public speaking anxiety
Conditions
Interventions
All participants receive two standardized sessions of exposure for SAD, 26
randomly allocated participants will receive tVNS during the first session, 26
will receive sham stimulation during the fir
Sponsors
Universiteit Leiden
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion 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).
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective Units of Distress (SUDs): participants will provide fear ratings (ranging from 0; no fear to 100 most anxiety imaginable) prior, during and after both exposure sessions. Main outcome is the change of the SUDs during the first exposure session. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures: - SUDs ratings during the second exposure session, i.e. retention of extinction memory - Self-reported social anxiety (Social Phobia Scale) - Cardiac activity (Heart Rate Variability; HRV) - Harm Expectancies | — |
Countries
Netherlands
Outcome results
None listed