Job SatisfactionNCT02677428
Remotely-Delivered Benefits Counseling for Service Connection Applicants
A study testing Remotely-Delivered Benefits Counseling in people with Job Satisfaction and Unemployment, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
A significant portion of Veterans who apply for disability benefits have difficulty finding and sustaining employment, and are concerned that working for pay will jeopardize their receipt of service-connection benefits. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Job Satisfaction, Unemployment
- What is being tested?
- Remotely-Delivered Benefits Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2015to 1 Nov 2020
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All enrolled participants will have difficulty working as evidenced by a "Yes" response to any sub-part of the following question:
- During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious):
- (a) Cut down on the amount of time you spent on work or other activities?
- (b) Accomplished less than you would like?
- (c) Didn't do work or other activities as carefully as usual?
- Participants will also meet the following inclusion criteria:
Show all 14Show fewer
- i. A Compensation and Pension evaluation by a psychiatrist or psychologist is scheduled
- ii. Does not have a service-connected physical disability rated over 30%
- iii. Is not service-connected for a psychiatric condition (0% service-connection is allowed, as Veterans with 0% service-connection have not received any benefit payments)
- iv. Age 18-65
- v. Reports access to an internet-connected computer/tablet and a working telephone
- vi. Reports working an average of two or fewer days per week for pay over the preceding 4 weeks
- vii. Self-reported ability to participate psychologically and physically, able to give informed consent and complete assessments; viii. Reports being able to read (this is necessary for understanding the website)
- ix. Expressed interest in sampling whatever website is provided
Who cannot join
- Already receiving Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI)
- Has a conservator
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, 01053-9764
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516
About this study
A significant portion of Veterans who apply for disability benefits have difficulty finding and sustaining employment, and are concerned that working for pay will jeopardize their receipt of service-connection benefits. In a completed clinical trial, Veterans who received Motivational Interview-formatted counseled about opportunities to work and receive service-connection went on to work for pay significantly more often than controls. The proposed clinical trial will test this counseling's efficacy when it is delivered by an automated computer program.
Read the detailed description
Current application rates suggest that more than half of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans will eventually apply for some form of service-connection, with approximately 100,000 Veterans per year being evaluated for psychiatric conditions. Veterans applying for service-connection for psychiatric conditions are in distress, and often are having occupational difficulties, but these are unaddressed during a typical Compensation and Pension evaluation. Counseling that addresses beneficiaries' concerns about losing compensation payments if working for pay, when supplemented by vocational supports, has been associated with increased employment among people disabled by chronic psychiatric conditions. This group has developed an online Benefits Counseling intervention tailored to help Veterans applying for service-connection engage in work-related activities. The investigators have demonstrated the efficacy of a face-to-face version of Benefits Counseling in a completed Rehabilitation Research \& Development-funded six-month clinical trial in which Veterans assigned to Benefits Counseling worked significantly more days than controls,(p<.05, effect size = 0.69), reflecting an average of three more days of employment at six month follow-up. The investigators then used a supplement from Rehabilitation Research \& Development to develop a web-based version of this counseling, so that the counseling could be delivered without a counselor on-site. The web-based intervention was modified based on user feedback, but the extent to which it will be used by Veterans at home and how it will impact their behavior is unknown. In the proposed clinical trial, Veterans working two or fewer days per week who are presenting for a Compensation \& Pension examination for a psychiatric disorder will be assessed at baseline and then urged to log in afterwards to a website for random assignment to either Remotely-Delivered Benefits Counseling (n=65) or Veterans Benefits Administration web sites (n=65), and will then be assessed at 4, 12, and 24 weeks after randomization in order to calculate standardized group mean differences between the slopes over time. The primary outcome measure will be the treatment-by-time slope of hours of paid work. Exploratory analyses will estimate associations of potential mediators of treatment response with this outcome. The proposed study will provide estimates of the efficacy of remotely-delivered Benefits Counseling initiated at Compensation and Pension examinations, a widely-used point of contact with VA.
- Conditions
- Job Satisfaction, Unemployment
- Being tested
- Remotely-Delivered Benefits Counseling, Control
- Keywords
- Veterans, world wide web, Counseling, Workman's Compensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remotely-Delivered Benefits CounselingBehavioural
Veterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided.
ControlBehavioural
The control condition will involve referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information about benefits-related websites controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation \& Pension-related information: (a) the VBA website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C\&P office where issues pertaining to an individual Veteran's specific application are addressed.
| Study group | Role | What they receive |
|---|---|---|
| Remotely Delivered Benefits Counseling | Experimental | Veterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided. Receives: Behavioral: Remotely-Delivered Benefits Counseling |
| Control | Active comparator | The control condition will involve referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information about benefits-related websites controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation \& Pension-related information: (a) the Veterans Benefits Administration (VBA) website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C\&P office where issues pertaining to an individual Veteran's specific application are addressed. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hours Per Week of Paid Work
This calendar measure will be used to determine whether, and on what days the Veteran engaged in paid work activities.
Measured: Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment
Secondary outcomes (1)
Work Importance and Confidence Ruler
This measure consists of six questions about respondent's ability to work to his/her "fullest capacity" currently, how ready they are to work to fullest capacity, how important it is to work to fullest capacity, how important it is to work for pay, and how confident one in in ability work to fullest capacity. Items are rated on an 11 point Likert scale, ranging from 0 to 10, with higher scores indicating more importance (0 "not at all important" to 10 "very important") and more confidence (0 "not at all confident" to 10 "completely confident") in one's ability. We report the mean/median of the scores (range 0-10) at each timepoint by treatment group.
This measure has been used to show that Veteran-rated importance of work was associated with engagement in Compensated Work Therapy among Veterans with vocational and psychiatric difficulties. It was collected at Baseline, Week 4, Week 12 and week 24.
Measured: Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study start1 Dec 2015
- Primary completion1 Jul 2019
- Study completion1 Nov 2020
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.
- Other trials for Job SatisfactionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Marc I. Rosen, MD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677428
- Sponsor's protocol ID
- D1319-R
- Status last verified
- Nov 2020
- First submitted
- 22 Jan 2016
- Last updated
- 20 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only with a data sharing agreement. There is no provision for data sharing in the approved IRB protocol.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely-Delivered Benefits Counseling for Service Connection Applicants
- ClinicalTrials.gov ID
- NCT02677428
- Acronym / sponsor ID
- D1319-R
- Conditions
- Job Satisfaction, Unemployment
- Keywords
- Veterans, world wide web, Counseling, Workman's Compensation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Posted 3 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A significant portion of Veterans who apply for disability benefits have difficulty finding and sustaining employment, and are concerned that working for pay will jeopardize their receipt of service-connection benefits. In a completed clinical trial, Veterans who received Motivational Interview-formatted counseled about opportunities to work and receive service-connection went on to work for pay significantly more often than controls. The proposed clinical trial will test this counseling's efficacy when it is delivered by an automated computer program.
Detailed description
Current application rates suggest that more than half of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans will eventually apply for some form of service-connection, with approximately 100,000 Veterans per year being evaluated for psychiatric conditions. Veterans applying for service-connection for psychiatric conditions are in distress, and often are having occupational difficulties, but these are unaddressed during a typical Compensation and Pension evaluation. Counseling that addresses beneficiaries' concerns about losing compensation payments if working for pay, when supplemented by vocational supports, has been associated with increased employment among people disabled by chronic psychiatric conditions. This group has developed an online Benefits Counseling intervention tailored to help Veterans applying for service-connection engage in work-related activities. The investigators have demonstrated the efficacy of a face-to-face version of Benefits Counseling in a completed Rehabilitation Research \& Development-funded six-month clinical trial in which Veterans assigned to Benefits Counseling worked significantly more days than controls,(p<.05, effect size = 0.69), reflecting an average of three more days of employment at six month follow-up. The investigators then used a supplement from Rehabilitation Research \& Development to develop a web-based version of this counseling, so that the counseling could be delivered without a counselor on-site. The web-based intervention was modified based on user feedback, but the extent to which it will be used by Veterans at home and how it will impact their behavior is unknown. In the proposed clinical trial, Veterans working two or fewer days per week who are presenting for a Compensation \& Pension examination for a psychiatric disorder will be assessed at baseline and then urged to log in afterwards to a website for random assignment to either Remotely-Delivered Benefits Counseling (n=65) or Veterans Benefits Administration web sites (n=65), and will then be assessed at 4, 12, and 24 weeks after randomization in order to calculate standardized group mean differences between the slopes over time. The primary outcome measure will be the treatment-by-time slope of hours of paid work. Exploratory analyses will estimate associations of potential mediators of treatment response with this outcome. The proposed study will provide estimates of the efficacy of remotely-delivered Benefits Counseling initiated at Compensation and Pension examinations, a widely-used point of contact with VA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remotely Delivered Benefits Counseling | Experimental | Behavioral: Remotely-Delivered Benefits CounselingVeterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided. |
| Control | Active comparator | Behavioral: ControlThe control condition will involve referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information about benefits-related websites controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation \& Pension-related information: (a) the Veterans Benefits Administration (VBA) website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C\&P office where issues pertaining to an individual Veteran's specific application are addressed. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- All enrolled participants will have difficulty working as evidenced by a "Yes" response to any sub-part of the following question:
- Participants will also meet the following inclusion criteria:
Key exclusion criteria (2 listed)
- Already receiving Supplemental Security Income (SSI) or Social Security Disability Insurance (SSDI)
- Has a conservator
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 |
|---|---|---|
| Remotely-Delivered Benefits CounselingVeterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided. | Behavioural | Remotely Delivered Benefits Counseling |
| ControlThe control condition will involve referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information about benefits-related websites controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation \& Pension-related information: (a) the VBA website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C\&P office where issues pertaining to an individual Veteran's specific application are addressed. | Behavioural | Control |
Primary outcome
Hours Per Week of Paid Work
Time frame: Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment
This calendar measure will be used to determine whether, and on what days the Veteran engaged in paid work activities.
1 secondary outcome
Work Importance and Confidence Ruler
Time frame: Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Only with a data sharing agreement. There is no provision for data sharing in the approved IRB protocol.
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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.
Marc I. Rosen, MD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remotely-Delivered Benefits Counseling in people with Job Satisfaction and Unemployment, run by VA Office of Research and Development at 2 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 14 inclusion and 2 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 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 3 Aug 2020). 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?
Hours Per Week of Paid Work (time frame: Assessed at baseline, and 4, 12 and 24 weeks post-randomization. Each assessment is for the period since prior assessment). 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 20 Nov 2020.