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: June 3, 2014
Last verified: June 2014
  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: December 2014
Estimated Primary Completion Date: September 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
clinical trials
psychotherapy

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

ClinicalTrials.gov processed this record on September 18, 2014