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

Primary Purpose

Vocational Rehabilitation, Schizophrenia, Mental Disorders

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized cognitive training program
Sponsored by
Human Service Center, Illinois
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vocational Rehabilitation focused on measuring Serious mental illness, Supported Employment, Cognitive remediation, Cognitive impairments

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Human Service Center (HSC)

Outcomes

Primary Outcome Measures

competitive employment status at 12, 18, and 24 months
number of days employed in a competitive job at 12, 18, and 24 months
number of jobs acquired and lost at 12, 18, and 24 months

Secondary Outcome Measures

improvement in cognitive functioning (various measures of cognitive functioning) at 3, 12, 18, and 24 months
retention in either research condition
clinical status at 3, 12, 18, and 24 months

Full Information

First Posted
August 29, 2005
Last Updated
October 31, 2007
Sponsor
Human Service Center, Illinois
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1. Study Identification

Unique Protocol Identification Number
NCT00138021
Brief Title
Cognitive Remediation in Supported Employment at Human Service Center (HSC)
Acronym
CT+SE
Official Title
Cognitive Remediation in Supported Employment at HSC
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Human Service Center, Illinois

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocational Rehabilitation, Schizophrenia, Mental Disorders, Cognitive Symptoms
Keywords
Serious mental illness, Supported Employment, Cognitive remediation, Cognitive impairments

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Computerized cognitive training program
Other Intervention Name(s)
The computerized cognitive training program using the Cogpack Software, version 7.4 (Marker Software, 2005).
Intervention 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).
Primary Outcome Measure Information:
Title
competitive employment status at 12, 18, and 24 months
Time Frame
12, 18, and 24 months
Title
number of days employed in a competitive job at 12, 18, and 24 months
Time Frame
at 12, 18, and 24 months
Title
number of jobs acquired and lost at 12, 18, and 24 months
Time Frame
at 12, 18, and 24 months
Secondary Outcome Measure Information:
Title
improvement in cognitive functioning (various measures of cognitive functioning) at 3, 12, 18, and 24 months
Time Frame
3, 12, 18, and 24 months
Title
retention in either research condition
Time Frame
3 & 12 months
Title
clinical status at 3, 12, 18, and 24 months
Time Frame
3, 12, 18, and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Loveland, Ph.D.
Organizational Affiliation
Fayette Companies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Service Center (HSC)
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61654-1346
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16079391
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 Oct;31(4):898-909. doi: 10.1093/schbul/sbi037. Epub 2005 Aug 3.
Results Reference
background

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

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