Impact of Supported Employment Versus Standard Vocational Rehabilitation in Veterans With Post-traumatic Stress Disorder
|ClinicalTrials.gov Identifier: NCT00728325|
Recruitment Status : Unknown
Verified December 2013 by Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation.
Recruitment status was: Active, not recruiting
First Posted : August 5, 2008
Last Update Posted : December 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|PTSD||Behavioral: Supported Employment (SE) Behavioral: Standard Vocational Rehabilitation (VRP)||Not Applicable|
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.
- I.a. First Component Primary Hypothesis (obtained employment): Subjects assigned to IPS will have higher rates of obtained employment for the 12-mo observation period than the VRP subjects.
- I.b. Second Component Primary Hypothesis (maintained employment): Among those subjects employed, those assigned to IPS will have worked more weeks for the 12-mo observation period than the VRP subjects.
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:
- greater work intensity (# weeks, days, # hours, wages earned)
- higher total earnings
- greater improvement in quality of life outcomes
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Supported Employment Versus Standard Vocational Rehabilitation in Veterans With PTSD|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||May 2014|
|Estimated Study Completion Date :||May 2014|
Active Comparator: 1
Standard Vocational Rehabilitation (VRP)
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).
Other Name: Veterans in Vocational Rehabilitation Program
Supported Employment (SE)
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.
Other Name: Veterans in Vocational Rehabilitation Program
- Using an intent to treat analysis, subjects' maintained employed rate is measured using the Employment Index. [ Time Frame: 12 months ]
- Using an intent-to-treat analysis, the change from baseline to endpoint in PTSD symptoms is compared between groups using the Clinician Administered PTSD Scale (CAPS). [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728325
|United States, Alabama|
|Birmingham VA Medical Center|
|Birmingham, Alabama, United States, 35233|
|Tuscaloosa VA Medical Center|
|Tuscaloosa, Alabama, United States, 35404|
|United States, Massachusetts|
|Bedford VA Medical Center|
|Bedford, Massachusetts, United States, 01730|
|Principal Investigator:||Lori L. Davis, M.D.||Tuscaloosa VA Medical Center|