Acupuncture for Generalized Anxiety Disorder

NCT07798986 · tracked via the Priya Life Science China tracker

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Phase

Not applicable

Started

2026-09-01

Last updated

2026-09-02

Condition(s) studied

Generalized Anxiety Disorder (GAD)

Investigational drug(s) / intervention(s)

sham electro-acupuncture2Hz electro-acupuncture100Hz electro-acupuncture2Hz/100Hz electro-acupuncturemanual acupuncture

sham electro-acupuncture: After connecting the electro - acupuncture device, the power was cut off for 30 minutes each time.Treatment was carried out 3 times a week for 4 consecutive weeks, a total of 12 times.

2Hz electro-acupuncture: Electro-acupuncture device was connected to the bilateral Shenmen (HT7) and Neiguan (PC6) acupoints. The intensity was set to the level that the subjects could tolerate, and the frequencies were 2Hz for 30 minutes each time. Treatment was carried out 3 times a week for 4 consecutive weeks, a total of 12 times.

100Hz electro-acupuncture: Electro-acupuncture device was connected to the bilateral Shenmen (HT7) and Neiguan (PC6) acupoints. The intensity was set to the level that the subjects could tolerate, and the frequencies were 100Hz for 30 minutes each time. Treatment was carried out 3 times a week for 4 consecutive weeks, a total of 12 times.

2Hz/100Hz electro-acupuncture: Electro-acupuncture device was connected to the bilateral Shenmen (HT7) and Neiguan (PC6) acupoints. The intensity was set to the level that the subjects could tolerate, and the frequencies were 2Hz/100Hz for 30 minutes each time. Treatment was carried out 3 times a week for 4 consecutive weeks, a total of 12 times.

manual acupuncture: Needles with a specification of 0.25×25mm were selected. Manual acupuncture is performed at the acupoints of Neiguan (PC6), Shenmen (HT7), Taichong (LR3), Sanyinjiao (SP6) and Sishencong (EX-HN1).

Study summary

Generalized anxiety disorder (GAD) is a common mental disorder characterized by persistent excessive worry, which seriously affects patients' quality of life. Electroacupuncture (EA) has been widely used in the clinical treatment of anxiety disorders, but the optimal stimulation parameters remain unclear. This study will adopt a randomized controlled trial (RCT) design to systematically compare the clinical efficacy of three different EA stimulation parameters (2 Hz continuous wave, 100 Hz continuous wave, and 2 Hz/100 Hz dense-disperse wave) in patients with GAD. Multidimensional outcome assessment tools will be used to comprehensively evaluate the therapeutic effects of different stimulation modes. The results of this study are expected to provide evidence-based reference for the selection of electroacupuncture parameters in the treatment of GAD, so as to optimize the clinical treatment regimen and improve the therapeutic effect.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

Inclusion Criteria: Only those who meet the following four criteria simultaneously can be included in this study: 1. Meet the diagnostic criteria for GAD; 2. Between 18 and 60 years old; 3. Conscious and able to communicate normally; 4. Have good compliance, be willing to cooperate with the study, and sign the informed consent form. Exclusion Criteria: Exclude patients meeting any of the following criteria: 1. Organic mental disorder, schizophrenia, bipolar disorder, mania/other psychoses, alcohol/drug addiction, current drug use disorder/lifetime drug abuse, post-stroke/postpartum anxiety; 2. History of suicidal behavior or severe suicidal tendency; 3. Pregnancy or breastfeeding; 4. Mental retardation, unable to cooperate; 5. Electroacupuncture contraindications: bleeding tendency, coagulation dysfunction, internal metal implants; 6. Participation in other clinical trials within 1 month.

Primary outcome measure(s)

the score of Hamilton anxiety rating scale, HAMA — week 0, week 4, week 8 and week 16 after enrollment
This scale consists of 14 items. Trained physicians or assessors conduct a semi-structured interview to rate the subject's recent anxiety symptoms. The items cover two major dimensions: psychic anxiety (e.g., tension, fear) and somatic anxiety (e.g., muscle tension, cardiovascular symptoms).A higher score indicates more severe symptoms, with 7 set as the cut-off value.

Trial sites (1)

Facility	City	Region	Status
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07798986 on ClinicalTrials.gov ↗ ← All trials in China