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Supported Employment: Motivational Enhancement for Entry and Outcome

Primary Purpose

Psychotic Disorders, Bipolar Disorder, Unemployment

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Adapted Motivational Interviewing (AMI)
Support and Education for Recovery (SER)
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 Psychotic Disorders focused on measuring Veterans, Vocational Rehabilitation

Eligibility Criteria

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

Inclusion Criteria:

  • Eligible to receive VA services
  • Diagnosis of serious mental illness: schizophrenia, schizoaffective, psychosis NOS, bipolar disorder, or depression with psychotic features
  • Currently unemployed
  • Not currently enrolled in Supported Employment services
  • Expects to stay within 100 miles of Bedford, MA for the next 18 months
  • Has a significant other (friend or family member) who is also willing to participate (a criterion required only from March 2011 to March 2012 of the recruitment period)

Exclusion Criteria:

  • Currently in prison
  • Not able to provide informed consent
  • Not able to speak and understand English

Sites / Locations

  • Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Adapted Motivational Interviewing (AMI)

Support and Education for Recovery (SER)

Arm Description

Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the Veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.

Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the Veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.

Outcomes

Primary Outcome Measures

Participation in Vocational Rehabilitation Services
Yes/No: Did veteran complete an intake for a VA Supported Employment program at any time from randomization to 18 month follow-up. Outcome: Number of participants who completed an intake for VA Supported Employment program at any time from randomization to 18 month follow-up.

Secondary Outcome Measures

Employment
Yes/No: Did veteran work at least one day in a competitive job at any time from randomization to 18 month follow-up. Outcome: Number of participants who worked at least one day in a competitive job at any time from randomization to 18 month follow-up.

Full Information

First Posted
December 31, 2009
Last Updated
February 8, 2016
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01041976
Brief Title
Supported Employment: Motivational Enhancement for Entry and Outcome
Official Title
Supported Employment: Motivational Enhancement for Entry and Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
September 2015 (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
The purpose of this study is to compare 6 monthly counseling sessions to 6 monthly information sessions on Veterans' decisions to (a) participate in vocational rehabilitation services and (b) become employed.
Detailed Description
Approximately 85-90% of those with serious mental illness are unemployed (9, 10). This level of unemployment exists despite the finding that, among people who have a psychiatric disability and are unemployed, 55-61% desire employment, with the total reaching 75% when concern about losing benefits was taken into account (1, 2). The rewards of employment for adults with SMI are greater than simply an increase in financial resources. Studies have found that people with serious mental illness who worked competitively scored higher on measures of self-esteem, satisfaction with finances, leisure, and overall life satisfaction compared to those worked little or not at all (11). Supported employment (SE) has been more effective than any other vocational rehabilitation approach for this population (3, 4) and the VA has mandated that SE be integrated into all current VHA Compensated Work Therapy (CWT) programs (VHA Directive 2007-005). Two areas of concern include (a) national utilization of SE services is low (13), and (b) the percentage of SE participants who obtain at least one job during the studies averages 56% even though everyone who enters the program expressed an interest in working (13). Motivational interviewing (MI) is an evidence-based practice that has been effective in enhancing a range of clinical services (6), but has just recently been applied to employment and vocational services by Drebing et al. (7) and Glynn et al (8). The proposed project is a randomized trial of Adapted Motivational Interviewing for Supported Employment (AMI-SE) provided to Veterans and their significant others (family members or key friends) in order to address the internal and external barriers to the Veteran enrolling in supported employment and returning to work.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Bipolar Disorder, Unemployment
Keywords
Veterans, Vocational Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adapted Motivational Interviewing (AMI)
Arm Type
Experimental
Arm Description
Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the Veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
Arm Title
Support and Education for Recovery (SER)
Arm Type
Placebo Comparator
Arm Description
Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the Veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
Intervention Type
Behavioral
Intervention Name(s)
Adapted Motivational Interviewing (AMI)
Intervention Description
Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the Veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
Intervention Type
Behavioral
Intervention Name(s)
Support and Education for Recovery (SER)
Intervention Description
Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the Veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
Primary Outcome Measure Information:
Title
Participation in Vocational Rehabilitation Services
Description
Yes/No: Did veteran complete an intake for a VA Supported Employment program at any time from randomization to 18 month follow-up. Outcome: Number of participants who completed an intake for VA Supported Employment program at any time from randomization to 18 month follow-up.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Employment
Description
Yes/No: Did veteran work at least one day in a competitive job at any time from randomization to 18 month follow-up. Outcome: Number of participants who worked at least one day in a competitive job at any time from randomization to 18 month follow-up.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eligible to receive VA services Diagnosis of serious mental illness: schizophrenia, schizoaffective, psychosis NOS, bipolar disorder, or depression with psychotic features Currently unemployed Not currently enrolled in Supported Employment services Expects to stay within 100 miles of Bedford, MA for the next 18 months Has a significant other (friend or family member) who is also willing to participate (a criterion required only from March 2011 to March 2012 of the recruitment period) Exclusion Criteria: Currently in prison Not able to provide informed consent Not able to speak and understand English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Mueller, PhD MSEd
Organizational Affiliation
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Supported Employment: Motivational Enhancement for Entry and Outcome

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