- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06465680
Intern Health Study 2024 (IHS)
Intern Health Study: 2024 Cohort Micro-Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Medical intern during the 2024-2025 internship year
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Within-participant micro-randomization
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 358 core message sets. Each core message set will be comprised of 4 messages containing comparable content, however they will be tailored based on the participant's wearable (steps, sleep) or mood data for the specified time interval (7 days, 30 days, since the start of internship) as follows: 1) no data, 2) low, 3) moderate, or 4) high. |
The study's mobile app will be used to deliver push notifications.
The 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 five therapeutic approaches: 1) CBT-Behavioral, 2) CBT-Cognitive, 3) Distanced Self-Talk, 4) Mindfulness, 5) Motivational Interviewing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average daily mood
Time Frame: Daily, through study completion at the end of intern year (1 year)
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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.
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Daily, through study completion at the end of intern year (1 year)
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Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Quarterly (every 3 months for 1 year)
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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.
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Quarterly (every 3 months for 1 year)
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Average daily step count
Time Frame: Daily, through study completion at the end of intern year (1 year)
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Participant's daily step counts are recorded through a fitness tracker.
High step counts are considered a positive outcome as it indicates more physical activity.
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Daily, through study completion at the end of intern year (1 year)
|
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Average nightly sleep duration
Time Frame: Daily, through study completion at the end of intern year (1 year)
|
Participant's nightly sleep duration (in minutes) is recorded through a fitness tracker.
High sleep duration is considered a positive outcome.
|
Daily, through study completion at the end of intern year (1 year)
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MH-101459-2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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