Acupuncture for Generalized Anxiety Disorder
Efficacy of Different Electroacupuncture Parameters for Generalized Anxiety Disorder: A Randomized Controlled Trial
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
CompletedFirst Posted
Study publicly available on registry
September 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
September 2, 2026
June 1, 2026
2.2 years
June 24, 2026
August 31, 2026
Conditions
Outcome Measures
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.
week 0, week 4, week 8 and week 16 after enrollment
Secondary Outcomes (3)
the score of Zung self-rating anxiety scale, SAS
week 0, week 4, week 8 and week 16 after enrollment
the score of Pittsburgh sleep quality index, PSQI
week 0, week 4, week 8 and week 16 after enrollment
the score of Short form-12 health survey, SF-12
week 0, week 4, week 8 and week 16 after enrollment
Other Outcomes (3)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
From enrollment to the end of treatment at 4 weeks
acupuncture compliance rate
4 weeks after treatment
the level of Heart Rate Variability
week 0 and week 6 after enrollment
Study Arms (4)
sham electroacupuncture group (SEA group)
SHAM COMPARATORIn 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)
EXPERIMENTALNeedles 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)
EXPERIMENTALNeedles 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)
EXPERIMENTALNeedles 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.
Interventions
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.
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.
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.
Needles with a specification of 0.25Ă—25mm were selected. Manual acupuncture is performed at the acupoints of Neiguan (PC6), Shenmen (HT7), Taichong (LR3), Sanyinjiao (SP6) and Sishencong (EX-HN1).
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2026
First Posted
September 2, 2026
Study Start
September 1, 2026
Primary Completion (Estimated)
October 30, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
September 2, 2026
Record last verified: 2026-06