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Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms
Sponsor: Lishu Gao
Summary
This study aims to evaluate the clinical efficacy and safety of electroacupuncture (EA) as an adjunctive treatment for generalized anxiety disorder (GAD). Participants in the clinical trial will be randomly assigned to an EA group, a sham EA group, or a waiting-list control group. All participants in the clinical trial will receive monotherapy with one of three SSRIs: sertraline, paroxetine, or escitalopram, selected by a psychiatrist according to clinical suitability, previous treatment response, and tolerability. Clinical efficacy will be assessed using the Hamilton Anxiety Rating Scale (HAMA). The neuroimaging substudy will include healthy controls and two groups of patients with GAD receiving SSRI monotherapy with an unchanged medication type and daily dose for at least 2 weeks: an EA group and a sham EA group. Healthy controls will undergo a single resting-state functional MRI (rs-fMRI) scan, whereas patients will undergo scans before and after a single 30-minute EA or sham EA session on the same day. Functional connectivity (FC), regional homogeneity (ReHo), and amplitude of low-frequency fluctuation (ALFF) will be compared between healthy controls and patients before intervention, and pre-to-post changes will be compared between the EA and sham EA groups.
Official title: Clinical Efficacy of Electroacupuncture for Generalized Anxiety Disorder and Its Central Mechanism Based on Neuroimaging Changes
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
123
Start Date
2026-03-10
Completion Date
2027-12-31
Last Updated
2026-10-26
Healthy Volunteers
Yes
Conditions
Interventions
Electroacupuncture (EA)
Electroacupuncture (EA) is performed at acupoints including GV20 (Baihui), EX-HN1 (Sishencong), GV29 (Shenting), EX-HN16 (Anmian, bilateral), HT7 (Shenmen, bilateral), PC6 (Neiguan, bilateral), CV6 (Qihai), CV4 (Guanyuan), ST36 (Zusanli, bilateral), SP6 (Sanyinjiao, bilateral), and LR3 (Taichong, bilateral). Sterile disposable needles (φ0.18×25mm or φ0.25×40mm) are used. Electric stimulation (continuous wave, 100Hz) is applied to specific point pairs (e.g., left Sishencong + anterior Sishencong) for 30 minutes. The current intensity is adjusted to the patient's maximum tolerance. Treatment is administered 3 times per week for 4 weeks (12 sessions total).
Sham Electroacupuncture (SEA)
Sham electroacupuncture (SEA) is performed by inserting needles into non-acupoints located 5-10 mm away from the real points used in the EA group. Shallow needling (depth of 1-2 mm) is applied. A sham EA device with a disconnected electrode lead is used; although the screen displays parameters identical to the EA group, there is no actual current output. The duration, frequency, and total number of sessions are identical to the EA group (3 times/week for 4 weeks).
Medication
Each participant will receive only one of the following SSRIs: sertraline, paroxetine, or escitalopram. Medication selection will be made by a psychiatrist before randomization. Dosing and dose adjustments will follow the prespecified medication management protocol, with the same rules applied across all three study groups. Any medication changes and their reasons will be recorded.
Locations (1)
Affiliated Hangzhou First People's Hospital
Hangzhou, Zhejiang, China