search
Back to results

Evaluation and Treatment of Substance Abuse in Veterans With PTSD Disability Claims (SBIRT-PTSD)

Primary Purpose

Attendance at Treatment, PTSD, Substance Use, and Attendance at Treatment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SBIRT
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attendance at Treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SBIRT

No additional treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Substance Use by Treatment Group Over Time
Mean days self-reported risky drug or alcohol use
Mean PTSD Severity Score
Measure on Clinical Assessment of PTSD Severity (CAPS IV) rating scale (range 0-136, higher is more severe symptoms).

Full Information

First Posted
May 10, 2012
Last Updated
January 10, 2020
Sponsor
VA Office of Research and Development
Collaborators
Yale University
search

1. Study Identification

Unique Protocol Identification Number
NCT01597856
Brief Title
Evaluation and Treatment of Substance Abuse in Veterans With PTSD Disability Claims
Acronym
SBIRT-PTSD
Official Title
Evaluation and Treatment of Substance Use in Veterans With PTSD Disability Claims
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 18, 2013 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attendance at Treatment, PTSD, Substance Use, and Attendance at Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
346 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SBIRT
Arm Type
Experimental
Arm Description
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.
Arm Title
No additional treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SBIRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment Attendance by Treatment Group Over Time
Description
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
Time Frame
4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
Secondary Outcome Measure Information:
Title
Substance Use by Treatment Group Over Time
Description
Mean days self-reported risky drug or alcohol use
Time Frame
4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks
Title
Mean PTSD Severity Score
Description
Measure on Clinical Assessment of PTSD Severity (CAPS IV) rating scale (range 0-136, higher is more severe symptoms).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc I. Rosen, MD
Organizational Affiliation
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30726261
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.
Results Reference
result
PubMed Identifier
30589882
Citation
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.
Results Reference
result
PubMed Identifier
28558337
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. Epub 2017 May 23.
Results Reference
result

Learn more about this trial

Evaluation and Treatment of Substance Abuse in Veterans With PTSD Disability Claims

We'll reach out to this number within 24 hrs