跳至主要内容
临床试验/NCT03972293
NCT03972293已完成不适用

2018 Intern Health Study Micro-randomized Trial: Developing a Mobile Health App to Improve Mental Health and Maintain Healthy Behaviors During the Internship Year

University of Michigan2 个研究点 分布在 1 个国家目标入组 2,134 人开始时间: 2018年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,134
试验地点
2
主要终点
Patient Health Questionnaire-9 (PHQ-9)

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
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Medical intern during the 2018-2019 internship year
  • iPhone user
  • Affiliated with one of 47 recruitment institutions
  • Downloaded app, completed consent, and filled out baseline survey prior to June 25th 2018

排除标准

  • 未提供

研究组 & 干预措施

Within-participant Micro-randomization

Experimental

Each week in the study, with probability .25 for each, a participant is randomized to receive either a week of mood notifications, activity notifications, sleep notifications, or no notifications.

If the participant is assigned to receive mood, activity, or sleep notifications on a given week, then, for every day of that week the participant is randomized to: send notification on that day (with probability .5), or to not send a notification on that day (with probability .5).

干预措施: Intern Health Study behavioral change mobile notification (Behavioral)

Within-participant Micro-randomization

Experimental

Each week in the study, with probability .25 for each, a participant is randomized to receive either a week of mood notifications, activity notifications, sleep notifications, or no notifications.

If the participant is assigned to receive mood, activity, or sleep notifications on a given week, then, for every day of that week the participant is randomized to: send notification on that day (with probability .5), or to not send a notification on that day (with probability .5).

干预措施: Intern Health Study mobile app (Behavioral)

No intervention

Experimental

Participants in this arm will not receive any notifications for the entire duration of the trial. Primary and secondary outcomes will still be collected on participants in arm 2 through the study app and Fitbit.

干预措施: Intern Health Study mobile app (Behavioral)

结局指标

主要结局

Patient Health Questionnaire-9 (PHQ-9)

时间窗: 4 months

Four months into the study, all participants complete the Patient Health Questionnaire 9. High scores on the PHQ-9 correspond to a larger number of depressive symptoms. PHQ-9 scores are compared between the two arms: receive notifications vs do not receive notifications.

Average daily mood

时间窗: 7 days

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 For interns randomized to arm 1, average daily moods scores on weeks when a specific category of notification is sent are compared to mood scores on weeks when no notifications are sent.

次要结局

  • Average nightly sleep duration(7 days)
  • Average daily step count(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Srijan Sen

Associate Professor

University of Michigan

研究点 (2)

Loading locations...

相似试验