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.
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.
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;
Parallel
sham electro-acupuncture
DeviceAfter 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
DeviceElectro-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
DeviceElectro-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
DeviceElectro-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 interventionNeedles 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).
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.
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.
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.
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.
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.
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%.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
