Evaluating an Online Mindfulness-Based Intervention for Individuals With Insomnia in China: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 主要终点
- change of sleep quality
研究概览
简要总结
Insomnia has significantly negative impact on work, quality of life, psycho-somatic health on individuals and imposes substantial economic burdens on society. Mindfulness-based interventions (MBIs) have shown its efficacy in the treatment of insomnia, however the effect of online MBIs need more studies to verify. This study aims to compare the effectiveness of an online MBI named 'Mindful Living With Insomnia (MLWI)' to online CBI-I for insomnia.
详细描述
This will be an online based, randomized, controlled trial. Investigators will recruit 1000 participants, and will randomize and allocate participants 1:1 to the 'Mindful Living With Insomnia (MLWI)' group (n=500) and the 'CBT-I' group (n=500). The Intervention will involve 12 sessions over 6 weeks course, 2 sessions a week and 0.5 hours per session. The primary outcome will be sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), severity of insomnia symptoms assessed by the Insomnia Severity Index (ISI), and sleep parameters recorded using Mi Smart Band. The secondary outcomes include perceived stress, anxiety, depression, and mindfulness. Outcomes will be evaluated at baseline, the end of the intervention period, and at a 3-month follow-up. Analysis of covariance, regression analysis, χ2 test, t-test, Pearson's correlations will be applied in data analysis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 59 years old
- •Being able to read and write Chinese
- •PSQI exceeding 5 at screening
- •Being able to access online services
- •Willing to participate in the study
排除标准
- •Unable to communicate
- •With somatic disorders
- •With mental disorders except for insomnia disorder
- •Being treated with pharmacotherapy
- •Significant current mindfulness practices (>15 minutes/ day)
结局指标
主要结局
change of sleep quality
时间窗: Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up
The 19-item Pittsburgh Sleep Quality Index (PSQI) measured sleep quality subjectively and assesses sleep disturbances during the past month on a 4-point Likert scale of 0 -3.A lower global PSQI score indicates better sleep quality.
次要结局
- change of severity of insomnia symptoms(Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up)
- change of perceived stress(Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up)
- change of mindfulness(Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up)
- change of sleep duration and quality(Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up)
- change of depression(Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up)
- change of anxiety(Outcomes will be evaluated at baseline, the end of the 6-week Intervention Period, and at a 3-month follow-up)
研究者
Chen Pan
Principal Investigator
Central South University