Integrating Digital Phenotypes and AI-Driven Cognitive-Behavioral Therapy: Advancing Precision Medicine in Depression Through Digital Medicine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Quality of Life Assessment
研究概览
简要总结
This project aims to integrate digital phenotyping and AI-driven iCBT into a comprehensive platform for MDD diagnosis and treatment in Taiwan. The study will explore dynamic, real-time behavioral and physiological markers to refine diagnostic classifications and optimize personalized therapeutic strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) Aged 18-75 years
- •Diagnosis of major depressive disorder disorder (Based on Diagnostic Statistical Manual 5)
- •21-item Hamilton Depression Scale (HAMD21)>17
- •No changes in current psychiatric treatment for depression (e.g., no treatment, antidepressant medication, psychotherapy, or non-invasive brain stimulation) within the past four weeks, and
- •Full competency to understand the study details and provide written informed consent
排除标准
- •Scores of 5 ( Markedly ill), 6,(Severely ill), and 7 (Among the most extremely ill) according to the Clinical Global Impression Scale-Severity (CGI-S)
- •Psychotic disorders, bipolar affective disorder, a substance use disorders in the past 6 months, active suicidal or homicidal ideation (per assessment or HAMD>3)
- •Unstable or active medical illness.
结局指标
主要结局
Quality of Life Assessment
时间窗: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
Quality of Life Assessment is measured by the EuroQol questionnaire (EQ-5D). The Index Score (usually 0 to 1), where 1.0 is full health, index scores below 0.6 are often characterized as representing low quality of life
Depression Severity
时间窗: Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24
Depression severity is measured by the 21-item Hamilton Rating Scale for Depression (HAM-D). A higher score indicates greater severity, a score of ≥18 indicates moderate to severe depression.
Depression Severity
时间窗: Weeks 0, 1, 2, 4, 8,12, 16, 20, 24
Depression severity is measured by the 9-item Patient Health Questionnaire (PHQ-9). A score of ≥10 is the most common threshold used to identify individuals likely to have major depressive disorder.
Stress Level
时间窗: Weeks 0, 1, 2, 4, 8,12, 16, 20, 24
Stress level is measured by the Life Events Perceived Stress (LEPS). A total score of ≥27 is widely recognized as the cut-off for high perceived stress.
次要结局
- Resilience Scale(Weeks 0, 4)
- Potential traumatic experiences(Weeks 0, 4)
- Psychological well-being(Weeks 0, 4)
- Nutrition Assessment(Weeks 0, 4)
- Peripheral Neuropathy Symptom Assessment(Weeks 0, 4)
- Physical Activity Level(Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24)
- Heart Rate Variability (HRV)(Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24)
- Sleep Patterns (Sleep Score)(Weeks 0, 1, 2, 4, 8, 12, 16, 20, 24)
研究者
Kuan-Pin
Professor
National Science and Technology Council, Taiwan