- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00895258
Cognitive Training to Improve Work Outcomes in Severe Mental Illness
Study Overview
Status
Conditions
Detailed Description
Unemployment in people with severe mental illnesses (SMIs), such as schizophrenia, bipolar disorder, and major depressive disorder, has both economic and health-related costs. Unemployed people with SMIs often report an improved quality of life after finding a job, through increases in self-esteem, socialization, opportunities to use skills and abilities, external structure, and income. Supported employment plans, such as Individualized Placement and Support (IPS), help to place and support people with SMIs in jobs available in their community. However, people with SMIs often have difficulties keeping jobs. Research suggests these difficulties are due to cognitive deficits-underlying patterns of thought. This study will test two versions of IPS to see which produces the best outcomes for people with SMIs looking for jobs: one version will be supplemented with cognitive training (CT), which will address cognitive deficits related to work, and the other version will be supplemented with enhanced support (ES), which will increase the support people with SMIs receive with their jobs.
Participation in this study will last 24 months. Participants will first undergo a baseline assessment and then will be randomly assigned to receive IPS with CT or IPS with ES. Participants in both groups will complete one IPS session and one support session-either CT or ES-each week for 12 weeks. The IPS sessions will involve working with a vocational counselor to find a job and then receiving support in training for and maintaining that job. Participants receiving CT sessions will be taught strategies to improve attention, learning and memory, and problem-solving. Participants receiving ES will receive extra sessions of vocational support. All participants will complete assessments at six times: at study entry and after 3, 6, 12, 18, and 24 months. These assessments will include interviews about life circumstances, psychiatric symptoms, and job satisfaction. The first four assessment sessions will involve additional tests-administered with a pencil and paper or on a computer-that measure thinking, learning, memory, and problem-solving abilities.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92103
- UCSD Outpatient Psychiatric Services
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Receiving psychiatric care at UCSD Outpatient Psychiatric Services
- DSM-IV diagnosis of a severe mental illness, including schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder
- Unemployed in the past 30 days, but stating a goal of work
- Fluency and literacy in English
Exclusion Criteria:
- Presence of dementia
- Presence of mental retardation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: IPS-CT
Participants will receive individual placement and support (IPS) plus cognitive training (CT).
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One IPS plus one CT session each week for 12 weeks
|
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ACTIVE_COMPARATOR: IPS-ES
Participants will receive individual placement and support (IPS) plus enhanced support (ES).
|
One IPS plus one ES session each week for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Weeks worked
Time Frame: Measured weekly for 2 years
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Measured weekly for 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cognition, based on the extended Measurement And Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery
Time Frame: Measured at baseline and after 3, 6, 12, 18, and 24 months
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Measured at baseline and after 3, 6, 12, 18, and 24 months
|
|
Functioning
Time Frame: Measured at baseline and after 3, 6, 12, 18, and 24 months
|
Measured at baseline and after 3, 6, 12, 18, and 24 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Elizabeth W. Twamley, PhD, University of California, San Diego
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH080150 (NIH)
- DSIR 82-SEDX
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