Veterans Individual Placement and Support Towards Advancing Recovery
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/21/2019 |
| Start Date: | December 31, 2013 |
| End Date: | February 3, 2017 |
CSP #589 - Veterans Individual Placement and Support Towards Advancing Recovery
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.
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.
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.
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.
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
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