The Impact of Vocational Rehabilitation on Mentally III Veterans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00333801
First received: June 2, 2006
Last updated: March 6, 2015
Last verified: March 2015
  Purpose

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).


Condition Intervention
Posttraumatic Stress Disorder (PTSD)
Behavioral: Vocational Rehabilitation Program (VRP)
Behavioral: Individual Placement and Support (IPS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Vocational Rehabilitation on Mentally III Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Obtain Competitive Employment [ Time Frame: 1 calendar year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • PTSD, Depression, Disability Outcomes [ Time Frame: one-year ] [ Designated as safety issue: No ]
    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.

  • Employment Outcomes (Weeks Competitively Employed) [ Time Frame: one year ] [ Designated as safety issue: No ]
    Number of weeks employed for any time in a competitive job (not set-aside job)

  • Employment Outcomes (Days Competitively Employed [ Time Frame: one year ] [ Designated as safety issue: No ]
    Number of days employed in a competitive job (not set-aside job)

  • Employment Outcomes (Hours Competitively Employed) [ Time Frame: one year ] [ Designated as safety issue: No ]
    hours employed in a competitive (not set-aside) job

  • Employment Outcomes (Gross Income Competitive) [ Time Frame: one year ] [ Designated as safety issue: No ]
    total gross income (US dollars) from all competitive wages, salary, commissions

  • Employment Outcomes (Total Gross Income From All Sources [ Time Frame: one year ] [ Designated as safety issue: No ]
    total gross income from all sources of work including noncompetitive and competitive jobs


Enrollment: 100
Study Start Date: April 2006
Study Completion Date: July 2012
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Transition work program (TWP)
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 Name: Supported emplooyment

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.

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333801

Locations
United States, Alabama
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, United States, 35404
Sponsors and Collaborators
Investigators
Principal Investigator: Lori L. Davis, MD Tuscaloosa VA Medical Center, Tuscaloosa, AL
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00333801     History of Changes
Other Study ID Numbers: D4092-I, Promis Number 0052, MIRB 00033, TVAMC 03-19
Study First Received: June 2, 2006
Results First Received: November 25, 2014
Last Updated: March 6, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Posttraumatic Stress Disorder
Veterans
Vocational Rehabilitation
Supported Employment
Individual Placement and Support

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2015