Transcutaneous vagus nerve stimulation to enhance exposure efficacy in public speaking anxiety
- Conditions
- public speaking anxietysocial anxiety disorder10002861
- Registration Number
- NL-OMON49420
- Lead Sponsor
- niversiteit Leiden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 52
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. 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. (History of) Substance or alcohol dependence
H. Somatic illness
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 <p>Subjective Units of Distress (SUDs): participants will provide fear ratings<br /><br>(ranging from 0; no fear to 100 most anxiety imaginable) prior, during and<br /><br>after both exposure sessions. Main outcome is the change of the SUDs during the<br /><br>first exposure session.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures:<br /><br>- SUDs ratings during the second exposure session, i.e. retention of extinction<br /><br>memory<br /><br>- Self-reported social anxiety (Social Phobia Scale)<br /><br>- Cardiac activity (Heart Rate Variability; HRV)<br /><br>- Harm Expectancies</p><br>