The purpose of this study is to determine the clinical efficacy and neuro-cognitive mechanisms of Gaze-Contingent Usic Reward Therapy for social anxiety disorder, compared with treatment with SSRIs or waitlist control.
Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. The purpose of this study is to determine whether giving gaze-contingent feedback is an effective treatment for social anxiety disorder, compared to treatment with SSRI (Escitelopram) and a waitlist control. A secondary purpose is to explore the unique neuro-cognitive mechanisms of this treatment, using eye-tracking, MRI and fMRI measurements. Participants will be assessed using clinical interviews and self-rated questionnaires before, during and after 12 weeks of treatment or wait. Outcome measures will be social anxiety symptoms, as well as dwell time on threat in eye-tracking paradigms tested in previous studies, and BOLD signals in MRI measurements. Neuro-cognitive mechanisms will be explored as potential mediators of clinical efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
Feedback according to participants' viewing patterns, in order to modify their attention.
10-20 mg of Escitalopram
Participants will wait for 12 weeks while in touch with the clinic, then receive GC-MRT for 8 weeks.
Tel Aviv University
Tel Aviv, Israel
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores
The LSAS is a 24-item scale, each item corresponding to a situation selected on the basis of clinical experience. Each item is rated on a severity scale ranging from 0 to 3 with regard to the passing week, measuring separately two components of social anxiety, specifically, fear/anxiety and avoidance of social interaction and performance situations. Although the assessor may request and ask for further detail and adjust the rating based on clinical experience, this option is not often exercised, and inter-rater agreement is not considered to be a relevant concern.
Time frame: 6 weeks into intervention, 1 week after intervention completion
Change from baseline - the Social Phobia Inventory scores
This is a 17-item self-report measure of social anxiety evaluating fear, avoidance and physiological discomfort. Each item is rated on scale ranging from 0 to 4 with a possible total score of 68.
Time frame: At baseline, at weeks 2,4,6,8,10 of the intervention or wait period, 1 week after intervention completion
Clinical Global Impression
A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7.
Time frame: 6 weeks into intervention, 1 week after intervention completion
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