Efficacy of the Mobile Application for Prediction and Prevention of Mood Episode Recurrence Based on Machine Learning

Efficacy of the Mobile Phone Application (Circadian Rhythms for Mood) for Prediction and Prevention of Mood Episode Recurrence in Mood Disorders Based on Machine Learning of Daily Digital Phenotype Variables : a Sham-controlled Randomized Clinical Trial

This study was designed to evaluate the efficacy of the mobile application named Circadian Rhythm for Mood (CRM), which was developed to prevent recurring episodes of mood disorders (major depressive disorders, bipolar disorders type 1 and 2) based on machine learning.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder; Bipolar 1 Disorder; Bipolar II Disorder
• Intervention / Treatment: Other: Circadian Rhythms for Mood (CRM) application - Active; Other: Circadian Rhythms for Mood (CRM) application - Sham

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and female patients, 19-70 years old
• Diagnosis with Bipolar I disorder, Bipolar II disorder, Major depressive disorder based on DSM-5 criteria, in euthymic state for more than two weeks at the time of the recruitment
• Android smartphone users, capable of installing and executing the CRM application
• Consent to wear wearable device (Fitbit) continuously and synchronize and backup data regularly

Exclusion Criteria:

• Patients who have not experienced major depressive, manic, or hypomanic episode in the last two years
• Patients who are difficult to specify mood episode or evaluate symptoms of mood episode independently due to personality traits (borderline personality trait, cyclothymic temperament, etc.)
• Patients with degenerative neurological disorders (Parkinson's disease, dementia, Huntington's disease, etc.), neurodevelopmental disorders (intellectual disorder, autism spectrum disorder, down syndrome, etc.), epilepsy, severe traumatic brain damage, stroke, and other brain neurological disorders
• Inmates or patients who are forced into custody for the treatment of mental or physical illness (non-voluntary isolation or hospitalization)
• Patients with difficulties in understanding the objectives and process of the study and the potential benefits and risks of participating in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active CRM	Other: Circadian Rhythms for Mood (CRM) application - Active; The study subjects participating in this clinical trial wear wearable activity tracker 24 hours a day for a continuous period of time and run the CRM app once a day to check their conditions (feelings, vitality, sleep, etc.) in the Daily Symptom Assessment (eMoodChart). The active intervention group are provided with mood prediction results and instructions as feedback through the 'life report' and push notification in the application.
Sham Comparator: Sham CRM	Other: Circadian Rhythms for Mood (CRM) application - Sham; The study subjects assigned to the sham intervention group are provided with feedbacks operated by dummy algorithm. The application is visually indistinguishable from active CRM, and it is designed to minimize behavioral change.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of total number of recurrent mood episodes between the active and sham groups	We aim to evaluate the efficacy of reducing recurrence rate of mood episodes through the CRM mobile application.	12 months
Comparison of duration of mood episodes between the active and sham groups	We aim to evaluate the efficacy of reducing duration of mood episodes through the CRM mobile application.	12 months

Collaborators and Investigators

• Sponsor: Hucircadian
• Collaborators: Pusan National University Hospital; Korea University Guro Hospital; Korea University Ansan Hospital; Inje University Ilsan Paik Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2022
• Primary Completion (Actual): December 21, 2023
• Study Completion (Actual): December 21, 2023

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Mood Disorders; Recurrence; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: HC-CRM-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No