NCT07052357

Brief Summary

The aim of this study is to evaluate the efficacy of using a reinforcement learning algorithm to determine the optimal content of a mobile health intervention (message delivered via smartphone) for improving the mood, physical activity, and sleep of medical interns.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Apr 2025Jun 2026

Study Start

First participant enrolled

April 3, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

July 4, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

June 26, 2025

Last Update Submit

June 26, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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)

  • Average daily step count

    Participant's daily step counts are recorded through a fitness tracker. 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)

  • Average nightly sleep duration

    Participant's nightly sleep duration (in minutes) is recorded through a fitness tracker. High sleep duration is considered a positive outcome.

    Daily, through study completion at the end of intern year (1 year)

  • 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)

Study Arms (1)

Within-participant micro-randomization

EXPERIMENTAL

Each week a policy outcome is chosen at random with ⅓ mood, ⅓ activity, ⅓ sleep - this determines which category of message a participant will receive. Each day in the study, a reinforcement learning algorithm will determine 1) if a participant will receive a notification that day or no notification that day, 2) the therapeutic strategy employed by the notification (Behavioral Strategy, Cognitive Strategy, Mindfulness, Motivational Interviewing, Distanced Self-Talk), and 3) if personalized data feedback will be included. If assigned to receive a notification, 1 core message set that meets the above criteria will be randomly selected from a pool of 358 core message sets. Each core message set will be comprised of 4 messages containing comparable content, however they will be tailored based on the participant's wearable (steps, sleep) or mood data for the specified time interval (7 days, 30 days, since the start of internship) as follows: 1) no data, 2) low, 3) moderate, or 4) high.

Behavioral: Intern Health Study behavioral change mobile notification

Interventions

The study's mobile app will be used to deliver push notifications. The 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 five therapeutic approaches: 1) CBT-Behavioral, 2) CBT-Cognitive, 3) Distanced Self-Talk, 4) Mindfulness, 5) Motivational Interviewing.

Within-participant micro-randomization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical intern during the 2025-2026 internship year
  • iPhone or Android phone user
  • Completed the Intern Health Study consent and baseline survey by June 20 prior to the start of intern year

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48375, United States

Location

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Frances and Kenneth Eisenberg Professor of Depression and Neurosciences

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 4, 2025

Study Start

April 3, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

July 4, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

De-identified survey data (baseline survey, plus quarterly survey which contains the PHQ-9) will be shared via the ICPSR repository (https://www.openicpsr.org/openicpsr/project/129225/version/V1/view).

Time Frame
Data will be made available 12 months after the end of the study It will be made available indefinitely after that date.
Access Criteria
Deidentified data will be publicly available via ICPSR https://www.openicpsr.org/openicpsr/project/129225/version/V1/view
More information

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