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
1 other identifier
interventional
93
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable major-depressive-disorder
Started May 2022
Shorter than P25 for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2022
CompletedStudy Start
First participant enrolled
May 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2023
CompletedMarch 17, 2025
March 1, 2025
1.6 years
May 27, 2022
March 12, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Active CRM
ACTIVE COMPARATORSham CRM
SHAM COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hucircadianlead
- Korea University Guro Hospitalcollaborator
- Korea University Ansan Hospitalcollaborator
- Pusan National University Hospitalcollaborator
- Inje University Ilsan Paik Hospitalcollaborator
Study Sites (1)
Korea University Anam Hospital
Seoul, South Korea
Related Publications (1)
Yeom JW, Yoon Y, Seo JY, Cho CH, Lee T, Lee JB, Jeon S, Kim L, Lee HJ. Daily Self-Monitoring and Feedback of Circadian Rhythm Measures in Major Depression and Bipolar Disorder Using Wearable Devices and Smartphones-The Circadian Rhythm for Mood (CRM(R)) Trial Protocol: A Randomized Sham Controlled Double-Blind Trial. Psychiatry Investig. 2024 Aug;21(8):918-924. doi: 10.30773/pi.2024.0133. Epub 2024 Aug 2.
PMID: 39086163DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2022
First Posted
June 2, 2022
Study Start
May 27, 2022
Primary Completion
December 21, 2023
Study Completion
December 21, 2023
Last Updated
March 17, 2025
Record last verified: 2025-03