Work Activity Augmented by Cognitive Rehabilitation for Schizophrenia

Phase 2

Completed

• Conditions: Schizoaffective Disorder; Schizophrenia
• Interventions: Behavioral: cognitive rehabilitation; Behavioral: work therapy

• Registration Number: NCT00430560
• Lead Sponsor: VA Office of Research and Development

Brief Summary

This research investigates the benefits of productive activity and cognitive rehabilitation for patients with schizophrenia. Key questions are:

1. does cognitive rehabilitation plus work activity produce better outcomes than work activity alone?

2. Is cognitive rehabilitation more helpful for individuals with moderate or greater cognitive impairment than for individuals without such impairment?

3. Does cognitive rehabilitation reduce the dropout rate and increase participation in work activity for cognitively impaired subjects?

4. What features of cognitive rehabilitation are most important for clinical and rehabilitation outcomes?

Detailed Description

This is a randomized, matching study in which subjects are stratified by degree of cognitive impairment, then randomly assigned to one of two conditions: Work Services Only vs. Work Services plus cognitive rehabilitation. Longitudinal analysis of work activity, work performance, symptoms, quality of life, cognitive function and service utilization are made.

Study Timeline

• Study Start: 2000-10
• Primary Completion: 2005-10
• Study First Submitted: 2007-01-31
• Study First Submitted QC: 2007-01-31
• Study First Posted: 2007-02-02
• Study Completion: 2015-10
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• diagnosis of schizophrenia or schizoaffective disorder

Exclusion Criteria

• change in psychiatric medications or housing within 30 days of study intake
• episode of drug abuse within 30 days of study intake
• GAF score 30 or less
• known neurological disease or developmental disability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	cognitive rehabilitation	work therapy plus cognitive remediation
1	work therapy	work therapy

Primary Outcome Measures

Name	Time	Method
Neuropsychological test performance	data collection completed

Secondary Outcome Measures

Name	Time	Method
Hours worked	data collection completed
Hours of productive activity	data collection completed
Psychiatric symptoms	data collection completed
Quality of life	data collection completed

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States