Posttraumatic Stress Disorder (PTSD)VIP-STARNCT01817712
Veterans Individual Placement and Support Towards Advancing Recovery
A study testing Individual Placement & Support and VA Transitional Work Program in people with Posttraumatic Stress Disorder (PTSD), run by VA Office of Research and Development at 13 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Individual Placement & Support and VA Transitional Work Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 541 participants
- Where
- 13 sitesUnited States
- Study dates
- 31 Dec 2013to 3 Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, 87108-5153
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, 35404
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Individual Placement & Support, VA Transitional Work Program
- Keywords
- Posttraumatic neuroses, posttraumatic stress disorder, PTSD, Supported employment, IPS, CWT, TWP, Individual placement and support, Compensated work therapy, Transitional work program
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Placement & SupportBehavioural
Also called Supported Employment, IPS
IPS uses an integrated "place-train" approach to help people obtain and maintain community-based competitive employment in their chosen occupation.
VA Transitional Work ProgramBehavioural
Also called TWP
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.
| Study group | Role | What they receive |
|---|---|---|
| Individual Placement and Support (IPS) | Experimental | The IPS intervention must achieve a rating of >66 of a possible 75 points on the Supported Employment Fidelity Scale. The fidelity ratings are conducted by the National IPS Fidelity Monitor at biannual on-site monitoring visits. Receives: Behavioral: Individual Placement & Support |
| VA Transitional Work Program (TWP) | Active comparator | TWP will adhere to a lower rating (less than or equal to 55 of a possible 75 points) on the Supported Employment Fidelity Scale rated by the National Fidelity Monitor. The TWP specialist participates in face-to-face supervision with the local Compensated Work Therapy (CWT) team according to the CWT manager's schedule. Receives: Behavioral: VA Transitional Work Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 78 weeks
Secondary outcomes (2)
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.
Measured: Weekly for 78 weeks
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).
Measured: 18-months (Change from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study start31 Dec 2013
- Primary completion20 Dec 2016
- Study completion3 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lori Lynne Davis, MD AB, Study chair, Tuscaloosa VA Medical Center, Tuscaloosa, AL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817712
- Sponsor's protocol ID
- 589
- Acronym
- VIP-STAR
- Status last verified
- Feb 2019
- First submitted
- 20 Mar 2013
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30945920Mueller 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.
PubMed 30932508Davis 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.
PubMed 29490371
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #589 - Veterans Individual Placement and Support Towards Advancing Recovery
- ClinicalTrials.gov ID
- NCT01817712
- Acronym / sponsor ID
- VIP-STAR / 589
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- Posttraumatic neuroses, posttraumatic stress disorder, PTSD, Supported employment, IPS, CWT, TWP, Individual placement and support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 31 Dec 2013 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 3 Feb 2017 (actual)
- First posted
- 25 Mar 2013 (estimated)
- Results
- Posted 19 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Placement and Support (IPS) | Experimental | Behavioral: Individual Placement & SupportThe IPS intervention must achieve a rating of >66 of a possible 75 points on the Supported Employment Fidelity Scale. The fidelity ratings are conducted by the National IPS Fidelity Monitor at biannual on-site monitoring visits. |
| VA Transitional Work Program (TWP) | Active comparator | Behavioral: VA Transitional Work ProgramTWP will adhere to a lower rating (less than or equal to 55 of a possible 75 points) on the Supported Employment Fidelity Scale rated by the National Fidelity Monitor. The TWP specialist participates in face-to-face supervision with the local Compensated Work Therapy (CWT) team according to the CWT manager's schedule. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual Placement & SupportAlso: Supported Employment, IPSIPS uses an integrated "place-train" approach to help people obtain and maintain community-based competitive employment in their chosen occupation. | Behavioural | Individual Placement and Support (IPS) |
| VA Transitional Work ProgramAlso: TWPThe 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. | Behavioural | VA Transitional Work Program (TWP) |
Primary outcome
Number of Participants Who Obtained and Maintained Competitive Employment for at Least 50% of the Active Follow-up Period
Time frame: 78 weeks
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).
2 secondary outcomes
Cumulative Gross Income
Time frame: Weekly for 78 weeks
Change in PCL-5 Score of PTSD Symptoms
Time frame: 18-months (Change from baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30945920Davis 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.
- Derived from this study: PubMed 30932508Mueller 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.
- Derived from this study: PubMed 29490371Davis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Lynne Davis, MD AB study chair
Tuscaloosa VA Medical Center, Tuscaloosa, AL
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Placement & Support and VA Transitional Work Program in people with Posttraumatic Stress Disorder (PTSD), run by VA Office of Research and Development at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Obtained and Maintained Competitive Employment for at Least 50% of the Active Follow-up Period (time frame: 78 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01817712, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.