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NCT Number: NCT07798986

Acupuncture for Generalized Anxiety Disorder

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.

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Key information

Conditions

Generalized Anxiety Disorder (GAD) Anxiety Disorders Generalized Anxiety Disorder Mental Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Only those who meet the following four criteria simultaneously can be included in this study:

  • Meet the diagnostic criteria for GAD;
  • Between 18 and 60 years old;
  • Conscious and able to communicate normally;
  • 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:

  • Organic mental disorder, schizophrenia, bipolar disorder, mania/other psychoses, alcohol/drug addiction, current drug use disorder/lifetime drug abuse, post-stroke/postpartum anxiety;
  • History of suicidal behavior or severe suicidal tendency;
  • Pregnancy or breastfeeding;
  • Mental retardation, unable to cooperate;
  • Electroacupuncture contraindications: bleeding tendency, coagulation dysfunction, internal metal implants;
  • Participation in other clinical trials within 1 month.

Treatment and study plan

Sham Electro-acupuncture

Device

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

Device

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

Device

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

Device

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

Other

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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%.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoting Wu, Doctor

CONTACT

[email protected]

+8618196671636

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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