Cognitive-Behavioral Therapy in Veterans With Schizophrenia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cognitive-Behavioral Therapy in Veterans With Schizophrenia

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Behavioral: Supportive Therapy (ST)
* Behavioral: Cognitive Behavioral Therapy for Psychosis (CBTp)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy for Psychosis (CBTp)<br>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)<br>* approximately 20 sessions of individual manualized psychotherapy in which participants are taught to evaluate the data supporting beliefs that may interfere with recovery<br>|
| Active Comparator: Supportive Therapy (ST)<br>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)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Positive Schizophrenia Symptoms | 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 | Pre-treatment to end of treatment, approximately 6 months post-randomization | 
| Changes in Positive Schizophrenia Symptoms | 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 | Pre-treatment to follow-up, approximately 6 months post end-of-treatment | 
| Changes in Global Social Functioning | 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) | Pre-treatment to end of treatment, approximately 6 months post-randomization | 
| Changes in Global Social Functioning | 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) | Pre-treatment to follow-up, approximately 6 months post end-of-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Distress From Schizophrenia Symptoms | 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. | Pre-treatment to end-of-treatment, approximately 6 months post-randomization | 
| Changes in Distress From Schizophrenia Symptoms | 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. | Pre-treatment to follow-up, approximately 6 months post end-of-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical trials, psychotherapy