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Attention Bias Modification Training for Social Phobia (ABMSP)

Primary Purpose

Social Anxiety Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Attentional Bias Modification Training (ABMT)
General Attention Control Training
Sponsored by
University of Wisconsin, Milwaukee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Attentional bias, Cognitive process, Mobile training

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of social anxiety disorder (based on the DIAMOND interview - Social anxiety module) Moderate or severe symptoms of social anxiety as revealed by the Liebowitz Social Anxiety Scale (LSAS score of ≥ 40) or MINI-SPIN (Score of ≥ 6) Ages 18-60 English as a primary language Possession of a mobile device for access to the app (Inquisit 6) Exclusion Criteria: Self-reported visual impairment that cannot be adjusted and will prevent them from clearly recognizing words and pictures on mobile screen Self-reported history of a bipolar disorder or psychotic disorder

Sites / Locations

  • University of Wisconsin-MilwaukeeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Integrated ABM (I-ABM)

Placebo Training (PLT)

Arm Description

The I-ABM will include four progressively difficult levels of training blocks, each containing 72 trials. Participants will be required to tap or swipe the probe in the correct direction during the first and second levels of training. The inhibitory control components will be included in the third and fourth levels, where participants should not respond to the probe under certain conditions. Each training will take 10-15 minutes, and participants will complete the sessions three times a week for three weeks.

The PLT has four training blocks that follow the same basic design as the I-ABM training. However, the PLT will not aim to change social anxiety-related attention bias. Participants will simply swipe or tap the probe regardless of the stimuli condition, which is expected to exert a minimum level of effect on changing the attention bias linked to social anxiety. Participants will complete the training three times per week for three weeks.

Outcomes

Primary Outcome Measures

Change in Mini-Social Phobia Inventory (Mini-SPIN) across Pre-training, Post-training, and 2-week follow up
The Mini-Social Phobia Inventory (Mini-SPIN; Connor et al., 2001) is a 3-item measure which assesses the degree to which an individual experiences fear or avoidance in social situations. The measure uses a 5-point-Likert rating scale ranges from 0="not at all" to 4="extremely", with a total score range of 0-12. At a cutoff score of 6, the Mini-SPIN showed sensitivity of 89% and specificity of 90% for detecting generalized social anxiety disorder (Connor et al., 2001). The higher the scores, the more severe the symptoms of social anxiety.

Secondary Outcome Measures

Change in Depression, Anxiety, and Stress Scale (DASS-21) across Pre-training, Post-training, and 2-week follow-up
The Depression, Anxiety, and Stress scale (DASS-21; Lovibond & Lovibond, 1995) comprises 21 items with three subscales (depression, anxiety, and stress), each subscale consisting of seven items. Items are rated on a 4-point scale ranging from 0="did not apply to me at all" to 3="applied to me very much or most of the time". Total scores in each subscale are calculated by adding the scores from seven items and multiplying by two, with each subscale having a total score range of 0-42. The DASS-21 showed good internal reliability (coefficient alpha ranged between 0.74 and 0.93). The higher the scores, the more severe the depression, anxiety, and stress symptoms.
Change in Liebowitz Social Anxiety Scale (LSAS-SR) across Pre-training, Post-training, and 2-week follow-up
The Liebowitz Social Anxiety Scale-Self Report (LSAS-SR; Liebowitz, 1987) assesses the severity of social anxiety and its associated avoidance across a variety of life domains. The LSAS-SR consists of 24 items that are rated on a 5-point scale from 0 ("none") to 4 ("very severe"). The LSAS-SR is divided into two subscales: fear and avoidance, with total scores ranging from 0-72 for each. The The higher the scores, the more severe the symptoms of social anxiety.

Full Information

First Posted
August 21, 2023
Last Updated
September 19, 2023
Sponsor
University of Wisconsin, Milwaukee
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1. Study Identification

Unique Protocol Identification Number
NCT06054386
Brief Title
Attention Bias Modification Training for Social Phobia (ABMSP)
Official Title
Mobile-based Attentional Bias Modification Training (ABMT) for Socially Anxious Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Milwaukee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Attentional bias has primarily been investigated as a primary cognitive etiology of social anxiety symptoms. Previous research has found that individuals with high social anxiety showed facilitated attentional engagement to threat stimuli or delayed disengagement of attention from threat. Attentional Bias Modification Training (ABMT) was developed through applying the attentional mechanism in social anxiety. During ABMT, participants are deliberately induced to shift their attention away from threat stimuli and toward neutral stimuli. Despite its proven effectiveness, a recent meta-study found that the effect size of ABMT is significant but too small. As a result, the current study focuses on improving the existing ABMT by incorporating integrative factors into attention training. The current study aims to integrate bottom-up and top-down cognitive processes in ABMT. Participants will be randomly assigned to one of two conditions (active or placebo training) and will complete the ABMT for three weeks. The ABMT's efficacy will be assessed by comparing pre- and post-training measures.
Detailed Description
Individuals with at least mild level of social anxiety symptoms will be invited to the current study. Participants will be randomly assigned to one of the two attention training conditions: a Integrated Attentional Bias Modification (I-ABM) training or placebo training (PLT). Before and after the training, participants will complete computerized tasks (e.g., attention network task, dot-probe task) and self-report questionnaires. The basic design of I-ABM training will follow the dot-probe task, which will ask participants to swipe or tap on the probe in the correct direction. The I-ABM training aims to shift attention away from threatening stimuli or improve the inhibitory control ability. The PLT training will have the same basic design, but this will not include therapeutic components. Participants will complete the training three times per week for three weeks (a total of 9 training sessions), and there will be post-training and a 2-week follow-up assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
Attentional bias, Cognitive process, Mobile training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrated ABM (I-ABM)
Arm Type
Active Comparator
Arm Description
The I-ABM will include four progressively difficult levels of training blocks, each containing 72 trials. Participants will be required to tap or swipe the probe in the correct direction during the first and second levels of training. The inhibitory control components will be included in the third and fourth levels, where participants should not respond to the probe under certain conditions. Each training will take 10-15 minutes, and participants will complete the sessions three times a week for three weeks.
Arm Title
Placebo Training (PLT)
Arm Type
Placebo Comparator
Arm Description
The PLT has four training blocks that follow the same basic design as the I-ABM training. However, the PLT will not aim to change social anxiety-related attention bias. Participants will simply swipe or tap the probe regardless of the stimuli condition, which is expected to exert a minimum level of effect on changing the attention bias linked to social anxiety. Participants will complete the training three times per week for three weeks.
Intervention Type
Other
Intervention Name(s)
Attentional Bias Modification Training (ABMT)
Intervention Description
The ABMT is aimed to modify attentional bias for negative stimuli in social anxiety by deliberately inducing the participant's attention to positive or neutral stimuli. In the training, after a pair of facial stimuli (e.g., threatening-neutral, neutral-neutral) are presented, a left or right arrow appears in one of the location. Participants are instructed to press the button in the correct direction as quickly and accurately as possible.
Intervention Type
Other
Intervention Name(s)
General Attention Control Training
Intervention Description
The general attention control training aimed to improve participants' general attention control ability by asking them to press a left or right arrow in the correct direction. The basic design of attention control training is the same as the ABMT, but the attention control training does not aim to alter the direction of attention toward or away from certain stimuli.
Primary Outcome Measure Information:
Title
Change in Mini-Social Phobia Inventory (Mini-SPIN) across Pre-training, Post-training, and 2-week follow up
Description
The Mini-Social Phobia Inventory (Mini-SPIN; Connor et al., 2001) is a 3-item measure which assesses the degree to which an individual experiences fear or avoidance in social situations. The measure uses a 5-point-Likert rating scale ranges from 0="not at all" to 4="extremely", with a total score range of 0-12. At a cutoff score of 6, the Mini-SPIN showed sensitivity of 89% and specificity of 90% for detecting generalized social anxiety disorder (Connor et al., 2001). The higher the scores, the more severe the symptoms of social anxiety.
Time Frame
Pre-training (before the first mobile training), Post-training (after three weeks of training), 2-Week follow-up (two weeks after the post training assessment)
Secondary Outcome Measure Information:
Title
Change in Depression, Anxiety, and Stress Scale (DASS-21) across Pre-training, Post-training, and 2-week follow-up
Description
The Depression, Anxiety, and Stress scale (DASS-21; Lovibond & Lovibond, 1995) comprises 21 items with three subscales (depression, anxiety, and stress), each subscale consisting of seven items. Items are rated on a 4-point scale ranging from 0="did not apply to me at all" to 3="applied to me very much or most of the time". Total scores in each subscale are calculated by adding the scores from seven items and multiplying by two, with each subscale having a total score range of 0-42. The DASS-21 showed good internal reliability (coefficient alpha ranged between 0.74 and 0.93). The higher the scores, the more severe the depression, anxiety, and stress symptoms.
Time Frame
Pre-training (before the first mobile training), Post-training (after three weeks of training), 2-Week follow-up (two weeks after the post training assessment)
Title
Change in Liebowitz Social Anxiety Scale (LSAS-SR) across Pre-training, Post-training, and 2-week follow-up
Description
The Liebowitz Social Anxiety Scale-Self Report (LSAS-SR; Liebowitz, 1987) assesses the severity of social anxiety and its associated avoidance across a variety of life domains. The LSAS-SR consists of 24 items that are rated on a 5-point scale from 0 ("none") to 4 ("very severe"). The LSAS-SR is divided into two subscales: fear and avoidance, with total scores ranging from 0-72 for each. The The higher the scores, the more severe the symptoms of social anxiety.
Time Frame
Pre-training (before the first mobile training), Post-training (after three weeks of training), 2-Week follow-up (two weeks after the post training assessment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of social anxiety disorder (based on the DIAMOND interview - Social anxiety module) Moderate or severe symptoms of social anxiety as revealed by the Liebowitz Social Anxiety Scale (LSAS score of ≥ 40) or MINI-SPIN (Score of ≥ 6) Ages 18-60 English as a primary language Possession of a mobile device for access to the app (Inquisit 6) Exclusion Criteria: Self-reported visual impairment that cannot be adjusted and will prevent them from clearly recognizing words and pictures on mobile screen Self-reported history of a bipolar disorder or psychotic disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yourim Kim, M.A.
Phone
414-251-5124
Email
yourim@uwm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Han-Joo Lee, PhD
Phone
414-229-5858
Email
leehj@uwm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han-Joo Lee, PhD
Organizational Affiliation
414-229-5858
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin-Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yourim Kim, M.A.
Phone
414-251-5124
Email
yourim@uwm.edu
First Name & Middle Initial & Last Name & Degree
Han-Joo Lee, PhD
Phone
414-229-5858
Email
leehj@uwm.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
19926442
Citation
Amir N, Bomyea J, Beard C. The effect of single-session interpretation modification on attention bias in socially anxious individuals. J Anxiety Disord. 2010 Mar;24(2):178-82. doi: 10.1016/j.janxdis.2009.10.005. Epub 2009 Oct 27.
Results Reference
background
PubMed Identifier
11668666
Citation
Connor KM, Kobak KA, Churchill LE, Katzelnick D, Davidson JR. Mini-SPIN: A brief screening assessment for generalized social anxiety disorder. Depress Anxiety. 2001;14(2):137-40. doi: 10.1002/da.1055.
Results Reference
background
PubMed Identifier
26080314
Citation
Heeren A, Mogoase C, Philippot P, McNally RJ. Attention bias modification for social anxiety: A systematic review and meta-analysis. Clin Psychol Rev. 2015 Aug;40:76-90. doi: 10.1016/j.cpr.2015.06.001. Epub 2015 Jun 6.
Results Reference
background
PubMed Identifier
7726811
Citation
Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
Results Reference
background
PubMed Identifier
12457635
Citation
Mogg K, Bradley BP. Selective orienting of attention to masked threat faces in social anxiety. Behav Res Ther. 2002 Dec;40(12):1403-14. doi: 10.1016/s0005-7967(02)00017-7.
Results Reference
background
PubMed Identifier
21970428
Citation
Schofield CA, Johnson AL, Inhoff AW, Coles ME. Social anxiety and difficulty disengaging threat: evidence from eye-tracking. Cogn Emot. 2012;26(2):300-11. doi: 10.1080/02699931.2011.602050. Epub 2011 Oct 5.
Results Reference
background
PubMed Identifier
2885745
Citation
Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.
Results Reference
background

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Attention Bias Modification Training for Social Phobia (ABMSP)

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