Cognitive Training to Improve Work Outcomes in Severe Mental Illness
|ClinicalTrials.gov Identifier: NCT00895258|
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : June 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Bipolar Disorder Depression||Behavioral: Individual placement and support plus cognitive training (IPS-CT) Behavioral: Individual placement and support plus enhanced support (IPS-ES)||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||163 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cognitive Training to Improve Work Outcomes in Severe Mental Illness|
|Study Start Date :||April 2008|
|Primary Completion Date :||March 2014|
|Study Completion Date :||March 2014|
Participants will receive individual placement and support (IPS) plus cognitive training (CT).
Behavioral: Individual placement and support plus cognitive training (IPS-CT)
One IPS plus one CT session each week for 12 weeks
Active Comparator: IPS-ES
Participants will receive individual placement and support (IPS) plus enhanced support (ES).
Behavioral: Individual placement and support plus enhanced support (IPS-ES)
One IPS plus one ES session each week for 12 weeks
- Weeks worked [ Time Frame: Measured weekly for 2 years ]
- 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 ]
- Functioning [ Time Frame: Measured at baseline and after 3, 6, 12, 18, and 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895258
|United States, California|
|UCSD Outpatient Psychiatric Services|
|San Diego, California, United States, 92103|
|Principal Investigator:||Elizabeth W. Twamley, PhD||University of California, San Diego|