Intern Health Study 2024

NCT ID: NCT06465680

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Depression Mood Sleep Physical Activity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intern Health Study behavioral change mobile notification

Intervention Type BEHAVIORAL

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.

Interventions

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Intern Health Study behavioral change mobile notification

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Srijan Sen

Research Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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MH-101459-2024

Identifier Type: -

Identifier Source: org_study_id

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