Brief Alcohol Treatment for Women Veterans in Primary Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary Care, Primary care usual care.
- Who it may be relevant to
- Registry conditions: Alcohol Misuse. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Brief, Integrated Intervention for Women Veterans With Unhealthy Alcohol Use in Primary Care
Overview
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.
Interventions
- 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 - 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
Primary outcome measures
- Change in self-reported quality of life from baseline to 6-months post-treatment [Time frame: From baseline to 6 months post-treatment]
- Change in self-reported alcohol-related problems from baseline to 6 months post-treatment [Time frame: From baseline to 6 months post-treatment]
- Change in self-reported alcohol-related functional impairment from baseline to 6 months post-treatment [Time frame: Baseline to 6 months post-treatment]
- Feasibility - average session length [Time frame: For the duration of the intervention period, 8-12 weeks post-baseline.]
- Intervention fidelity [Time frame: For the duration of the intervention period, 8-12 weeks post-baseline.]
- Self-reported patient acceptability of the experimental intervention [Time frame: After completing the behavioral health treatment, 8-12 weeks post-baseline.]
Secondary outcome measures (1)
- Self-reported change in alcohol consumption from baseline to 6 months post-treatment [Time frame: Baseline to 6 months post-treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Syracuse VA Medical Center — Syracuse
Identifiers
NCT: NCT07414589 · 1825686 · K01AA031524-01A1