Primary Care Treatment Integrating Motivation and Exposure
- Conditions
- Alcohol-Related DisordersStress Disorders, Post-Traumatic
- Interventions
- Behavioral: PC-TIMEBehavioral: PC-TAU
- Registration Number
- NCT03812146
- Lead Sponsor
- Syracuse VA Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PC-TIME PC-TIME PC-TIME consists of meeting with a behavioral health provider for 5, 30-minute sessions that will be delivered over the course of 8 weeks (spaced about 1-2 weeks apart). PC-TIME sessions integrate two effective treatments: motivational enhancement therapy approaches and brief Prolonged Exposure. PC-TAU PC-TAU Primary Care - treatment as usual. Participants in PC-TAU will be referred to the PCMHI mental health provider within their primary care team, and will receive whichever care or intervention is typically provided. PCMHI in VA consists of licensed, independent providers (typically psychologists or clinical social workers) providing brief assessment and interventions to veterans and consultation to other members of the PC team.
- Primary Outcome Measures
Name Time Method Average Number of Drinks Per Drinking Day 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 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 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 Outcome Measures
Name Time Method Post-intervention Treatment Engagement 20 weeks With HIPAA authorization, information from participants' VA administrative data will be extracted to assess if treatment condition relates to engagement in specialty treatment. Number of mental health or substance use visits attended between enrollment and 20 week follow-up will be extracted for each participant.
Trial Locations
- Locations (2)
Buffalo VA Medical Center
🇺🇸Buffalo, New York, United States
Syracuse Veterans Affairs Medical Center
🇺🇸Syracuse, New York, United States