Clinical Trial: Veterans Individual Placement and Support Towards Advancing Recovery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: CSP #589 - Veterans Individual Placement and Support Towards Advancing Recovery

Brief 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,

Detailed Summary:

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
Sponsor: VA Office of Research and Development

Current Primary Outcome: Obtaining and maintaining competitive employment for at least 50% of the active follow-up period [ Time Frame: Greater than or equal to 39 out of 78 weeks ]

The primary outcome will be achievement of a "steady worker" status, defined as obtaining and maintaining competitive employment for at least 50% of the active follow-up period (i.e., greater than or equal to 39 weeks).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cumulative Gross Income [ Time Frame: Weekly for 78 weeks ]
    Cumulative Gross Income is collected using the Employment Calendar source document and Employment Calendar Reconciliation case report form used for the primary outcome ascertainment. When possible, the CRC verifies income earned by reviewing paycheck stubs that the participant is instructed to maintain with the Employment Calendar.
  • PTSD Symptoms [ Time Frame: Baseline and every 3 months during follow-up ]
    PTSD Symptoms are assessed every three months during the follow-up period using the self-report PTSD Checklist (PCL) that the participant completes during the follow-up visits.
  • Self Esteem [ Time Frame: Baseline and every 3 months during follow-up ]
    Self Esteem is assessed every three months during follow-up by the self-reporting Rosenberg Self Esteem Scale (RSES) that the participant completes during the follow-up visits.
  • Quality of Life [ Time Frame: Baseline and every 6 months during follow-up ]
    Quality of Life is assessed every three months during the follow-up period using the self-report Quality of Life Inventory (QOLI) that the participant completes during the follow-up visits.


Original Secondary Outcome:

  • Cumulative Gross Income [ Time Frame: Greater than or equal to 39 out of 78 weeks ]
    Cumulative Gross Income is collected using the Employment Calendar source document and Employment Calendar Reconciliation case report form used for the primary outcome ascertainment. When possible, the CRC verifies income earned by reviewing paycheck stubs that the participant is instructed to maintain with the Employment Calendar.
  • PTSD Symptoms [ Time Frame: Greater than or equal to 39 out of 78 weeks ]
    PTSD Symptoms are assessed every three months during the follow-up period using the self-report PTSD Checklist (PCL) that the participant completes during the follow-up visits.
  • Self Esteem [ Time Frame: Greater than or equal to 39 out of 78 weeks ]
    Self Esteem is assessed every three months during follow-up by the self-reporting Rosenberg Self Esteem Scale (RSES) that the participant completes during the follow-up visits.
  • Quality of Life [ Time Frame: Greater than or equal to 39 out of 78 weeks ]
    Quality of Life is assessed every three months during the follow-up period using the self-report Quality of Life Inventory (QOLI) that the participant completes during the follow-up visits.


Information By: VA Office of Research and Development

Dates:
Date Received: March 20, 2013
Date Started: December 31, 2013
Date Completion:
Last Updated: March 24, 2017
Last Verified: March 2017