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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00237796 |
The primary purpose of this project is to evaluate the efficacy of a group therapy intervention, cognitive behavioral social skills training (CBSST), that teaches social functioning skills and cognitive-behavioral compensatory aids to older patients with schizophrenia. CBSST, therefore, targets the multidimensional deficits that lead to disability in aging veterans with severe mental illness.
Condition | Intervention |
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Psychotic Disorders Schizoaffective Disorder Schizophrenia |
Behavioral: Cognitive Behavioral Social Skills Training Behavioral: Goal Directed Supportive Care Contact |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Functional Rehabilitation of Older Patients With Schizophrenia |
Estimated Enrollment: | 100 |
Study Start Date: | February 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
CBSST
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Behavioral: Cognitive Behavioral Social Skills Training
Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
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2: Active Comparator
Goal Directed Supportive Care
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Behavioral: Goal Directed Supportive Care Contact
Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
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This is a randomized-controlled clinical trial comparing 2 treatment conditions: Goal focused supportive care (SC); and CBSST. Subjects (N=100) will be recruited, treated for 9 months and followed longitudinally for 9 months after treatment. A multidimensional evaluation of treatment outcome, including social functioning (primary outcome), neuropsychological functioning, cognitive insight, psychotic symptoms, and health services utilization, will be conducted at baseline, end of treatment (9-month follow-up), and 9 months post-treatment. 100 patients with schizophrenia or schizoaffective disorder will participate on a voluntary basis and will be paid $50.00 per assessment visit. Subjects will not be paid or given any incentive for treatment. The following inclusion/exclusion criteria will be used: (i) Voluntary informed consent for participation (given by the patient or conservator); (ii) Age 45 or older; (iii) DSM-IV-diagnosis (APA, 1994) of schizophrenia or schizoaffective disorder at any stage of illness; (iv) No prior exposure to SST or CBT in the past 5 years; (v) Level of care required at baseline does not interfere with outpatient group therapy participation (e.g., partial or inpatient hospitalization for psychiatric, or physical illness). We anticipate that we will be able to provide an empirically validated intervention that can be used by clinicians on multidisciplinary rehabilitation teams to reduce disability in aging patients with schizophrenia. The products from this research will be written research reports and a therapy manual and patient workbook to guide rehabilitation that can be disseminated (e.g., via the internet) to relevant clinicians.
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
- Has not received Cognitive Behavioral Therapy (CBT) or Social Skills Training (SST) or Dialectical Behavioral Therapy (DBT) in the past 5 years
United States, California | |
VA San Diego Healthcare System, San Diego | |
San Diego, California, United States, 92161 |
Principal Investigator: | Eric L. Granholm, PhD | VA San Diego Healthcare System, San Diego |
Responsible Party: | Department of Veterans Affairs ( Granholm, Eric - Principal Investigator ) |
Study ID Numbers: | O3341R |
Study First Received: | October 7, 2005 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00237796 |
Health Authority: | United States: Federal Government |
Behavioral Cognitive Functioning Older CBT |
Rehabilitation Schizophrenia Skills Social Training |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Pathologic Processes Disease |