Cognitive Training to Improve Work Outcomes in Severe Mental Illness

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
ETwamley, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00895258
First received: May 7, 2009
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Training to Improve Work Outcomes in Severe Mental Illness

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Weeks worked [ Time Frame: Measured weekly for 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognition, based on the extended Measurement And Treatment Research to Improve Cognition in Schizophrenia (MATRICS) battery [ Time Frame: Measured at baseline and after 3, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
  • Functioning [ Time Frame: Measured at baseline and after 3, 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]

Enrollment: 163
Study Start Date: April 2008
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895258

Locations
United States, California
UCSD Outpatient Psychiatric Services
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Elizabeth W. Twamley, PhD University of California, San Diego
  More Information

No publications provided

Responsible Party: ETwamley, Associate Professor of Psychiatry, UCSD, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00895258     History of Changes
Other Study ID Numbers: R01 MH080150, R01MH080150, DSIR 82-SEDX
Study First Received: May 7, 2009
Last Updated: June 18, 2014
Health Authority: United States: Federal Government

Keywords provided by University of California, San Diego:
Schizoaffective Disorder
Major Depressive Disorder
Supported Employment
Work
Rehabilitation
Severe Mental Illness
Cognitive Training
Cognitive Rehabilitation
Cognitive Remediation

Additional relevant MeSH terms:
Mental Disorders
Bipolar Disorder
Depression
Depressive Disorder
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 15, 2014