Acupuncture combined with traditional Chinese medicine e-aid cognitive behavioral therapy for insomnia (TCM-eCBT-I) for chronic insomnia: study protocol for a randomized controlled trial

Abstract

Introduction 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. 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 protocol Methods and analysis This 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 dissemination This 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 registration Chinese Clinical Trial Registry ChiCTR2000032960. Registered on 17 May 2020

Treatment of insomnia based on the mechanism of pathophysiology by acupuncture combined with herbal medicine: A review

“…Despite the challenges faced, this has not dampened the enthusiasm of TCM researchers. Cheng-Yong Liu et al [51] designed a randomized controlled protocol of acupuncture combined with cognitive behavioral therapy for the treatment of insomnia. It is of high scientific value to explore the possibility of combining these 2 treatments.…”

“…[27] Owing to the limitations of medication use, including potential dependence and resistance to long-term use, [50] and the recognition of excessive anxiety factors in the insomnia trajectory, non-pharmacological approaches and traditional Chinese medicine treatments have received increasing attention in the last 2 decades. [51] Cognitive Behavioral Therapy for insomnia has been recommended as the first-line treatment for insomnia, and TCM treatment has both traditional herbal treatment components and non-pharmacological treatments, such as acupuncture and tui-na, emphasizing the combination of pharmacological and non-pharmacological treatments, which are compatible with cognitive behavioral therapy for insomnia in many aspects and can be mutually informed to promote understanding and treatment of insomnia. [52] Based on the theory of TCM, human sleep is inseparable from the tranquility of the "heart and mind," and when the "heart and mind are at peace," 1 can sleep peacefully.…”