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

Hucircadian

Status: Completed

Conditions: Major Depressive Disorder; Bipolar II Disorder; Bipolar 1 Disorder

Treatments: Other: Circadian Rhythms for Mood (CRM) application - Sham; Other: Circadian Rhythms for Mood (CRM) application - Active

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05400785

HC-CRM-01

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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93 participants in 2 patient groups

Active CRM

Active Comparator group

Treatment:

Other: Circadian Rhythms for Mood (CRM) application - Active

Sham CRM

Sham Comparator group

Treatment:

Other: Circadian Rhythms for Mood (CRM) application - Sham