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Clinical Trials/NCT00688259
NCT00688259
Completed
Not Applicable

Cognitive-Behavioral Therapy in Veterans With Schizophrenia

VA Office of Research and Development1 site in 1 country122 target enrollmentApril 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
VA Office of Research and Development
Enrollment
122
Locations
1
Primary Endpoint
Changes in Positive Schizophrenia Symptoms
Status
Completed
Last Updated
last year

Overview

Brief Summary

This is a study comparing the benefits of two types of individual psychotherapy (cognitive-behavioral therapy for psychosis and supportive therapy) in symptomatic Veteran outpatients diagnosed with schizophrenia or schizoaffective disorder. Treatment lasted approximately 6 months, with outcome data on symptoms, functioning, and distress levels collected at baseline, post-treatment, and 6 months post -treatment follow-up.

Detailed Description

This is a randomized controlled trial comparing 6 months of participation in one of two active treatments, cognitive-behavioral therapy for psychosis or supportive therapy in symptomatic Veterans diagnosed with schizophrenia or schizoaffective disorder who are still symptomatic. Assessments of clinical status and social functioning were obtained at baseline, end of treatment, and 6 month follow-up. We hypothesized that participation in the cognitive-behavioral therapy would lead to greater reductions in symptoms and distress about symptoms, and more improvements in social functioning.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
January 2015
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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 with 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
  • illness that would prohibit regular attendance in therapy
  • substance dependence diagnosis in the past 6 months.

Outcomes

Primary Outcomes

Changes in Positive Schizophrenia Symptoms

Time Frame: Pre-treatment to follow-up, approximately 6 months post end-of-treatment

Mean positive symptoms Interview rating on the Brief Psychiatric Rating Scale (Ventura, Lukoff. Nuechterlein. Liberman, Green, \& Shaner, 1993), with range of 1-7 and higher scores indicating greater symptoms Ventura, J. Lukoff D, Nuechterlein KH, Liberman RP, Green M, Shaner A: Appendix 1: Brief Psychiatric Rating Scale (BPRS) Expanded Version (4.0) scales, anchor points and administration manual. International Journal of Methods in Psychiatric Research 1993; 3:227-243

Changes in Global Social Functioning

Time Frame: Pre-treatment to follow-up, approximately 6 months post end-of-treatment

Interview rating of overall adaptive functioning rated on a 1-7 scale on the Social Adjust Scale II (Schooler N, Hogarty G, Weissman M:, 1979) with low scores indicating better functioning Schooler N, Hogarty G,\& Weissman M, (1979). Social Adjustment Scale (SAS) II, in Resource Materials for Community Mental Health Program Evaluators. Edited by Hargreaves W, Attkisson C, Sorenson J. Rockville MD, US Department of Health, Education, and Welfare, 1979, pp 290-303)

Secondary Outcomes

  • Changes in Distress From Schizophrenia Symptoms(Pre-treatment to follow-up, approximately 6 months post end-of-treatment)

Study Sites (1)

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