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2018 Intern Health Study Micro-randomized Trial (IHS)

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ClinicalTrials.gov Identifier: NCT03972293
Recruitment Status : Completed
First Posted : June 3, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Srijan Sen, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Depression Mood Sleep Physical Activity Behavioral: Intern Health Study behavioral change mobile notification Behavioral: Intern Health Study mobile app Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants are randomized to two arms: 'receive notifications' or 'do not receive notifications'. The 'do not receive notifications' group will not receive any notifications for the entire study. The 'receive notifications' group will receive notifications according to a micro-randomized trial design.

For the 'receive notifications' group, each participant-week is randomized between 4 different interventions (mood notifications, activity notifications, sleep notifications or no notifications). If the participant-week is randomized to a mood notification, activity notification, or sleep notification week, the participant will receive notifications of that category during that week.

For mood notification, activity notification, and sleep notification weeks, each participant-day is also randomized between: send notification that day or do not send notification that day.

Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Within-participant Micro-randomization

Each week in the study, with probability .25 for each, a participant is randomized to receive either a week of mood notifications, activity notifications, sleep notifications, or no notifications.

If the participant is assigned to receive mood, activity, or sleep notifications on a given week, then, for every day of that week the participant is randomized to: send notification on that day (with probability .5), or to not send a notification on that day (with probability .5).

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.

Behavioral: 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.

Experimental: No intervention
Participants in this arm will not receive any notifications for the entire duration of the trial. Primary and secondary outcomes will still be collected on participants in arm 2 through the study app and Fitbit.
Behavioral: 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.




Primary Outcome Measures :
  1. Average daily mood [ Time Frame: 7 days ]

    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.


  2. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 4 months ]

    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.



Secondary Outcome Measures :
  1. Average daily step count [ Time Frame: 7 days ]

    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.


  2. Average nightly sleep duration [ Time Frame: 7 days ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972293


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Srijan Sen, M.D., Ph.D. University of Michigan

Additional Information:
Publications:
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Responsible Party: Srijan Sen, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03972293     History of Changes
Other Study ID Numbers: 0003302
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data will be made available 12 months after the end of the trial. It will be made available indefinitely after that date.
Access Criteria: The data will be shared directly with the NIMH. NIMH will apply their criteria for qualified researchers and analyses.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms