The Impact of Vocational Rehabilitation on Mentally III Veterans

Posttraumatic Stress Disorder (PTSD) Clinical Trial

Official title:

The Impact of Vocational Rehabilitation on Mentally III Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333801
• Other study ID #: D4092-I
• Secondary ID: Promis Number 00
• Status: Completed
• Phase: N/A
• Start date: April 1, 2006
• Est. completion date: July 26, 2012

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Other known NCT identifiers

• NCT00260507

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 26, 2012
• Est. primary completion date: April 24, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Tuscaloosa VA Medical Center, Tuscaloosa, AL	Tuscaloosa	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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: 10.103 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obtain Competitive Employment	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	PTSD, Depression, Disability Outcomes	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
Secondary	Employment Outcomes (Weeks Competitively Employed)	Number of weeks employed for any time in a competitive job (not set-aside job)	one year
Secondary	Employment Outcomes (Days Competitively Employed	Number of days employed in a competitive job (not set-aside job)	one year
Secondary	Employment Outcomes (Hours Competitively Employed)	hours employed in a competitive (not set-aside) job	one year
Secondary	Employment Outcomes (Gross Income Competitive)	total gross income (US dollars) from all competitive wages, salary, commissions	one year
Secondary	Employment Outcomes (Total Gross Income From All Sources	total gross income from all sources of work including noncompetitive and competitive jobs	one year