Clinical trial NCT03972293: 2018 Intern Health Study Micro-randomized Trial
Official title: 2018 Intern Health Study Micro-randomized Trial: Developing a Mobile Health App to Improve Mental Health and Maintain Healthy Behaviors During the Internship Year
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Mood
Sleep
Physical Activity
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 2134
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to two arms: 'receive notifications' or 'do not receive notifications'. The 'do not receive notifications' group will not receive any notifications for the entire study. The 'receive notifications' group will receive notifications according to a micro-randomized trial design.

For the 'receive notifications' group, each participant-week is randomized between 4 different interventions (mood notifications, activity notifications, sleep notifications or no notifications). If the participant-week is randomized to a mood notification, activity notification, or sleep notification week, the participant will receive notifications of that category during that week.

For mood notification, activity notification, and sleep notification weeks, each participant-day is also randomized between: send notification that day or do not send notification that day.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average daily mood
timeFrame: 7 days
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 4 months
Secondary outcomes:
measure: Average daily step count
timeFrame: 7 days
measure: Average nightly sleep duration
timeFrame: 7 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Srijan Sen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.