Cognitive Training to Improve Work Outcomes in Severe Mental Illness

Sponsor

University of California, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT00895258

Collaborator

National Institute of Mental Health (NIMH) (NIH)

163

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

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

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 Design

Study Type:

Interventional

Actual Enrollment :

163 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Cognitive Training to Improve Work Outcomes in Severe Mental Illness

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IPS-CT 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

Arm

Intervention/Treatment

Experimental: IPS-CT

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

Outcome Measures

Primary Outcome Measures

Weeks worked [Measured weekly for 2 years]

Secondary Outcome Measures

Cognition, based on the extended Measurement And Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery [Measured at baseline and after 3, 6, 12, 18, and 24 months]
Functioning [Measured at baseline and after 3, 6, 12, 18, and 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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