2018 Intern Health Study Micro-randomized Trial (IHS)

University of Michigan

Status: Completed

Conditions: Physical Activity; Mood; Depression; Sleep

Treatments: Behavioral: Intern Health Study behavioral change mobile notification; Behavioral: Intern Health Study mobile app

Study type: Interventional

Funder types: Other

Identifiers

NCT03972293

0003302

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,134 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

-None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

2,134 participants in 2 patient groups

Within-participant Micro-randomization

Experimental group

Description:

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).

Treatment:

Behavioral: Intern Health Study mobile app

Behavioral: Intern Health Study behavioral change mobile notification

No intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Intern Health Study mobile app