The Impact of Vocational Rehabilitation on Mentally III Veterans
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00333801|
Recruitment Status : Completed
First Posted : June 6, 2006
Results First Posted : March 19, 2015
Last Update Posted : March 19, 2015
|Condition or disease||Intervention/treatment|
|Posttraumatic Stress Disorder (PTSD)||Behavioral: Vocational Rehabilitation Program (VRP) Behavioral: Individual Placement and Support (IPS)|
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 (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Vocational Rehabilitation on Mentally III Veterans|
|Study Start Date :||April 2006|
|Primary Completion Date :||April 2010|
|Study Completion Date :||July 2012|
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
- 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.
- 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.
- Employment Outcomes (Weeks Competitively Employed) [ Time Frame: one year ]Number of weeks employed for any time in a competitive job (not set-aside job)
- Employment Outcomes (Days Competitively Employed [ Time Frame: one year ]Number of days employed in a competitive job (not set-aside job)
- Employment Outcomes (Hours Competitively Employed) [ Time Frame: one year ]hours employed in a competitive (not set-aside) job
- Employment Outcomes (Gross Income Competitive) [ Time Frame: one year ]total gross income (US dollars) from all competitive wages, salary, commissions
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333801
|United States, Alabama|
|Tuscaloosa VA Medical Center|
|Tuscaloosa, Alabama, United States, 35404|
|Principal Investigator:||Lori L. Davis, MD||Tuscaloosa VA Medical Center, Tuscaloosa, AL|