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

Schizophrenia Clinical Trial

— CT+SE  

Official title:

Cognitive Remediation in Supported Employment at HSC

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00138021
• Other study ID #: 05 -132
• Status: Active, not recruiting
• Phase: N/A
• First received: August 29, 2005
• Last updated: October 31, 2007
• Start date: July 2005
• Est. completion date: May 2008

Study information

• Verified date: October 2007
• Source: Human Service Center, Illinois
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognitive Symptoms
• Mental Disorders
• Neurobehavioral Manifestations
• Psychotic Disorders
• Schizophrenia
• Vocational Rehabilitation

Intervention

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).

Locations

Country	Name	City	State
United States	Human Service Center (HSC)	Peoria	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Human Service Center, Illinois

Country where clinical trial is conducted

United States, 

References & 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. Epub 2005 Aug 3. — View Citation

Outcome

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