Gaze Contingent Feedback in Social Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of social anxiety disorder (SAD)

Detailed Description
-----------------
The study examines giving social anxious participants gaze-contingent feedback as a novel attention training procedure. Half of the participants will receive contingent feedback while the other half would receive non-contingent placebo feedback.

Official Title
-----------------
Gaze Contingent Feedback in Treatment of SAD

Conditions
-----------------
Phobia, Social

Intervention / Treatment
-----------------
* Behavioral: attention modification
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A signed consent form Men and women between the ages of 18 and 60. Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV A minimum of a 1-year duration of SP 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 Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure. Exclusion Criteria: Psychotic episode in the past or the present time. Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury). Another psychotherapeutic treatment during the study. Usage of neuroleptic medication. Change in medication status during the study. Substantial usage of drugs or alcohol in the present time. Poor judgment capacity (i.e., children under 18 and special populations).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: gaze-contingent<br>attention modification: participants will receive gaze-contingent feedback according to their viewing patterns | Behavioral: attention modification<br>* participants will receive gaze-continent feedback according to their viewing patterns<br>|
| Placebo Comparator: non-gaze contingent<br>Placebo: participants will receive non-gaze-contingent feedback according to their viewing patterns | Other: Placebo<br>* participants will receive non-gaze-continent feedback unrelated to their viewing patterns<br>|

What is the study measuring?
-----------------
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. It has been shown to have strong psychometric properties, including high internal consistency, strong convergent and discriminative validity and high test-retest reliability. | post treatment (1 week after treatment completion) and 3-month follow up | 

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. The SPIN has been used in clinical and nonclinical samples and its psychometric properties have been found to be sound. | post treatment (1 week after treatment completion) and 3-month follow up |