Clinical trial NCT00728325: Impact of Supported Employment Versus Standard Vocational Rehabilitation in Veterans With Post-traumatic Stress Disorder
Official title: The Impact of Supported Employment Versus Standard Vocational Rehabilitation in Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PTSD
Keywords: PTSD
Vocational Rehabilitation
Supported Employment
Lead sponsor: Tuscaloosa Research & Education Advancement Corporation
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2008-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* signed informed consent
* diagnosis of PTSD (based on MINI)
* male or female
* any race or ethnicity
* age 19-60
* currently unemployed
* interested in competitive employment
* planning to remain in a 100-mile radius of participating VAMC for the 12- mo duration

Exclusion Criteria:

* Lifetime history of severe traumatic brain injury that has resulted in severe cognitive disorder
* diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder
* dementia (a standard exclusion from VRP)
* immediate need of detoxification from alcohol or drugs (a standard VRP exclusion)
* pending active legal charges or expected incarceration

Primary outcomes:
measure: Using an intent to treat analysis, subjects' maintained employed rate is measured using the Employment Index.
timeFrame: 12 months
Secondary outcomes:
measure: 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).
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Center
state: Alabama
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center
state: Alabama
city: Bedford
country: United States
facility: Bedford VA Medical Center
state: Massachusetts
Study officials:
affiliation: Tuscaloosa Veterans Affairs Medical Center
name: Lori L. Davis, M.D.
role: PRINCIPAL_INVESTIGATOR
References: