2018 Intern Health Study Micro-randomized Trial

Depression Clinical Trial

— IHS  

Official title:

2018 Intern Health Study Micro-randomized Trial: Developing a Mobile Health App to Improve Mental Health and Maintain Healthy Behaviors During the Internship Year

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03972293
• Other study ID #: 0003302
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: August 2019
• 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: Completed
• Enrollment: 2134
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Medical intern during the 2018-2019 internship year

• iPhone user

• Affiliated with one of 47 recruitment institutions

• Downloaded app, completed consent, and filled out baseline survey prior to June 25th 2018

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 have 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. To increase the category of interest, the notifications use two types of messages: life insights and tips. Life insights provide participants information on their historical data (for a given category) in order to help them self-monitor. Tips are non-data based notifications which provide general advice for improving the category of interest.
• Intern Health Study mobile app
The Intern Health Study mobile app is able to conduct a daily mood survey. It also aggregates and visualizes historical data on intern mood, activity, and sleep.

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, 

References & Publications (2)

Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S:1220-8. doi: 10.1037/hea0000305. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. — View Citation

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; For interns randomized to arm 1, average daily moods scores on weeks when a specific category of notification is sent are compared to mood scores on weeks when no notifications are sent.	7 days
Primary	Patient Health Questionnaire-9 (PHQ-9)	Four months into the study, all participants complete the Patient Health Questionnaire 9. High scores on the PHQ-9 correspond to a larger number of depressive symptoms.; PHQ-9 scores are compared between the two arms: receive notifications vs do not receive notifications.	4 months
Secondary	Average daily step count	Participant's daily step counts are recorded through a Fitbit. High step counts are considered a positive outcome as it indicates more physical activity.; For interns randomized to arm 1, average daily step counts on weeks when activity notifications are sent are compared to step counts on weeks when no notifications are sent.	7 days
Secondary	Average nightly sleep duration	Participant's nightly sleep duration (in minutes) is recorded through a Fitbit. High sleep duration is considered a positive outcome.; For interns randomized to arm 1, nightly sleep duration on weeks when sleep notifications are sent are compared to sleep duration on weeks when no notifications are sent.	7 days

External Links

•   Intern Health Study Website