Expired Study
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Peoria, Illinois 61654


Purpose:

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.


Study summary:

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).


Criteria:

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


Study is Available At:


Original ID:

05 -132


NCT ID:

NCT00138021


Secondary ID:


Study Acronym:

CT+SE


Brief Title:

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


Official Title:

Cognitive Remediation in Supported Employment at HSC


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Human Service Center, Illinois


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:David Loveland, Ph.D.
Principal Investigator
Fayette Companies

Study Dates

Start Date:July 2005
Completion Date:May 2008
Completion Type:Anticipated
Verification Date:October 2007
Last Changed Date:October 31, 2007
First Received Date:August 29, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:clinical status at 3, 12, 18, and 24 months
Time Frame:3, 12, 18, and 24 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:retention in either research condition
Time Frame:3 & 12 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:improvement in cognitive functioning (various measures of cognitive functioning) at 3, 12, 18, and 24 months
Time Frame:3, 12, 18, and 24 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:number of jobs acquired and lost at 12, 18, and 24 months
Time Frame:at 12, 18, and 24 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:number of days employed in a competitive job at 12, 18, and 24 months
Time Frame:at 12, 18, and 24 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:competitive employment status at 12, 18, and 24 months
Time Frame:12, 18, and 24 months
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Computerized cognitive training program
Description: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

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Human Service Center, Illinois

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:McGurk SR, Mueser KT, Pascaris A. Cognitive Training and Supported Employment for Persons With Severe Mental Illness: One-Year Results From a Randomized Controlled Trial. Schizophr Bull. 2005 Aug 3; [Epub ahead of print]
PMID:16079391

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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