A Brief, Integrated Intervention for Women Veterans With Unhealthy Alcohol Use in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in self-reported quality of life from baseline to 6-months post-treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary Care (Behavioral)
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
干预措施: Primary care usual care (Behavioral)
结局指标
主要结局
Change in self-reported quality of life from baseline to 6-months post-treatment
时间窗: 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.
Change in self-reported alcohol-related problems from baseline to 6 months post-treatment
时间窗: 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.
Change in self-reported alcohol-related functional impairment from baseline to 6 months post-treatment
时间窗: 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
Feasibility - average session length
时间窗: 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).
Intervention fidelity
时间窗: 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.
Self-reported patient acceptability of the experimental intervention
时间窗: 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.
次要结局
- Self-reported change in alcohol consumption from baseline to 6 months post-treatment(Baseline to 6 months post-treatment)