Brief Alcohol Treatment for Women Veterans in Primary Care

NCT07414589 | Not Yet Recruiting

• 2 other identifiers: 1825686K01AA031524-01A1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Misuse

Keywords

alcohol; integrated primary care; women Veterans

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Self-reported change in alcohol consumption from baseline to 6 months post-treatment

  Baseline to 6 months post-treatment

Study Arms (2)

Brief intervention for unhealthy alcohol use

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

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

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.

Brief intervention for unhealthy alcohol use

Primary care usual care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Syracuse VA Medical Center: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Syracuse VA Medical Center

Syracuse, New York, 13210, United States

Location

MeSH Terms

Interventions

Ethanol; Primary Health Care

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Katherine A Buckheit, PhD

  Veterans Health Research Institute of Central New York, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine A Buckheit, PhD

CONTACT

315-425-4400; katheirne.buckheit@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 17, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): August 1, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available once the database is finalized and will remain available in the future.
• Access Criteria: Access to the data can be obtained by emailing the PIs and describing the reason the data is needed.

Locations

US (1)