Digital Phenotypes for Predicting Depression

NCT ID: NCT07151846

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 540 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-27
• Study Completion Date: 2026-08-31

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient group

Adults (19-75 years) with a clinical diagnosis of a major mood disorder (bipolar I/II or major depressive disorder) per DSM-5, with at least one prior depressive episode.

No interventions assigned to this group

High Risk

Adults (19-75 years) with no formal diagnosis of bipolar disorder or major depressive disorder, but who meet at least one of the following:

1. Elevated scores at screening (K-MDQ ≥7 or PHQ-9 ≥5), or

2. Report of persistent mood symptoms (e.g., ≥2 weeks of low mood or ≥several days of elevated/irritable mood) during MINI interview.

No interventions assigned to this group

Healthy Control

Adults (19-75 years) with no current or past diagnosis of bipolar disorder or major depressive disorder, and who screen below cutoff on both K-MDQ (\<7) and PHQ-9 (\<5).

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Adults aged 19 to 75 years and 11 months.

2. Diagnosed with a major mood disorder (bipolar I or II disorder, or major depressive disorder) based on DSM-5, with a history of psychiatric visits for mood symptoms.

3. Has experienced at least one prior depressive episode (major, minor, or brief).

4. Owns a smartphone with stable internet connectivity, can operate it without difficulty, and agrees to install a digital phenotyping application, wear a Fitbit device daily, and complete daily mood logs throughout the study period.

1. Adults aged 19 to 75 years and 11 months.

2. No current or past diagnosis of bipolar disorder or major depressive disorder.

3. Scores below clinical thresholds on both K-MDQ (<7) and PHQ-9 (<5) at baseline assessment.

4. Owns a smartphone with stable internet connectivity, can operate it without difficulty, and agrees to install a digital phenotyping application, wear a Fitbit device daily, and complete daily mood logs throughout the study period.

1. Adults aged 19 to 75 years and 11 months.

2. No current or past diagnosis of bipolar disorder or major depressive disorder.

3. Meets either of the following:

A. Scores above the threshold on K-MDQ (≥7) or PHQ-9 (≥5) at baseline. B. Reports persistent mood symptoms during MINI (e.g., ≥2 weeks of depressive mood/anhedonia, or several days of elevated/irritable mood).

4. Owns a smartphone with stable internet connectivity, can operate it without difficulty, and agrees to install a digital phenotyping application, wear a Fitbit device daily, and complete daily mood logs throughout the study period.

Exclusion Critera (Overall)

1. Inability to provide informed consent due to cognitive impairment, severe psychiatric symptoms, or language barriers.

2. Presence of any neurological or medical condition that may significantly affect mood, cognition, or behavior (e.g., epilepsy, dementia, traumatic brain injury).

3. Current substance use disorder or dependence (excluding nicotine or caffeine) that is either untreated or clinically unstable.

4. Severe suicidal ideation or risk as determined by clinical judgment at screening.

5. Ongoing participation in another interventional clinical trial, particularly those involving psychotropic medications or digital health interventions.

6. Inability or unwillingness to wear a wearable device (Fitbit) or use the required mobile application daily throughout the study.

7. Lack of stable internet access or a compatible smartphone required for digital phenotyping data collection.

8. Any other condition that, in the investigator's judgment, may compromise the participant's safety, compliance, or the integrity of the study data.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Korea University Medicine

UNKNOWN

Sponsor Role: collaborator

Hucircadian

INDUSTRY

Sponsor Role: collaborator

Korea University Anam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Heon-Jeong Lee, MD, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heon-Jeong Lee, Professor

Role: PRINCIPAL_INVESTIGATOR

Korea University Anam Hospital

Locations

Korea University Anam Hospital

Seoul, Seongbuk-gu, South Korea

Countries

South Korea

Other Identifiers

RS-2024-00469788

Identifier Type: OTHER

Identifier Source: secondary_id

MY MENTAL HERO

Identifier Type: -

Identifier Source: org_study_id