Transcutaneous vagus nerve stimulation to enhance exposure efficacy in public speaking anxiety
- Conditions
- Social anxiety disorder
- Registration Number
- NL-OMON20935
- Lead Sponsor
- eiden University Behandel en Expertise Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 52
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
A. Between 18-70 years old
B. Social Anxiety Disorder (SAD) as established with a structured interview (MINI), and with speech anxiety as primary fear.
C. Self-reported SAD symptoms above clinical cut-off (score > 30 on the LSAS)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
A. Prior non response to exposure therapy (i.c. speech exposure) for SAD symptoms, as defined by the patient’s report of receiving specific and regular exposure assignments as part of previous therapy.
B. Prior participation in tVNS research
C. Entry of patients with other mood or anxiety disorders will be permitted in order to increase accrual of a clinically relevant sample; however in cases where SAD is not judged to be the predominant disorder, participants will not be eligible.
D. Psychosis or delusion disorders (current or in the past)
E. Patients with significant suicidal ideations or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from participation and referred for appropriate clinical intervention.
F. Mental retardation
G. Substance or alcohol dependence
H. Somatic illness (neurological and cardiac conditions)
I. Pregnancy or lactation
J. Antipsychotic medication
K. Participants that use antidepressants or benzodiazepines will not be excluded, but have to be on a stable dose for at least 6 weeks prior to enrollment.
L. Insufficient ability to speak and write Dutch
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Facilitation of extinction, as expressed by steeper slopes of SUDs decline during the first session in the tVNS condition.
- Secondary Outcome Measures
Name Time Method Enhanced retention of extinction memory, as expressed by lower mean SUD ratings during session 2 in the tVNS condition.