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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00261716
Other study ID # O3176-R
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received December 1, 2005
Last updated October 14, 2014
Start date January 2005
Est. completion date February 2015

Study information

Verified date October 2014
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Many persons with schizophrenia have difficulty getting and keeping a job. This study is designed to compare the benefits of four sessions of motivational interviewing or illness education in increasing employment rates accruing from participation in supported employment.


Description:

Many individuals with serious psychiatric illnesses wish to work, and yet employment rates for this population are lower than the general population (Cook & Razanno, 2000). IPS is a type of supported employment intervention designed to assist individuals with serious psychiatric illnesses return to work. Four randomized trials demonstrate that, in comparison to control conditions such as group therapy or referrals to traditional vocational rehabilitation services, IPS participants are three more times more likely to obtain a job during the study, and at least twice as likely to be competitively employed at any point in the study (Drake et al, 1996; Drake et al, 1999: Lehman et al, 2002; Mueser et al, submitted). Just as with the general population, the rewards of work for individuals with serious mental illness include considerably more than the financial remuneration. For example, employment appears to confer higher self-esteem, greater life satisfaction, and perhaps even better treatment compliance, symptom improvement, and insight in persons with psychiatric illnesses (Bell et al, 1996; Lysacker et al, 1995; Mueser et al, 1997; Bond et al, 1997; Kashner et al, 2002). Despite its demonstrated effectiveness, these IPS results could be improved. Most IPS participants are not competitively employed at any point in time, it takes an average of about four months to obtain a first job, a typical job lasts only approximately 20-25 weeks, and employment rates across the sample asymptote at about month 8 or 9 of participation in the trials. Furthermore, obtaining a first job seems to be an almost insurmountable impediment for approximately 35%-40% of individuals in the trials. Motivational deficits may play a prominent role in explaining the limited benefits accruing from IPS in persons with serious and persisting psychiatric illnesses, especially in those with schizophrenia. Building a successful work life requires sustained effort over months and years (Palmer, 1989). After a period of unemployment, individuals must obtain their first reemployment position, and then transition to others as circumstances arise. Many persons with schizophrenia experience high degrees of negative symptoms, demoralization, and ambivalence, which likely all interfere with the persistent efforts required to initiate and maintain a successful vocational adjustment. Enhancing already validated vocational rehabilitation programs, such as IPS, with specific techniques to address motivational deficits may be essential to increasing employment rates among persons with schizophrenia. In this study, we will test a novel strategy designed to improve motivation for positive behavior change, motivational interviewing, adapted for work-related problems, in persons with schizophrenia. With the objective of improving work outcomes, we will assign 90 outpatients with schizophrenia or schizoaffective disorder to one of two 18 month psychosocial treatment groups, traditional Individual Placement and Support (IPS) with the addition of psychoeducation about schizophrenia or with the addition of Vocationally-oriented Motivational Interviewing (VOMI). We are hypothesizing that: 1) clients with schizophrenia who participate in IPS+VOMI will have better vocational outcomes (including 1a) a greater likelihood of obtaining a first job, 1b) more total weeks worked, 1c) more total hours employed, 1d) and more wages) than clients who receive IPS with psychoeducation; 2) If they are separated from their first job, clients with schizophrenia who participate in IPS+VOMI will be more likely to obtain a second (and subsequent) job than clients who receive IPS with psychoeducation (main effect of IPS + VOMI); and 3) Regardless of their treatment condition, working clients with schizophrenia will have greater improvements in social adjustment, symptoms, and life satisfaction than those who are not working.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 48
Est. completion date February 2015
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Patient must have schizophrenia or schizoaffective disease

- Currently unemployed but want to get at least a part time job

- Be on a stable medication regimen and compliant with treatment

- Live within one hour of the hospital

- Be willing to have care transferred to the Schizophrenia Outpatient Clinic at VA Greater Los Angeles Healthcare System

Exclusion Criteria:

- Organic brain disease

- Physical illnesses that would preclude working

Study Design

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


Intervention

Behavioral:
Supported employment with motivational interviewing.
supported employment with 4 sessions of motivational interviewing prior to each job search
Supported employment with illness education.
supportive employment with 4 sessions of illness education

Locations

Country Name City State
United States VA Greater Los Angeles Healthcare System, West LA West Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary job acquisition and tenure 18 months No
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