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| Name | Class |
|---|---|
| Korea University Guro Hospital | OTHER |
| Korea University Ansan Hospital | OTHER |
| Pusan National University Hospital | OTHER |
| Inje University Ilsan Paik Hospital |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active CRM | Active Comparator |
| |
| Sham CRM | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39086163 | Derived | 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. |
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| OTHER |
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|
| 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. |
|
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
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| ID | Term |
|---|---|
| D002940 | Circadian Rhythm |
| C030614 | picolinic acid |
| ID | Term |
|---|---|
| D010507 | Periodicity |
| D002909 | Chronobiology Phenomena |
| D010829 | Physiological Phenomena |
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