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Cognitive-Behavioral Therapy in Veterans With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00688259
Recruitment Status : Completed
First Posted : June 2, 2008
Results First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Behavioral: Supportive Therapy (ST) Behavioral: Cognitive Behavioral Therapy for Psychosis (CBTp) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral Therapy in Veterans With Schizophrenia
Study Start Date : April 2009
Actual Primary Completion Date : September 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy for Psychosis (CBTp)
approximately 6 months of weekly individual manualized cognitive-behavioral psychotherapy for psychosis in which participants set personal goals, identify problematic/ illness-related beliefs and experiences that may interfere with achieving those goals, evaluate the data supporting those beliefs, and then modify the beliefs or behavior as warranted by the data to make progress on those goals.
Behavioral: Cognitive Behavioral Therapy for Psychosis (CBTp)
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: Supportive Therapy (ST)
approximately 6 months of weekly manualized supportive psychotherapy to promote a strong alliance between the therapist and the participant in order to provide a safe place to discuss issues pertaining to the participants' lives and concerns
Behavioral: Supportive Therapy (ST)
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 Outcome Measures :
  1. Changes in Positive Schizophrenia Symptoms [ Time Frame: Pre-treatment to end of treatment, approximately 6 months post-randomization ]

    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


  2. 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


  3. Changes in Global Social Functioning [ Time Frame: Pre-treatment to end of treatment, approximately 6 months post-randomization ]

    Interview rating of overall adaptive functioning rated on a 1-7 scale on the Social Adjust Scale II (Schooler, Hogarty, Weissman:, 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)


  4. 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 Outcome Measures :
  1. Changes in Distress From Schizophrenia Symptoms [ Time Frame: Pre-treatment to end-of-treatment, approximately 6 months post-randomization ]

    Interview rating of overall preoccupation and distress from hallucinations and delusions rated on the psychotic symptom rating scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher,; 1999) total score, with a range of 0-85 and low scores indicating less preoccupation and distress

    Haddock, G., McCarron, J., Tarrier, N., & Faragher, E. B. (1999). Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychological medicine, 29(04), 879-889.


  2. Changes in Distress From Schizophrenia Symptoms [ Time Frame: Pre-treatment to follow-up, approximately 6 months post end-of-treatment ]

    Interview rating of overall preoccupation and distress from hallucinations and delusions rated on the psychotic symptom rating scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher,; 1999) total score, with a range of 0-85 and low scores indicating less preoccupation and distress

    Haddock, G., McCarron, J., Tarrier, N., & Faragher, E. B. (1999). Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychological medicine, 29(04), 879-889.




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688259


Locations
United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Shirley M. Glynn, PhD VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00688259     History of Changes
Other Study ID Numbers: MHBB-016-07S
First Posted: June 2, 2008    Key Record Dates
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data on major outcomes can be shared. Investigators can contact PI.

Keywords provided by VA Office of Research and Development:
clinical trials
psychotherapy

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders