NCT06054386

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

2.4 years

First QC Date

August 21, 2023

Last Update Submit

April 3, 2024

Conditions

Keywords

Attentional biasCognitive processMobile training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in Depression, Anxiety, and Stress Scale (DASS-21) across Pre-training, Post-training, and 2-week follow-up

    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)

  • Change in Liebowitz Social Anxiety Scale (LSAS-SR) across Pre-training, Post-training, and 2-week follow-up

    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)

Study Arms (2)

Integrated ABM (I-ABM)

ACTIVE COMPARATOR

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.

Other: Attentional Bias Modification Training (ABMT)

Placebo Training (PLT)

PLACEBO COMPARATOR

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.

Other: General Attention Control Training

Interventions

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.

Integrated ABM (I-ABM)

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.

Placebo Training (PLT)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, 53211, United States

RECRUITING

Related 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.

    PMID: 19926442BACKGROUND
  • 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.

    PMID: 11668666BACKGROUND
  • 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.

    PMID: 26080314BACKGROUND
  • 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.

    PMID: 7726811BACKGROUND
  • 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.

    PMID: 12457635BACKGROUND
  • 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.

    PMID: 21970428BACKGROUND
  • Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.

    PMID: 2885745BACKGROUND

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Han-Joo Lee, PhD

    414-229-5858

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yourim Kim, M.A.

CONTACT

Han-Joo Lee, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

September 26, 2023

Study Start

April 7, 2022

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

April 5, 2024

Record last verified: 2024-04

Locations