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Veterans Individual Placement and Support Towards Advancing Recovery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01817712
Acronym
VIP-STAR
Enrollment
541
Registered
2013-03-25
Start date
2013-12-31
Completion date
2017-02-03
Last updated
2019-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALIndividual Placement & Support

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

BEHAVIORALVA 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Obtained and Maintained Competitive Employment for at Least 50% of the Active Follow-up Period78 weeksThe 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).

Secondary

MeasureTime frameDescription
Cumulative Gross IncomeWeekly for 78 weeksCumulative 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.
Change in PCL-5 Score of PTSD Symptoms18-months (Change from baseline)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).

Countries

United States

Participant flow

Participants by arm

ArmCount
Individual Placement and Support (IPS)
Individual Placement & Support: IPS uses an integrated place-train approach to help people obtain and maintain community-based competitive employment in their chosen occupation.
271
VA Transitional Work Program (TWP)
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.
270
Total541

Baseline characteristics

CharacteristicTotalVA Transitional Work Program (TWP)Individual Placement and Support (IPS)
Age, Continuous42.2 Years
STANDARD_DEVIATION 10.9
41.9 Years
STANDARD_DEVIATION 11.2
42.5 Years
STANDARD_DEVIATION 10.7
Alcohol Use disorder past 12 months132 Participants78 Participants54 Participants
Current Agoraphobia123 Participants59 Participants64 Participants
Current (last month) PTSD Checklist (PCL-5)45.6 units on a scale
STANDARD_DEVIATION 16.4
45.1 units on a scale
STANDARD_DEVIATION 17
46.2 units on a scale
STANDARD_DEVIATION 15.8
Current Major Depressive Episode170 Participants83 Participants87 Participants
Current Panic Disorder70 Participants33 Participants37 Participants
Duration of longest job in lifetime8.5 years
STANDARD_DEVIATION 6.1
8.7 years
STANDARD_DEVIATION 6.4
8.3 years
STANDARD_DEVIATION 5.8
Duration of PTSD13.3 years
STANDARD_DEVIATION 11.4
13.4 years
STANDARD_DEVIATION 11.3
13.3 years
STANDARD_DEVIATION 11.6
Education Level
Associate's Degree
90 Participants35 Participants55 Participants
Education Level
Bachelor's Degree
97 Participants57 Participants40 Participants
Education Level
High School Diploma
92 Participants39 Participants53 Participants
Education Level
Less than High School
5 Participants4 Participants1 Participants
Education Level
Master's or Doctoral Degree
33 Participants17 Participants16 Participants
Education Level
Some College Credit
224 Participants118 Participants106 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
90 Participants47 Participants43 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
451 Participants223 Participants228 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Housing Status
Inaquate Housing
77 Participants35 Participants42 Participants
Housing Status
Other Housing
36 Participants20 Participants16 Participants
Housing Status
Single Family Home
243 Participants121 Participants122 Participants
Housing Status
Townhouse/Apartment/Condo
185 Participants94 Participants91 Participants
Inadequate Housing Status
Homeless Shelter or other
31 Participants12 Participants19 Participants
Inadequate Housing Status
Transitional Housing
46 Participants23 Participants23 Participants
Length of current unemployment2.8 Years
STANDARD_DEVIATION 3.8
2.9 Years
STANDARD_DEVIATION 4.1
2.7 Years
STANDARD_DEVIATION 3.5
Marital Status
Divorced
161 Participants79 Participants82 Participants
Marital Status
Married
173 Participants84 Participants89 Participants
Marital Status
Never Married
135 Participants67 Participants68 Participants
Marital Status
Separated/Cohabitating/widowed
72 Participants40 Participants32 Participants
Non-alcohol use disorder past 12 months87 Participants40 Participants47 Participants
Past Major Depressive Episode356 Participants173 Participants183 Participants
PCL-5 Current Severity
Mild (19-37)
124 Participants60 Participants64 Participants
PCL-5 Current Severity
Moderate (38-59)
266 Participants138 Participants128 Participants
PCL-5 Current Severity
Severe (60-80)
112 Participants49 Participants63 Participants
PCL-5 Current Severity
Very Mild (0-18)
34 Participants20 Participants14 Participants
PTSD Checklist (PCL-5) at current diagnostic threshold413 Participants204 Participants209 Participants
Race/Ethnicity, Customized
African American
225 Participants110 Participants115 Participants
Race/Ethnicity, Customized
All Other
68 Participants36 Participants32 Participants
Race/Ethnicity, Customized
More than one race
25 Participants12 Participants13 Participants
Race/Ethnicity, Customized
White
274 Participants136 Participants138 Participants
Region of Enrollment
United States
541 Participants270 Participants271 Participants
Sex: Female, Male
Female
99 Participants52 Participants47 Participants
Sex: Female, Male
Male
442 Participants218 Participants224 Participants
Social Anxiety Disorder (generalized)63 Participants28 Participants35 Participants
Time at Current Residence3.6 Years
STANDARD_DEVIATION 5.9
3.7 Years
STANDARD_DEVIATION 6.2
3.6 Years
STANDARD_DEVIATION 5.7
Total CAPS-IV lifetime84.5 units on a scale
STANDARD_DEVIATION 18.6
84.8 units on a scale
STANDARD_DEVIATION 18.3
84.1 units on a scale
STANDARD_DEVIATION 18.9
Years of Homelessness1.9 Years
STANDARD_DEVIATION 2
1.9 Years
STANDARD_DEVIATION 2.8
1.9 Years
STANDARD_DEVIATION 1.7

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
3 / 2712 / 270
other
Total, other adverse events
36 / 27140 / 270
serious
Total, serious adverse events
63 / 27164 / 270

Outcome results

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).

Time frame: 78 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Individual Placement and Support (IPS)Number of Participants Who Obtained and Maintained Competitive Employment for at Least 50% of the Active Follow-up Period105 Participants
VA Transitional Work Program (TWP)Number of Participants Who Obtained and Maintained Competitive Employment for at Least 50% of the Active Follow-up Period63 Participants
p-value: <0.00195% CI: [1.46, 3.14]Regression, Logistic
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).

Time frame: 18-months (Change from baseline)

ArmMeasureValue (LEAST_SQUARES_MEAN)
Individual Placement and Support (IPS)Change in PCL-5 Score of PTSD Symptoms-3.66 units on a scale
VA Transitional Work Program (TWP)Change in PCL-5 Score of PTSD Symptoms-0.82 units on a scale
p-value: 0.0795% CI: [-3.91, 0.12]Mixed Models Analysis
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.

Time frame: Weekly for 78 weeks

ArmMeasureValue (MEDIAN)
Individual Placement and Support (IPS)Cumulative Gross Income7290 Dollars
VA Transitional Work Program (TWP)Cumulative Gross Income1886 Dollars
p-value: 0.004Kruskal-Wallis

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026