Benefits Counseling to Preserve Function Among Disability Applicants

February 10, 2016 updated by: VA Office of Research and Development
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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?
    • 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

Exclusion Criteria:

  • Already receiving VA payments
  • Already receiving SSI or SSDI payments
  • Has a conservator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
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.
Behavioral: Benefits Counseling
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.
Other Names:
  • Motivational Interviewing
Active Comparator: Arm 2
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.
Behavioral: VA 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.
Other Names:
  • New patient orientation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Month 1
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.
Month 3
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.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D6432-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings