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

Not Applicable

Completed

• Conditions: Social Anxiety Disorder
• Interventions: Behavioral: Gaze Contingent Music Reward Therapy; Behavioral: Waitlist; Drug: Escitalopram

• Registration Number: NCT03346239
• Lead Sponsor: Tel Aviv University

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Study Start: 2018-07-20
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gaze Contingent Music Reward Therapy	Gaze Contingent Music Reward Therapy	Participants will receive gaze-contingent feedback according to their viewing patterns, over a course of 12 weeks.
Waitlist Control	Waitlist	Participants will wait for treatment for 12 weeks, then receive GC-MRT for 12 weeks.
Selective Serotonin Reuptake Inhibitors	Escitalopram	Participants will receive 10-20 mg of Escitalopram over a course of 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores	6 weeks into intervention, 1 week 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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline - the Social Phobia Inventory scores	At baseline, at weeks 2,4,6,8,10 of the intervention or wait period, 1 week 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	6 weeks into intervention, 1 week after intervention completion	A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7.

Trial Locations

Locations (1)

Tel Aviv University; 🇮🇱 Tel Aviv, Israel