NCT00138021

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

November 2, 2007

Status Verified

October 1, 2007

First QC Date

August 29, 2005

Last Update Submit

October 31, 2007

Conditions

Keywords

Serious mental illnessSupported EmploymentCognitive remediationCognitive impairments

Outcome Measures

Primary Outcomes (3)

  • competitive employment status at 12, 18, and 24 months

    12, 18, and 24 months

  • number of days employed in a competitive job at 12, 18, and 24 months

    at 12, 18, and 24 months

  • number of jobs acquired and lost at 12, 18, and 24 months

    at 12, 18, and 24 months

Secondary Outcomes (3)

  • improvement in cognitive functioning (various measures of cognitive functioning) at 3, 12, 18, and 24 months

    3, 12, 18, and 24 months

  • retention in either research condition

    3 & 12 months

  • clinical status at 3, 12, 18, and 24 months

    3, 12, 18, and 24 months

Interventions

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).

Also known as: The computerized cognitive training program using the Cogpack Software, version 7.4 (Marker Software, 2005).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Service Center (HSC)

Peoria, Illinois, 61654-1346, United States

Location

Related Publications (1)

  • 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.

    PMID: 16079391BACKGROUND

MeSH Terms

Conditions

SchizophreniaMental DisordersNeurobehavioral ManifestationsCognitive Dysfunction

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive Disorders

Study Officials

  • David Loveland, Ph.D.

    Fayette Companies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

July 1, 2005

Study Completion

May 1, 2008

Last Updated

November 2, 2007

Record last verified: 2007-10

Locations