Acupuncture for Generalized Anxiety Disorder

August 31, 2026 updated by: Second Affiliated Hospital, Zhejiang University, School of Medicine

Efficacy of Different Electroacupuncture Parameters for Generalized Anxiety Disorder: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaoting Wu, Doctor
  • Phone Number: +8618196671636
  • Email: xiaotwu@163.com

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: sham electroacupuncture group (SEA group)
In the SEA group, shallow punctures were made at the points 1 cm outward/radially from bilateral Neiguan (PC6), Shenmen (HT7), Taichong (LR3), Sanyinjiao (SP6), and Sishencong (EX-HN1) respectively, and then the power was cut off after connecting the electro - acupuncture device.Each treatment lasts 30 minutes, with 3 treatments per week for 4 consecutive weeks, totaling 12 treatments.
Device: 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.
Other: 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).
Experimental: 2Hz continuous wave electroacupuncture group (2Hz EA group)
Needles are routinely inserted at bilateral Neiguan (PC6), Shenmen (HT7), Taichong (LR3), Sanyinjiao (SP6) and Sishencong (EX-HN1). Electroacupuncture is applied to bilateral Shenmen-Neiguan pairs, with intensity adjusted to subject tolerance, and frequencies of 2Hz. 30 minutes per session, 3 sessions weekly for 4 consecutive weeks, 12 sessions total.
Other: 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).
Device: 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.
Experimental: 100Hz continuous wave electroacupuncture group (100Hz EA group)
Needles are routinely inserted at bilateral Neiguan (PC6), Shenmen (HT7), Taichong (LR3), Sanyinjiao (SP6) and Sishencong (EX-HN1). Electroacupuncture is applied to bilateral Shenmen-Neiguan pairs, with intensity adjusted to subject tolerance, and frequencies of 100Hz. 30 minutes per session, 3 sessions weekly for 4 consecutive weeks, 12 sessions total.
Other: 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).
Device: 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.
Experimental: 2Hz/100Hz dense-disperse wave electroacupuncture group (2Hz/100Hz EA group)
Needles are routinely inserted at bilateral Neiguan (PC6), Shenmen (HT7), Taichong (LR3), Sanyinjiao (SP6) and Sishencong (EX-HN1). Electroacupuncture is applied to bilateral Shenmen-Neiguan pairs, with intensity adjusted to subject tolerance, and frequencies of 100Hz. 30 minutes per session, 3 sessions weekly for 4 consecutive weeks, 12 sessions total.
Other: 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).
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the score of Hamilton anxiety rating scale, HAMA
Time Frame: 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.
week 0, week 4, week 8 and week 16 after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the score of Zung self-rating anxiety scale, SAS
Time Frame: week 0, week 4, week 8 and week 16 after enrollment
This rating scale contains 20 items, and subjects complete the self-assessment independently without external interference. The standard score ranges from 25 to 100. A higher SAS score indicates more severe symptoms, with 53 set as the cut-off value.
week 0, week 4, week 8 and week 16 after enrollment
the score of Pittsburgh sleep quality index, PSQI
Time Frame: week 0, week 4, week 8 and week 16 after enrollment
PSQI is commonly used to assess the sleep quality of participants over the past month. The total score ranges from 0 to 21. A higher PSQI score indicates poorer sleep quality, with a cut-off value of 7.
week 0, week 4, week 8 and week 16 after enrollment
the score of Short form-12 health survey, SF-12
Time Frame: week 0, week 4, week 8 and week 16 after enrollment
This scale consists of 12 items, which is used to evaluate the recent health status of subjects, covering dimensions including physical function, pain, vitality, and social function. A higher score indicates better health status, and a standard score below 50 indicates that the health status is below the average level.
week 0, week 4, week 8 and week 16 after enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: From enrollment to the end of treatment at 4 weeks
Details of all adverse events will be recorded on the Case Report Form (CRF). Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 after the completion of the trial.
From enrollment to the end of treatment at 4 weeks
acupuncture compliance rate
Time Frame: 4 weeks after treatment
At the end of the acupuncture intervention (end of week 4), compliance will be evaluated with the formula: Compliance Rate = (actual treatment times/total treatment times) *100%.
4 weeks after treatment
the level of Heart Rate Variability
Time Frame: week 0 and week 6 after enrollment
After obtaining the consent of the subjects, the level of Heart Rate Variability data will be collected before and after the intervention to further explore the anti - anxiety mechanism of electroacupuncture.
week 0 and week 6 after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 30, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

August 31, 2026

First Posted (Actual)

September 2, 2026

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR-33-25-070485

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Regarding the scope of data sharing and the rules for usage authorization, the parties involved in the research cooperation are still in communication and negotiation, and no final decision has been made yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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