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NCT Number: NCT07414589

Brief Alcohol Treatment for Women Veterans 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.

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Key information

Conditions

Alcohol Misuse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Syracuse VA Medical Center

Syracuse, New York, 13210, United States

Location contact

Katherine A Buckheit, PhD

CONTACT

[email protected]

315-425-4400 ext. 56742

Katherine A Buckheit, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

Primary outcomes

  1. Change in self-reported quality of life from baseline to 6-months post-treatment

    Time frame: 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.

  2. Change in self-reported alcohol-related problems from baseline to 6 months post-treatment

    Time frame: 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.

  3. Change in self-reported alcohol-related functional impairment from baseline to 6 months post-treatment

    Time frame: 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

  4. Feasibility - average session length

    Time frame: For the duration of the intervention period, 8-12 weeks post-baseline.

    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).

  5. Intervention fidelity

    Time frame: For the duration of the intervention period, 8-12 weeks post-baseline.

    An independent rater will listen to session tapes and record if each essential element was delivered on a checklist.

  6. Self-reported patient acceptability of the experimental intervention

    Time frame: After completing the behavioral health treatment, 8-12 weeks post-baseline.

    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.

Secondary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine A Buckheit, PhD

CONTACT

[email protected]

315-425-4400 ext. 56742

Sponsors and collaborators

Lead sponsor

Syracuse VA Medical Center

Fed

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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