Clinical trial NCT00688259: Cognitive-Behavioral Therapy in Veterans With Schizophrenia
Official title: Cognitive-Behavioral Therapy in Veterans With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: clinical trials
psychotherapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-06-02
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes in Positive Schizophrenia Symptoms
timeFrame: Pre-treatment to end of treatment, approximately 6 months post-randomization
measure: Changes in Positive Schizophrenia Symptoms
timeFrame: Pre-treatment to follow-up, approximately 6 months post end-of-treatment
measure: Changes in Global Social Functioning
timeFrame: Pre-treatment to end of treatment, approximately 6 months post-randomization
measure: Changes in Global Social Functioning
timeFrame: Pre-treatment to follow-up, approximately 6 months post end-of-treatment
Secondary outcomes:
measure: Changes in Distress From Schizophrenia Symptoms
timeFrame: Pre-treatment to end-of-treatment, approximately 6 months post-randomization
measure: Changes in Distress From Schizophrenia Symptoms
timeFrame: Pre-treatment to follow-up, approximately 6 months post end-of-treatment
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Shirley M. Glynn, PhD
role: PRINCIPAL_INVESTIGATOR
References: