Generalized Anxiety Disorder (GAD)
Conditions
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.
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).
Sponsors
Second Affiliated Hospital, Zhejiang University, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 informed consent form.
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 contraindications: bleeding tendency, coagulation dysfunction, internal metal implants; 6. Participation in other clinical trials within 1 month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the score of Hamilton anxiety rating scale, HAMA | 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
| Measure | Time frame | Description |
|---|---|---|
| the score of Zung self-rating anxiety scale, SAS | 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. |
| the score of Pittsburgh sleep quality index, PSQI | 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. |
| the score of Short form-12 health survey, SF-12 | 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. |
Countries
China
Contacts
CONTACTXiaoting Wu, Doctor
Outcome results
None listed