- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01597856
Evaluation and Treatment of Substance Abuse in Veterans With PTSD Disability Claims (SBIRT-PTSD)
Evaluation and Treatment of Substance Use in Veterans With PTSD Disability Claims
Study Overview
Status
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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West Haven, Connecticut, United States, 06516
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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Tennessee
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Nashville, Tennessee, United States, 37212-2637
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SBIRT
The SBIRT-VA manual codifies basic substance abuse screening, treatment, Motivational Interviewing and referral procedures. It is designed for providers with minimal substance abuse expertise and is easy for experienced substance abuse providers to deliver. Study sessions include identifying the Veterans' values through a card sort, the change ruler, on which the Veteran rates his/her willingness to change current behavior, listing the pros and cons of changing. |
SBIRT Therapy overview-
|
|
No Intervention: No additional treatment
Veterans assigned to the control condition will not receive any study-related therapy.
A Veteran who completes a Compensation examination ordinarily has no further treatment, referral, or debriefing as part of the Compensation examination.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Attendance by Treatment Group Over Time
Time Frame: 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Substance Use by Treatment Group Over Time
Time Frame: 4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
|
Mean days self-reported risky drug or alcohol use
|
4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
|
|
Mean PTSD Severity Score
Time Frame: 12 weeks
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Measure on Clinical Assessment of PTSD Severity (CAPS IV) rating scale (range 0-136, higher is more severe symptoms).
|
12 weeks
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.0209488. eCollection 2018.
- 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. Epub 2017 May 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 11-091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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