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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Department of Veterans Affairs
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01597856
First received: May 10, 2012
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Attendance at Treatment
PTSD, Substance Use, and Attendance at Treatment
Behavioral: SBIRT
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation and Treatment of Substance Use in Veterans With PTSD Disability Claims

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Treatment Attendance [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    Weeks engaged in substance abuse and/or mental health treatment


Secondary Outcome Measures:
  • substance use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Days of alcohol use

  • PTSD [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    symptom severity measured by Clinician Administered PTSD Scale (CAPS)


Estimated Enrollment: 640
Study Start Date: March 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Behavioral: SBIRT

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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597856

Contacts
Contact: Marc I Rosen, MD (202) 932-5711 ext 2112 marc.rosen@va.gov
Contact: Theodore Speroff, PhD (615) 873-6057 ted.speroff@va.gov

Locations
United States, Connecticut
VA Connecticut Health Care System (West Haven) Recruiting
West Haven, Connecticut, United States, 06516
Contact: Fred S Wright, MD    203-937-3830    fred.wright@va.gov   
Contact: Marybeth Fernandez    (203) 932-5711 ext 3348    Marybeth.Fernandez@va.gov   
Principal Investigator: Marc I. Rosen, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Marc I. Rosen, MD VA Connecticut Health Care System (West Haven)
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01597856     History of Changes
Other Study ID Numbers: IIR 11-091
Study First Received: May 10, 2012
Last Updated: August 11, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on September 18, 2014