A Randomized Controlled Trial of Supported Employment Among Veterans With Posttraumatic Stress Disorder

From 2006 to 2010, veterans with PTSD at the Tuscaloosa VA Medical Center (VAMC) were enrolled in a 12-month, prospective randomized comparison of IPS and VRP. This study (www.ClinicalTrials.gov identifier number NCT00333801) was approved by the Tuscaloosa VAMC Institutional Review Board. A trained investigator or clinical research coordinator explained all study procedures, alternatives to participation, and potential benefits and risks to prospective participants and obtained their written informed consent before study enrollment. Veterans were eligible for the study if they had a diagnosis of PTSD, were aged 19 to 60, were eligible for the Tuscaloosa VAMC VRP (that is, had a medical clearance that they were able to participate in a work activity; work restrictions had to be noted, if present), were currently unemployed, were interested in competitive employment, and were planning to remain in a 100-mile radius of the Tuscaloosa VAMC for the 12-month duration. Veterans were excluded if they had a lifetime history of severe traumatic brain injury that resulted in severe cognitive disorder; a diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder (because these individuals are already eligible for IPS); a diagnosis of dementia; immediate need of detoxification from alcohol or drugs; or pending active legal charges with expected incarceration. A history of mild to moderate traumatic brain injury and all other comorbid axis I diagnoses, including substance use disorders, bipolar disorder type II, major depression, and other anxiety disorders, were permissible.

Both interventions operated under the VHA Compensated Work Therapy program. The final goal for both interventions was competitive employment, although the methods and pathways were different. Table 1 provides an overview of the interventions and the differences between them. The IPS intervention involved several important features. Eligibility was based on the participant's choice and interest in competitive work. The IPS specialist was integrated into the clinical mental health or PTSD treatment team, carried out all phases of the vocational services, provided predominantly community-based services, provided assertive engagement and outreach in community-based employment, had a caseload of no more than 25 clients, and provided continuous, time-unlimited, follow-along supports for vocational services. IPS involved rapid job search and individualized placement in diverse competitive jobs, with ongoing work-based vocational assessment and assistance in finding subsequent jobs, if needed. Group supervision is regularly scheduled with IPS specialists and an IPS supervisor. The IPS model is described in A Working Life for People With Severe Mental Illness (17) and an IPS manual from the Substance Abuse and Mental Health Services Administration (18). These references served as the study's manuals for IPS.

VRP followed the standard care in place at the Tuscaloosa VAMC, which included one or more of these components: routine prevocational testing and evaluation for all patients on referral to VRP, vocational rehabilitation therapy that provided a work regimen with monetary incentives derived from contracts whereby participants are paid on a piece-rate basis related to their production, and a transitional work program that included a temporary work experience (that is, time limited) either within the Tuscaloosa VAMC or in community settings (called the transitional work external or transitional work experience). The VRP model featured a VRP specialist who carried out some, but not all, phases of the vocational service; provided some community-based services (if a temporary work setting was external to VAMC), provided time-limited job search assistance to help the client obtain competitive employment, and had no maximum caseload. VRP had an initial short-term set-aside of transitional work experiences (such as work in VAMC environmental management services, food services, delivery services, or community jobs in food or other service delivery environments) that were not necessarily individualized to the patient's long-term preferences and had very little integration with the mental health treatment team. The VRP specialist assisted the veteran in a limited search for placement in a competitive job that was delayed until after the set-aside work experience neared completion and provided time-limited follow-along support during the set-aside work experience, with little or no long-term follow-up vocational assistance after the first competitive job was obtained.

After providing informed consent at baseline, participants underwent a psychiatric and general medical evaluation, including a medical history, psychiatric history, and family psychiatric history. The clinical research coordinator recorded a comprehensive history of level of education, past employment, housing, relationships, major traumatic life events, and disability status. The clinical research coordinator also evaluated the participant for PTSD and other axis I disorders using the Mini-International Neuropsychiatric Interview (19). Participants were instructed to keep a job log formatted in a daily calendar that captured whether they were employed, number of hours worked, wages earned, and reasons for missed work. At baseline and one-, two-, three-, four-, six-, eight-, ten-, and 12- month follow-up visits, the clinical research coordinator collected the participants' job logs and reviewed the calendar with the participant for completeness. The clinical research coordinator recorded on a case report form the number of job interviews, job offers, and jobs obtained and the type of jobs, number of hours worked, wages earned, and reasons for missed work or job termination for each week.

At the follow-up visits, a trained assessor administered the Clinician Administered PTSD Scale (20), Clinical Global Impression-Severity (21), 16-item Quick Inventory of Depressive Symptomatology-Clinician Rated (22), and the Clinical Global Impression-Improvement, and veterans completed the Quick Inventory of Depression Symptomatology-Self-Report, World Health Organization Disability Assessment Schedule II (23), Sheehan Disability Scale (24), and Davidson Trauma Scale (25). The assessors were kept blind to the intervention assignment. Although there was a concerted effort to maintain this blind, accidental unblinding occurred infrequently (exact frequency unknown), in which case the ratings were subsequently conducted by a different blinded rater.

To minimize attrition, the investigators provided thorough preenrollment education to all prospective participants about the study objectives and procedures to assess and confirm their commitment to and feasibility for long-term follow-up. If needed, the clinical research coordinator and assessor traveled to the participant's community for the participant's convenience. To enhance the rate of return and to address a loss-of-wage or transportation cost barrier, all participants received a modest payment for follow-up interviews, regardless of whether they continued in the IPS or VRP assignment.

After signing informed consent and undergoing baseline assessments, eligible participants were assigned to receive either IPS or VRP. Assignment was based on a randomization list that was prepared before the study began. The IPS supported employment was provided for 12 months, and the VRP was of variable time-limited service as determined by the Tuscaloosa VAMC's VRP program limits. Participants were followed and assessed at 12 months after baseline, regardless of intervention adherence, employment status, type of discharge, or attrition from the IPS or VRP intervention.

The IPS specialists received ongoing training and supervision via monthly conference calls and quarterly site visits by the national IPS consultant (RT). During these visits, the consultant also conducted fidelity monitoring, which included reviewing the IPS specialist's caseload, meeting with veterans from both IPS and VRP interventions, interviewing participants' clinical providers, interviewing participants' employers, and rating the adherence of the IPS intervention with the Supported Employment Fidelity Scale (26). The national consultant also conducted a Supported Employment Fidelity Scale assessment of VRP to ensure that the ratings were low—that is, that VRP remained different from the IPS intervention as was intended by the study design.

The primary outcome was whether the participant engaged in competitive employment (yes or no). Competitive employment was defined as a job for regular wages in a setting that was not set aside, sheltered, or enclaved, that is, the same job could be held by people without a mental illness or disability and was not a set-aside job in the VRP. Day labor (that is, pick-up cash-based day jobs for yard work, babysitting, manual labor, and so forth) and military drill were not counted as competitive employment; however, data on income from all sources were collected. Secondary outcomes included the proportions of eligible weeks, days, and hours worked and gross income earned in competitive employment. Eligible weeks were defined as those in which the participant was not encumbered by a set-aside job (that is, a set-aside job in the VRP condition) and in which the participant was active in the study (that is, weeks during which the participant had exited the study were not counted because determining whether the participant was employed was not possible).

Using intent-to-treat analyses and two-tailed tests with significance set at p≤.05, we compared rates of competitive employment (the primary hypothesis) with chi square tests and number of eligible weeks of competitive employment (the secondary hypothesis) with a Mann-Whitney test. We also compared groups on the number of weeks, days, and hours worked in a competitive job; gross wages earned from all sources; and gross wages earned from competitive jobs. The between-group difference was tested by using either a t test or a Mann-Whitney test, depending on the distribution of the variable. There was no imputation for employment outcomes during the weeks in which the participants exited early and were no longer in the study. We examined the time (number of weeks) until the first week worked in a competitive job and used a Kaplan-Meier survival analysis with a log-rank test to compare intervention groups. Participants who did not get a job were classified as censored at their final assessment point.