Abstract
IntroductionThe incidence of insomnia is getting higher and higher. Long-term insomnia seriously affects people’s health. Drug use is usually accompanied with adverse events. Both acupuncture and cognitive behavioral therapy for insomnia (CBT-I) have been proven to be safe and effective non-pharmacological treatments for insomnia. As the insomniacs’ bad sleep behavior and wrong cognition have not been effectively corrected, acupuncture has a quick effect, high patient compliance but unstable long-term efficacy, while CBT-I is complex, time-consuming, and expensive; additionally, patient compliance is low, and the number of trained therapists is limited, making it difficult to carry out. Therefore, this study aims to use the insomnia TCM system to construct a convenient and feasible traditional Chinese medicine e-aid cognitive behavioral therapy for insomnia (TCM-eCBT-I) for Chinese people, and combine the advantages of acupuncture and TCM-eCBT-I for maintaining long-term efficacy, and three treatments will be evaluated to provide clinicians with a more effective clinical protocolMethods and analysisThis study is a single-center, open-label, randomized controlled trial. Ninety subjects will be recruited and randomly assigned to three groups: the acupuncture group, the TCM-eCBT-I group, and the acupuncture combined with TCM-eCBT-I group, in a ratio of 1:1:1. We will evaluate the Pittsburgh Sleep Quality Index (PSQI) and Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS), Insomnia Severity Index (ISI), sleep diary, Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), and Fatigue Scale-14 Scale (FS-14) scales. All adverse reactions will be assessed through the ADVERSE event table. All outcomes will be evaluated online at 0 weeks, 4 weeks, 8 weeks, 16 weeks, and 28weeks.Ethics and disseminationThis study has been approved by the Institutional Review Board of the Affiliated Hospital of Nanjing University of Chinese Medicine (2020 NL-018-02). Informed consent will be obtained from all the subjects. The results will be shared with sleep researchers, public, and relevant academic institutions through high-impact peer-reviewed publications.Trial registrationChinese Clinical Trial Registry ChiCTR2000032960. Registered on 17 May 2020
Highlights
The incidence of insomnia is getting higher and higher
We developed the insomnia TCM system for chronic insomnia based on WeChat public platform, which is used for TCM diagnosis, information collection, and management of chronic insomnia
This study aims to construct a convenient and feasible TCM-eCBT-I, to combine the advantages of acupuncture and TCM-eCBT-I, and to explore the chronic disease management model of acupuncture in the treatment of chronic insomnia
Summary
The incidence of insomnia is getting higher and higher. Long-term insomnia seriously affects people’s health. Drug use is usually accompanied with adverse events Both acupuncture and cognitive behavioral therapy for insomnia (CBT-I) have been proven to be safe and effective non-pharmacological treatments for insomnia. Long-term insomnia affects the neuroendocrine immune network system, resulting in multiple organ dysfunction and decreasing immune function and is often accompanied by anxiety and depression, daytime fatigue, cognitive dysfunction, and other injuries [3,4,5]. It can even cause traffic accidents, endanger personal and public safety, and place heavy burden on society and families [6,7,8]. In the past two decades, non-pharmacological treatments have attracted increasing attention [11]
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