Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety
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|ClinicalTrials.gov Identifier: NCT03346239|
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : September 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Social Anxiety Disorder||Behavioral: Gaze Contingent Music Reward Therapy Drug: Escitalopram Behavioral: Waitlist||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety|
|Actual Study Start Date :||July 20, 2018|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||May 1, 2020|
Experimental: Gaze Contingent Music Reward Therapy
Participants will receive gaze-contingent feedback according to their viewing patterns, over a course of 12 weeks.
Behavioral: Gaze Contingent Music Reward Therapy
Feedback according to participants' viewing patterns, in order to modify their attention.
Active Comparator: Selective Serotonin Reuptake Inhibitors
Participants will receive 10-20 mg of Escitalopram over a course of 12 weeks.
10-20 mg of Escitalopram
Other Name: Cipralex
Placebo Comparator: Waitlist Control
Participants will wait for treatment for 12 weeks, then receive GC-MRT for 12 weeks.
Participants will wait for 12 weeks while in touch with the clinic, then receive GC-MRT for 8 weeks.
- Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores [ Time Frame: 6 weeks into intervention, 1 week after intervention completion and 3 months after intervention completion ]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.
- Change from baseline - the Social Phobia Inventory scores [ Time Frame: At baseline, at weeks 2,4,6,8,10 of the intervention or wait period, 1 week after intervention completion and 3 months after intervention completion ]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.
- Clinical Global Impression [ Time Frame: 6 weeks into intervention, 1 week after intervention completion and 3 months after intervention completion ]A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346239
|Contact: Yair Bar-Haim, PhD||+972 3 firstname.lastname@example.org|
|Contact: Gal Arad, MA||+972 email@example.com|
|Tel Aviv University||Recruiting|
|Tel Aviv, Israel|
|Contact: Gal Arad, MA|
|Principal Investigator:||Yair Bar-Haim, PhD||Tel Aviv University|