Cognitive-Behavioral Therapy in Veterans With Schizophrenia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00688259
First received: May 28, 2008
Last updated: January 2, 2014
Last verified: December 2013
  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:


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: June 2014
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

Locations
United States, California
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
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: January 2, 2014
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 April 17, 2014