A Pilot Randomized Controlled Trial of LDART, a Social Support Intervention for Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
This study is a pilot randomized controlled trial to evaluate feasibility, acceptability, and preliminary efficacy of a digital intervention called Let's Do Addiction Recovery Together! (LDART) in adults with alcohol use disorder, relative to a control group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently reside in Connecticut, USA
- •Have a smartphone that can send and receive text messages and have internet access that can be access over the course of a month
- •Had ≥5 heavy drinking days (defined as ≥4 or ≥5 drinks in one sitting for women and men, respectively) in the past 28 days
- •Alcohol Symptom Checklist ≥4, indicating moderate/severe AUD
- •Have some self-reported desire to cut down or quit drinking
排除标准
- •Unable to provide informed consent, as assessed by the consent quiz
- •Unable to speak, read, or write in English
- •Vulnerable population status
- •Unlikely to be able to complete study procedures in the next 2-3 months
研究组 & 干预措施
LDART
Participants will be given access to LDART for 28 days.
干预措施: LDART (Device)
Rethinking Drinking
Participants will be emailed a PDF of this psychoeducational booklet.
干预措施: Psychoeducational control (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: From enrollment to the final assessment time point (Day 56)
The percentage of eligible participants who are enrolled relative to the total number of eligible potential participants who completed the screening.
Accrual rate
时间窗: From enrollment to the final assessment time point (Day 56)
The rate of enrollment, defined as number of participants enrolled per month.
Intervention engagement
时间窗: From beginning the intervention (Day 1) to the end of the intervention period (Day 28)
Number of nights that participants in the active condition completed the activities on the LDART website, out of 28 nights.
Intervention acceptability
时间窗: The second assessment time point (post-intervention, Day 28)
Rating scores on the end-user version of the Mobile App Rating Scale (uMARS). Total score range 1-5 with higher scores indicating a better quality app.
Retention rate
时间窗: From enrollment to the final assessment time point (Day 56)
The percentage of enrolled participants who complete all study-related procedures (i.e., assessments at 3 monthly time points).
次要结局
- Change from baseline in number of heavy drinking days(Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56))
- Change from baseline in number of drinking days(Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56))
- Change from baseline in number of hours spent engaging with recovery groups(Baseline (Day 0), Post-intervention (Day 28), 1-month post-intervention (Day 56))