Generalized Anxiety Disorder
Conditions
Keywords
Electroacupuncture, Generalized Anxiety Disorder, fMRI, Clinical Efficacy
Brief summary
This study aims to evaluate the clinical efficacy and safety of electroacupuncture (EA) as an adjunctive treatment for generalized anxiety disorder (GAD). Participants in the clinical trial will be randomly assigned to an EA group, a sham EA group, or a waiting-list control group. All participants in the clinical trial will receive monotherapy with one of three SSRIs: sertraline, paroxetine, or escitalopram, selected by a psychiatrist according to clinical suitability, previous treatment response, and tolerability. Clinical efficacy will be assessed using the Hamilton Anxiety Rating Scale (HAMA). The neuroimaging substudy will include healthy controls and two groups of patients with GAD receiving SSRI monotherapy with an unchanged medication type and daily dose for at least 2 weeks: an EA group and a sham EA group. Healthy controls will undergo a single resting-state functional MRI (rs-fMRI) scan, whereas patients will undergo scans before and after a single 30-minute EA or sham EA session on the same day. Functional connectivity (FC), regional homogeneity (ReHo), and amplitude of low-frequency fluctuation (ALFF) will be compared between healthy controls and patients before intervention, and pre-to-post changes will be compared between the EA and sham EA groups.
Interventions
PROCEDUREElectroacupuncture (EA)
Electroacupuncture (EA) is performed at acupoints including GV20 (Baihui), EX-HN1 (Sishencong), GV29 (Shenting), EX-HN16 (Anmian, bilateral), HT7 (Shenmen, bilateral), PC6 (Neiguan, bilateral), CV6 (Qihai), CV4 (Guanyuan), ST36 (Zusanli, bilateral), SP6 (Sanyinjiao, bilateral), and LR3 (Taichong, bilateral). Sterile disposable needles (φ0.18×25mm or φ0.25×40mm) are used. Electric stimulation (continuous wave, 100Hz) is applied to specific point pairs (e.g., left Sishencong + anterior Sishencong) for 30 minutes. The current intensity is adjusted to the patient's maximum tolerance. Treatment is administered 3 times per week for 4 weeks (12 sessions total).
PROCEDURESham Electroacupuncture (SEA)
Sham electroacupuncture (SEA) is performed by inserting needles into non-acupoints located 5-10 mm away from the real points used in the EA group. Shallow needling (depth of 1-2 mm) is applied. A sham EA device with a disconnected electrode lead is used; although the screen displays parameters identical to the EA group, there is no actual current output. The duration, frequency, and total number of sessions are identical to the EA group (3 times/week for 4 weeks).
DRUGMedication
Each participant will receive only one of the following SSRIs: sertraline, paroxetine, or escitalopram. Medication selection will be made by a psychiatrist before randomization. Dosing and dose adjustments will follow the prespecified medication management protocol, with the same rules applied across all three study groups. Any medication changes and their reasons will be recorded.
Sponsors
Lishu Gao
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
Yes
Inclusion criteria
* Meet the DSM-5 diagnostic criteria for Generalized Anxiety Disorder (GAD). * the patient has been taking the same anxiolytic medication consistently for 2 weeks prior to enrollment. * HAMA score ≥ 14. * Right-handed（for MRI). * Aged 18-60 years, with at least primary school education. * Signed informed consent.
Exclusion criteria
* Complicated with severe cardiovascular, cerebrovascular, or organic diseases. * History of other psychiatric disorders (e.g., schizophrenia, bipolar disorder). * Contraindications for MRI (e.g., metal implants, claustrophobia). * Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective rate of HAMA score reduction at Week 4 | Week 4 (at the end of treatment) | The percentage of participants who achieved a HAMA score reduction rate of ≥50% from baseline. HAMA scores are evaluated to categorize outcomes as recovered, markedly effective, effective, or ineffective. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Hamilton Anxiety Scale (HAMA) Scores | Baseline, Week 2, Week 4, and Week 8 | HAMA is used to assess the severity of anxiety symptoms. It contains 14 items, including somatic and psychic anxiety. Total scores range from 0 to 56, where higher scores indicate more severe anxiety |
| Change from Baseline in Zung Self-Rating Anxiety Scale (SAS) Scores | Baseline, Week 2, Week 4, and Week 8. | The SAS is a 20-item self-report scale assessing anxiety symptoms. Each item is scored from 1 to 4, with positively worded items reverse-scored. The total raw score ranges from 20 to 80 and is multiplied by 1.25 to obtain a standardized score ranging from 25 to 100. Higher scores indicate more severe anxiety. Changes from baseline will be assessed at Weeks 2, 4, and 8, with negative changes indicating improvement. |
| Change from Baseline in Social Disability Screening Schedule (SDSS) Scores | Baseline, Week 2, Week 4, and Week 8 | SDSS is used to evaluate the daily functioning of patients. It consists of 10 items, with each item scored from 0 to 2. Higher total scores reflect a higher degree of social disability. |
| Frequency of Participants with Changes in medication Dosage | Week 2, Week 4, and Week 8 | The study will record whether the daily dose of medication increased, remained unchanged, or decreased compared to the baseline. |
Countries
China
Contacts
CONTACTLishu Gao
Outcome results
None listed