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2018 Intern Health Study Micro-randomized Trial (IHS)

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ClinicalTrials.gov Identifier: NCT03972293
Recruitment Status : Active, not recruiting
First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Srijan Sen, University of Michigan

Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date June 3, 2019
Actual Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 2018 Intern Health Study Micro-randomized Trial
Official Title  ICMJE 2018 Intern Health Study Micro-randomized Trial: Developing a Mobile Health App to Improve Mental Health and Maintain Healthy Behaviors During the Internship Year
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Depression
  • Mood
  • Sleep
  • Physical Activity
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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).

    Interventions:
    • Behavioral: Intern Health Study behavioral change mobile notification
    • Behavioral: Intern Health Study mobile app
  • 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.
    Intervention: Behavioral: Intern Health Study mobile app
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 30, 2019)
2134
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2019
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03972293
Other Study ID Numbers  ICMJE 0003302
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Srijan Sen, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Srijan Sen, M.D., Ph.D. University of Michigan
PRS Account University of Michigan
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP