Clinical trial NCT00333801: The Impact of Vocational Rehabilitation on Mentally III Veterans
Official title: The Impact of Vocational Rehabilitation on Mentally III Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Keywords: Posttraumatic Stress Disorder
Veterans
Vocational Rehabilitation
Supported Employment
Individual Placement and Support
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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 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.

Primary outcomes:
measure: Obtain Competitive Employment
timeFrame: 1 calendar year
Secondary outcomes:
measure: PTSD, Depression, Disability Outcomes
timeFrame: one-year
measure: Employment Outcomes (Weeks Competitively Employed)
timeFrame: one year
measure: Employment Outcomes (Days Competitively Employed
timeFrame: one year
measure: Employment Outcomes (Hours Competitively Employed)
timeFrame: one year
measure: Employment Outcomes (Gross Income Competitive)
timeFrame: one year
measure: Employment Outcomes (Total Gross Income From All Sources
timeFrame: one year
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center, Tuscaloosa, AL
state: Alabama
Study officials:
affiliation: Tuscaloosa VA Medical Center, Tuscaloosa, AL
name: Lori Lynne Davis, MD AB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis LL, Leon AC, Toscano R, Drebing CE, Ward LC, Parker PE, Kashner TM, Drake RE. A randomized controlled trial of supported employment among veterans with posttraumatic stress disorder. Psychiatr Serv. 2012;63(5):464-70. doi: 10.1176/appi.ps.201100340.
citation: Davis LL, Pilkinton P, Poddar S, Blansett C, Toscano R, Parker PE. Impact of social challenges on gaining employment for veterans with posttraumatic stress disorder: an exploratory moderator analysis. Psychiatr Rehabil J. 2014 Jun;37(2):107-9. doi: 10.1037/prj0000058. Epub 2014 Apr 7.