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Using Cognitive Training to Improve Employment Programs for People With Severe Mental Illnesses
This study is currently recruiting participants.
Study NCT00895258   Information provided by National Institute of Mental Health (NIMH)
First Received: May 7, 2009   Last Updated: June 25, 2009   History of Changes

May 7, 2009
June 25, 2009
April 2008
December 2012   (final data collection date for primary outcome measure)
Weeks worked [ Time Frame: Measured weekly for 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00895258 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Using Cognitive Training to Improve Employment Programs for People With Severe Mental Illnesses
Cognitive Training to Improve Work Outcomes in Severe Mental Illness

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.

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.

Phase II
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
  • Schizophrenia
  • Bipolar Disorder
  • Depression
  • Behavioral: Individual placement and support plus cognitive training (IPS-CT)
  • Behavioral: Individual placement and support plus enhanced support (IPS-ES)
  • Experimental: Participants will receive individual placement and support (IPS) plus cognitive training (CT).
  • Active Comparator: Participants will receive individual placement and support (IPS) plus enhanced support (ES).
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
152
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Cynthia Z. Burton, BA 619-497-6618 czburton@ucsd.edu
Contact: Elizabeth W. Twamley, PhD 619-497-6684 etwamley@ucsd.edu
United States
 
NCT00895258
Elizabeth W. Twamley, PhD, University of California, San Diego
R01 MH080150, DSIR 82-SEDX
National Institute of Mental Health (NIMH)
 
Principal Investigator: Elizabeth W. Twamley, PhD University of California, San Diego
National Institute of Mental Health (NIMH)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP