Intern Health Study: 2024 Cohort Micro-Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,047
- 试验地点
- 2
- 主要终点
- Average daily mood
研究概览
简要总结
The aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.
详细描述
Due to their high stress workloads, medical interns suffer from depression at higher rates than the general population. Interns also tend to have lower sleep and decreased physical activity. The goal of this trial is to evaluate the efficacy of a mobile health intervention intending to help improve the mental health of medical interns. The intervention sends mobile phone notifications which aim to help interns improve their mood, maintain physical activity, and obtain adequate sleep during their internship year.
The primary aim of the study is to evaluate how notifications affect participants' weekly mood, as measured through a daily one question mood survey. The second primary aim of the study is to evaluate how notifications affect participants' long-term mental health, as measured by the Patient Health Questionnaire. The first secondary aim is to evaluate how mood notifications affect participants' weekly mood. The second secondary aim is to evaluate how activity notifications affect participants' weekly step count. The third secondary aim is to evaluate how sleep notifications affect participants' weekly sleep duration. In order to better optimize notification delivery, the final aim (exploratory) is to understand moderators of these effects. Moderators of interest are previous week's mood, previous week's step count, previous week's sleep duration, study week, sex, previous history of depression, and baseline neuroticism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Medical intern during the 2024-2025 internship year
- •iPhone or Android phone user
- •Logged into the Intern Health Study mobile app, completed consent, and filled out baseline survey by June 30 prior to the start of intern year
排除标准
- 未提供
研究组 & 干预措施
Within-participant micro-randomization
Each day in the study, with probability .5 for each, a participant is randomized to receive a notification that day or no notification that day.
If a participant is assigned to receive a notification that day, 1 message set will be randomly selected from a pool of 358 core message sets. Each core message set will be comprised of 4 messages containing comparable content, however they will be tailored based on the participant's wearable (steps, sleep) or mood data for the specified time interval (7 days, 30 days, since the start of internship) as follows: 1) no data, 2) low, 3) moderate, or 4) high.
干预措施: Intern Health Study behavioral change mobile notification (Behavioral)
结局指标
主要结局
Average daily mood
时间窗: Daily, through study completion at the end of intern year (1 year)
Through the mobile app, participants enter a mood score (scale 1 - 10) every day of the study. 1 corresponds to lowest mood and 10 corresponds to highest mood.
Average daily step count
时间窗: Daily, through study completion at the end of intern year (1 year)
Participant's daily step counts are recorded through a fitness tracker. High step counts are considered a positive outcome as it indicates more physical activity.
Average nightly sleep duration
时间窗: Daily, through study completion at the end of intern year (1 year)
Participant's nightly sleep duration (in minutes) is recorded through a fitness tracker. High sleep duration is considered a positive outcome.
Patient Health Questionnaire-9 (PHQ-9)
时间窗: Quarterly (every 3 months for 1 year)
Prior to the start of the intervention and at quarterly intervals throughout internship year, all participants complete the Patient Health Questionnaire 9. High scores on the PHQ-9 correspond to a larger number of depressive symptoms.
次要结局
未报告次要终点
研究者
Srijan Sen
Research Professor
University of Michigan