2018 Intern Health Study Micro-randomized Trial (IHS)

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Physical Activity; Sleep; Mood
• Intervention / Treatment: Behavioral: Intern Health Study mobile app; Behavioral: Intern Health Study behavioral change mobile notification

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.

• Study Type: Interventional
• Enrollment (Actual): 2134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Within-participant Micro-randomization; 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).	Behavioral: Intern Health Study mobile app; The Intern Health Study mobile app is able to conduct a daily mood survey. It also aggregates and visualizes historical data on intern mood, activity, and sleep.; Behavioral: Intern Health Study behavioral change mobile notification; The study's mobile app will be used to deliver intervention notifications. The intervention notifications appear on the participant's phone lock screen. The notifications have 3 categories: mood notifications, activity notifications, sleep notifications. Mood notifications aim to increase the participant's mood. Activity notifications aim to increase the participant's physical activity. Sleep notifications aim to increase the participant's sleep duration. To increase the category of interest, the notifications use two types of messages: life insights and tips. Life insights provide participants information on their historical data (for a given category) in order to help them self-monitor. Tips are non-data based notifications which provide general advice for improving the category of interest.
Experimental: No intervention; 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.	Behavioral: Intern Health Study mobile app; The Intern Health Study mobile app is able to conduct a daily mood survey. It also aggregates and visualizes historical data on intern mood, activity, and sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily mood	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.	7 days
Patient Health Questionnaire-9 (PHQ-9)	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.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average daily step count	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.	7 days
Average nightly sleep duration	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.	7 days

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Srijan Sen, M.D., Ph.D., University of Michigan

Publications and helpful links

General Publications

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.
• NeCamp T, Sen S, Frank E, Walton MA, Ionides EL, Fang Y, Tewari A, Wu Z. Assessing Real-Time Moderation for Developing Adaptive Mobile Health Interventions for Medical Interns: Micro-Randomized Trial. J Med Internet Res. 2020 Mar 31;22(3):e15033. doi: 10.2196/15033.

Helpful Links

• Intern Health Study Website

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 10, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 0003302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified genomic and survey information (baseline survey, plus quarterly survey which contains the PHQ-9) will be shared with the National Institute for Mental Health (NIMH).
• IPD Sharing Time Frame: Data will be made available 12 months after the end of the trial. It will be made available indefinitely after that date.
• IPD Sharing Access Criteria: The data will be shared directly with the NIMH. NIMH will apply their criteria for qualified researchers and analyses.
• IPD Sharing Supporting Information Type: Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No