Veterans Individual Placement and Support Towards Advancing Recovery
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The primary objective of CSP#589 VIP-STAR is to evaluate the effectiveness of Individual
      Placement & Support (IPS) in unemployed Veterans with PTSD. The primary hypothesis is that,
      compared to those treated with transitional work program (TWP), unemployed Veterans with PTSD
      treated with IPS will be significantly more likely to become a steady worker. A steady worker
      is defined as holding a competitive job for greater than or equal to 50% of the 18-month
      study follow-up period (i.e., greater than or equal to 39 of the 78 weeks). All participants
      will be followed for 18 months post-randomization.

      12/14/12: Analytic plan augmented to allow for a sensitivity analysis of the primary outcome
      that would exclude the first 12 weeks post-randomization, and evaluate between group
      proportion of steady worker status, as defined by working in a competitive job for greater
      than or equal to 50% of the weeks during week 13-78.

      7/1/13: Analysis plan has been augmented to include a logistic regression analysis of the
      primary outcome, adjusted for participating medical center.

      10/4/13: Addition of the IPS-25 Fidelity Scale. The addition of the IPS-25 scale should
      increase the validity of study results.

      1/15/15: Addition of an Interactive Voice Recognition/Web-based (IVR/Web) System; as an
      option for weekly data capture of the primary outcome data (employment history).

      8/17/15: Approval of Supplemental Data Collection at Participant Study Exit; use of the data
      collected will supplement the study analysis plan and, provide further insight into the
      impact of vocational rehab. A Participant Satisfaction Survey will allow study participants
      to indicate their level of satisfaction with the study, vocational rehabilitation
      intervention and, suggestions for future research.
    

Detailed description: 
      Posttraumatic stress disorder (PTSD) affects more than 600,000 US Veterans and is the most
      common psychiatric condition for which Veterans seek VA disability benefits, making up a
      substantial proportion of the $23 billion pensions and disability annual budget. Although
      many Veterans with PTSD are college educated, few have jobs, almost 40% are impoverished, and
      most report work, role and social functioning scores below those of persons with serious
      mental illness. Veterans returning from the Gulf War-era II conflicts, defined as having
      served in the military since Sept 2001, often experience PTSD and confront unemployment upon
      their military discharge. According to a March 2011 report from the U.S. Department of Labor,
      the 2010 unemployment rates were 11.5% for these Gulf War-era II Veterans, 21% for
      service-connected disabled Gulf War-era II Veterans, 13% for all service-connected Veterans
      of all eras combined and 9.4% for non Veterans. The current methods used by the VA
      Compensated Work Therapy (CWT) programs do not sufficiently meet the employment
      rehabilitation needs of Veterans with PTSD. In a VA Northeast Program Evaluation Center
      (NEPEC) study evaluating administrative data of 5,862 Veterans from 122 CWT programs,
      Veterans with PTSD were 19% less likely to be employed at discharge from the VA CWT program
      compared to those without a diagnosis of PTSD. The rate of competitive employment at
      discharge was only 30% for Veterans with PTSD. Similarly, another VA study found that
      Veterans with PTSD involved in CWT were no more likely to be employed at 4 months follow-up
      compared to those who participated in a specialized PTSD treatment program.

      Over the past two decades of studies, the Individual Placement and Support (IPS) model of
      Supported Employment has yielded remarkably robust and consistent employment outcomes for
      individuals with serious mental illness (defined as schizophrenia, schizoaffective disorder,
      bipolar disorder, and major depression with psychotic features). Overall, approximately
      two-thirds of participants in clinical trials with serious mental illness who received IPS
      achieved competitive employment. However, Veterans with PTSD have very different clinical
      characteristics and employment challenges compared to Veterans with SMI. Serving as the first
      study in a PTSD population, a recent single site pilot study found superior outcomes from IPS
      compared to the conventional VA vocational rehabilitation program (VRP) in unemployed
      Veterans with PTSD (n=85). During the 12-month study follow-up period, 76% of the Veterans
      with PTSD randomized to IPS gained competitive employment, compared to 28% of those
      randomized to VRP. Together with the evidence base accumulated in the serious mentally ill
      population, the positive results of the pilot study in PTSD support a VA Cooperative Study to
      definitively test the effectiveness of IPS in Veterans with PTSD.

      As the primary outcome, the two groups will be compared in terms of the proportion of study
      participants who met the definition of steady worker, i.e., hold competitive employment for
      at least 50% of the follow-up period. Competitive employment is defined as a job receiving
      regular wages in a setting that is not set aside, sheltered, or enclaved, that is, the same
      job could be held by people without a mental illness or disability and is not a set-aside job
      in the TWP program. Secondary outcomes will include change in other occupational outcomes,
      PTSD symptoms, self esteem, community integration, and quality of life. We will explore the
      differences between groups in terms of occurrences of negative health outcomes.

      These findings would provide generalizable evidence of the effectiveness of differing
      employment support to the VHA stakeholders who inform policy and service delivery for
      Veterans with PTSD. Given the number of Veterans with PTSD, it is of critical importance for
      the VA to offer employment service programs based on the best evidence-based
      recovery-oriented model for this group. Conducting a large multi-site study is the next
      logical step in confirming IPS as an evidence-based employment service for Veterans with
      PTSD.
    

Intervention name(s): Individual Placement & Support; VA Transitional Work Program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): IPS uses an integrated "place-train" approach to help people obtain and maintain community-based competitive employment in their chosen occupation.; The long-standing approach to vocational rehabilitation in VHA and state programs is the "train-place" or "stepwise" model that is founded on the assumption that the patient or client benefits from some form of pre-vocational training, instruction, or practice in a protected, but artificial, work setting prior to entering or being placed in a competitive work role.
Other intervention name(s): Supported Employment, IPS; TWP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Posttraumatic neuroses; posttraumatic stress disorder; PTSD; Supported employment; IPS; CWT; TWP; Individual placement and support; Compensated work therapy; Transitional work program