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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05400785
• Other study ID #: HC-CRM-01
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: December 2022
• Source: Hucircadian
• Contact: Heon-Jeong Lee, MD, PhD
• Phone: +82 10 4529 5653
• Email: leehjeong[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: October 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar 1 Disorder
• Bipolar II Disorder
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Recurrence

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Hucircadian	Inje University Ilsan Paik Hospital, Korea University Ansan Hospital, Korea University Guro Hospital, Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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