Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Tuscaloosa Research & Education Advancement Corporation Department of Defense |
---|---|
Information provided by: | Tuscaloosa Research & Education Advancement Corporation |
ClinicalTrials.gov Identifier: | NCT00728325 |
This prospective randomized study evaluates the impact of Supportive Employment (SE) compared to standard vocational rehabilitation (VRP) on occupational, sobriety, psychiatric, and quality of life outcomes and health care costs for veterans with chronic posttraumatic stress disorder (PTSD).
Condition | Intervention |
---|---|
PTSD |
Behavioral: Supported Employment (SE) Behavioral: Standard Vocational Rehabilitation (VRP) |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | The Impact of Supported Employment Versus Standard Vocational Rehabilitation in Veterans With PTSD |
Estimated Enrollment: | 100 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1
Veterans with PTSD enrolled in a VA rehabilitation program
|
Behavioral: Supported Employment (SE)
SE(IPS)involves: a vocational rehabilitation employment specialist who is integrated into the clinical treatment team, carries out all phases of the vocational services, provides predominantly community-based services, provides assertive engagement and outreach, has a case load of ≤ 25 clients; engages in rapid job search, individualized placement in diverse and potentially permanent competitive job(s), ongoing work-based vocational assessment, and assistance in finding subsequent jobs if needed with the view that all jobs are positive learning experiences; continuous time-unlimited follow-along supports to provide vocational services; and weekly group supervision with IPS/VRP team and with IPS supervisor/trainer monthly.
Behavioral: Standard Vocational Rehabilitation (VRP)
Standard Vocational Rehabilitation (VRP) includes 1) the Vocational Assistance Program (includes routine prevocational testing and evaluation for all patients upon referral to VRP), 2) Vocational Rehabilitation Therapy that operates under the Compensated Work Therapy/Veterans Industries (CWT) and provides a work regimen with monetary incentives derived from contracts whereby participants are paid on a piece rate basis related to their production, and 3) Transitional Work Program (TWP) that includes a temporary work experience either within the VAMC or in community settings (called the Transitional Work External or TWE).
|
Hypotheses or Key Questions
I. Primary Hypothesis (obtained + maintained employment): Subjects assigned to IPS will have a higher maintained employed rate for the 12-mo observation period than their standard VRP counterparts.
II. Secondary Hypothesis: Those subjects who obtain competitive employment will have significantly reduced symptoms of PTSD from baseline to endpoint compared to those subjects who do not obtain competitive employment.
III. Confirmatory and Correlational Hypotheses: Compared to VRP subjects, those subjects assigned to IPS will have:
Supplemental hypothesis (moderator): Because of the superior integration with the mental health (MH) treatment team, social work services, and community resources that the IPS-SE employment specialist provides as part of this model, we hypothesize that the IPS-SE model will have greater success in the maintenance of competitive employment compared to standard VRP for veterans with PTSD challenged in one or more of these psychosocial domains. From a research perspective, a variable that characterizes subjects for whom a particular treatment will be effective is called a moderator of treatment.
The hypothesized moderators of IPS-SE and standard VRP for subjects with PTSD are: 1) Transportation, 2) Housing, 3) Financial Means, and 4) Family Care Burden. We hypothesize that these variables will have moderating effects for each of two outcomes: 1) number of weeks the participant is competitively employed during the 12-month study period and 2) their score on the Sheehan Disability Scale.
Several principles are important in defining a moderator. First, the moderator must precede treatment. In our RCT, these psychosocial domains are baseline characteristics of subjects enrolled in the study. Second, the moderator must be uncorrelated with treatment choice. This will be the case in this RCT due to a 1:1 randomization, which should balance baseline characteristics between the two groups. Third, a moderator of treatment must have a differential effect of treatment for each level of the moderator. The treatment effect (e.g., active vs. comparator) must be shown to be greater for one level of the moderator (i.e. IPS-SE will show a greater effect size than standard VRP in subjects with a moderator present). Also, an index that combines these domains will be explored and formulated to identify subjects that may benefit to greater extent from IPS-SE.
Ages Eligible for Study: | 19 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lori L. Davis, M.D. | 205-554-3819 | lori.davis@va.gov |
Contact: Catherine M. Blansett, Ph.D. | 205-554-2000 ext 3627 | catherine.blansett@va.gov |
United States, Alabama | |
Birmingham VA Medical Center | Recruiting |
Birmingham, Alabama, United States, 35233 | |
Contact: Lori L. Davis, M.D. 205-554-3819 lori.davis@va.gov | |
Contact: Elizabeth Denson, M.S.W 205-933-8101 ext 6817 elizabeth.densen@va.gov | |
Principal Investigator: Lori L. Davis, M.D. | |
Tuscaloosa VA Medical Center | Recruiting |
Tuscaloosa, Alabama, United States, 35404 | |
Contact: Lori L. Davis, M.D. 205-554-3819 lori.davis@va.gov | |
Contact: Catherine M. Blansett, Ph.D 205-554-2000 ext 3627 catherine.blansett@va.gov | |
Principal Investigator: Lori L. Davis, M.D. | |
United States, Massachusetts | |
Bedford VA Medical Center | Recruiting |
Bedford, Massachusetts, United States, 01730 | |
Contact: Charles Drebing, Ph.D. 781-687-2462 charles.drebing@va.gov | |
Contact: Lisa N. Meuller, Ph.D. 781-687-3192 lisa.meuller@va.gov | |
Principal Investigator: Charles E. Drebing, Ph.D. |
Principal Investigator: | Lori L. Davis, M.D. | Tuscaloosa VA Medical Center |
Responsible Party: | Tuscaloosa VA Medical Center ( Lori L. Davis, M.D ) |
Study ID Numbers: | PT074312, VA IRB ID: 00123 |
Study First Received: | July 15, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00728325 |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
PTSD Vocational Rehabilitation Supported Employment |
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |