ClinicalTrials.gg
Not yet recruitingNCT07798986Updated Sep 2, 2026

Acupuncture for Generalized Anxiety Disorder

An interventional study of sham electro-acupuncture and 2Hz electro-acupuncture in Generalized Anxiety Disorder (GAD), sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 23 studies in Generalized Anxiety Disorder with a site in China — 16 open to participants now, 16 under way, 3 of them phase 3. Generalized Anxiety Disorder · China.

Planned enrollment
11th of 20
120 · median 122
Started
2026
with 7 others
No phase
11 of 23
9 open now
Primary completion
2028-10
later than 15 of 15 live
Registered
21st of 23
by date

Among the 23 studies in Generalized Anxiety Disorder with a site in China, this one is the 11th largest by planned enrollment of the 20 interventional ones that give a count, is one of 8 that started in 2026, is one of 11 with no phase, reaches primary completion later than 15 of the 15 other live ones, and was the 21st registered.

Generalized Anxiety Disorder

518 studies on the registry are indexed under Generalized Anxiety Disorder; 125 are open to participants now.

Browse Generalized Anxiety Disorder studies →

Open to participants now

16 of the 23 studies in Generalized Anxiety Disorder with a site in China are open now. Recruiting first, the newest first:

10 more — sign in →

All 16 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 86 Generalized Anxiety Disorder studies recruiting now, 32 (37%) set no upper age limit and 52 (60%) stop at 75 or younger; 15 take children under 18; 16 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

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.

03

Conditions studied

  • Generalized Anxiety Disorder (GAD)
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form.

Exclusion criteria

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 : bleeding tendency, coagulation dysfunction, internal metal implants;
  6. Participation in other clinical trials within 1 month.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • 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 · Other: manual acupuncture

  • 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.

    Device: 2Hz electro-acupuncture · Other: manual acupuncture

  • 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.

    Device: 100Hz electro-acupuncture · Other: manual acupuncture

  • 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.

    Device: 2Hz/100Hz electro-acupuncture · Other: manual acupuncture

Interventions

  • Devicesham 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.

  • Device2Hz 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.

  • Device100Hz 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.

  • Device2Hz/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.

  • Othermanual 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).

06

What researchers measure

Primary outcomes

  1. the score of Hamilton anxiety rating scale, HAMA

    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.

    Time frame: week 0, week 4, week 8 and week 16 after enrollment

Secondary outcomes

  1. the score of Zung self-rating anxiety scale, SAS

    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.

    Time frame: week 0, week 4, week 8 and week 16 after enrollment

  2. the score of Pittsburgh sleep quality index, PSQI

    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.

    Time frame: week 0, week 4, week 8 and week 16 after enrollment

  3. the score of Short form-12 health survey, SF-12

    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.

    Time frame: week 0, week 4, week 8 and week 16 after enrollment

Other outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    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.

    Time frame: From enrollment to the end of treatment at 4 weeks

  2. acupuncture compliance rate

    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%.

    Time frame: 4 weeks after treatment

  3. the level of Heart Rate Variability

    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.

    Time frame: week 0 and week 6 after enrollment

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided — 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Oct 2028, 25 months later.

Of 174 non-industry interventional studies with no phase under Generalized Anxiety Disorder, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 55. This study's planned 25 months is below that.

Counting every sponsor, half of 183 studies reached it within 28 months; a quarter within 15 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2026
First posted
Sep 2, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Oct 30, 2028
CompletionEst.
Dec 31, 2028
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07798986
Responsible party
Sponsor
First posted
Sep 2, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Oct 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 2, 2026

Study contacts

Xiaoting Wu, Doctor
Contact
xiaotwu@163.com
+8618196671636

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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