Vocational RehabilitationCT+SENCT00138021
Cognitive Remediation in Supported Employment at Human Service Center (HSC)
A study testing Computerized cognitive training program in people with Vocational Rehabilitation and Schizophrenia, run by Human Service Center, Illinois at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vocational Rehabilitation, Schizophrenia, Mental Disorders
- What is being tested?
- Computerized cognitive training program
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in a Supported Employment Program
- Has acquired and lost at least one job while in the Supported Employment Program
- Presently unemployed
Who cannot join
- Has not acquired at least one job while in the Supported Employment Program
- Presently employed
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Service Center (HSC)
Peoria, Illinois, 61654-1346
About this study
Official title: 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.
Read the 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).
- Being tested
- Computerized cognitive training program
- Keywords
- Serious mental illness, Supported Employment, Cognitive remediation, Cognitive impairments
- Medical subject headings
- Schizophrenia, Mental Disorders, Neurobehavioral Manifestations, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive training programDevice
Also called The computerized cognitive training program using the Cogpack Software, version 7.4 (Marker Software, 2005).
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
competitive employment status at 12, 18, and 24 months
Measured: 12, 18, and 24 months
number of days employed in a competitive job at 12, 18, and 24 months
Measured: at 12, 18, and 24 months
number of jobs acquired and lost at 12, 18, and 24 months
Measured: 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
Measured: 3, 12, 18, and 24 months
retention in either research condition
Measured: 3 & 12 months
clinical status at 3, 12, 18, and 24 months
Measured: 3, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startJul 2005
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vocational RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Human Service Center, Illinois
- Sponsor type
- University, hospital or other
- Investigators
- David Loveland, Ph.D., Principal investigator, Fayette Companies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138021
- Sponsor's protocol ID
- 05 -132
- Acronym
- CT+SE
- Status last verified
- Oct 2007
- First submitted
- 29 Aug 2005
- Last updated
- 2 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 16079391
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation in Supported Employment at HSC
- ClinicalTrials.gov ID
- NCT00138021
- Acronym / sponsor ID
- CT+SE / 05 -132
- Keywords
- Serious mental illness, Supported Employment, Cognitive remediation, Cognitive impairments
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Human Service Center, IllinoisUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- May 2008 (estimated)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Enrolled in a Supported Employment Program
- Has acquired and lost at least one job while in the Supported Employment Program
- Presently unemployed
Key exclusion criteria (2 listed)
- Has not acquired at least one job while in the Supported Employment Program
- Presently employed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized cognitive training programAlso: The computerized cognitive training program using the Cogpack Software, version 7.4 (Marker Software, 2005).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). | Device | – |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2007.
- Background: PubMed 16079391McGurk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Loveland, Ph.D. principal investigator
Fayette Companies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized cognitive training program in people with Vocational Rehabilitation and Schizophrenia, run by Human Service Center, Illinois at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
competitive employment status at 12, 18, and 24 months (time frame: 12, 18, and 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00138021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2007.