Intern Health Study 2022 and 2023

Not Applicable

Completed

• Conditions: Mood; Sleep; Physical Activity; Depression
• Interventions: Behavioral: Intern Health Study behavioral change mobile notification

• Registration Number: NCT05436145
• 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.

Study Timeline

• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-28
• Study Start: 2022-07-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2562

Inclusion Criteria

• Medical intern during the 2022-2023 or 2023-2024 internship years
• iPhone or Android phone user
• Logged into the Intern Health Study mobile app, completed consent, and filled out baseline survey by June 30 prior to the start of intern year

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Within-participant micro-randomization	Intern Health Study behavioral change mobile notification	Each day in the study, with probability .5 for each, a participant is randomized to receive a notification that day or no notification that day. If a participant is assigned to receive a notification that day, 1 message set will be randomly selected from a pool of 60 message sets. There are 2 types of message sets: 1) Support and 2) Consequences. If a participant is assigned to receive a Support message set, they will be randomized to receive either the Emotional or Practical Support version. If a participant is assigned to receive a Consequences message set, they will be randomized to receive either the Gain Framed or Loss Framed version.

Primary Outcome Measures

Name	Time	Method
Average daily step count	Daily, through study completion at the end of intern year (1 year)	Participant's daily step counts are recorded through a Fitbit or Apple Watch. High step counts are considered a positive outcome as it indicates more physical activity.
Patient Health Questionnaire-9 (PHQ-9)	Quarterly (every 3 months for 1 year)	Prior to the start of the intervention and at quarterly intervals throughout internship year, all participants complete the Patient Health Questionnaire 9. High scores on the PHQ-9 correspond to a larger number of depressive symptoms.
Average daily mood	Daily, through study completion at the end of intern year (1 year)	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.
Average nightly sleep duration	Daily, through study completion at the end of intern year (1 year)	Participant's nightly sleep duration (in minutes) is recorded through a Fitbit or Apple Watch. High sleep duration is considered a positive outcome.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States