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

Sponsor

Hucircadian (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05400785

Collaborator

Korea University Guro Hospital (Other), Korea University Ansan Hospital (Other), Pusan National University Hospital (Other), Inje University Ilsan Paik Hospital (Other)

Enrollment

Location

Arms

17.1

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mood Disorders Bipolar I Disorder Bipolar II Disorder Major Depressive Disorder	Other: Circadian Rhythms for Mood (CRM) application - Active Other: Circadian Rhythms for Mood (CRM) application - Sham	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

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

Actual Study Start Date :

May 27, 2022

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Comparison of total number of recurrent mood episodes and between active group and sham group [12 months]
We aim to evaluate the effect of reducing recurrence rate of mood episode through CRM mobile application.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Anam Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Hucircadian
Korea University Guro Hospital
Korea University Ansan Hospital
Pusan National University Hospital
Inje University Ilsan Paik Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hucircadian

ClinicalTrials.gov Identifier:

NCT05400785

Other Study ID Numbers:

HC-CRM-01

First Posted:

Jun 2, 2022

Last Update Posted:

Jul 5, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Disease

Recurrence

Depressive Disorder

Depressive Disorder, Major

Mood Disorders

Study Results

No Results Posted as of Jul 5, 2022