An interventional study of Intern Health Study behavioral change mobile notification in Depression, Mood and Sleep, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
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.
8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 2,562 is above the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →University of Michigan is the lead sponsor of 1,503 studies on the registry; 189 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 132 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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 include 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. All notifications are categorized as one of two types of message sets: 1) Support, or 2) Consequences. Within each message set the core content is adapted to provide either 1) Emotional Support or Practical Support, or 2) Gain or Loss-Framed Consequences.
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.
Time frame: Daily, through study completion at the end of intern year (1 year)
Average daily step count
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.
Time frame: Daily, through study completion at the end of intern year (1 year)
Average nightly sleep duration
Participant's nightly sleep duration (in minutes) is recorded through a Fitbit or Apple Watch. High sleep duration is considered a positive outcome.
Time frame: Daily, through study completion at the end of intern year (1 year)
Patient Health Questionnaire-9 (PHQ-9)
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.
Time frame: Quarterly (every 3 months for 1 year)
Plan to share: Yes — 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).
Supporting information: Informed consent form
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.
Data sharing details ↗ · www.openicpsr.org
Ran from Jul 2022 to primary completion in Jun 2024, 23 months.
Of 3,016 non-industry interventional studies with no phase under Depression, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 23 months is close to that.
Counting every sponsor, half of 3,112 studies reached it within 22 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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