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Clinical Trials/NCT00430560
NCT00430560CompletedPhase 2

Work Activity Augmented by Cognitive Rehabilitation: Continuation and Follow-up

VA Office of Research and Development1 site in 1 country150 target enrollmentStarted: October 1, 2000Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
150
Locations
1
Primary Endpoint
Neuropsychological test performance

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

1

Active Comparator

work therapy

Intervention: work therapy (Procedure)

1

Active Comparator

work therapy

Intervention: work therapy (Behavioral)

2

Experimental

work therapy plus cognitive remediation

Intervention: cognitive rehabilitation (Behavioral)

Outcomes

Primary Outcomes

Neuropsychological test performance

Time Frame: data collection completed

Secondary Outcomes

  • Quality of life(data collection completed)
  • Psychiatric symptoms(data collection completed)
  • Hours of productive activity(data collection completed)
  • Hours worked(data collection completed)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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