Brief Alcohol Treatment for Women Veterans in Primary Care

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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

Первичные конечные точки

• Change in self-reported quality of life from baseline to 6-months post-treatment [Срок оценки: From baseline to 6 months post-treatment]
• Change in self-reported alcohol-related problems from baseline to 6 months post-treatment [Срок оценки: From baseline to 6 months post-treatment]
• Change in self-reported alcohol-related functional impairment from baseline to 6 months post-treatment [Срок оценки: Baseline to 6 months post-treatment]
• Feasibility - average session length [Срок оценки: For the duration of the intervention period, 8-12 weeks post-baseline.]
• Intervention fidelity [Срок оценки: For the duration of the intervention period, 8-12 weeks post-baseline.]
• Self-reported patient acceptability of the experimental intervention [Срок оценки: After completing the behavioral health treatment, 8-12 weeks post-baseline.]

Вторичные конечные точки (1)

• Self-reported change in alcohol consumption from baseline to 6 months post-treatment [Срок оценки: Baseline to 6 months post-treatment]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Syracuse VA Medical Center — Syracuse

Идентификаторы

NCT: NCT07414589 · 1825686 · K01AA031524-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗