Brief Alcohol Treatment for Women Veterans in Primary Care

A Brief, Integrated Intervention for Women Veterans With Unhealthy Alcohol Use in Primary Care

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alcohol Misuse
• Intervention / Treatment: Behavioral: Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary Care; Behavioral: Primary care usual care

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katherine A Buckheit, PhD; Phone Number: 56742 315-425-4400; Email: katheirne.buckheit@va.gov

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210
      • Syracuse VA Medical Center
      • Contact: Katherine A Buckheit, PhD; Phone Number: 56742 315-425-4400; Email: katherine.buckheit@va.gov
      • Principal Investigator: Katherine A Buckheit, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief intervention for unhealthy alcohol use; 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.	Behavioral: Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary Care; The intervention consists of 4-6 30-minute behavioral health appointments with a behavioral health provider in an integrated primary care setting. It includes 4 core alcohol-focused appointments focused on providing information and skills to manage unhealthy alcohol use that have been adapted from existing evidence-based treatments in integrated primary care and specialty care. 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, including mood, trauma, sleep, and pain.
Active Comparator: Usual Care; 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	Behavioral: Primary care usual care; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in self-reported quality of life from baseline to 6-months post-treatment	Quality of life will be assessed by the abbreviated World Health Organization Quality of Life Assessment (WHOQOL-BREF), a 26-item self-report measure of QoL in the past 2 weeks in 4 areas (social, physical, psychological, and environment) on a 1-5 scale.	From baseline to 6 months post-treatment
Change in self-reported alcohol-related problems from baseline to 6 months post-treatment	Alcohol problems will be assessed by the Short Inventory of Problems-Revised (SIP-R)147, a 17-item self-report measure of frequency of alcohol problems on a 0-3 scale.	From baseline to 6 months post-treatment
Change in self-reported alcohol-related functional impairment from baseline to 6 months post-treatment	Alcohol-specific functional impairment will be assessed by the Addiction Severity Index - Lite, a semi-structured interview developed among Veterans in substance use treatment that assesses alcohol and drug use and problems and 5 areas of functioning: medical, legal, psychiatric, employment, and family/social	Baseline to 6 months post-treatment
Feasibility - average session length	Length of sessions in the experimental condition will be measured to test if the average is within guidelines for integrated primary care treatment (30 minutes maximum).	For the duration of the intervention period, 8-12 weeks post-baseline.
Intervention fidelity	An independent rater will listen to session tapes and record if each essential element was delivered on a checklist.	For the duration of the intervention period, 8-12 weeks post-baseline.
Self-reported patient acceptability of the experimental intervention	Patient acceptability will be assessed with the Client Satisfaction Questionnaire (CSQ), an 8-item self-report measure. Acceptability ratings of at least "moderate" on the majority (5/8) of items on the CSQ will be considered acceptable.	After completing the behavioral health treatment, 8-12 weeks post-baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported change in alcohol consumption from baseline to 6 months post-treatment	Alcohol use will be assessed with the Timeline Followback (TLFB), a calendar-based measure that records standard drinks consumed each day in the past month to yield percent of drinking days, average drinks per drinking day, percent of heavy drinking (i.e., ≥4 drinks/occasion) days, and a variable indicating if alcohol use is above NIAAA-recommendations.	Baseline to 6 months post-treatment

Collaborators and Investigators

• Sponsor: Syracuse VA Medical Center
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Investigators: Principal Investigator: Katherine A Buckheit, PhD, Veterans Health Research Institute of Central New York, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): August 1, 2030

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: alcohol; women Veterans; integrated primary care
• Additional Relevant MeSH Terms: Health Services Administration; Organic Chemicals; Alcohols; Patient Care Management; Comprehensive Health Care; Ethanol; Primary Health Care
• Other Study ID Numbers: 1825686; K01AA031524-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Once all data collection is complete and the coded database is finalized, IPD will be shared according to PI discretion. For instance, IPD may be shared to be used in meta-analyses or other review papers. No identifiable participant information will be shared.
• IPD Sharing Time Frame: The data will be available once the database is finalized and will remain available in the future.
• IPD Sharing Access Criteria: Access to the data can be obtained by emailing the PIs and describing the reason the data is needed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No