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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-27

Study Completion Date

2023-12-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder Bipolar 1 Disorder Bipolar II Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Active CRM

Group Type ACTIVE_COMPARATOR

Circadian Rhythms for Mood (CRM) application - Active

Intervention Type OTHER

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 CRM

Group Type SHAM_COMPARATOR

Circadian Rhythms for Mood (CRM) application - Sham

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No