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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01597856
Other study ID # IIR 11-091
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 18, 2013
Est. completion date December 31, 2017

Study information

Verified date January 2020
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Veterans can apply for compensation and pension (C & P) benefits for a disability related to military service. The application exam for these benefits provides an opportunity for Veterans returning from service to access VA care. The investigators will recruit Veterans applying for C & P to participate in this study. All enrolled participants will complete questionnaires around the time of their C & P exam related to substance abuse, PTSD, service use, and attitudes. The investigators will monitor enrolled Veterans' attendance at treatment over time, and examine whether C & P award, substance use, and beliefs about benefits are related to treatment attendance. Some enrolled participants will be assigned to one of two study groups: a treatment group and a no-additional-treatment group. People assigned to these groups will complete the same substance abuse, PTSD, service use, and attitudes questionnaires two additional times during the study. Participants assigned to the treatment group will receive information about the relationship between substance use and PTSD and will be referred to relevant treatment. The investigators will test whether Veterans who receive no-additional-treatment have different symptoms over time and attend less treatment sessions (mental health or substance abuse) than people assigned to treatment.


Description:

The Compensation examination that determines if a Veteran is entitled to any disability payments related to military service is a crucial gateway to accessing VA care for returning OEF/OIF Veterans. However, researchers and oversight agencies have noted that examiners typically do not have guidelines for evaluating comorbid conditions like substance abuse and for referring patients to treatment.

In the Evaluative Component of this study, OEF/OIF Veterans presenting for Compensation evaluations for PTSD will be approached to undergo a paid battery of confidential substance use, PTSD, service use and attitude assessments prior to their scheduled Compensation examinations. The batteries will be collected again twice, four and twelve weeks after the Compensation examinations. Long-term follow-up data will be extracted from VA databases including diagnoses, the results of the Veterans' Compensation evaluations, award determination, use of VA services and attendance at mental health and/or substance abuse treatment.

In the Clinical Trial Component of this study, one hundred sixty Veterans identified during the baseline evaluation as having a substance use disorder will be randomly assigned to a session of Screening, Brief Intervention and Referral to Treatment (SBIRT) or to No-Additional-Treatment. SBIRT is an approach to identifying and treating patients with substance abuse issues who are presenting for purposes other than substance abuse treatment. It involves Motivational Interviewing, which has been a consistently effective approach to facilitating engagement in substance abuse treatment in Veterans (Davis, Baer et al. 2003) and other populations. The study will examine factors associated with attendance at treatment including substance use, Veterans' beliefs about benefits, and compensation award. Group comparisons will be conducted on rates of treatment attendance, alcohol use, and PTSD symptoms.


Recruitment information / eligibility

Status Completed
Enrollment 346
Est. completion date December 31, 2017
Est. primary completion date September 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Veteran of OEF or OIF,

- Not currently receiving VBA Compensation for PTSD,

- Able to participate psychologically and physically, able to give informed consent and complete, assessments, and participate in study procedures

- Between the ages of 18-65 years old.

Exclusion Criteria:

- Will not be able to attend the week 4 or 12 appointment because of anticipated incarceration or move

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SBIRT
SBIRT Therapy overview- Therapist explains purpose of the therapy. Inquiry about Compensation examination-ask if Veteran has questions about determination process and address concerns. Discuss relationship between PTSD and substance use- long-term substance use is a form of avoidance and barrier to recovery. Discuss treatment needs, administer screening, provide feedback.

Locations

Country Name City State
United States Tennessee Valley Healthcare System Nashville Campus, Nashville, TN Nashville Tennessee
United States VA Connecticut Healthcare System West Haven Campus, West Haven, CT West Haven Connecticut

Sponsors (2)

Lead Sponsor Collaborator
VA Office of Research and Development Yale University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Black AC, Meshberg-Cohen S, Perez-Ortiz AC, Thornhill TA, Rosen MI. Veterans' compensation claims beliefs predict timing of PTSD treatment use relative to compensation and pension exam. PLoS One. 2018 Dec 27;13(12):e0209488. doi: 10.1371/journal.pone.0209 — View Citation

Jankowski RL, Black AC, Lazar CM, Brummett BR, Rosen MI. Consideration of substance use in compensation and pension examinations of veterans filing PTSD claims. PLoS One. 2019 Feb 6;14(2):e0210938. doi: 10.1371/journal.pone.0210938. eCollection 2019. — View Citation

Meshberg-Cohen S, Kachadourian L, Black AC, Rosen MI. Relationship between substance use and attitudes towards seeking professional psychological help among veterans filing PTSD claims. Addict Behav. 2017 Nov;74:9-12. doi: 10.1016/j.addbeh.2017.05.024. Ep — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment Attendance by Treatment Group Over Time Mean number of weeks of substance abuse and/or mental health treatment attended (as measured by the Electronic Medical Record) by treatment group over time 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
Secondary Substance Use by Treatment Group Over Time Mean days self-reported risky drug or alcohol use 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
Secondary Mean PTSD Severity Score Measure on Clinical Assessment of PTSD Severity (CAPS IV) rating scale (range 0-136, higher is more severe symptoms). 12 weeks