Enhancement of one exposure session for social anxiety disorder with transcranial alternating current stimulation: a proof-of-concept study
- Conditions
- performance anxietysocial anxiety disordersocial phobiaspeech anxiety10002861
- Registration Number
- NL-OMON56518
- Lead Sponsor
- Radboud Universiteit Nijmegen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
A. 18-45 years old
B. Meeting the DSM-5 criteria for SAD as assessed with the Mini International
Neuropsychiatric Interview (MINI), with a predominant fear of public speaking
C. Self-reported SAD symptoms above clinical cut-off (score > 30 on the
Liebowitz Social Anxiety Scale)
D. Magnetic resonance imaging (MRI) compatible
E. tACS compatible
A. Prior non-response to exposure therapy (i.c. speech exposure) for SAD
symptoms, as defined by the subject*s report of receiving specific and regular
exposure assignments as part of previous therapy
B. Entry of subjects 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
C. Psychosis or delusion disorders (current or in the past)
D. Subjects with significant suicide ideations or who have enacted suicidal
behaviors within 6 months prior to intake will be excluded from participation
and referred for appropriate clinical intervention
E. Intellectual disability
F. Substance or alcohol dependence
G. Somatic illness
H. Pregnancy or lactation
I. Antipsychotic medication
J. 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
K. Insufficient ability to speak and write Dutch
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main outcome of the study is subjective anxiety during the speech delivery<br /><br>as assessed with subjective units of distress ratings. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Additional parameters are self-reported social anxiety symptoms (via the Social<br /><br>Phobia Scale questionnaire), in-session avoidance behaviour (body posture,<br /><br>speech prosody, eye gaze), magnetic resonance imaging scans, physiological<br /><br>measures (heart rate, skin conductance, salivary testosterone and cortisol),<br /><br>implicit measures of approach-avoidance biases to emotional faces (via the<br /><br>computerized Approach-Avoidance Task), and computational estimates of learning<br /><br>rate adaptation to volatility (via the computerized Reversal Learning Task).</p><br>