The Impact of Vocational Rehabilitation on Mentally III Veterans

January 24, 2024 updated by: VA Office of Research and Development
To study the impact of Individual Placement and Support (IPS) supported employment (SE) compared to treatment-as-usual vocational rehabilitation program (VRP) for veterans with posttraumatic stress disorder (PTSD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives: to study the impact of Individual Placement and Support (IPS) supported employment (SE) compared to treatment-as-usual vocational rehabilitation program (VRP) for veterans with posttraumatic stress disorder (PTSD).

Research Design: This prospective randomized study evaluates the impact of IPS-SE compared to VRP on occupational, sobriety, psychiatric, and quality of life outcomes and health care costs for veterans with chronic PTSD who enter the Tuscaloosa VA Medical Center's (TVAMC) vocational rehabilitation program.

Methodology: Occupational functioning is determined primarily by whether the veteran can obtain and maintain competitive employment, and, secondarily, by time worked and wages earned for those employed. Veterans who meet inclusion criteria will be randomized to either IPS-SE or VRP. Outcomes will be assessed over a fixed 12-month observation period (beginning at randomization and computed for the entire 12-month observation period) as percent subjects employed at least one week (employed rate), and monthly employment rates (maintained employed rate). In addition, PTSD symptoms and other health-related quality of life measures will be evaluated. This strategy uses all available data during the 1-year period.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35404-5015
        • Tuscaloosa VA Medical Center, Tuscaloosa, AL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or Female
  • Age, greater than or equal to 19 and less than 61.
  • Enrollment in the TVAMC VRP
  • Signed informed consent
  • Chronic post-traumatic stress disorder
  • Any race or ethnic origin
  • Anticipation of remaining in the catchment area for the 12-month study duration

Exclusion Criteria:

  • Lifetime history of severe traumatic brain injury that has resulted in severe cognitive impairment
  • History of schizophrenia, schizoaffective, disorder, or bipolar I disorder
  • Pending litigation
  • In need of immediate detoxification.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individual Placement and Support (IPS)
Inidividual Placement and Support (IPS). IPS Supported Employment involves an IPS specialists working with client to identify job preferences, rapidly begin community-based job search, engage in competitive employment, sustain employment via open-ended IPS follow-along supports, and integrate IPS within the PTSD treatment team.
Behavioral: Individual Placement and Support (IPS)
Individual Placement and Support (IPS) is an evidence--based model of supported employment that emphasizes rapid job search within client preferences, community job development, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of the IPS specialist within the treatment team.
Other Names:
  • Supported emplooyment
Active Comparator: Vocational Rehabilitation Program (VRP)
Vocational Rehabilitation Program (VRP). VRP is the treatment as usual, which mostly consisted of transitional work program (TWP) in which client is placed in a set-aside noncompetitive job for time-limited period and then pursues competitive employment at time of discharge from VRP. Limited integration with treatment team and limited follow-along supports that are time-limited
Behavioral: Vocational Rehabilitation Program (VRP)
Vocational Rehabilitation Program (VRP) is a treatment-as-usual method using traditional train-place approaches, such as prevocational work skills training , compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist
Other Names:
  • Transition work program (TWP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obtain Competitive Employment
Time Frame: 1 calendar year
The primary outcome: competitive employment (Yes or No). Competitive employment was defined as a job for regular wages in a setting that was not set aside, or sheltered, that is, the job could be held by people without a mental illness or disability and was not a set-aside job in the VRP. Day labor (babysitting, manual labor by the day, drill, temporary work for family or friends) was not considered competitive employment.
1 calendar year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD, Depression, Disability Outcomes
Time Frame: one-year
Clinician Administered PTSD Scale for DSM-IV (CAPS) score range 0-136 with higher=more severe; Quick Inventory of Depression Scale - Clinician-rated (QIDS-CR) score range 0-27 with higher=more severe; Clinical Global Impression-Severity (CGI-S) score range 1-7 with higher=more severe; Davidson Trauma Scale (DTS) score range 0-136 with higher=more severe; and World Health Organization Disability Assessment Scale (WHODAS-II) 36-items rated on 5-point scale, from 1 (no difficulty) to 5 (extreme difficulty/cannot do) in 6 domains of life; domain scores are transformed from the total raw score (sum of items) of each domain according to the following formula: Transformed score=[(actual raw score - lowest possible raw score) / (possible raw score range)] x 100.
one-year
Employment Outcomes (Weeks Competitively Employed)
Time Frame: one year
Number of weeks employed for any time in a competitive job (not set-aside job)
one year
Employment Outcomes (Days Competitively Employed
Time Frame: one year
Number of days employed in a competitive job (not set-aside job)
one year
Employment Outcomes (Hours Competitively Employed)
Time Frame: one year
hours employed in a competitive (not set-aside) job
one year
Employment Outcomes (Gross Income Competitive)
Time Frame: one year
total gross income (US dollars) from all competitive wages, salary, commissions
one year
Employment Outcomes (Total Gross Income From All Sources
Time Frame: one year
total gross income from all sources of work including noncompetitive and competitive jobs
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Lori Lynne Davis, MD AB, Tuscaloosa VA Medical Center, Tuscaloosa, AL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2006

Primary Completion (Actual)

April 24, 2010

Study Completion (Actual)

July 26, 2012

Study Registration Dates

First Submitted

June 2, 2006

First Submitted That Met QC Criteria

June 5, 2006

First Posted (Estimated)

June 6, 2006

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4092-I
  • Promis Number 0052 (Other Grant/Funding Number: TVAMC)
  • MIRB 00033 (Other Identifier: TVAMC - reference number)
  • TVAMC 03-19 (Other Identifier: TVAMC - Year/project number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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