|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00895258 |
Purpose
This study will compare the efficacy of two types of supportive treatments for a program called Individual Placement and Support, which helps people with severe mental illnesses find and keep jobs.
| Condition | Intervention | 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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Cognitive Training to Improve Work Outcomes in Severe Mental Illness |
| Estimated Enrollment: | 152 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
IPS-CT: Experimental
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
|
|
IPS-ES: Active Comparator
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Cynthia Z. Burton, BA | 619-497-6618 | czburton@ucsd.edu |
| Contact: Elizabeth W. Twamley, PhD | 619-497-6684 | etwamley@ucsd.edu |
| United States, California | |
| UCSD Outpatient Psychiatric Services | Recruiting |
| San Diego, California, United States, 92103 | |
| Contact: Cynthia Z. Burton, BA 619-497-6618 czburton@ucsd.edu | |
| Contact: Elizabeth W. Twamley, PhD 619-497-6684 etwamley@ucsd.edu | |
| Principal Investigator: Elizabeth W. Twamley, PhD | |
| Principal Investigator: | Elizabeth W. Twamley, PhD | University of California, San Diego |
More Information
| Responsible Party: | University of California, San Diego ( Elizabeth W. Twamley, PhD ) |
| Study ID Numbers: | R01 MH080150, DSIR 82-SEDX |
| Study First Received: | May 7, 2009 |
| Last Updated: | June 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00895258 History of Changes |
| Health Authority: | United States: Federal Government |
|
Schizoaffective Disorder Major Depressive Disorder Supported Employment Work Rehabilitation |
Severe Mental Illness Cognitive Training Cognitive Rehabilitation Cognitive Remediation |
|
Schizophrenia Affective Disorders, Psychotic Pathologic Processes Disease Depression Bipolar Disorder |
Mental Disorders Mood Disorders Depressive Disorder Schizophrenia and Disorders with Psychotic Features Behavioral Symptoms |