NCT05416346已完成不适用
The Feasibility and Effectiveness of Digital Cognitive Behavioral Therapy for Insomnia in China: A Pilot Randomized Controlled Trial
Peking University1 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2021年4月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Sleep Condition Indicator-8
研究概览
简要总结
Digital cognitive behavioral therapy for insomnia (dCBT-i) is found to be effective but is rarely used in China. Hence, the investigators developed an automated Chinese dCBT-i program and examined its feasibility, acceptability, and preliminary effectiveness in individuals with insomnia symptoms.
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
- •were aged 18 or older;
- •had a positive screening result for chronic insomnia, i.e., a score of 16 or lower on the Sleep Condition Indicator (SCI);
- •had stable access to the internet via a smartphone.
排除标准
- •additional sleeping conditions except for insomnia (such as restless legs syndrome and sleep apnea);
- •psychosis or mania;
- •serious physical health concerns necessitating surgery or with prognosis <6 months;
- •undergoing medical or psychological treatment for insomnia with a health professional;
- •habitual night shift, evening, or rotating shift-workers.
结局指标
主要结局
Sleep Condition Indicator-8
时间窗: week 4
Sleep Condition Indicator-8 is an 8-item scale validated against Diagnostic and Statistical Manual-5 criteria, concerning sleep quality and daytime personal functioning. It scores between 0 to 32, with higher scores meaning better sleep.
sleep diary
时间窗: week 4
recording one's sleep efficiency, total sleep time, sleep onset latency, wakefulness after sleep onset, and subjective sleep quality
次要结局
- the Insomnia Severity Index 7-item version(week 4)
- the Generalized Anxiety Disorder 7-item version(week 4)
- the Patient Health Questionnaire 9-item version(week 4)
- the Dysfunctional Beliefs and Attitudes about Sleep Scale 16-item version(week 4)
- the Epworth Sleepiness Scale(week 4)
研究者
研究点 (1)
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