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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active CRM<br> | Other: Circadian Rhythms for Mood (CRM) application - Active<br>* 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.<br>|
| Sham Comparator: Sham CRM<br> | Other: Circadian Rhythms for Mood (CRM) application - Sham<br>* 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.<br>|

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 |