NCT01597856

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

March 18, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 10, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

4.5 years

First QC Date

May 10, 2012

Results QC Date

November 19, 2018

Last Update Submit

January 10, 2020

Conditions

Attendance at TreatmentPTSD, Substance Use, and Attendance at Treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Substance Use by Treatment Group Over Time

    4 weeks pre-baseline through week 12 post baseline, total of 16 Weeks

  • Mean PTSD Severity Score

    12 weeks

Study Arms (2)

SBIRT

EXPERIMENTAL

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.

Behavioral: SBIRT

No additional treatment

NO INTERVENTION

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.

Interventions

SBIRTBEHAVIORAL

SBIRT Therapy overview- 1. Therapist explains purpose of the therapy. 2. Inquiry about Compensation examination-ask if Veteran has questions about determination process and address concerns. 3. Discuss relationship between PTSD and substance use- long-term substance use is a form of avoidance and barrier to recovery. 4. Discuss treatment needs, administer screening, provide feedback.

SBIRT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

Location

Related Publications (3)

  • 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.

    PMID: 30726261RESULT

  • 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.

    PMID: 30589882RESULT

  • 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.

    PMID: 28558337RESULT

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersChemically-Induced Disorders

Results Point of Contact

Title
Christina Lazar
Organization
VA Connecticut/ Yale University
Christina.Lazar@Yale.edu
203-932-5711

Study Officials

  • Marc I. Rosen, MD

    VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2012

First Posted

May 14, 2012

Study Start

March 18, 2013

Primary Completion

September 30, 2017

Study Completion

December 31, 2017

Last Updated

January 27, 2020

Results First Posted

January 10, 2020

Record last verified: 2020-01

Locations

US(2)