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Clinical Trials/NCT03812146
NCT03812146
Completed
Not Applicable

An Integrated Brief Alcohol and PTSD Intervention for Veterans in Primary Care

Syracuse VA Medical Center2 sites in 1 country63 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress Disorders, Post-Traumatic
Sponsor
Syracuse VA Medical Center
Enrollment
63
Locations
2
Primary Endpoint
Average Number of Drinks Per Drinking Day
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This project aims to develop and test an integrated brief intervention to reduce heavy alcohol use and PTSD severity in veterans receiving Veterans Affairs Primary Care. Standard brief alcohol interventions have been unsuccessful in reducing heavy drinking in traumatized individuals and current integrated treatment for alcohol use disorder and PTSD are too long to be delivered in Primary Care. Therefore, this application addresses this gap by developing an intervention tailored to the specific needs of heavy drinking veterans who have co- occurring PTSD. This study aims to incorporate two evidenced-based interventions: Brief Motivational Interviewing (BMI) with Prolonged Exposure for Primary Care (PE-PC). This newly developed brief intervention will be piloted in an open trial to gather veteran participant feedback and develop clinician training and fidelity procedures.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
November 23, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Syracuse VA Medical Center
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • A score of 8-25 for men, 6-25 for women on the AUDIT and have past month drinking (i.e., have not quit drinking over the last month)
  • Score ≥30 on the PTSD Checklist-5 (PCL-5) and report a traumatic event on the Criterion A screener

Exclusion Criteria

  • Score of a 26 or higher on the AUDIT
  • gross cognitive impairment as assessed by the Mini Mental Status Exam
  • current symptoms of mania or psychosis
  • currently in need of detox services
  • Have had a suicide attempt in the last two months or a current intent to commit suicide as assessed on the P4 Screener. (Patients with recent suicide attempts or intent may be enrolled following receipt of suicide prevention services)
  • Are currently receiving psychotherapy for heavy drinking or PTSD outside of PC within the last 2 months
  • Have started or changed the dose of a psychotropic medication for heavy drinking or PTSD in the last two months that was prescribed outside of VA PC
  • Have a preference to be directly referred to VA specialty care for heavy drinking or PTSD.

Outcomes

Primary Outcomes

Average Number of Drinks Per Drinking Day

Time Frame: 8 weeks

The Timeline Follow-back instrument is presented as a 30-day calendar and it is used to obtain count estimates of daily drinking.

PTSD Checklist-5

Time Frame: 8 weeks

This 21-item self-report measure asks respondents to rate how much they have been bothered by DSM-5 PTSD symptoms in the past month on a 0-4 Likert-type scale. The scale ranges from 0-84 with 84 being the most severe PTSD. The total score was used to indicate PTSD severity at post-treatment.

Change in Clinician Administered PTSD Scale (CAPS)-5 Severity Rating

Time Frame: Baseline and 8 weeks

This 30-item structured interview assesses DSM-5 symptoms of Posttraumatic stress disorder. It includes assessment of traumatic events and symptom severity ratings are based on symptom frequency and intensity. CAPS-5 total symptom severity score ranges 0-80, with higher scores representing higher severity (worse outcome).

Secondary Outcomes

  • Post-intervention Treatment Engagement(20 weeks)

Study Sites (2)

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