Cognitive Training to Improve Work Outcomes in Severe Mental Illness

Phase 2

Completed

• Conditions: Schizophrenia; Bipolar Disorder; Depression
• Interventions: Behavioral: Individual placement and support plus cognitive training (IPS-CT); Behavioral: Individual placement and support plus enhanced support (IPS-ES)

• Registration Number: NCT00895258
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2009-05-07
• Study First Submitted QC: 2009-05-07
• Study First Posted: 2009-05-08
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-18
• Last Update Posted: 2014-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IPS-CT	Individual placement and support plus cognitive training (IPS-CT)	Participants will receive individual placement and support (IPS) plus cognitive training (CT).
IPS-ES	Individual placement and support plus enhanced support (IPS-ES)	Participants will receive individual placement and support (IPS) plus enhanced support (ES).

Primary Outcome Measures

Name	Time	Method
Weeks worked	Measured weekly for 2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UCSD Outpatient Psychiatric Services; 🇺🇸 San Diego, California, United States