Clinical trial NCT00895258: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Bipolar Disorder
Depression
Keywords: Schizoaffective Disorder
Major Depressive Disorder
Supported Employment
Work
Rehabilitation
Severe Mental Illness
Cognitive Training
Cognitive Rehabilitation
Cognitive Remediation
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-05-08
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Weeks worked
timeFrame: Measured weekly for 2 years
Secondary outcomes:
measure: Cognition, based on the extended Measurement And Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery
timeFrame: Measured at baseline and after 3, 6, 12, 18, and 24 months
measure: Functioning
timeFrame: Measured at baseline and after 3, 6, 12, 18, and 24 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Outpatient Psychiatric Services
state: California
Study officials:
affiliation: University of California, San Diego
name: Elizabeth W. Twamley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.