Back to resultsAttention Bias Modification Versus Attention Control in Treatment of Social Anxiety
Primary Purpose
Social Anxiety Disorder (Social Phobia), Social Anxiety, Social Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Attention Bias Modification
Attention Control
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety Disorder (Social Phobia) focused on measuring social anxiety, social phobia, attention bias modification, attention control
Eligibility Criteria
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).
Sites / Locations
- Tel Aviv University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
GCMRT
attention control
Arm Description
Attention bias modification: participants will receive gaze-contingent feedback according to their viewing patterns on disgusted and neutral faces
Attention control modification: participants will receive gaze-contingent feedback according to their viewing patterns on rounded and sharp geometric shapes
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Clinical Global Impression
A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7. Higher scores mean worse outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05018260
Brief Title
Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety
Official Title
Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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)
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder (Social Phobia), Social Anxiety, Social Anxiety Disorder
Keywords
social anxiety, social phobia, attention bias modification, attention control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
particiapants, investigators and outcome assessors are blind to allocation
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GCMRT
Arm Type
Experimental
Arm Description
Attention bias modification: participants will receive gaze-contingent feedback according to their viewing patterns on disgusted and neutral faces
Arm Title
attention control
Arm Type
Experimental
Arm Description
Attention control modification: participants will receive gaze-contingent feedback according to their viewing patterns on rounded and sharp geometric shapes
Intervention Type
Behavioral
Intervention Name(s)
Attention Bias Modification
Intervention Description
Feedback according to participants' viewing patterns, in order to modify their attention bias to threat
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Intervention Description
Feedback according to participants' viewing patterns, in order to strengthen their attention control
Primary Outcome Measure Information:
Title
Change from baseline - the Liebowitz Social Anxiety Scale (LSAS) - Diagnostic Interview scores
Description
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.
Time Frame
at baseline, one week after end of intervention
Secondary Outcome Measure Information:
Title
Change from baseline - the Social Phobia Inventory scores
Description
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.
Time Frame
at baseline, one week after end of intervention
Title
Clinical Global Impression
Description
A global measure of clinician impression improvement and severity of illness, ranging from 1 to 7. Higher scores mean worse outcome.
Time Frame
at baseline, one week after end of intervention
Other Pre-specified Outcome Measures:
Title
Change from baseline -Attention Control Scale- ACS
Description
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.
Time Frame
at baseline, one week after end of intervention
Title
Change from baseline - Patient Health Questionnaire- PHQ9
Description
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.
Time Frame
at baseline, one week after end of intervention
Title
Viewing patterns on disgusted and neutral faces, and round/sharp shapes< representing attention bias.
Description
gaze patterns measured using an established eye tracking task, measuring dwell time on different types of stimuli within a 4X4 matrix.
Time Frame
at baseline, one week after end of intervention
Title
reaction times on the Flanker task, representing attention control
Description
attention control will be measured using the established Flanker test, to assess change from baseline following treatment.
Time Frame
at baseline, one week after end of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yair Bar-Haim, PhD
Organizational Affiliation
Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv University
City
Tel Aviv
ZIP/Postal Code
55555
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety
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