NCT05400785已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hucircadian
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Comparison of duration of mood episodes between the active and sham groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Comparison of duration of mood episodes between the active and sham groups
时间窗: 12 months
We aim to evaluate the efficacy of reducing duration of mood episodes through the CRM mobile application.
Comparison of total number of recurrent mood episodes between the active and sham groups
时间窗: 12 months
We aim to evaluate the efficacy of reducing recurrence rate of mood episodes through the CRM mobile application.
次要结局
未报告次要终点
研究者
研究点 (1)
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