Veterans Individual Placement and Support Towards Advancing Recovery

Posttraumatic Stress Disorder (PTSD) Clinical Trial

— VIP-STAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817712
• Other study ID #: 589
• Status: Completed
• Phase: N/A
• Start date: December 31, 2013
• Est. completion date: February 3, 2017

Study information

• Verified date: February 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 541
• Est. completion date: February 3, 2017
• Est. primary completion date: December 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder (PTSD)
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Individual Placement & Support
IPS uses an integrated "place-train" approach to help people obtain and maintain community-based competitive employment in their chosen occupation.
• VA Transitional Work Program
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.

Locations

Country	Name	City	State
United States	New Mexico VA Health Care System, Albuquerque, NM	Albuquerque	New Mexico
United States	Birmingham VA Medical Center, Birmingham, AL	Birmingham	Alabama
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York
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	Durham VA Medical Center, Durham, NC	Durham	North Carolina
United States	Edward Hines Jr. VA Hospital, Hines, IL	Hines	Illinois
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	Miami VA Healthcare System, Miami, FL	Miami	Florida
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota
United States	San Francisco VA Medical Center, San Francisco, CA	San Francisco	California
United States	Tuscaloosa VA Medical Center, Tuscaloosa, AL	Tuscaloosa	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Obtained and Maintained Competitive Employment for at Least 50% of the Active Follow-up Period	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).	78 weeks
Secondary	Cumulative Gross Income	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.	Weekly for 78 weeks
Secondary	Change in PCL-5 Score of PTSD Symptoms	PTSD Symptoms are assessed every three months during the follow-up period using the self-report PTSD Checklist (PCL-5) that the participant completes during the follow-up visits. Range of values 0-80 (higher score is worse).	18-months (Change from baseline)