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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00338975 |
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 |
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Schizophrenia |
Behavioral: Cognitive behavioral social skills training (CBSST) Behavioral: Goal oriented supportive contact (SC) Behavioral: Social Skills Training Behavioral: Goal Setting |
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 |
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 |
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1: Experimental
Participants will receive cognitive behavioral social skills training
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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 .
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2: Active Comparator
Participants will receive goal oriented supported contact
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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 .
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Catherine Loh, PhD | 858-552-8585 ext 7386 | cloh@ucsd.edu |
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 |
Principal Investigator: | Eric L. Granholm, PhD | VA San Diego Healthcare System/University of California San Diego |
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 |
Psychotic Disorders Schizoaffective Disorder Cognitive Behavioral Therapy Social Skills Training |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |