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Completed

NCT Number: NCT05436145

Intern Health Study 2022 and 2023

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Mood Motor Activity Physical Activity Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intern Health Study behavioral change mobile notification

Behavioral

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.

Primary outcomes

  1. Average daily mood

    Time frame: 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.

  2. Average daily step count

    Time frame: 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.

  3. 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 Fitbit or Apple Watch. High sleep duration is considered a positive outcome.

  4. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Intern Health Study: 2022 and 2023 Cohort Micro-Randomized Trial

Acronym: IHS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 28, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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