AUTHOR=Zhu Fengya , Liu Junqian , Wang Yuan , Ma Tingting , Wang Tianyu , Yang Bin , Miao Runqing , Wu Jie TITLE=Dose-effect relationship of different acupuncture courses on chronic insomnia disorder: study protocol for a randomized controlled trial JOURNAL=Frontiers in Psychiatry VOLUME=14 YEAR=2023 URL=https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1277133 DOI=10.3389/fpsyt.2023.1277133 ISSN=1664-0640 ABSTRACT=Background

Chronic insomnia disorder (CID) is increasing in prevalence year by year, is long lasting, and potentially risky. Acupuncture has been widely used in the clinical management of this condition. However, there is still a lack of direct evidence on the dose-effect relationship between different acupuncture courses and clinical efficacy. To identify this relationship, we will design a randomized controlled trial to clarify the difference in efficacy of different acupuncture courses for CID.

Methods and design

This is a prospective, parallel, single center randomized controlled trial. Two hundred and one participants with CID will be randomly divided into three groups (Group A, Group B, and Group C). The three groups will be given acupuncture therapy for 4, 6, and 8 weeks, three sessions per week, with at least 1 day between sessions. Follow-up will continue until the third month after the end of treatment. The primary outcome is the Insomnia Severity Index (ISI), and secondary outcomes include percentage of ISI < 8 points, the Pittsburgh Sleep Quality Index (PSQI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), Fatigue Severity Scale (FSS), medication use, and safety.

Discussion

This study is expected to provide direct evidence for the optimal treatment cycle of acupuncture for CID, as well as to facilitate health economic evaluation.

Clinical trial registration

https://clinicaltrials.gov/, identifier [ChiCTR2300073711].