跳至主要内容
临床试验/NCT06013085
NCT06013085尚未招募不适用

Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition

Tri-Service General Hospital0 个研究点目标入组 100 人开始时间: 2023年9月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wen-Chii Tzeng

Professor

Tri-Service General Hospital

相似试验