Jiangsu Vocational College of Medicine, Yancheng, Jiangsu, China.
Community Health Service Center of Dongting Lake Street, China.
Medicine (Baltimore). 2021 Dec 10;100(49):e28046. doi: 10.1097/MD.0000000000028046.
Brief behavioral therapy for insomnia (BBT-I) has been proven to be a simple and effective alternative to cognitive behavioral therapy. However, low adherence limits the application in Chinese primary medical institutions, resulting in delayed or irregular treatment for many patients. This study aimed to explore the efficacy of traditional Chinese medicine external treatments on the adherence to behavioral therapy for insomnia in Chinese primary healthcare institutions, with a particular focus on patients who live in regions with weak healthcare systems.
This randomized controlled clinical trial will be conducted in primary medical institutions and will recruit 98 adult participants with insomnia. BBT-I will be used as the base treatment. The participants will be divided into experimental (combined with Wuqinxi and other traditional Chinese medicine [TCM] external treatment n = 49) and control (combined with trazodone treatment, n = 49) groups, and each group will be treated for 4 consecutive weeks. The severity index of insomnia will be used as the main indicator of disease evaluation, with an 8-point reduction in the score considered as effective and a score <8 considered as cured. The secondary indicators of the disease evaluation will include the Pittsburgh sleep quality index, Zung's self-rating anxiety scale, Zung's self-rating depression scale, treatment adherence, and adverse event reports. All participants will be followed up at the time of enrollment, 4 weeks after treatment, and 3 months after the end of treatment.
This clinical trial will provide evidence for the efficacy of traditional Chinese medicine external treatment on the adherence to behavioral therapy for insomnia in primary medical institutions. This cheap and accessible model may benefit insomnia patients in medically underserved areas.
Chinese Clinical Trial Registry ChiCTR2100042845. Registered on 30 January 2021, dataset: http://www.chictr.org.cn/showproj.aspx?proj=65691. Official scientific title of the research topic: Wuqinxi and other external treatment of Chinese Medicine combined with brief behavior therapy for insomnia.
简短行为疗法治疗失眠（BBT-I）已被证明是认知行为疗法的一种简单有效的替代方法。然而，由于依从性低，限制了它在我国基层医疗机构的应用，导致许多患者的治疗延迟或不规律。本研究旨在探讨中医外治法对我国基层医疗机构失眠行为治疗依从性的影响，特别是针对医疗体系薄弱地区的患者。
本随机对照临床试验将在基层医疗机构进行，招募 98 名成年失眠患者。将采用 BBT-I 作为基础治疗。参与者将被分为实验组（结合五禽戏和其他中医外治法，n=49）和对照组（结合曲唑酮治疗，n=49），每组治疗连续 4 周。采用失眠严重程度指数作为疾病评估的主要指标，评分降低 8 分为有效，评分<8 分为治愈。疾病评估的次要指标包括匹兹堡睡眠质量指数、zung 焦虑自评量表、zung 抑郁自评量表、治疗依从性和不良事件报告。所有参与者将在入组时、治疗后 4 周和治疗结束后 3 个月进行随访。
本临床试验将为中医外治法对基层医疗机构失眠行为治疗依从性的疗效提供证据。这种廉价且易于获得的模式可能有益于医疗服务不足地区的失眠患者。
中国临床试验注册中心 ChiCTR2100042845。注册于 2021 年 1 月 30 日，数据集：http://www.chictr.org.cn/showproj.aspx?proj=65691。研究课题的官方科学标题：五禽戏等中医外治法结合简短行为疗法治疗失眠。
