening, encouraging, paraphrasing, and summarizing. Therapists will not develop a formulation or teach skills.
Behavioral: Goal Setting
All participants are asked to identify a personally meaningful goal as soon as possible in therapy. Over the 36 weeks, Participants in CBSST learn skills related to goal attainment, while participants in SC do not recieve skills aimed at goal attainment, but are encouraged to discuss their goals .

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338975

Contacts
Contact: Catherine Loh, PhD 858-552-8585 ext 7386 cloh@ucsd.edu

Locations
United States, California
VA San Diego Healthcare System Recruiting
San Diego, California, United States, 92161
Contact: Sherry Edwards     858-552-8585 ext 2275     sedwards@ucsd.edu    
Principal Investigator: Eric L. Granholm, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Eric L. Granholm, PhD VA San Diego Healthcare System/University of California San Diego
  More Information

Publications:
Responsible Party: Veterans Medical research Foundation ( Eric L. Granholm, PhD )
Study ID Numbers: R01 MH71410, DSIR 83-ATAP
Study First Received: June 16, 2006
Last Updated: September 18, 2008
ClinicalTrials.gov Identifier: NCT00338975  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Psychotic Disorders
Schizoaffective Disorder
Cognitive Behavioral Therapy
Social Skills Training

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 30, 2009