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Completed

NCT Number: NCT05400785

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

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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Key information

Conditions

Major Depressive Disorder Bipolar 1 Disorder Bipolar Disorder Bipolar II Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Anam Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Circadian Rhythms for Mood (CRM) application - Active

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.

Circadian Rhythms for Mood (CRM) application - Sham

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.

Primary outcomes

  1. Comparison of total number of recurrent mood episodes between the active and sham groups

    Time frame: 12 months

    We aim to evaluate the efficacy of reducing recurrence rate of mood episodes through the CRM mobile application.

  2. Comparison of duration of mood episodes between the active and sham groups

    Time frame: 12 months

    We aim to evaluate the efficacy of reducing duration of mood episodes through the CRM mobile application.

Sponsors and collaborators

Lead sponsor

Hucircadian

Industry

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2022
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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