Cognitive-Behavioral Therapy in Veterans With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Cognitive-Behavioral Therapy in Veterans With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688259
• Other study ID #: MHBB-016-07S
• Status: Completed
• Phase: N/A
• First received: May 28, 2008
• Last updated: May 9, 2017
• Start date: April 2009
• Est. completion date: January 2015

Study information

• Verified date: May 2017
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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
• 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

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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