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Work Activity Augmented by Cognitive Rehabilitation for Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00430560
First Posted: February 2, 2007
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
VA Connecticut Healthcare System
Information provided by (Responsible Party):
VA Office of Research and Development
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Work Activity Augmented by Cognitive Rehabilitation: Continuation and Follow-up

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Neuropsychological test performance [ Time Frame: data collection completed ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: October 2000
Study Completion Date: October 2015
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430560


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

Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00430560     History of Changes
Other Study ID Numbers: D2356-R
MDB0003
First Submitted: January 31, 2007
First Posted: February 2, 2007
Last Update Posted: September 11, 2017
Last Verified: September 2017

Keywords provided by VA Office of Research and Development:
work therapy
cognitive rehabilitation
schizophrenia
schizoaffective disorder
treatment outcome

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders