N/A
N=63
Primary Care Treatment Integrating Motivation and Exposure
Stress Disorders, Post-Traumatic · Alcohol-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03812146 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Change in Clinician Administered PTSD Scale (CAPS)-5 Severity Rating — 28.46; 33.45 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PC-TIME (Behavioral); PC-TAU (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Syracuse VA Medical Center
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinician Administered PTSD Scale (CAPS)-5 Severity Rating |
28.46; 33.45 | — |
| PRIMARY Average Number of Drinks Per Drinking Day |
2.34; 3.72 | — |
| PRIMARY PTSD Checklist-5 |
34.17; 43.40 | — |
| SECONDARY Post-intervention Treatment Engagement |
5.61; 5.73 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03812146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.