Intern Health Study 2022 and 2023

Depression Clinical Trial

— IHS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05436145
• Other study ID #: MH-101459
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2562
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Mood
• Physical Activity
• Sleep

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Daily, through study completion at the end of intern year (1 year)
Primary	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.	Daily, through study completion at the end of intern year (1 year)
Primary	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.	Daily, through study completion at the end of intern year (1 year)
Primary	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.	Quarterly (every 3 months for 1 year)

External Links

•   Sen Lab Website
•   Study Participant Web Site