Cognitive Training to Improve Work Outcomes in Severe Mental Illness

NCT ID: NCT00895258

Last Updated: 2014-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2014-03-31

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.

Conditions

Schizophrenia; Bipolar Disorder; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IPS-CT

Participants will receive individual placement and support (IPS) plus cognitive training (CT).

Group Type: EXPERIMENTAL

Individual placement and support plus cognitive training (IPS-CT)

Intervention Type: BEHAVIORAL

One IPS plus one CT session each week for 12 weeks

IPS-ES

Participants will receive individual placement and support (IPS) plus enhanced support (ES).

Group Type: ACTIVE_COMPARATOR

Individual placement and support plus enhanced support (IPS-ES)

Intervention Type: BEHAVIORAL

One IPS plus one ES session each week for 12 weeks

Interventions

Individual placement and support plus cognitive training (IPS-CT)

One IPS plus one CT session each week for 12 weeks

Intervention Type: BEHAVIORAL

Individual placement and support plus enhanced support (IPS-ES)

One IPS plus one ES session each week for 12 weeks

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

ETwamley

Associate Professor of Psychiatry, UCSD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth W. Twamley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

UCSD Outpatient Psychiatric Services

San Diego, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29480043 (View on PubMed)

Other Identifiers

R01MH080150

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 82-SEDX

Identifier Type: -

Identifier Source: secondary_id

R01MH080150

Identifier Type: NIH

Identifier Source: org_study_id

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