Social Anxiety Disorder, Social Fear
Conditions
Keywords
vagus nerve stimulation, social anxiety disorder
Brief summary
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?
Detailed description
Social Anxiety Disorder (SAD) is a common psychiatric condition characterized by excessive fear of social situations, leading to significant functional impairment and reduced quality of life. Conventional treatments, including pharmacotherapy and cognitive behavioral therapy, have limitations in terms of response rate and adverse effects. Transcutaneous auricular vagus nerve stimulation (taVNS) is a novel, non-invasive neuromodulation approach targeting the auricular branch of the vagus nerve, which has shown potential anxiolytic effects in clinical studies. This clinical trial is designed to evaluate the efficacy and safety of taVNS in patients with SAD. The trial adopts a randomized, doubled-blind, sham-controlled design. Participants will be allocated to receive either active taVNS or sham stimulation using identical devices. Active taVNS will deliver bilateral electrical stimulation at the concha cymba and concha cavum with a current intensity up to the individual's maximum tolerable level (≤5 mA), whereas sham stimulation will use a weak current intensity of 0.1 mA. The primary objectives of this pilot study are to determine whether taVNS demonstrates preliminary clinical efficacy in improving social anxiety symptoms and to assess the incidence of adverse events during treatment. The findings will provide critical data to guide future large-scale randomized controlled trials evaluating the therapeutic potential of taVNS in SAD.
Interventions
DEVICEtaVNS
The 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.
DEVICEsham-taVNS
The 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.
Sponsors
Second Affiliated Hospital, Zhejiang University, School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Fulfillment of the DSM-5 diagnostic criteria for Social Anxiety Disorder (SAD). A Liebowitz Social Anxiety Scale (LSAS) score of ≥30 and a Clinical Global Impression-Severity (CGI-S) score of ≥4. Age between 18 and 70 years. Voluntary provision of written informed consent. If on psychotropic medications, maintenance of a stable dose for at least six weeks prior to enrollment.
Exclusion criteria
A lifetime history of bipolar disorder, schizophrenia, or obsessive-compulsive disorder. Any cognitive impairments that could interfere with the study. Significant suicidal ideation or behavior within the past six months. Patients with rapidly deteriorating conditions. Previous taVNS treatment within the past month. Contraindications to auricular vagus nerve stimulation, such as ear infections, inflammation, skin lesions, or hypersensitivity of the ear. Presence of a pacemaker or other implanted medical devices, or severe neurological, renal, cardiovascular, or hepatic diseases. Concurrent engagement in any form of psychotherapy. History of substance or alcohol abuse. Inability to comply with psychological assessments. Incapable of providing informed consent. Pregnant or lactating. Other reasons as deemed unsuitable for inclusion by the research team.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LSAS (Liebowitz Social Anxiety Scale) | Assessments will be conducted at baseline, weeks 2, 4, and 8 of the intervention, and at week 12 during follow-up. | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SPIN (Social Phobia Inventory) | Baseline; weeks 2, 4, 8 during intervention; 12-week follow-up. | The outcome measure is the total score of the Social Phobia Inventory (SPIN) (measurement tool: Social Phobia Inventory, a 17-item self-report questionnaire; unit: total score). The SPIN is a 17-item scale with a minimum total score of 0 and a maximum total score of 68; higher scores represent more severe social phobia symptoms (i.e., a worse outcome). |
| HAMA (Hamilton Anxiety Rating Scale.) | Baseline and weeks 2, 4, 8 of intervention, plus 12-week follow-up. | 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). |
| Adherence to the intervention | Assessment wii be conducted at baseline, and at weeks 2, 4, and 8 of the intervention. | Intervention completion times or rates will be used for the evaluation. |
| Rate of adherence to the intervention | Adherence will be assessed weekly during the 8-week 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. |
Countries
China
Contacts
CONTACTBin Gao
PRINCIPAL_INVESTIGATORHan Xu
The Second Affiliated Hospital Zhejiang University of medicine
Outcome results
None listed