Cognitive Training to Improve Work Outcomes in Severe Mental Illness

Depression Clinical Trial

Official title:

Cognitive Training to Improve Work Outcomes in Severe Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895258
• Other study ID #: R01MH080150
• Secondary ID: R01MH080150DSIR
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2009
• Last updated: June 18, 2014
• Start date: April 2008
• Est. completion date: March 2014

Study information

• Verified date: June 2014
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Mental Disorders
• Schizophrenia

Intervention

Behavioral:
• Individual placement and support plus cognitive training (IPS-CT)
One IPS plus one CT session each week for 12 weeks
• Individual placement and support plus enhanced support (IPS-ES)
One IPS plus one ES session each week for 12 weeks

Locations

Country	Name	City	State
United States	UCSD Outpatient Psychiatric Services	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weeks worked		Measured weekly for 2 years	No
Secondary	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	No
Secondary	Functioning		Measured at baseline and after 3, 6, 12, 18, and 24 months	No