Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety

Sponsor

Tel Aviv University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05018260

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Social Anxiety Disorder (Social Phobia) Social Anxiety Social Anxiety Disorder	Behavioral: Attention Bias Modification Behavioral: Attention Control	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

particiapants, investigators and outcome assessors are blind to allocation

Primary Purpose:

Treatment

Official Title:

Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety

Actual Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores [at baseline, one week after end of intervention]
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

Change from baseline - the Social Phobia Inventory scores [at baseline, one week after end of intervention]
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 [at baseline, one week after end of intervention]
A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7.

Other Outcome Measures

Change from baseline -Attention Control Scale- ACS [at baseline, one week after end of intervention]
assesses attention control
Change from baseline -Patient Health Questionnaire- PHQ9 [at baseline, one week after end of intervention]
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.
Viewing patterns on disgusted and neutral faces, and round/sharp shapes< representing attention bias. [at baseline, one week after end of intervention]
gaze patterns measured using an established eye tracking task, measuring dwell time on different types of stimuli within a 4X4 matrix.
reaction times on the Flanker task, representing attention control [at baseline, one week after end of intervention]
attention control will be measured using the established Flanker test, to assess change from baseline following treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).