Clinical trial NCT01817712: Veterans Individual Placement and Support Towards Advancing Recovery
Official title: CSP #589 - Veterans Individual Placement and Support Towards Advancing Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder (PTSD)
Keywords: Posttraumatic neuroses
posttraumatic stress disorder
PTSD
Supported employment
IPS
CWT
TWP
Individual placement and support
Compensated work therapy
Transitional work program
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-03-25
Enrollment: 541
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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.

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

Primary outcomes:
measure: Number of Participants Who Obtained and Maintained Competitive Employment for at Least 50% of the Active Follow-up Period
timeFrame: 78 weeks
Secondary outcomes:
measure: Cumulative Gross Income
timeFrame: Weekly for 78 weeks
measure: Change in PCL-5 Score of PTSD Symptoms
timeFrame: 18-months (Change from baseline)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Center, Birmingham, AL
state: Alabama
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center, Tuscaloosa, AL
state: Alabama
city: San Francisco
country: United States
facility: San Francisco VA Medical Center, San Francisco, CA
state: California
city: Miami
country: United States
facility: Miami VA Healthcare System, Miami, FL
state: Florida
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System, Albuquerque, NM
state: New Mexico
city: Bronx
country: United States
facility: James J. Peters VA Medical Center, Bronx, NY
state: New York
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
city: Dallas
country: United States
facility: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
city: Madison
country: United States
facility: William S. Middleton Memorial Veterans Hospital, Madison, WI
state: Wisconsin
Study officials:
affiliation: Tuscaloosa VA Medical Center, Tuscaloosa, AL
name: Lori Lynne Davis, MD AB
role: STUDY_CHAIR
References:
citation: Davis LL, Resnick SG, Maieritsch KP, Weber KC, Erbes CR, Strom TQ, McCall KP, Kyriakides TC. Employment outcomes from VA vocational services involving transitional work for veterans with a diagnosis of posttraumatic stress disorder. Psychiatr Rehabil J. 2019 Sep;42(3):257-267. doi: 10.1037/prj0000357. Epub 2019 Apr 4.
citation: Mueller L, Wolfe WR, Neylan TC, McCaslin SE, Yehuda R, Flory JD, Kyriakides TC, Toscano R, Davis LL. Positive impact of IPS supported employment on PTSD-related occupational-psychosocial functional outcomes: Results from a VA randomized-controlled trial. Psychiatr Rehabil J. 2019 Sep;42(3):246-256. doi: 10.1037/prj0000345. Epub 2019 Apr 1.
citation: Davis LL, Kyriakides TC, Suris AM, Ottomanelli LA, Mueller L, Parker PE, Resnick SG, Toscano R, Scrymgeour AA, Drake RE; VA CSP #589 Veterans Individual Placement and Support Toward Advancing Recovery Investigators. Effect of Evidence-Based Supported Employment vs Transitional Work on Achieving Steady Work Among Veterans With Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Apr 1;75(4):316-324. doi: 10.1001/jamapsychiatry.2017.4472.