Use of CBT-I Based Chatbot for Assisted Treatment in Patients With Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The Pittsburgh Sleep Quality Index
研究概览
简要总结
The recent lifestyle has put many people in a state of high stress, and the outbreak of COVID-19 in recent years has caused a steady increase in the number of people diagnosed with "Coronasomnia" (Covid-somnia) after recovering from the disease. For reasons outlined above, a lot number of people were suffering from Insomnia. To propose some method to improve patients' sleep disorders become a popular research issue. The American Academy of Sleep Medicine strongly recommends using the Cognitive Behavioral Therapy for insomnia (CBT-I) method, one of the non-pharmacological treatments for insomnia. However, CBT-I is primarily a physical therapy, so patients may not be able to access this therapy due to time and location constraints. This project aims to combine the technology of Cognitive Behavioral Therapy for Insomnia (CBT-I) and chatbot to help insomnia patients learn more about their sleep habits and improve their sleep quality at home through remote access. Investigators will design a friendly chatbot based on the CBT-I concept to assist insomnia patients to improve their sleep quality and life quality.
This project will be executed at Taipei Municipal Wanfang Hospital. Patients of insomnia will be referred by the attending physician from outpatient clinic. It is estimated that 120 patients will be enrolled, 60 in the experimental group and 60 in the control group. The experimental group will receive four weeks of cognitive behavioral therapy for insomnia via a chatbot, while the control group will be treated as usual. Patients will be assessed for improvement in sleep severity at the end of four weeks and follow up after 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Significant insomnia symptoms, including difficulty initiating sleep, difficulty maintaining sleep, early-morning awakening.
- •The sleep difficulty occurs at least three nights per week and is present for at least 3 months.
- •Patient possess a personal internet-connected cell phone or communicator.
排除标准
- •Unwilling to participate in this research.
- •Have poor cognitive function and cannot understand the content of the questionnaire; or cannot complete the test due to their physical condition
- •Comorbid with schizophrenia, bipolar disorder, or substance use disorder
- •Medications received have been adjusted in the past one month or will be adjusted during experiment
- •Those who received in the past one month or will receive during experiment treatments such as: psychotherapy, cranial electrical stimulation, repetitive transcranial magnetic stimulation, transcranial direct current stimulation, or nutraceuticals aimed at improving mood or insomnia.
- •Suicidal patients
研究组 & 干预措施
Experimental group
four weeks of cognitive behavioral therapy for insomnia via a chatbot
干预措施: Kunbot (Device)
Control group
treated as usual
干预措施: Treatment as usual (Other)
结局指标
主要结局
The Pittsburgh Sleep Quality Index
时间窗: From enrollment to the end of treatment at 4 weeks
Value: 0\~21, higher score means a worse outcome
次要结局
- Patient Health Questionnaire(From enrollment to the end of treatment at 4 weeks)
- Beck Depression Inventory(From enrollment to the end of treatment at 4 weeks)
- Beck Anxiety Inventory(From enrollment to the end of treatment at 4 weeks)
- Brief Symptom Rating Scale(From enrollment to the end of treatment at 4 weeks)