Overview

This trial is active, not recruiting.

Conditions schizophrenia, schizoaffective disorder
Treatments supportive therapy, cognitive-behavioral therapy for psychosis
Phase phase 3
Sponsor Department of Veterans Affairs
Start date April 2009
End date September 2014
Trial size 122 participants
Trial identifier NCT00688259, MHBB-016-07S

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery
cognitive-behavioral therapy for psychosis cbt 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
(Active Comparator)
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
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

Primary Outcomes

Measure
BPRS, SAS, distress from symptoms
time frame: post-treatment and 6 month follow-up

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title Cognitive-Behavioral Therapy in Veterans With Schizophrenia
Principal investigator Shirley M. Glynn, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.