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Motivational Interviewing to Improve Work Outcomes in Schizophrenia

Primary Purpose

Schizoaffective Disorder, Schizophrenia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IPS
IE
VOMI
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizoaffective Disorder focused on measuring clinical trial, employment, schizoaffective disorder, schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Greater Los Angeles Healthcare System, West LA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IPS and VOMI

IPS and IE

Arm Description

Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching

Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching

Outcomes

Primary Outcome Measures

Obtained Employment
Number of participants who obtained a competitive job
Average Number of Days Worked
Average number of total days each participant worked in the study
Average Number of Hours Worked Per Week For Those Who Worked
Average number of hours worked per week among participants who obtained a job

Secondary Outcome Measures

Obtained a Second Job if Lost First Job and Still Had at Least 2 Months in the Program
Number of participants who obtained a second or third job if lost his/her first job but still had at least 2 months in the study
Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale
Employment status at each major follow-up assessment period and psychiatric symptomatology as reflected in the Total Brief Psychiatric Rating Scale Score (Ventura J, et al., Training and quality assurance with the Structured Clinical Interview for DSM-IV (SCID-I/P). Psychiatry Research, 1998. 79(2): p. 163-173) with scale range from 24 to 168, with higher scores indicating greater symptomatology
Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman)
Employment status at each major follow-up assessment period and self-reported Life Satisfaction (range from 1 (terrible) to 7 (delighted)) on the Quality of Life Scale (Lehman A, Kernan E, and Postrado L, Toolkit for Evaluating Quality of Life for Persons with Severe Mental Illness. 1995, Baltimore, MD: The Evaluation Center at HSRI).
Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler)
Employment status at each major follow-up assessment period and overall adjustment as rated on the Social Adjustment Scale II (Schooler, N., G. Hogarty, and M. Weissman, Social Adjustment Scale II (SAS-II), in Resource Materials for Community Mental Health Program Evaluations, W.A. Hargreaves, C.C. Atkisson, and J.E. Sorenson, Editors. 1979, NIMH: Rockville, MD. p. 290-303), on a 1 (excellent adjustment ) to 7 (severe maladjustment) scale.

Full Information

First Posted
December 1, 2005
Last Updated
June 17, 2016
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00261716
Brief Title
Motivational Interviewing to Improve Work Outcomes in Schizophrenia
Official Title
Motivational Interviewing to Improve Work Outcomes in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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. Over 20 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. 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, and these findings may be worse in individuals iwth schizophrenia (Twamely et al, 2003) . 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 tested 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 assigned 38 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 illness education (IE) about schizophrenia/schizoaffective disorder, as appropriate, or with the addition of Vocationally-oriented Motivational Interviewing (VOMI). We hypothesized that: 1) clients with schizophrenia who participated in IPS+VOMI would better vocational outcomes than IPS+IE clients. 2) If they are separated from their first job, clients with schizophrenia who participate in IPS+VOMI would be more likely to obtain a second job than clients who receive IPS+IE; and 3) Regardless of their treatment condition, working clients with schizophrenia would have greater social adjustment, symptoms, and life satisfaction than those who are not working.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizoaffective Disorder, Schizophrenia
Keywords
clinical trial, employment, schizoaffective disorder, schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPS and VOMI
Arm Type
Experimental
Arm Description
Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching
Arm Title
IPS and IE
Arm Type
Active Comparator
Arm Description
Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching
Intervention Type
Behavioral
Intervention Name(s)
IPS
Intervention Description
Individual Placement and Support Evidence based supported employment
Intervention Type
Behavioral
Intervention Name(s)
IE
Intervention Description
Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search
Intervention Type
Behavioral
Intervention Name(s)
VOMI
Intervention Description
Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search
Primary Outcome Measure Information:
Title
Obtained Employment
Description
Number of participants who obtained a competitive job
Time Frame
18 months of study
Title
Average Number of Days Worked
Description
Average number of total days each participant worked in the study
Time Frame
18 months of study
Title
Average Number of Hours Worked Per Week For Those Who Worked
Description
Average number of hours worked per week among participants who obtained a job
Time Frame
18 months of study
Secondary Outcome Measure Information:
Title
Obtained a Second Job if Lost First Job and Still Had at Least 2 Months in the Program
Description
Number of participants who obtained a second or third job if lost his/her first job but still had at least 2 months in the study
Time Frame
18 months of the study
Title
Association Between Employment Status and Psychiatric Symptoms as Measured on the Brief Psychiatric Rating Scale
Description
Employment status at each major follow-up assessment period and psychiatric symptomatology as reflected in the Total Brief Psychiatric Rating Scale Score (Ventura J, et al., Training and quality assurance with the Structured Clinical Interview for DSM-IV (SCID-I/P). Psychiatry Research, 1998. 79(2): p. 163-173) with scale range from 24 to 168, with higher scores indicating greater symptomatology
Time Frame
6,12, 18 months
Title
Association Between Employment Status and Self-reported Life Satisfaction Measured on the Quality of Life Scale (Lehman)
Description
Employment status at each major follow-up assessment period and self-reported Life Satisfaction (range from 1 (terrible) to 7 (delighted)) on the Quality of Life Scale (Lehman A, Kernan E, and Postrado L, Toolkit for Evaluating Quality of Life for Persons with Severe Mental Illness. 1995, Baltimore, MD: The Evaluation Center at HSRI).
Time Frame
6,12, 18 months
Title
Association Between Employment Status and Overall Adjustment as Rated on the Social Adjustment Scale II (Schooler)
Description
Employment status at each major follow-up assessment period and overall adjustment as rated on the Social Adjustment Scale II (Schooler, N., G. Hogarty, and M. Weissman, Social Adjustment Scale II (SAS-II), in Resource Materials for Community Mental Health Program Evaluations, W.A. Hargreaves, C.C. Atkisson, and J.E. Sorenson, Editors. 1979, NIMH: Rockville, MD. p. 290-303), on a 1 (excellent adjustment ) to 7 (severe maladjustment) scale.
Time Frame
6, 12, and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley M. Glynn, PhD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West LA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, West LA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Contact PI for access to data

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Motivational Interviewing to Improve Work Outcomes in Schizophrenia

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