STUDY PROTOCOL article
Front. Psychiatry
Sec. Sleep Disorders
Volume 16 - 2025 | doi: 10.3389/fpsyt.2025.1532001
This article is part of the Research TopicChronic insomnia: Treatment and managementView all 17 articles
Efficacy of electroacupuncture treatment for generalized anxiety disorder related insomnia: A study protocol for randomized controlled trial
Provisionally accepted
- Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
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Background: Generalized anxiety disorder (GAD) is a prevalent mental disorder characterized by excessive tension, worry, fear, and autonomic symptoms, which brings huge suffering to patients. Insomnia, one of the most common symptoms experienced by individuals with GAD, often exacerbates anxiety symptoms. Electroacupuncture (EA), a non-pharmacological treatment for insomnia, presents several advantages, including significant efficacy, minimal side effects, and high patient acceptance. However, there is a lack of high-quality randomized controlled trials evaluating the efficacy and safety of EA. Methods: This study was designed as a randomized, sham-controlled clinical trial. 84 eligible patients with GAD-related insomnia will be randomly assigned to receive either three sessions of EA or sham EA weekly for 8 weeks. The primary outcome will be the change in the Pittsburgh Sleep Quality Index (PSQI) score at week 8. Hamilton Anxiety Rating Scale (HAMA), Insomnia Severity Index (ISI), sleep diary entries, actigraphy sleep assessment, 12-item Short-Form Health Survey, and weekly usage of medication will provide a thorough evaluation of sleep, anxiety, and overall living conditions. Discussion: This study aims to evaluate the efficacy and safety of EA for treating insomnia in patients with GAD, proving EA can enhance patients' quality of life and reduce their dependence on medications. Clinical trial registration: ClinicalTrials.gov, identifier ChiCTR2400083326. Word count: 4451 Number of figures: 3 Number of charts: 2 1 objective indicators and scales. This study aims to assess the clinical efficacy and safety of EA in treating GAD-related insomnia, thereby providing substantial clinical evidence for the use of EA in this context.This study is a randomized, single-blinded, sham-controlled trial that has been registered with the Chinese Clinical Trial Registry (ChiCTR2400083326. The protocol adheres to the Standard Protocol Items:Recommendations for Intervention Trials (SPIRIT) 2013(34), as detailed in Supplementary File 1. Patients or the public were not involved in the design, conduct, reporting, or dissemination plans of our research.
Keywords: generalized anxiety disorder, insomnia, Electroacupuncture, randomized controlled trial, protocol
Received: 21 Nov 2024; Accepted: 17 Apr 2025.
Copyright: © 2025 Yao, Wang, Liu, Liu, Fan, Yin and Chen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Ping Yin, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
Yuelai Chen, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China
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