Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- sleep efficiency
研究概览
简要总结
Background: Neuropsychiatric conditions, such as insomnia, anxiety, depression, and pain are the most common symptoms experienced by nurses after acute infection of COVID-19. Although medication can assist nurses to improve these symptoms simultaneously in a short period of time, they are at risk of overuse of benzodiazepine hypnotics. Previous research supports the usefulness of cognitive behavioral therapy for insomnia (CBT-I) as self-management strategies in adults with insomnia, anxiety, depression, and pain. However, their effects on post COVID-19 condition have not been researched, and no previous head-to-head study compared the effects on these two approaches on insomnia and neuropsychiatric symptoms.
Aim: To investigate the effects of CBT-I on insomnia, anxiety, depression, and pain in nurses with post COVID-19 condition.
Methods: In this two-arm, parallel randomized controlled trial, 100 participants will be 1:1 randomly assigned to one of two groups (CBT-I and control). The intervention phase will last 6 weeks, followed by a three-month follow-up. Primary outcomes are insomnia severity and sleep quality, whereas anxiety, depression, pain, and health-related quality of life are secondary outcomes. These variables will be assessed before and after the intervention, and at 1, 2, and 3 months after the end of the intervention. Additionally, discontinuing benzodiazepine hypnotics will be measured at 3 months after the end of the intervention.
Discussion: This study will provide evidence of the effects of CBT-I on improving insomnia, anxiety, depression, and pain among nurses with post COVID-19 condition. Results could also enhance means by which to discontinue benzodiazepine hypnotics.
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
- 20 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •nurses with post COVID-19 condition
排除标准
- •history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker
结局指标
主要结局
sleep efficiency
时间窗: 20 weeks
measured by Fitbit Charge 5
sleep quality
时间窗: 20 weeks
measured by Pittsburgh Sleep Quality Index
insomnia severity
时间窗: 20 weeks
measured by Insomnia Severity Index before and after the intervention, and at 1, 2, and 3 months after the end of the intervention
次要结局
- depression(20weeks)
- anxiety(20weeks)
- health-related quality of life(20weeks)
研究者
Wen-Chii Tzeng
Professor
Tri-Service General Hospital
