N/A
N=541
Veterans Individual Placement and Support Towards Advancing Recovery
Posttraumatic Stress Disorder (PTSD)
Bottom Line
View on ClinicalTrials.gov: NCT01817712 ↗Enrolled (actual)
541
Serious AEs
23.5%
Results posted
Feb 2019
Primary outcome: Primary: Number of Participants Who Obtained and Maintained Competitive Employment for at Least 50% of the Active Follow-up Period — 105; 63 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Individual Placement & Support (Behavioral); VA Transitional Work Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Obtained and Maintained Competitive Employment for at Least 50% of the Active Follow-up Period |
105; 63 | <0.001 sig |
| SECONDARY Cumulative Gross Income |
7290; 1886 | 0.004 sig |
| SECONDARY Change in PCL-5 Score of PTSD Symptoms |
-3.66; -0.82 | 0.07 |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01817712). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.