Primary Care Treatment Integrating Motivation and Exposure (PC-TIME)

Syracuse VA Medical Center

Status: Completed

Conditions: Stress Disorders, Post-Traumatic; Alcohol-Related Disorders

Treatments: Behavioral: PC-TIME; Behavioral: PC-TAU

Study type: Interventional

Funder types: Other U.S. Federal agency; NIH

Identifiers

NCT03812146

1R34AA026745-01 (U.S. NIH Grant/Contract)

1250312

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups

PC-TIME

Experimental group

Description:

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.

Treatment:

Behavioral: PC-TIME

PC-TAU

Active Comparator group

Description:

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.

Treatment:

Behavioral: PC-TAU