Generalized Anxiety Disorder
Conditions
Interventions
control group:sham electroacupuncture + treatment as usual
intervention group:electroacupuncture + treatment as usual
Sponsors
Second Xiangya Hospital of CSU
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Subjects were determined to meet the diagnostic criteria for Generalized Anxiety Disorder (GAD) as per the DSM-5 through the Structured Clinical Interview for DSM Disorders (SCID), with a Hamilton Anxiety Rating Scale (HAMA) score greater than 14 points; 2.Participants had not received any pharmacological treatment for at least 4 weeks prior to the trial commencement or had been on stable pharmacological treatment for over 4 weeks. 3.Participants should have an educational level of junior high school or above, and possess the capability to sign an informed consent form as well as to complete self-rating scales and cognitive assessments. 4.Participants are required to sign an informed consent document. 5. Age 18-60 years old
Exclusion criteria
Exclusion criteria: 1.Diagnosed with mental disorders due to organic diseases, or other mental disorders in DSM-5 except for anxiety disorders. 2.Individuals with severe suicidal ideation or a history of suicide attempts. 3.Individuals who have used beta-blockers within the past month; those with irregular caffeine intake should discontinue caffeine, and those who consume caffeine daily should reduce their intake by half. 4.Individuals who have received other non-pharmacological treatments within the last six months, such as acupuncture, Electroconvulsive Therapy (ECT), Repetitive Transcranial Magnetic Stimulation (rTMS), or systematic psychotherapy for a total of more than 10 sessions; 5.Individuals with a history of alcohol and substance dependence. 6.Individuals with a history of cranial trauma or coma. 7.Individuals with brain organic lesions, severe somatic or chronic somatic diseases that are not well controlled (such as thyroid diseases, hemophilia, lupus erythematosus or rheumatoid arthritis and other immune system diseases, lung, liver, kidney damage, acute or severe infections, major trauma, local trauma at the acupuncture site, infectious skin diseases, cardiovascular diseases such as arterial dissection/aneurysm, etc., abnormal heart rate, hypertension with systolic blood pressure >140mmHg, diabetes with fasting blood glucose >7 or random blood glucose >7.8 or glycated hemoglobin >6.5%, etc.). 8.Pregnant and lactating women. 9.Individuals with a history of epileptic seizures or a family history of epilepsy. 10.Individuals currently undergoing hormone therapy (such as corticosteroids, Levothyroxine, insulin, etc., excluding topical steroids). 11.Individuals with liver function tests showing transaminases (ALT and AST, direct/indirect/total bilirubin) at 1.5 times or above the upper limit of the normal range. 12.Other circumstances deemed unsuitable for inclusion in the study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMA score reduction at the end of week 4;HAMA scoring; | — |
Secondary
| Measure | Time frame |
|---|---|
| TESS scoring;HAMD scoring;STAI scoring;GAD-7 scoring;EQ-5D scoring;PHQ-15 scoring;TCM syndrome differentiation and classification;PHQ-9 scoring;HAMA score reduction at the end of week 2 & 8;Acupuncture-related Adverse Event Record Form; | — |
Countries
China
Contacts
Public ContactJin Liu
Second Xiangya Hospital of CSU
Outcome results
None listed