NCT07151846

Digital Phenotypes for Predicting Depression

Discovery and Validation of Digital Phenotypes for Predicting Recurrence of Depressive Episodes

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 540 (estimated)
• Sponsor: Korea University Anam Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This longitudinal study aims to identify and validate digital phenotypes that can predict recurrence of major depressive episodes using passively collected, real-time sensing data from smartphones and wearable devices. Over a 12-month period, 540 participants-including patients with mood disorders and healthy or high-risk controls-will complete five clinical assessments at 3-month intervals, wear a Fitbit device daily, and log daily mood ratings via a mobile app. The study includes the development of AI-based predictive models and the construction of an anonymized wearable big-data repository for mood disorders.

Detailed description

This is a 12-month longitudinal follow-up study designed to identify digital phenotypes capable of predicting the recurrence of major depressive episodes using passively collected real-time data from smartphones and wearable devices. A total of 540 participants will be enrolled, including 200 patients diagnosed with mood disorders who have experienced at least one depressive episode in the past two years, and 340 healthy or high-risk control participants without a clinical diagnosis. Clinical interviews and self-report measures will be conducted five times at 3-month intervals. Throughout the study period, participants will wear a Fitbit device daily and use the "My Mental Hero" mobile application to record their mood once a day at a self-selected time. Data collected will be used to develop machine learning models for predicting depressive recurrence and to build a large-scale, anonymized wearable big-data repository for mood disorders. Participants will receive no interventions beyond data collection, and neither randomization nor blinding will be implemented. Trained psychiatrists, clinical psychologists, or research nurses will conduct the assessments. Initial visits will include informed consent, device setup, and app training, taking approximately 1-2 hours. Subsequent assessments will take about one hour, with additional brief interviews (≤30 minutes) conducted if a mood episode is suspected. While follow-up assessments for patients and high-risk participants will be conducted in person, those for healthy controls may be conducted remotely (via Zoom or phone) under secure and private conditions without screen recording. Remote assessments may also be used for patient and high-risk groups if necessary.

Conditions

• Depression - Major Depressive Disorder
• Depression Bipolar
• Bipolar Disorder (BD)
• Mood Disorders

Timeline

• Start date: 2025-02-27
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2025-09-03
• Last updated: 2025-09-03

Locations

1 site across 1 country: South Korea