Brief Alcohol Treatment for Women Veterans in Primary Care

Syracuse VA Medical Center

Status: Begins enrollment in 3 months

Conditions: Alcohol Misuse

Treatments: Behavioral: Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary Care; Behavioral: Primary care usual care

Study type: Interventional

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

Identifiers

NCT07414589

1825686

K01AA031524-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this study is to develop and test a brief behavioral treatment for women Veterans with alcohol use in primary care. The study involves a development phase, an open trial phase, and a pilot randomized controlled trial. The main questions it aims to answer are:

• Is the treatment feasible and acceptable to women Veteran primary care patients?
• Can the treatment help reduce alcohol use, alcohol-related problems, and improve quality of life? Researchers will compare the new treatment to usual treatment that primary care patients would normally receive. Participants will be asked to participate in either the new behavioral treatment or usual primary care treatment and attend 3 appointments to answer questions about their alcohol use, quality of life, other mental health symptoms, and what they thought of their behavioral treatment.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Veteran status
• past-year Syracuse VAMC or community-based outpatient clinic (CBOC) primary care appointment
• identify as woman OR use women's PC services
• unhealthy alcohol use (AUDIT ≥ 7)

Exclusion criteria

• current substance use treatment outside PC
• current psychosis, mania, or dementia (>10 on the BOMC)
• need for a higher level of alcohol or substance use care (detoxification, residential treatment) as indicated by a) patient preference b) withdrawal symptoms that indicate a need to monitor (≥23 on the AWSC) or high risk substance use (≥27 on the ASSIST)
• imminent risk of suicide.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Brief intervention for unhealthy alcohol use

Experimental group

Description:

Participants in this arm will attend 4-6 30-minute behavioral health appointments with a behavioral health provider in an integrated primary care setting. All participants will attend 4 core alcohol-focused appointments focused on providing information and skills to manage unhealthy alcohol use. Participants may elect to attend up to 2 additional optional appointments focused on supplemental strategies to manage alcohol use or to address co-occurring mental and behavioral health concerns.

Treatment:

Behavioral: Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary Care

Usual Care

Active Comparator group

Description:

Primary care usual care consists of universal annual alcohol screening; those who are identified as at-risk receive a brief advice intervention from their primary care provider and may be offered an integrated primary care referral. The brief advice intervention is standardized and triggered automatically by a positive screen. Integrated primary care consists of brief assessment and intervention with licensed, independent behavioral health providers. Patients may decline integrated primary care referrals, complete several appointments, and/or be referred to specialty treatment

Treatment:

Behavioral: Primary care usual care