Generalized Anxiety Disorder
Conditions
Sponsors
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for Generalized Anxiety Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; 2. Aged 18 to 70 years, with no restriction on gender; 3. Hamilton Anxiety Scale-14 is between 14 and 21 (inclusive of 14, exclusive of 21); 4. Hamilton Depression Scale-17 =17 and suicide factor score =2; 5. Agrees to participate in this study and signs the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals who have received anxiolytic medication treatment or used other hypnotic sedatives within 4 weeks before the start of the study, or those with anxiety caused by withdrawal reactions from anxiolytic medications; 2. Individuals with severe major diseases such as heart, liver, or kidney diseases; 3. Individuals with anxiety disorders caused by other physical diseases (e.g., hyperthyroidism, pheochromocytoma), or those with other primary mental disorders such as other anxiety disorders (social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, etc.), schizophrenia spectrum disorders, or bipolar affective disorders; 4. Individuals with intellectual or cognitive impairments who are unable to understand and complete the assessment scales; 5. Pregnant or breastfeeding women, or those planning pregnancy within the next 2 months; 6. Individuals with a history of drug abuse or addiction; 7. Individuals who have participated in other clinical trials in the past 2 months; 8. Individuals who have received other anxiolytic treatments in the past 2 months; 9. Individuals with metal allergies or severe fear of needles, or those with ulcers, abscesses, or skin infections at the acupuncture site, or those with implanted pacemakers; 10. Individuals who have received acupuncture or electroacupuncture treatment in the past 6 months; 11. Individuals with contraindications for magnetic resonance imaging (MRI), including the presence of metal objects in the body (e.g., heart stents, pacemakers, steel pins, or plates) or claustrophobia; 12. Left-handed individuals.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Hamilton Anxiety Scale-14 Score ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of Clinical Global Impression? Score ;Change of Generalized Anxiety Disorder-7 Score ;Change of Patient Health Questionnaire-9 Score ;Change of Insomnia Severity Index Score ;Change of Short Form 12 Health Survey Score ;Resting-state functional magnetic resonance imaging;Serum metabolomics; | — |
Countries
China
Contacts
Public ContactLumin Liu
Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed