Veterans' Disability ClaimsPhase 2NCT00715650
Benefits Counseling to Preserve Function Among Disability Applicants
A Phase 2 study testing Benefits Counseling and VA Orientation in people with Veterans' Disability Claims, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study will address the problem that claimants with psychiatric disabilities who apply for and receive disability benefits go on to work less than those whose claims are denied. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Veterans' Disability Claims
- What is being tested?
- Benefits Counseling and VA Orientation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2015
- Phase
- Phase 2
- 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
- Has never received VBA benefits
- Able to provide valid consent
- Expresses willingness to discuss benefits with a counselor
- Difficulty working as evidenced by a "Yes" to either (a), (b), or (c) of the question below about work-related difficulties: During the past 4 weeks, have you had any of the following problems (such as feeling depressed and anxious):
- Cut down on the amount of time you spent on work or other activities?
- Accomplished less than you would like?
Show all 9Show fewer
- Didn't do work or other activities as carefully as usual?
- Expresses willingness to try Benefits Counseling if assigned to it
- An evaluation by a psychiatrist or psychologist is scheduled
Who cannot join
- Already receiving VA payments
- Already receiving SSI or SSDI payments
- Has a conservator
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516
About this study
This study will address the problem that claimants with psychiatric disabilities who apply for and receive disability benefits go on to work less than those whose claims are denied.
Read the detailed description
The objective of this research is to conduct a 6-month randomized clinical trial comparing participants assigned to Benefits Counseling and to those assigned to the control condition, VA Orientation. Benefits Counseling is an adaptation of two counseling approaches to foster veterans' involvement in work and work-related activity compared to the control condition, VA Orientation. The first approach helped recipients of Social Security disability benefits for psychiatric illness return to work in part by alleviating beneficiaries' concerns that they would lose their benefits if they worked. The second approach is a Motivational Interviewing approach that showed great promise in engaging veterans with psychiatric disabilities in compensated work therapy.
- Conditions
- Veterans' Disability Claims
- Being tested
- Benefits Counseling, VA Orientation
- Keywords
- Rehabilitation, Vocational, Compensation and Redress, disability evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benefits CounselingBehavioural
Also called Motivational Interviewing
Benefits counseling is designed to improve the quality of life of disability applicants by accomplishing two functions: 1) Providing information concerning what vocational rehabilitation services are available and how they will affect receipt of disability payments, 2) Amplifying applicants' existing motivation to engage in work and related-activities, using a Motivational Interviewing approach.
VA OrientationBehavioural
Also called New patient orientation
VA Orientation is designed to provide the Veteran with information regarding the services available, how to access the services and where the service is located on the VA campus.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | This counseling consists of four sessions each approximately 60 minutes each. The four sessions are organized as follows: a) Orientation to Benefits Counseling: Your Benefits and Your Goals b) Work and Claims c) Financial Review: Implications of Your Work Plan and d) Your Plans After the Benefits Notice. The first session focuses on the disability application process as a non-confrontational way to explore attitudes towards work. The second session more directly addresses the claimant's attitudes about work and beliefs about whether work will prevent receipt of disability benefits. The third session addresses the same issue as the second, ambivalence about work and disability, from a financial perspective. The fourth session occurs after the disability determination has been made, and it is possible the veteran may feel differently about a benefit that has been awarded. Receives: Behavioral: Benefits Counseling |
| Arm 2 | Active comparator | This will consist of four-session orientation with the sessions organized as follows: a) overview of VHA services, b) Primary Care c) Pharmacy and laboratory services and d) specialty services. After the description of each service, participants will be invited to discuss which services they plan to utilize. The counselor will provide telephone numbers and directions to the sites at which these services are provided. Receives: Behavioral: VA Orientation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of Work and Work-related Activity
Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.
Measured: Baseline
Days of Work and Work-related Activity
Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.
Measured: Month 1
Days of Work and Work-related Activity
Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.
Measured: Month 3
Days of Work and Work-related Activity
Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2012
- Study completionDec 2015
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 (2)Papers the sponsor has linked to this study.
- Other trials for Veterans' Disability ClaimsStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Yale University
- 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
- NCT00715650
- Sponsor's protocol ID
- D6432-R
- Status last verified
- Feb 2016
- First submitted
- 11 Jul 2008
- Last updated
- 11 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Meshberg-Cohen S, Reid-Quinones K, Black AC, Rosen MI. Veterans' attitudes toward work and disability compensation: associations with substance abuse. Addict Behav. 2014 Feb;39(2):445-8. doi: 10.1016/j.addbeh.2013.09.005. Epub 2013 Sep 11.
PubMed 24090622Rosen MI, Ablondi K, Black AC, Mueller L, Serowik KL, Martino S, Mobo BH, Rosenheck RA. Work outcomes after benefits counseling among veterans applying for service connection for a psychiatric condition. Psychiatr Serv. 2014 Dec 1;65(12):1426-32. doi: 10.1176/appi.ps.201300478. Epub 2014 Oct 31.
PubMed 25082304
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits Counseling to Preserve Function Among Disability Applicants
- ClinicalTrials.gov ID
- NCT00715650
- Acronym / sponsor ID
- D6432-R
- Conditions
- Veterans' Disability Claims
- Keywords
- Rehabilitation, Vocational, Compensation and Redress, disability evaluation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Yale University
- Study start
- Dec 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Posted 17 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will address the problem that claimants with psychiatric disabilities who apply for and receive disability benefits go on to work less than those whose claims are denied.
Detailed description
The objective of this research is to conduct a 6-month randomized clinical trial comparing participants assigned to Benefits Counseling and to those assigned to the control condition, VA Orientation. Benefits Counseling is an adaptation of two counseling approaches to foster veterans' involvement in work and work-related activity compared to the control condition, VA Orientation. The first approach helped recipients of Social Security disability benefits for psychiatric illness return to work in part by alleviating beneficiaries' concerns that they would lose their benefits if they worked. The second approach is a Motivational Interviewing approach that showed great promise in engaging veterans with psychiatric disabilities in compensated work therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Benefits CounselingThis counseling consists of four sessions each approximately 60 minutes each. The four sessions are organized as follows: a) Orientation to Benefits Counseling: Your Benefits and Your Goals b) Work and Claims c) Financial Review: Implications of Your Work Plan and d) Your Plans After the Benefits Notice. The first session focuses on the disability application process as a non-confrontational way to explore attitudes towards work. The second session more directly addresses the claimant's attitudes about work and beliefs about whether work will prevent receipt of disability benefits. The third session addresses the same issue as the second, ambivalence about work and disability, from a financial perspective. The fourth session occurs after the disability determination has been made, and it is possible the veteran may feel differently about a benefit that has been awarded. |
| Arm 2 | Active comparator | Behavioral: VA OrientationThis will consist of four-session orientation with the sessions organized as follows: a) overview of VHA services, b) Primary Care c) Pharmacy and laboratory services and d) specialty services. After the description of each service, participants will be invited to discuss which services they plan to utilize. The counselor will provide telephone numbers and directions to the sites at which these services are provided. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has never received VBA benefits
- Able to provide valid consent
- Expresses willingness to discuss benefits with a counselor
- Difficulty working as evidenced by a "Yes" to either (a), (b), or (c) of the question below about work-related difficulties: During the past 4 weeks, have you had any of the following problems (such as feeling depressed and anxious):
- Expresses willingness to try Benefits Counseling if assigned to it
Key exclusion criteria (3 listed)
- Already receiving VA payments
- Already receiving SSI or SSDI payments
- 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 |
|---|---|---|
| Benefits CounselingAlso: Motivational InterviewingBenefits counseling is designed to improve the quality of life of disability applicants by accomplishing two functions: 1) Providing information concerning what vocational rehabilitation services are available and how they will affect receipt of disability payments, 2) Amplifying applicants' existing motivation to engage in work and related-activities, using a Motivational Interviewing approach. | Behavioural | Arm 1 |
| VA OrientationAlso: New patient orientationVA Orientation is designed to provide the Veteran with information regarding the services available, how to access the services and where the service is located on the VA campus. | Behavioural | Arm 2 |
Primary outcome
Days of Work and Work-related Activity
Time frame: Baseline
Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.
Days of Work and Work-related Activity
Time frame: Month 1
Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.
Days of Work and Work-related Activity
Time frame: Month 3
Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.
Days of Work and Work-related Activity
Time frame: Month 6
Number of days in the past 28 spent engaged in any kind of work or related activity. Measured using a timeline follow-back calendar.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24090622Meshberg-Cohen S, Reid-Quinones K, Black AC, Rosen MI. Veterans' attitudes toward work and disability compensation: associations with substance abuse. Addict Behav. 2014 Feb;39(2):445-8. doi: 10.1016/j.addbeh.2013.09.005. Epub 2013 Sep 11.
- Results publication: PubMed 25082304Rosen MI, Ablondi K, Black AC, Mueller L, Serowik KL, Martino S, Mobo BH, Rosenheck RA. Work outcomes after benefits counseling among veterans applying for service connection for a psychiatric condition. Psychiatr Serv. 2014 Dec 1;65(12):1426-32. doi: 10.1176/appi.ps.201300478. Epub 2014 Oct 31.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Benefits Counseling and VA Orientation in people with Veterans' Disability Claims, run by VA Office of Research and Development at 1 site 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 9 inclusion and 3 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 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2014). 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?
Days of Work and Work-related Activity (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT00715650, which also lists 2 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 11 Mar 2016.