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

May 28, 2008
December 6, 2012
April 2009
August 2013   (final data collection date for primary outcome measure)
BPRS, SAS, distress from symptoms [ Time Frame: post-treatment and 6 month follow-up ] [ Designated as safety issue: No ]
BPRS, SAS [ Time Frame: post-treatment and 3 month follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00688259 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cognitive-Behavioral Therapy in Veterans With Schizophrenia
Cognitive-Behavioral Therapy in Veterans With Schizophrenia

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • 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
  • 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
  • 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
    Intervention: Other: cognitive-behavioral therapy 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
    Intervention: Other: supportive therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
122
September 2013
August 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years to 70 Years
No
Contact: Shirley M Glynn, PhD (310) 269-3939 Shirley.Glynn@va.gov
United States
 
NCT00688259
MHBB-016-07S
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Shirley M. Glynn, PhD VA Greater Los Angeles Healthcare System, West LA
Department of Veterans Affairs
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP