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

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Behavioral: Gaze Contingent Music Reward Therapy; Drug: Escitalopram; Behavioral: Waitlist

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Tel Aviv University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Escitalopram; 10-20 mg of Escitalopram; Other Names: Cipralex
Placebo Comparator: Waitlist Control; Participants will wait for treatment for 12 weeks, then receive GC-MRT for 12 weeks.	Behavioral: Waitlist; Participants will wait for 12 weeks while in touch with the clinic, then receive GC-MRT for 8 weeks.

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.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline - the Patient Health Questionnaire (PHQ)- a measure of depression	Depression levels at pre and posttreatment and their change from baseline were used as moderators for clinical outcome	at baseline, one week after end of intervention
Change from baseline - viewing patterns on threat-neutral face matrices	gaze patterns, and specifically attention allocation to threat, at pre, mid and posttreatment and their change from baseline were used as moderators for clinical outcome, as well as indicators of target engagement for the GCMRT group. This is done using an established eye-tracking task (Lazarov et al, 2016). Data will also be extracted from the training sessions of GC-MRT participants to evaluate change during treatment.	at baseline, 6 weeks into intervention and one week after end of intervention

Collaborators and Investigators

• Sponsor: Tel Aviv University
• Collaborators: Tel-Aviv Sourasky Medical Center; Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2018
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: TAUgcMRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No