A Mobile App to Address Co-Occurring Sleep Problems and Heavy Alcohol Use Among Veterans Outside of Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 主要终点
- Alcohol use quantity
研究概览
简要总结
The goal of this clinical trial is to test the preliminary efficacy of a brief mobile app targeting insomnia symptoms among veterans. In this study, we will enhance the mobile app, Insomnia Coach, with content from brief alcohol interventions to help veterans reduce both insomnia symptoms and alcohol use behaviors. We will compare those veterans who are randomly assigned to receive this brief mobile app intervention to those who receive a control condition. This will help us determine if veterans randomly assigned to receive the intervention experience greater improvement on outcomes compared to those who do not receive the intervention. The study involves a beta-test phase of the app to ensure feasibility and acceptability by veterans, followed by a randomized controlled trial with 130 veterans who meet criteria for insomnia and alcohol use disorder.
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 (Participant)
盲法说明
Participants are asked to complete one of two mobile phone-based programs. They may not know which condition is the experimental condition and which is the control.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •U.S. veteran aged 18 or older separated or discharged from service in the Air Force, Army, Marine Corps, Navy, or Coast Guard
- •Not currently affiliated with active duty service or on active reserves or guard service
- •Served since September 11, 2001
- •No past 6-month treatment for alcohol or drug use or insomnia
- •Alcohol Use Disorder Identification Test (AUDIT) score of 8 or higher
- •Insomnia Severity Index (ISI) score of 10 or higher
排除标准
- •Positive screening for other substance use disorders (not including cannabis use disorder)
结局指标
主要结局
Alcohol use quantity
时间窗: Past 30 days
Number of drinks per drinking occasion
Insomnia symptoms
时间窗: Past 30 days
7-item Insomnia Severity Index (ISI). The ISI is a measure of insomnia symptoms including difficulty falling/staying asleep, sleep problems interfering with daily life, and concern about sleep problems.
Alcohol use frequency
时间窗: Past 30 days
Days used in past 30 days
次要结局
- Sleep quality(Past 30 days)
- Alcohol-related consequences(Past 30 days)
研究者
Eric Pedersen
Associate Professor
University of Southern California