Work Activity Augmented by Cognitive Rehabilitation for Schizophrenia

VA Office of Research and Development

Status and phase: Completed; Phase 3; Phase 2

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Behavioral: work therapy; Behavioral: cognitive rehabilitation

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00430560

MDB0003

D2356-R

Details and patient eligibility

About

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?

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

1

Active Comparator group

Description:

work therapy

Treatment:

Behavioral: work therapy

Behavioral: work therapy

2

Experimental group

Description:

work therapy plus cognitive remediation

Treatment:

Behavioral: cognitive rehabilitation