Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Behavioral: Gaze Contingent Music Reward Therapy
* Drug: Escitalopram
* Behavioral: Waitlist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A signed consent form Men and women between the ages of 18 and 65. Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV. SP as the primary diagnosis: In cases of co-morbidity, SP will be deemed as the most distressing and clinically significant condition among the co-morbid disorders. No current pharmaco-therapy. Exclusion Criteria: A diagnosis of psychotic or bipolar disorders. A diagnosis of a neurological disorder (i.e., epilepsy, brain injury). Drug or alcohol abuse. Any current pharmacological treatment. Any current psychotherapeutic treatment. Change in treatment during the study. Poor judgment capacity (i.e., children under 18 and special populations).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gaze Contingent Music Reward Therapy<br>Participants will receive gaze-contingent feedback according to their viewing patterns, over a course of 12 weeks. | Behavioral: Gaze Contingent Music Reward Therapy<br>* Feedback according to participants' viewing patterns, in order to modify their attention.<br>|
| Active Comparator: Selective Serotonin Reuptake Inhibitors<br>Participants will receive 10-20 mg of Escitalopram over a course of 12 weeks. | Drug: Escitalopram<br>* 10-20 mg of Escitalopram<br>* Other names: Cipralex;|
| Placebo Comparator: Waitlist Control<br>Participants will wait for treatment for 12 weeks, then receive GC-MRT for 12 weeks. | Behavioral: Waitlist<br>* Participants will wait for 12 weeks while in touch with the clinic, then receive GC-MRT for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks into intervention, 1 week after intervention completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 6 weeks into intervention, 1 week after intervention completion |