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Intern Health Study 2022 and 2023 (IHS)

Primary Purpose

Depression, Mood, Sleep

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intern Health Study behavioral change mobile notification
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Medical intern during the 2022-2023 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, 2022

Exclusion Criteria:

  • None

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Within-participant micro-randomization

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 21, 2022
Last Updated
October 5, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05436145
Brief Title
Intern Health Study 2022 and 2023
Acronym
IHS
Official Title
Intern Health Study: 2022 and 2023 Cohort Micro-Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Mood, Sleep, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2562 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Within-participant micro-randomization
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intern Health Study behavioral change mobile notification
Intervention Description
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 Outcome Measure Information:
Title
Average daily mood
Description
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)
Title
Average daily step count
Description
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)
Title
Average nightly sleep duration
Description
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)
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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).
IPD Sharing Time Frame
Data will be made available 12 months after the end of the trial. It will be made available indefinitely after that date.
IPD Sharing Access Criteria
The data will be shared directly with the NIMH. NIMH will apply their criteria for qualified researchers and analyses.
IPD Sharing URL
https://www.openicpsr.org/openicpsr/project/129225/version/V1/view
Links:
URL
https://www.srijan-sen-lab.com/intern-health-study
Description
Sen Lab Website
URL
https://www.internhealthstudy.org/
Description
Study Participant Web Site

Learn more about this trial

Intern Health Study 2022 and 2023

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