Clinical trial NCT06054386: Attention Bias Modification Training for Social Phobia (ABMSP)
Official title: Mobile-based Attentional Bias Modification Training (ABMT) for Socially Anxious Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: Attentional bias
Cognitive process
Mobile training
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Mini-Social Phobia Inventory (Mini-SPIN) across Pre-training, Post-training, and 2-week follow up
timeFrame: 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 outcomes:
measure: Change in Depression, Anxiety, and Stress Scale (DASS-21) across Pre-training, Post-training, and 2-week follow-up
timeFrame: 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)
measure: Change in Liebowitz Social Anxiety Scale (LSAS-SR) across Pre-training, Post-training, and 2-week follow-up
timeFrame: 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)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: University of Wisconsin-Milwaukee
state: Wisconsin
Study officials:
affiliation: 414-229-5858
name: Han-Joo Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
citation: Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.