Cognitive Remediation in Supported Employment at Human Service Center (HSC) (CT+SE)

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. Identifier: NCT00138021
Recruitment Status : Unknown
Verified October 2007 by Human Service Center, Illinois.
Recruitment status was:  Active, not recruiting
First Posted : August 30, 2005
Last Update Posted : November 2, 2007
Information provided by:
Human Service Center, Illinois

Brief Summary:
This project seeks to evaluate the feasibility and effectiveness of combining cognitive remediation and Supported Employment Program (SEP) services to improve work outcomes in people with a serious mental illness who have been unable to benefit from vocational services (i.e., acquire or maintain a job). Cognitive remediation involves treating and improving cognitive impairments, such as memory (e.g., short-term and working memory), attention span, or problem solving skills. It is hypothesized that cognitive remediation will significantly improve peoples' employment outcomes in a supported employment program.

Condition or disease Intervention/treatment Phase
Vocational Rehabilitation Schizophrenia Mental Disorders Cognitive Symptoms Device: Computerized cognitive training program Not Applicable

Detailed Description:

Ample evidence documents that supported employment is an effective strategy for improving the vocational outcomes of persons with schizophrenia and other severe mental illnesses. However, a significant amount of clients receiving supported employment services work little or not at all. With respect to factors that may influence the work outcomes of persons participating in supported employment programs, cognitive functioning appears to be potentially important. Cognitive impairment in persons with severe mental illness (SMI) is strongly correlated with functional adjustment in the community and has been shown to be correlated with work, both contemporaneously and prospectively. Studies have demonstrated that clients who did not receive the full benefits of supported employment had more deficits in executive functioning, memory, and psychomotor speed than those clients who had better work outcomes.

The current study will use a computerized cognitive training program that will be administered by a cognitive trainer. The program consists of 24 training modules (each one takes about one hour to complete). Clients in an SEP who have been unable to maintain a job that they acquired while in the program can participate in the research. Clients who have agreed to participate in the research project will be randomly assigned to either receive the computerized training and supported employment services (CT-SES) or supported employment services (SES) without the training (i.e., treatment-as-usual-condition). Both research groups will receive the same baseline, three-month, and 12-month follow up interviews that will consists of a brief clinical and neuropsychological evaluation, an assessment of problems associated with finding or maintaining employment, and employment outcomes while enrolled in the study. In addition, both groups will receive a telephonic interview at 18 and 24 months to assess their employment outcomes (clinical and neurological information will not be collected at 18 or 24 months).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Remediation in Supported Employment at HSC
Study Start Date : July 2005
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Device: Computerized cognitive training program
    The cognitive training model used in the McGurk et al. (2005) study is referred to as the "Thinking Skills for Work" program. The program is a manualized, remediative and compensatory training intervention that is integrated with SE services. The program includes a cognitive trainer, a structured training manual (McGurk & Mueser, unpublished training manual) and a computer-based cognitive training program (described below).
    Other Name: The computerized cognitive training program using the Cogpack Software, version 7.4 (Marker Software, 2005).

Primary Outcome Measures :
  1. competitive employment status at 12, 18, and 24 months [ Time Frame: 12, 18, and 24 months ]
  2. number of days employed in a competitive job at 12, 18, and 24 months [ Time Frame: at 12, 18, and 24 months ]
  3. number of jobs acquired and lost at 12, 18, and 24 months [ Time Frame: at 12, 18, and 24 months ]

Secondary Outcome Measures :
  1. improvement in cognitive functioning (various measures of cognitive functioning) at 3, 12, 18, and 24 months [ Time Frame: 3, 12, 18, and 24 months ]
  2. retention in either research condition [ Time Frame: 3 & 12 months ]
  3. clinical status at 3, 12, 18, and 24 months [ Time Frame: 3, 12, 18, and 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Enrolled in a Supported Employment Program
  • Has acquired and lost at least one job while in the Supported Employment Program
  • Presently unemployed

Exclusion Criteria:

  • Has not acquired at least one job while in the Supported Employment Program
  • Presently employed

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 identifier (NCT number): NCT00138021

United States, Illinois
Human Service Center (HSC)
Peoria, Illinois, United States, 61654-1346
Sponsors and Collaborators
Human Service Center, Illinois
Principal Investigator: David Loveland, Ph.D. Fayette Companies

Publications: Identifier: NCT00138021     History of Changes
Other Study ID Numbers: 05 -132
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: November 2, 2007
Last Verified: October 2007

Keywords provided by Human Service Center, Illinois:
Serious mental illness
Supported Employment
Cognitive remediation
Cognitive impairments

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Neurobehavioral Manifestations
Schizophrenia Spectrum and Other Psychotic Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms