2018 Intern Health Study Micro-randomized Trial
IHS
1 other identifier
interventional
2,134
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Apr 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 30, 2019
CompletedFirst Posted
Study publicly available on registry
June 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedAugust 13, 2019
August 1, 2019
1.2 years
May 30, 2019
August 10, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Average daily step count
7 days
Average nightly sleep duration
7 days
Study Arms (2)
Within-participant Micro-randomization
EXPERIMENTALEach 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 intervention
EXPERIMENTALParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (3)
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.
PMID: 26651463BACKGROUNDKroenke 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.
PMID: 11556941BACKGROUNDNeCamp 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.
PMID: 32229469DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Srijan Sen, M.D., Ph.D.
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 30, 2019
First Posted
June 3, 2019
Study Start
April 1, 2018
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
August 13, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF
- Time Frame
- Data will be made available 12 months after the end of the trial. It will be made available indefinitely after that date.
- Access Criteria
- The data will be shared directly with the NIMH. NIMH will apply their criteria for qualified researchers and analyses.
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).