CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 541 enrolled
Drug / intervention
Individual Placement & Support +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01817712
NCT01817712N/ACompleted

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

VA Office of Research and Development·interventional·Posted Mar 25, 2013·Updated Feb 19, 2019

In Brief

A clinical study evaluating Individual Placement & Support and VA Transitional Work Program for Posttraumatic Stress Disorder (PTSD). Completed, enrolled 541 participants across 13 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 25, 2013
Enrollment StartDec 31, 2013
Primary CompletionDec 20, 2016
Study CompletionFeb 3, 2017
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 13.3 years ago

Interventions

Individual Placement & Supportbehavioral

IPS uses an integrated "place-train" approach to help people obtain and maintain community-based competitive employment in their chosen occupation.

VA Transitional Work Programbehavioral

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.