Overview

This trial is active, not recruiting.

Conditions vocational rehabilitation, schizophrenia, mental disorders, cognitive symptoms
Treatment computerized cognitive training program
Sponsor Human Service Center, Illinois
Start date July 2005
End date May 2008
Trial size 50 participants
Trial identifier NCT00138021, 05 -132

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
competitive employment status at 12, 18, and 24 months
time frame: 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
number of jobs acquired and lost at 12, 18, and 24 months
time frame: at 12, 18, and 24 months

Secondary Outcomes

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
retention in either research condition
time frame: 3 & 12 months
clinical status at 3, 12, 18, and 24 months
time frame: 3, 12, 18, and 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Cognitive Remediation in Supported Employment at HSC
Principal investigator David Loveland, Ph.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in October 2007.
Information provided to ClinicalTrials.gov by Human Service Center, Illinois.