Generalized Anxiety Disorder (GAD)NCT07798986
Acupuncture for Generalized Anxiety Disorder
A study testing 2Hz electro-acupuncture, 100Hz electro-acupuncture and 2Hz/100Hz electro-acupuncture in people with Generalized Anxiety Disorder (GAD), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Generalized Anxiety Disorder (GAD)
- What is being tested?
- 2Hz electro-acupuncture, 100Hz electro-acupuncture and 2Hz/100Hz electro-acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang
About this study
Official title: 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.
- Conditions
- Generalized Anxiety Disorder (GAD)
- Being tested
- sham electro-acupuncture, 2Hz electro-acupuncture, 100Hz electro-acupuncture, 2Hz/100Hz electro-acupuncture, manual acupuncture
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham electro-acupunctureDevice
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-acupunctureDevice
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-acupunctureDevice
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-acupunctureDevice
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 acupunctureOther
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 group | Role | What they receive |
|---|---|---|
| sham electroacupuncture group (SEA group) | Sham comparator | 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. Receives: Device: sham electro-acupuncture; Other: manual acupuncture |
| 2Hz continuous wave electroacupuncture group (2Hz EA group) | Experimental | 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. Receives: Device: 2Hz electro-acupuncture; Other: manual acupuncture |
| 100Hz continuous wave electroacupuncture group (100Hz EA group) | Experimental | 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. Receives: Device: 100Hz electro-acupuncture; Other: manual acupuncture |
| 2Hz/100Hz dense-disperse wave electroacupuncture group (2Hz/100Hz EA group) | Experimental | 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. Receives: Device: 2Hz/100Hz electro-acupuncture; Other: manual acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 0, week 4, week 8 and week 16 after enrollment
Secondary outcomes (3)
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.
Measured: week 0, week 4, week 8 and week 16 after enrollment
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.
Measured: week 0, week 4, week 8 and week 16 after enrollment
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.
Measured: week 0, week 4, week 8 and week 16 after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety Disorder (GAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798986
- Sponsor's protocol ID
- MR-33-25-070485
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Electroacupuncture Parameters for Generalized Anxiety Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07798986
- Acronym / sponsor ID
- MR-33-25-070485
- Conditions
- Generalized Anxiety Disorder (GAD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| sham electroacupuncture group (SEA group) | Sham comparator | Device: sham electro-acupuncture, Other: manual acupunctureIn 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. |
| 2Hz continuous wave electroacupuncture group (2Hz EA group) | Experimental | Device: 2Hz electro-acupuncture, Other: manual acupunctureNeedles 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. |
| 100Hz continuous wave electroacupuncture group (100Hz EA group) | Experimental | Device: 100Hz electro-acupuncture, Other: manual acupunctureNeedles 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. |
| 2Hz/100Hz dense-disperse wave electroacupuncture group (2Hz/100Hz EA group) | Experimental | Device: 2Hz/100Hz electro-acupuncture, Other: manual acupunctureNeedles 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sham electro-acupunctureAfter 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. | Device | sham electroacupuncture group (SEA group) |
| 2Hz electro-acupunctureElectro-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. | Device | 2Hz continuous wave electroacupuncture group (2Hz EA group) |
| 100Hz electro-acupunctureElectro-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. | Device | 100Hz continuous wave electroacupuncture group (100Hz EA group) |
| 2Hz/100Hz electro-acupunctureElectro-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. | Device | 2Hz/100Hz dense-disperse wave electroacupuncture group (2Hz/100Hz EA group) |
| manual acupunctureNeedles 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). | Other | 100Hz continuous wave electroacupuncture group (100Hz EA group), 2Hz continuous wave electroacupuncture group (2Hz EA group), 2Hz/100Hz dense-disperse wave electroacupuncture group (2Hz/100Hz EA group), sham electroacupuncture group (SEA group) |
Primary outcome
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.
3 secondary outcomes
the score of Zung self-rating anxiety scale, SAS
Time frame: 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
the score of Short form-12 health survey, SF-12
Time frame: week 0, week 4, week 8 and week 16 after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2Hz electro-acupuncture, 100Hz electro-acupuncture and 2Hz/100Hz electro-acupuncture in people with Generalized Anxiety Disorder (GAD), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoting Wu, Doctor (+8618196671636, xiaotwu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the score of Hamilton anxiety rating scale, HAMA (time frame: week 0, week 4, week 8 and week 16 after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.