A Single-arm Clinical Trial to Evaluate the Safety and Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from baseline to week 9 (post-treatment) of ISI
研究概览
简要总结
The purpose of the study was to examine safety and efficacy of cognitive behavioral therapy (CBT)-based wearable integrated digital therapeutics for insomnia patients
详细描述
The investigators intend to conduct a single-arm clinical trial. Following voluntary consent during the screening visit, participants will undergo screening procedures. The screening process will proceed step by step, evaluating selection/exclusion criteria through assessments such as the Mini International Neuropsychiatric Interview (MINI), Columbia Suicide Severity Rating Scale (C-SSRS), etc. Participants who meet the selection criteria and do not meet the exclusion criteria will use the DTx app for 8 weeks. Surveys conducted after app installation (Insomnia Severity Index (ISI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-item Scale (GAD-7), and a sleep environment questionnaire) will serve as the baseline.
During the clinical trial period, sleep diaries and compliance (lesson completion rate) (applicable only to the experimental group) will be collected through the app. Sleep diaries will be used to evaluate sleep metrics such as sleep efficiency (SE), sleep onset latency (SOL), wake after sleep onset (WASO), etc.
For the experimental group, assessments as per the protocol will be conducted at baseline (Visit 1), and safety (adverse events) evaluation and termination of app usage will occur at 9 weeks (Visit 2).
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 19 to 65 years old
- •DSM-5 insomnia disorder patient
- •Capable of using mobile device and application
排除标准
- •currently on non-pharmacological treatment for insomnia (ex. CBT-I, light therapy, oriental therapy for insomnia)
- •sleep disorders diagnosis other than insomnia (ex. Obstructive sleep apnea, sleep behavior problem, restless leg syndrome)
- •progressive and active medical conditions
- •received continuous psychotherapy such as CBT, motivational enhancement therapy, psychotherapy, and psychoanalysis in the past 3 months
- •major psychiatric illness as assessed through MINI
- •suicide risk as assessed through C-SSRS
- •having occupational risk due to sleep restriction
- •shift workers
- •PHQ-9 of 20 or above
- •Individuals who have actually slept less than an average of 5 hours per night over the past month
- •Pregnant women or individuals planning pregnancy during the clinical trial period
结局指标
主要结局
Change from baseline to week 9 (post-treatment) of ISI
时间窗: 9 weeks
Change from baseline to week 9 (post-treatment) of ISI. ISI has 7 questions. Total score ranges from 0 to 28, where higher scores indicate more acute symptoms of insomnia.
次要结局
- Secondary Outcome - Changes from baseline to week 9 of SE(9 weeks)
- Changes from baseline to week 9 of SOL.(9 weeks)
- Changes from baseline to week 9 of WASO.(9 weeks)
- Changes from baseline to week 9 of PHQ-9.(9 weeks)
- Changes from baseline to week 9 of GAD-7.(9 weeks)
- Changes from baseline to week 9 of compliance.(9 weeks)