Cognitive Training to Improve Work Outcomes in Severe Mental Illness
Primary Purpose
Schizophrenia, Bipolar Disorder, Depression
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Individual placement and support plus cognitive training (IPS-CT)
Individual placement and support plus enhanced support (IPS-ES)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizoaffective Disorder, Major Depressive Disorder, Supported Employment, Work, Rehabilitation, Severe Mental Illness, Cognitive Training, Cognitive Rehabilitation, Cognitive Remediation
Eligibility Criteria
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
Sites / Locations
- UCSD Outpatient Psychiatric Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IPS-CT
IPS-ES
Arm Description
Participants will receive individual placement and support (IPS) plus cognitive training (CT).
Participants will receive individual placement and support (IPS) plus enhanced support (ES).
Outcomes
Primary Outcome Measures
Weeks worked
Secondary Outcome Measures
Cognition, based on the extended Measurement And Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery
Functioning
Full Information
NCT ID
NCT00895258
First Posted
May 7, 2009
Last Updated
June 18, 2014
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00895258
Brief Title
Cognitive Training to Improve Work Outcomes in Severe Mental Illness
Official Title
Cognitive Training to Improve Work Outcomes in Severe Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder, Depression
Keywords
Schizoaffective Disorder, Major Depressive Disorder, Supported Employment, Work, Rehabilitation, Severe Mental Illness, Cognitive Training, Cognitive Rehabilitation, Cognitive Remediation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IPS-CT
Arm Type
Experimental
Arm Description
Participants will receive individual placement and support (IPS) plus cognitive training (CT).
Arm Title
IPS-ES
Arm Type
Active Comparator
Arm Description
Participants will receive individual placement and support (IPS) plus enhanced support (ES).
Intervention Type
Behavioral
Intervention Name(s)
Individual placement and support plus cognitive training (IPS-CT)
Intervention Description
One IPS plus one CT session each week for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Individual placement and support plus enhanced support (IPS-ES)
Intervention Description
One IPS plus one ES session each week for 12 weeks
Primary Outcome Measure Information:
Title
Weeks worked
Time Frame
Measured weekly for 2 years
Secondary Outcome Measure Information:
Title
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
Title
Functioning
Time Frame
Measured at baseline and after 3, 6, 12, 18, and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth W. Twamley, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Outpatient Psychiatric Services
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29480043
Citation
Burton CZ, Vella L, Twamley EW. Prospective memory, level of disability, and return to work in severe mental illness. Clin Neuropsychol. 2019 Apr;33(3):594-605. doi: 10.1080/13854046.2018.1436725. Epub 2018 Feb 25.
Results Reference
derived
Learn more about this trial
Cognitive Training to Improve Work Outcomes in Severe Mental Illness
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