Veterans Individual Placement and Support Towards Advancing Recovery

Completed · Not applicable

Conditions studied: Posttraumatic Stress Disorder (PTSD)

In brief

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.

Key facts

Study ID

NCT01817712

Run by

VA Office of Research and Development

People needed

541

Starts

2013-12-31

Expected to finish

2017-02-03

Last updated by the study team

2019-02-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Veteran
• Age greater than or equal to 18* (*18 or 19 depending on state legal definition of a minor) to age 65
• Eligible for VA TWP services
• Diagnosis of PTSD, as confirmed by Clinician Administered PTSD Scale (CAPS)
• Currently unemployed (and not participating in TWP - Impact Statement #3 10/4/13)
• Expression of interest in competitive employment (part-time or full-time - Impact Statement #3 10/4/13)
• Willing and able to give informed consent

You may not qualify if…

• Lifetime diagnosis if (i) schizophrenia, (ii) schizoaffective or (iii) bipolar I disorder
• Diagnosis of dementia or severe cognitive disorder (evidenced in the medical record)
• Unlikely that participant can complete the study; reasons may include: expected deployment, expected incarceration, expected long-term hospitalization, or expected relocation from the vicinity of the participating medical center (PMC) during the study period
• Active suicidal or homicidal ideation
• Current participation in another interventional trial

Where it is running

• Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama, United States
• Tuscaloosa VA Medical Center, Tuscaloosa, AL — Tuscaloosa, Alabama, United States
• San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States
• Miami VA Healthcare System, Miami, FL — Miami, Florida, United States
• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States
• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
• New Mexico VA Health Care System, Albuquerque, NM — Albuquerque, New Mexico, United States
• James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States
• Durham VA Medical Center, Durham, NC — Durham, North Carolina, United States
• Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States
• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas, Texas, United States
• Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States
• William S. Middleton Memorial Veterans Hospital, Madison, WI — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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