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

October 31, 2007 updated by: Human Service Center, Illinois

Cognitive Remediation in Supported Employment at HSC

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Device: Computerized cognitive training 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).

Study Type

Interventional

Enrollment (Anticipated)

Phase

Not Applicable

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
- Illinois
  - Peoria, Illinois, United States, 61654-1346
    - Human Service Center (HSC)

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
improvement in cognitive functioning (various measures of cognitive functioning) at 3, 12, 18, and 24 months Time Frame: 3, 12, 18, and 24 months	3, 12, 18, and 24 months
retention in either research condition Time Frame: 3 & 12 months	3 & 12 months
clinical status at 3, 12, 18, and 24 months Time Frame: 3, 12, 18, and 24 months	3, 12, 18, and 24 months

Collaborators and Investigators

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

Sponsor

Human Service Center, Illinois

Investigators

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

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

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.

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

July 1, 2005

Study Completion (Anticipated)

May 1, 2008

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria