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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00530985
Other study ID # MR0024
Secondary ID MIRECC
Status Completed
Phase Phase 1
First received September 16, 2007
Last updated June 30, 2009
Start date February 2007
Est. completion date June 2009

Study information

Verified date June 2009
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

To test the hypothesis that veterans counseled around managing their benefits will work more and have a better quality of life than those receiving non-specific counseling.


Description:

The aim is to develop and test the efficacy of Benefits Counseling to improve quality of life among veterans who apply for VA benefits. Benefits Counseling involves providing claimants information about rehabilitation and work-related activities, benefits determination and management, and available substance abuse treatment . Benefits Counseling is designed to increase motivation to be active and promote engagement in substance abuse treatment. After enrolling 15 participants in an open-label pilot phase, 300 veterans who are not receiving benefits and are applying to VBA for disability benefits will be randomly assigned to Benefits Counseling or the control condition, VA Orientation, and both groups will be followed for one year.

The primary outcome measures will be observer-rated and self-rated quality of life. Secondary outcome measures will include substance use and treatment utilization.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. Applying for VA service connection and not currently receiving VBA benefits.

2. Veterans who have been rated 0% service-connected but do not receive financial benefits are eligible to participate.

3. Able to provide valid consent

4. Age 18-65

5. Expresses willingness to discuss benefits with a counselor

6. Anticipates difficulty working

Exclusion Criteria:

1. Already receiving VA payments

2. Already receiving SSI or SSDI

3. Has a conservator

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Benefits Counseling
Help deciding whether to work
VA Orientation
Orientation to services available at VA

Locations

Country Name City State
United States VA Connecticut Health Care System (West Haven) West Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Days engaged in work and work-related activities 6 months No
Secondary substance use (as measured by days having used illicit drugs, alcohol to intoxication in the preceding days) 6 months No
Secondary treatment utilization (days in last 30 having participated in rehabilitation and work-related activities, number of days having participated in non-inpatient substance abuse treatment, number of days on any inpatient unit) 6 months No
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