This clinical trial aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with social anxiety disorder (SAD). The study addresses the following key research questions:
* Does taVNS demonstrate preliminary clinical efficacy in the treatment of SAD? * What adverse events may occur during taVNS treatment, and what is the treatment compliance of the subjects?
None
None
Parallel
taVNS
DeviceThe study will employ the transcutaneous auricular vagus nerve stimulation (taVNS) stimulator for therapeutic intervention. Electrical stimulation was administered at bilateral cymba conchae (kidney auricular point, CO10) and cavum conchae (heart auricular point, CO15). The stimulation parameters were as follows: frequency of 20 Hz, pulse width \<1 ms, with current intensity adjusted to the patient's maximum tolerance level while being maintained below 5 mA. The intervention protocol consisted of two 30-minute stimulation sessions per day for 8 consecutive weeks.
sham-taVNS
DeviceThe study will employ the sham transcutaneous auricular vagus nerve stimulation (sham-taVNS) for this intervention. Electrical stimulation will be administered at bilateral cymba conchae (kidney auricular point, CO10) and cavum conchae (heart auricular point, CO15). The stimulation parameters were as follows: frequency of 20 Hz, pulse width \<1 ms, and current intensity of 0.1 mA. The intervention protocol consisted of two 30-minute stimulation sessions per day for 8 consecutive weeks.
LSAS (Liebowitz Social Anxiety Scale)
The outcome measure is the percentage reduction rate of the Liebowitz Social Anxiety Scale (LSAS) total score (unit: %, measurement tool: Liebowitz Social Anxiety Scale, a 24-item self-report questionnaire). The LSAS is a 24-item scale with a minimum total score of 0 and a maximum total score of 144; higher scores indicate more severe social anxiety symptoms (i.e., a worse outcome). The primary outcome was the change in LSAS total score, with core efficacy evaluated based on the difference in total scores between baseline and the 8-week intervention period. The LSAS score reduction rate (%) was calculated as \[(Pre-treatment total score - Post-treatment total score) / Pre-treatment total score\] × 100%.
HAMA (Hamilton Anxiety Rating Scale.)
The outcome measure is the total score of the Hamilton Anxiety Rating Scale (HAMA) (measurement tool: Hamilton Anxiety Rating Scale, a 14-item clinician-rated scale; unit: total score). The HAMA is a 14-item scale with a minimum total score of 0 and a maximum total score of 56; higher scores indicate more severe anxiety symptoms (i.e., a worse outcome).
Hamilton Depression Rating Scale (HAMD)
The outcome measure is the total score of the Hamilton Depression Rating Scale (HAMD) (measurement tool: Hamilton Depression Rating Scale, a 17-item clinician-rated scale; unit: total score). The HAMD is a 17-item scale with a minimum total score of 0 and a maximum total score of 52; higher scores indicate more severe depressive symptoms (i.e., a worse outcome).
Adherence to the intervention
Intervention completion times or rates will be used for the evaluation.
Rate of adherence to the intervention
Adherence will be defined as the percentage of prescribed stimulation sessions completed by each participant during the 8-week intervention period. A rate of 100% indicates that all scheduled sessions were completed as instructed.
Click on the lead sponsor to view all of their trials.
