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Work Activity Augmented by Cognitive Rehabilitation for Schizophrenia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Department of Veterans Affairs
Information provided by (Responsible Party):
VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:
NCT00430560
First received: January 31, 2007
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

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?

Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
 Behavioral: cognitive rehabilitation
Procedure: work therapy
Behavioral: work therapy
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Work Activity Augmented by Cognitive Rehabilitation: Continuation and Follow-up

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:
  • Neuropsychological test performance [ Time Frame: data collection completed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hours of productive activity [ Time Frame: data collection completed ] [ Designated as safety issue: No ]
  • Hours worked [ Time Frame: data collection completed ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: data collection completed ] [ Designated as safety issue: No ]
  • Psychiatric symptoms [ Time Frame: data collection completed ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2000
Estimated Study Completion Date: October 2012
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
work therapy
 Procedure: work therapy
opportunity to work in carefully supervised hospital job
Other Name: IWT
Behavioral: work therapy
work therapy
Experimental: 2
work therapy plus cognitive remediation
 Behavioral: cognitive rehabilitation
computer training
Other Name: computer training

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430560

Locations
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Connecticut Healthcare System
Department of Veterans Affairs
Investigators
Principal Investigator: Morris D Bell, Ph.D. VA Connecticut Healthcare System
  More Information

Publications:

Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT00430560     History of Changes
Other Study ID Numbers: MDB0003, D2356-R
Study First Received: January 31, 2007
Last Updated: September 18, 2012
Health Authority: United States: Federal Government

Keywords provided by VA Connecticut Healthcare System:
work therapy
cognitive rehabilitation
schizophrenia
schizoaffective disorder
treatment outcome

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013