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Cognitive-Behavioral Therapy in Veterans With Schizophrenia

This study is currently recruiting participants.
Verified December 2012 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00688259
First received: May 28, 2008
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

This is a study comparing the benefits of two types of individual psychotherapy (cognitive-behavioral therapy for psychosis and supportive therapy) in outpatients with schizophrenia or schizoaffective disorder. Treatment lasts 6 months and there are multiple assessment points.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
 Other: supportive therapy
Other: cognitive-behavioral therapy for psychosis
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral Therapy in Veterans With Schizophrenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • BPRS, SAS, distress from symptoms [ Time Frame: post-treatment and 6 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 122
Study Start Date: April 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery
 Other: cognitive-behavioral therapy for psychosis
approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery
Other Name: cbt for psychosis
Active Comparator: Arm 2
approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery
 Other: supportive therapy
approximately 20 sessions of manualized psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to recovery

Detailed Description:

This is a randomized controlled trial comparing 6 months of participation in one of two active treatments, cognitive-behavior therapy for psychosis or supportive therapy. Assessments of clinical status and social functioning will be obtained at baseline, mid-treatment, end of treatment, and 6 month follow-up. We hypothesize that participation in the cognitive-behavioral therapy will lead to greater reductions in symptoms and improvements in social functioning.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

outpatients with schizophrenia or schizoaffective disorder in proximity to the West Los Angeles VAMC at least one month since last hospitalization stable antipsychotic medication persisting psychotic symptoms with at least minimal distress competent to sign informed consent.

Exclusion Criteria:

in other individual psychotherapy presence of organic brain disease mental retardation or illness that would prohibit regular attendance in therapy substance dependence diagnosis in the past 6 months.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688259

Contacts
Contact: Shirley M Glynn, PhD (310) 269-3939 Shirley.Glynn@va.gov

Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA Recruiting
West Los Angeles, California, United States, 90073
Contact: Shirley M Glynn, PhD     310-269-3939     Shirley.Glynn@va.gov    
Principal Investigator: Shirley M. Glynn, PhD            
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Shirley M. Glynn, PhD VA Greater Los Angeles Healthcare System, West LA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00688259     History of Changes
Other Study ID Numbers: MHBB-016-07S
Study First Received: May 28, 2008
Last Updated: December 6, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
clinical trials
psychotherapy

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013