NCT05436145

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,562

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

June 21, 2022

Last Update Submit

July 1, 2024

Conditions

DepressionMoodSleepPhysical Activity

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 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)

  • 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)

  • 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 day in the study, with probability .5 for each, a participant is randomized to receive a notification that day or no notification that day. If a participant is assigned to receive a notification that day, 1 message set will be randomly selected from a pool of 60 message sets. There are 2 types of message sets: 1) Support and 2) Consequences. If a participant is assigned to receive a Support message set, they will be randomized to receive either the Emotional or Practical Support version. If a participant is assigned to receive a Consequences message set, they will be randomized to receive either the Gain Framed or Loss Framed version.

Behavioral: Intern Health Study behavioral change mobile notification

Interventions

Intern Health Study behavioral change mobile notificationBEHAVIORAL

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.

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 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Links

MeSH Terms

Conditions

DepressionMotor Activity

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 28, 2022

Study Start

July 1, 2022

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
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.
More information

Locations

US(1)