Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety

Social Anxiety Disorder Clinical Trial

Official title:

Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05018260
• Other study ID #: TAUAttentionControl
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: January 2023
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobia, Social
• Social Anxiety
• Social Anxiety Disorder

Intervention

Behavioral:
• Attention Bias Modification
Feedback according to participants' viewing patterns, in order to modify their attention bias to threat
• Attention Control
Feedback according to participants' viewing patterns, in order to strengthen their attention control

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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