Abstract
Abstract
Introduction
Insomnia disorder (ID) is characterized by dissatisfaction with the quantity or quality of sleep and is often accompanied by negative emotions such as anxiety and depression. Patients with insomnia become trapped in a vicious circle of bad moods and poor sleep. Resting-state functional magnetic resonance imaging (r-fMRI) studies have shown abnormalities in emotion-related brain networks in patients with ID. And it has been proven that reducing negative emotions improves sleep quality. As a traditional alternative therapy, acupuncture has been demonstrated to be effective not only in improving sleep quality but also in stabilizing emotions; however, the mode of action needs to be further explored. Therefore, a clinical trial was designed to explore the effect of acupuncture in improving sleep and mood and to intuitively investigate the regulation of the emotional network using fMRI.
Methods and analysis
A total of 60 participants with ID will be randomly allocated to a spirit-regulating group or a control group using non-effective acupoints acupuncture at a ratio of 1:1. All participants will receive 3 acupuncture treatment sessions per week for 4 weeks. In addition, 30 healthy individuals will be included in the healthy group. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes are the Hamilton Anxiety Scale (HAMA), the Hamilton Depression Scale (HAMD), the Hyperarousal Scale (HAS), and the Fatigue Scale-14 (FS-14), r-fMRI data, sleep diary, and actigraphy. The data will be collected prior to treatment, following treatment, and during the 12-week follow-up period; a sleep diary will be kept during the entire process.
Ethics and dissemination
This protocol has been approved by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine (Bejing TCM Hospital). The results will be published in peer-reviewed journals or presented at academic conferences.
Trial registration
Chinese Clinical Trials Register ChiCTR1800015282.
Protocol version: Version 1.0. Date: Dec.2020
Funder
national natural science foundation of china
Natural Science Foundation of Beijing Municipality
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference43 articles.
1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlingon: American Psychiatric Publishing; 2013.
2. Dopheide JA. Insomnia overview: epidemiology, pathophysiology, diagnosis and monitoring, and nonpharmacologic Therapy. Am J Manag Care. 2020;26(4 Suppl):S76–84. https://doi.org/10.37765/ajmc.2020.42769.
3. Lu L, Wang SB, Rao W, Zhang Q, Ungvari GS, Ng CH, et al. The prevalence of sleep disturbances and sleep quality in older Chinese adults: a comprehensive meta-analysis. Behav Sleep Med. 2019;17(6):683–97. https://doi.org/10.1080/15402002.2018.1469492.
4. Zvolensky MJ, Kauffman BY, Bogiaizian D, et al. Worry among Latinx college students: relations to anxious arousal, social anxiety, general depression, and insomnia. J Am Coll Health. 2019;8:1–8.
5. Lauriola M, Carleton RN, Tempesta D, Calanna P, Socci V, Mosca O, et al. A correlational analysis of the relationships among intolerance of uncertainty, anxiety sensitivity, subjective sleep quality, and insomnia symptoms. Int J Environ Res Public Health. 2019;16(18):3253. https://doi.org/10.3390/ijerph16183253.
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