This trial is active, not recruiting.

Conditions schizophrenia, schizoaffective disorder
Treatments cognitive rehabilitation, work therapy
Phase phase 2/phase 3
Sponsor VA Connecticut Healthcare System
Collaborator Department of Veterans Affairs
Start date October 2000
End date October 2005
Trial size 150 participants
Trial identifier NCT00430560, D2356-R, MDB0003


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?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
work therapy
work therapy IWT
opportunity to work in carefully supervised hospital job
work therapy
work therapy
work therapy plus cognitive remediation
cognitive rehabilitation computer training
computer training

Primary Outcomes

Neuropsychological test performance
time frame: data collection completed

Secondary Outcomes

Hours of productive activity
time frame: data collection completed
Hours worked
time frame: data collection completed
Quality of life
time frame: data collection completed
Psychiatric symptoms
time frame: data collection completed

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Work Activity Augmented by Cognitive Rehabilitation: Continuation and Follow-up
Principal investigator Morris D Bell, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by VA Connecticut Healthcare System.