Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety

The purpose of this study is to compare the clinical efficacy of treatment using gaze contingent music reward therapy (GC-MRT) with attention control treatment based on a similar paradigm, for social anxiety disorder (SAD)

Study Overview

• Status: Completed
• Conditions: Social Anxiety; Social Anxiety Disorder; Social Anxiety Disorder (Social Phobia)
• Intervention / Treatment: Behavioral: Attention Bias Modification; Behavioral: Attention Control

Detailed Description

This study examines the possibility that the effectiveness shown for GC-MRT in the treatment of SAD leans on attention control rather than bias modification. Therefore half of the participants will receive the classic GC-MRT course of treatment while the other half a version of the task with non-emotional stimuli (geometric shapes).

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 55555
    • 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: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GCMRT; Attention bias modification: participants will receive gaze-contingent feedback according to their viewing patterns on disgusted and neutral faces	Behavioral: Attention Bias Modification; Feedback according to participants' viewing patterns, in order to modify their attention bias to threat
Experimental: attention control; Attention control modification: participants will receive gaze-contingent feedback according to their viewing patterns on rounded and sharp geometric shapes	Behavioral: Attention Control; Feedback according to participants' viewing patterns, in order to strengthen their attention control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline - the Liebowitz Social Anxiety Scale (LSAS) - Diagnostic Interview scores	The Liebowitz Social Anxiety Scale (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. The minimum and maximum values of the LSAS total score are 0 and 144, respectively, with higher scores mean worse outcome. 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.	at baseline, one week after end of intervention

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 total score ranging from 0 to 68. Higher scores mean worse outcome.	at baseline, one week after end of intervention
Clinical Global Impression	A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7. Higher scores mean worse outcome.	at baseline, one week after end of intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline -Attention Control Scale- ACS	The Attention Control Scale (ACS) assesses attention control, using 20 items rated from 1 to 4. The total score ranging from 20 to 80, with higher scores mean better outcome.	at baseline, one week after end of intervention
Change from baseline - Patient Health Questionnaire- PHQ9	The Patient Health Questionnaire (PHQ9) assesses depressive symptoms using a self-report, 9 question questionnaire. Items are rated on a scale of 0-3 representing the frequency of depressive symptoms over the past 2 weeks. Scores range between 0 to 27, with higher scores mean worse outcome.	at baseline, one week after end of intervention
Viewing patterns on disgusted and neutral faces, and round/sharp shapes< representing attention bias.	gaze patterns measured using an established eye tracking task, measuring dwell time on different types of stimuli within a 4X4 matrix.	at baseline, one week after end of intervention
reaction times on the Flanker task, representing attention control	attention control will be measured using the established Flanker test, to assess change from baseline following treatment.	at baseline, one week after end of intervention

Collaborators and Investigators

• Sponsor: Tel Aviv University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: August 18, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: social anxiety; attention bias modification; social phobia; attention control
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Phobic Disorders; Disease; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: TAUAttentionControl

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