PTSDNCT00728325
Impact of Supported Employment Versus Standard Vocational Rehabilitation in Veterans With Post-traumatic Stress Disorder
A study testing Supported Employment (SE) and Standard Vocational Rehabilitation (VRP) in people with PTSD, run by Tuscaloosa Research & Education Advancement Corporation at 3 sites in United States.
Trial summary
This prospective randomized study evaluates the impact of Supportive Employment (SE) compared to standard vocational rehabilitation (VRP) on occupational, sobriety, psychiatric, and quality of life outcomes and health care costs for veterans with chronic posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- PTSD
- What is being tested?
- Supported Employment (SE) and Standard Vocational Rehabilitation (VRP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2008to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- signed informed consent
- diagnosis of PTSD (based on MINI)
- male or female
- any race or ethnicity
- age 19-60
- currently unemployed
- interested in competitive employment
- planning to remain in a 100-mile radius of participating VAMC for the 12- mo duration
Who cannot join
- Lifetime history of severe traumatic brain injury that has resulted in severe cognitive disorder
- diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder
- dementia (a standard exclusion from VRP)
- immediate need of detoxification from alcohol or drugs (a standard VRP exclusion)
- pending active legal charges or expected incarceration
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bedford VA Medical Center
Bedford, Massachusetts, 01730
Birmingham VA Medical Center
Birmingham, Alabama, 35233
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, 35404
About this study
Official title: The Impact of Supported Employment Versus Standard Vocational Rehabilitation in Veterans With PTSD
This prospective randomized study evaluates the impact of Supportive Employment (SE) compared to standard vocational rehabilitation (VRP) on occupational, sobriety, psychiatric, and quality of life outcomes and health care costs for veterans with chronic posttraumatic stress disorder (PTSD).
Read the detailed description
Hypotheses or Key Questions
- Primary Hypothesis (obtained + maintained employment): Subjects assigned to IPS will have a higher maintained employed rate for the 12-mo observation period than their standard VRP counterparts.
- I.a. First Component Primary Hypothesis (obtained employment): Subjects assigned to IPS will have higher rates of obtained employment for the 12-mo observation period than the VRP subjects.
- I.b. Second Component Primary Hypothesis (maintained employment): Among those subjects employed, those assigned to IPS will have worked more weeks for the 12-mo observation period than the VRP subjects.
II. Secondary Hypothesis: Those subjects who obtain competitive employment will have significantly reduced symptoms of PTSD from baseline to endpoint compared to those subjects who do not obtain competitive employment.
III. Confirmatory and Correlational Hypotheses: Compared to VRP subjects, those subjects assigned to IPS will have:
- greater work intensity (# weeks, days, # hours, wages earned)
- higher total earnings
- greater improvement in quality of life outcomes
Supplemental hypothesis (moderator): Because of the superior integration with the mental health (MH) treatment team, social work services, and community resources that the IPS-SE employment specialist provides as part of this model, we hypothesize that the IPS-SE model will have greater success in the maintenance of competitive employment compared to standard VRP for veterans with PTSD challenged in one or more of these psychosocial domains. From a research perspective, a variable that characterizes subjects for whom a particular treatment will be effective is called a moderator of treatment.
The hypothesized moderators of IPS-SE and standard VRP for subjects with PTSD are: 1) Transportation, 2) Housing, 3) Financial Means, and 4) Family Care Burden. We hypothesize that these variables will have moderating effects for each of two outcomes: 1) number of weeks the participant is competitively employed during the 12-month study period and 2) their score on the Sheehan Disability Scale.
Several principles are important in defining a moderator. First, the moderator must precede treatment. In our RCT, these psychosocial domains are baseline characteristics of subjects enrolled in the study. Second, the moderator must be uncorrelated with treatment choice. This will be the case in this RCT due to a 1:1 randomization, which should balance baseline characteristics between the two groups. Third, a moderator of treatment must have a differential effect of treatment for each level of the moderator. The treatment effect (e.g., active vs. comparator) must be shown to be greater for one level of the moderator (i.e. IPS-SE will show a greater effect size than standard VRP in subjects with a moderator present). Also, an index that combines these domains will be explored and formulated to identify subjects that may benefit to greater extent from IPS-SE.
- Conditions
- PTSD
- Being tested
- Supported Employment (SE), Standard Vocational Rehabilitation (VRP)
- Keywords
- PTSD, Vocational Rehabilitation, Supported Employment
- 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.
Supported Employment (SE)Behavioural
Also called Veterans in Vocational Rehabilitation Program
SE(IPS)involves: a vocational rehabilitation employment specialist who is integrated into the clinical treatment team, carries out all phases of the vocational services, provides predominantly community-based services, provides assertive engagement and outreach, has a case load of ≤ 25 clients; engages in rapid job search, individualized placement in diverse and potentially permanent competitive job(s), ongoing work-based vocational assessment, and assistance in finding subsequent jobs if needed with the view that all jobs are positive learning experiences; continuous time-unlimited follow-along supports to provide vocational services; and weekly group supervision with IPS/VRP team and with IPS supervisor/trainer monthly.
Standard Vocational Rehabilitation (VRP)Behavioural
Also called Veterans in Vocational Rehabilitation Program
Standard Vocational Rehabilitation (VRP) includes 1) the Vocational Assistance Program (includes routine prevocational testing and evaluation for all patients upon referral to VRP), 2) Vocational Rehabilitation Therapy that operates under the Compensated Work Therapy/Veterans Industries (CWT) and provides a work regimen with monetary incentives derived from contracts whereby participants are paid on a piece rate basis related to their production, and 3) Transitional Work Program (TWP) that includes a temporary work experience either within the VAMC or in community settings (called the Transitional Work External or TWE).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard Vocational Rehabilitation (VRP) Receives: Behavioral: Standard Vocational Rehabilitation (VRP) |
| 2 | Experimental | Supported Employment (SE) Receives: Behavioral: Supported Employment (SE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using an intent to treat analysis, subjects' maintained employed rate is measured using the Employment Index.
Measured: 12 months
Secondary outcomes (1)
Using an intent-to-treat analysis, the change from baseline to endpoint in PTSD symptoms is compared between groups using the Clinician Administered PTSD Scale (CAPS).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tuscaloosa Research & Education Advancement Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
- Investigators
- Lori L. Davis, M.D., Principal investigator, Tuscaloosa Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728325
- Sponsor's protocol ID
- PT074312
- Other IDs
- VA IRB ID: 00123
- Status last verified
- Dec 2013
- First submitted
- 15 Jul 2008
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Supported Employment Versus Standard Vocational Rehabilitation in Veterans With PTSD
- ClinicalTrials.gov ID
- NCT00728325
- Acronym / sponsor ID
- PT074312
- Conditions
- PTSD
- Keywords
- PTSD, Vocational Rehabilitation, Supported Employment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tuscaloosa Research & Education Advancement CorporationUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- May 2008
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 5 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomized study evaluates the impact of Supportive Employment (SE) compared to standard vocational rehabilitation (VRP) on occupational, sobriety, psychiatric, and quality of life outcomes and health care costs for veterans with chronic posttraumatic stress disorder (PTSD).
Detailed description
Hypotheses or Key Questions
- Primary Hypothesis (obtained + maintained employment): Subjects assigned to IPS will have a higher maintained employed rate for the 12-mo observation period than their standard VRP counterparts.
- I.a. First Component Primary Hypothesis (obtained employment): Subjects assigned to IPS will have higher rates of obtained employment for the 12-mo observation period than the VRP subjects.
- I.b. Second Component Primary Hypothesis (maintained employment): Among those subjects employed, those assigned to IPS will have worked more weeks for the 12-mo observation period than the VRP subjects.
II. Secondary Hypothesis: Those subjects who obtain competitive employment will have significantly reduced symptoms of PTSD from baseline to endpoint compared to those subjects who do not obtain competitive employment.
III. Confirmatory and Correlational Hypotheses: Compared to VRP subjects, those subjects assigned to IPS will have:
- greater work intensity (# weeks, days, # hours, wages earned)
- higher total earnings
- greater improvement in quality of life outcomes
Supplemental hypothesis (moderator): Because of the superior integration with the mental health (MH) treatment team, social work services, and community resources that the IPS-SE employment specialist provides as part of this model, we hypothesize that the IPS-SE model will have greater success in the maintenance of competitive employment compared to standard VRP for veterans with PTSD challenged in one or more of these psychosocial domains. From a research perspective, a variable that characterizes subjects for whom a particular treatment will be effective is called a moderator of treatment.
The hypothesized moderators of IPS-SE and standard VRP for subjects with PTSD are: 1) Transportation, 2) Housing, 3) Financial Means, and 4) Family Care Burden. We hypothesize that these variables will have moderating effects for each of two outcomes: 1) number of weeks the participant is competitively employed during the 12-month study period and 2) their score on the Sheehan Disability Scale.
Several principles are important in defining a moderator. First, the moderator must precede treatment. In our RCT, these psychosocial domains are baseline characteristics of subjects enrolled in the study. Second, the moderator must be uncorrelated with treatment choice. This will be the case in this RCT due to a 1:1 randomization, which should balance baseline characteristics between the two groups. Third, a moderator of treatment must have a differential effect of treatment for each level of the moderator. The treatment effect (e.g., active vs. comparator) must be shown to be greater for one level of the moderator (i.e. IPS-SE will show a greater effect size than standard VRP in subjects with a moderator present). Also, an index that combines these domains will be explored and formulated to identify subjects that may benefit to greater extent from IPS-SE.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Standard Vocational Rehabilitation (VRP)Standard Vocational Rehabilitation (VRP) |
| 2 | Experimental | Behavioral: Supported Employment (SE)Supported Employment (SE) |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- signed informed consent
- diagnosis of PTSD (based on MINI)
- male or female
- any race or ethnicity
- age 19-60
Key exclusion criteria (5 listed)
- Lifetime history of severe traumatic brain injury that has resulted in severe cognitive disorder
- diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder
- dementia (a standard exclusion from VRP)
- immediate need of detoxification from alcohol or drugs (a standard VRP exclusion)
- pending active legal charges or expected incarceration
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 |
|---|---|---|
| Supported Employment (SE)Also: Veterans in Vocational Rehabilitation ProgramSE(IPS)involves: a vocational rehabilitation employment specialist who is integrated into the clinical treatment team, carries out all phases of the vocational services, provides predominantly community-based services, provides assertive engagement and outreach, has a case load of ≤ 25 clients; engages in rapid job search, individualized placement in diverse and potentially permanent competitive job(s), ongoing work-based vocational assessment, and assistance in finding subsequent jobs if needed with the view that all jobs are positive learning experiences; continuous time-unlimited follow-along supports to provide vocational services; and weekly group supervision with IPS/VRP team and with IPS supervisor/trainer monthly. | Behavioural | 2 |
| Standard Vocational Rehabilitation (VRP)Also: Veterans in Vocational Rehabilitation ProgramStandard Vocational Rehabilitation (VRP) includes 1) the Vocational Assistance Program (includes routine prevocational testing and evaluation for all patients upon referral to VRP), 2) Vocational Rehabilitation Therapy that operates under the Compensated Work Therapy/Veterans Industries (CWT) and provides a work regimen with monetary incentives derived from contracts whereby participants are paid on a piece rate basis related to their production, and 3) Transitional Work Program (TWP) that includes a temporary work experience either within the VAMC or in community settings (called the Transitional Work External or TWE). | Behavioural | 1 |
Primary outcome
Using an intent to treat analysis, subjects' maintained employed rate is measured using the Employment Index.
Time frame: 12 months
1 secondary outcome
Using an intent-to-treat analysis, the change from baseline to endpoint in PTSD symptoms is compared between groups using the Clinician Administered PTSD Scale (CAPS).
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
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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 L. Davis, M.D. principal investigator
Tuscaloosa Veterans Affairs Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supported Employment (SE) and Standard Vocational Rehabilitation (VRP) in people with PTSD, run by Tuscaloosa Research & Education Advancement Corporation at 3 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 8 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: status not confirmed, as of the sponsor's last update on 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
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?
Using an intent to treat analysis, subjects' maintained employed rate is measured using the Employment Index. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2013.