Attention Bias Modification Training for Social Phobia (ABMSP)

Social Anxiety Disorder Clinical Trial

Official title:

Mobile-based Attentional Bias Modification Training (ABMT) for Socially Anxious Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06054386
• Other study ID #: UWM 21.197
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Milwaukee
• Contact: Yourim Kim, M.A.
• Phone: 414-251-5124
• Email: yourim[@]uwm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

Other:
• Attentional Bias Modification Training (ABMT)
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.
• General Attention Control Training
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.

Locations

Country	Name	City	State
United States	University of Wisconsin-Milwaukee	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Milwaukee

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View Citation

Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	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	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.	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)