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Completed

NCT Number: NCT00333801

The Impact of Vocational Rehabilitation on Mentally III Veterans

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).

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Key information

Conditions

Posttraumatic Stress Disorder (PTSD) Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404-5015, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vocational Rehabilitation Program (VRP)

Behavioral

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)

Individual Placement and Support (IPS)

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Employment Outcomes (Weeks Competitively Employed)

    Time frame: one year

    Number of weeks employed for any time in a competitive job (not set-aside job)

  3. Employment Outcomes (Days Competitively Employed

    Time frame: one year

    Number of days employed in a competitive job (not set-aside job)

  4. Employment Outcomes (Hours Competitively Employed)

    Time frame: one year

    hours employed in a competitive (not set-aside) job

  5. Employment Outcomes (Gross Income Competitive)

    Time frame: one year

    total gross income (US dollars) from all competitive wages, salary, commissions

  6. 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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2012
First posted
Jun 6, 2006
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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