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2018 Intern Health Study Micro-randomized Trial

Not Applicable
Completed
Conditions
Sleep
Depression
Mood
Physical Activity
Interventions
Behavioral: Intern Health Study behavioral change mobile notification
Behavioral: Intern Health Study mobile app
Registration Number
NCT03972293
Lead Sponsor
University of Michigan
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2134
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
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Exclusion Criteria

-None

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Within-participant Micro-randomizationIntern Health Study mobile appEach 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).
Within-participant Micro-randomizationIntern Health Study behavioral change mobile notificationEach 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).
No interventionIntern Health Study mobile appParticipants 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.
Primary Outcome Measures
NameTimeMethod
Patient Health Questionnaire-9 (PHQ-9)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 mood7 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.

Secondary Outcome Measures
NameTimeMethod
Average nightly sleep duration7 days

Participant's nightly sleep duration (in minutes) is recorded through a Fitbit. High sleep duration is considered a positive outcome.

For interns randomized to arm 1, nightly sleep duration on weeks when sleep notifications are sent are compared to sleep duration on weeks when no notifications are sent.

Average daily step count7 days

Participant's daily step counts are recorded through a Fitbit. High step counts are considered a positive outcome as it indicates more physical activity.

For interns randomized to arm 1, average daily step counts on weeks when activity notifications are sent are compared to step counts on weeks when no notifications are sent.

Trial Locations

Locations (1)

University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

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