Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 May 9:16:1532001.
doi: 10.3389/fpsyt.2025.1532001. eCollection 2025.

Efficacy of electroacupuncture treatment for generalized anxiety disorder related insomnia: a study protocol for randomized controlled trial

Wang Yao #  1 , Xi Wang #  1 , Huanyi Liu  1 , Lumin Liu  1 , Qian Fan  1 , Ping Yin  1 , Yuelai Chen  1
Affiliations

Efficacy of electroacupuncture treatment for generalized anxiety disorder related insomnia: a study protocol for randomized controlled trial

Wang Yao et al. Front Psychiatry. .

Abstract

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.

Keywords: electroacupuncture; generalized anxiety disorder; insomnia; protocol; randomized controlled trial.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted without any commercial or financial relationships that could be interpreted as potential conflicts of interest.

Figures

Figure 1
Figure 1
Flowchart of the study. HAMA, Hamilton Anxiety Scale; PSQI, the Pittsburgh Sleep Quality Index; ISI, Insomnia Severity Index; SF-12, 12-Item Short-Form Health Survey.
Figure 2
Figure 2
Locations of acupoints. Image of acupoints for treatment and control group.
Figure 3
Figure 3
EA and sham EA manipulation. Electroacupuncture and sham Electroacupuncture manipulation.
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Hoge EA, Ivkovic A, Fricchione GL. Generalized anxiety disorder: diagnosis and treatment. BMJ. (2012) 345:e7500. doi: 10.1136/bmj.e7500 - DOI - PubMed
    1. Szuhany KL, Simon NM. Anxiety disorders: A review. JAMA. (2022) 328:2431–45. doi: 10.1001/jama.2022.22744 - DOI - PubMed
    1. American Psychiatric Association. American Psychiatric Association . Diagnostic and statistical manual of mental disorders: DSM-5. 5th ed. Washington, D.C: American Psychiatric Association; (2013). p. 947.
    1. Yu W, Singh SS, Calhoun S, Zhang H, Zhao X, Yang F. Generalized anxiety disorder in urban China: Prevalence, awareness, and disease burden. J Affect Disord. (2018) 234:89–96. doi: 10.1016/j.jad.2018.02.012 - DOI - PubMed
    1. Buysse DJ. Insomnia. JAMA. (2013) 309:706–16. doi: 10.1001/jama.2013.193 - DOI - PMC - PubMed

LinkOut - more resources