Cognitive-Behavioral Therapy in Veterans With Schizophrenia

NCT00688259 | Completed Results DMC

• 1 other identifier: MHBB-016-07S
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

clinical trials; psychotherapy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Changes in Distress From Schizophrenia Symptoms

  Pre-treatment to end-of-treatment, approximately 6 months post-randomization

• Changes in Distress From Schizophrenia Symptoms

  Pre-treatment to follow-up, approximately 6 months post end-of-treatment

Study Arms (2)

Cognitive Behavioral Therapy for Psychosis (CBTp)

EXPERIMENTAL

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)

Supportive Therapy (ST)

ACTIVE COMPARATOR

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)

Interventions

Supportive Therapy (ST) BEHAVIORAL

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 (ST)

Cognitive Behavioral Therapy for Psychosis (CBTp) BEHAVIORAL

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 (CBTp)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Palliative Care; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Shirley M. Glynn, Ph.D.
• Organization: VA Greater Los Angeles Healthcare System at West Los Angeles

shirley.glynn@va.gov

3102683939

Study Officials

• Shirley M. Glynn, PhD

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 2, 2008
• Study Start: April 1, 2009
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 9, 2025
• Results First Posted: December 14, 2017

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)