Effectiveness of Digital Cognitive Behavioral Therapy for the Treatment of Depression: a Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 325
- 试验地点
- 1
- 主要终点
- Change from baseline in Hamilton Depression Rating Scale (HAMD)
研究概览
简要总结
The project proposes to develop a digital product based on cognitive behavioral therapy for the assisted treatment of depression. The digital cognitive behavioral therapy in this study is conducted based on a self-developed mobile applet. The therapy is developed by psychotherapists, which is conducted for a total of 8 weeks, with weekly sessions including AI-guided course work and homework. This study aims to evaluate the therapeutic effects of CBT-based digital products for depression in patients through a real-world study, and to explore its genetic and neuroimaging mechanisms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 14-60 years (including 14 and 60), no gender restriction;
- •HAMD >= 14;
- •Written informed consent obtained from the patient; written informed consent obtained from the guardian for minors.
排除标准
- •Persons with severe suicidal tendencies (item 10 of the MADRS scale ≥ 5).
结局指标
主要结局
Change from baseline in Hamilton Depression Rating Scale (HAMD)
时间窗: Week 4 and 8 of treatment duration
The outcome is assessed by 17-item Hamilton Depression Rating Scale (HAMD-17) Scale. Total HAMD scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. The change of HAMD from baseline to 8-week (after intervention) was used as the primary outcome.
Change from baseline in Hamilton Depression Rating Scale (HAMD)
时间窗: Week 4 and 8 of treatment duration
The outcome is assessed by 17-item Hamilton Depression Rating Scale (HAMD-17) Scale. Total HAMD scores range from 0 to 52, with higher scores indicating more severe depressive symptoms. The change of HAMD from baseline to 8-week (after intervention) was used as the primary outcome.
次要结局
- Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS)(Week 4 and 8 of treatment duration)
- Change from baseline in Positive and Negative Syndrome Scale (PANSS)(Week 4 and 8 of treatment duration)
- Response to treatment(Week 4 and 8 of treatment duration)
- Clinical Global Impression-Severity of Illness (CGI-S)(Week 4 and 8 of treatment duration)
- Change from baseline in Hamilton Anxiety Rating Scale (HAMA)(Week 4 and 8 of treatment duration)
- Change from baseline in Ruminative Responses Scale (RRS)(Week 4 and 8 of treatment duration)
- Change from baseline in Pittsburgh Sleep Quality Index (PSQI)(Week 4 and 8 of treatment duration)
- Change from baseline in Connor-Davidson Resilience Scale (CD-RISC)(Week 4 and 8 of treatment duration)
- Change from baseline in Thinc-Integrated Tool(THINC-it)(Week 8 of treatment duration)
- Mood Disorder Questionnaire (MDQ)(Week 4 and 8 of treatment duration)
- Rating Scale for Side Effects（SERS）(Week 4 and 8 of treatment duration)
- Client Satisfaction Questionnaire-3 （CSQ-3)(Week 8 of treatment duration)
- Change from baseline in Young Mania Rating Scale (YMRS)(Week 4 and 8 of treatment duration)
研究者
Weihua Yue
Professor
Peking University Sixth Hospital