Work Activity Augmented by Cognitive Rehabilitation for Schizophrenia

September 7, 2017 updated by: VA Office of Research and Development

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
work therapy
Procedure: work therapy
opportunity to work in carefully supervised hospital job
Other Names:
  • IWT
Behavioral: work therapy
work therapy
Experimental: 2
work therapy plus cognitive remediation
Behavioral: cognitive rehabilitation
computer training
Other Names:
  • computer training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neuropsychological test performance
Time Frame: data collection completed
data collection completed

Secondary Outcome Measures

Outcome Measure
Time Frame
Hours of productive activity
Time Frame: data collection completed
data collection completed
Hours worked
Time Frame: data collection completed
data collection completed
Quality of life
Time Frame: data collection completed
data collection completed
Psychiatric symptoms
Time Frame: data collection completed
data collection completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

VA Connecticut Healthcare System

Investigators

  • Principal Investigator: Morris D Bell, Ph.D., VA Connecticut Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 31, 2007

First Submitted That Met QC Criteria

January 31, 2007

First Posted (Estimate)

February 2, 2007

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2356-R
  • MDB0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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