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Enhancement of one exposure session for social anxiety disorder with transcranial alternating current stimulation: a proof-of-concept study

Conditions
performance anxiety
social anxiety disorder
social phobia
speech anxiety
10002861
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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
<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
NameTimeMethod
<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>
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