NCT07753538

Brief Summary

The overall goal of the current study is to develop and evaluate a computerized interpretation bias modification (IBM) training for treating social anxiety disorder (SAD). A key focus is placed on enhancing accessibility and efficacy of IBM for SAD by delivering it through a mobile platform, with three specific aims outlined. First, the current study aims to examine the efficacy of the IBM training in reducing social anxiety symptoms by comparing the pre-, post-, and follow-up assessments of the IBM group with a control group. Second, the current study aims to examine the effect of IBM on reducing participants' daily social anxiety symptoms using daily diary methodology. Third, the investigators also aim to evaluate the feasibility and acceptability of the IBM training. The investigators expect that at least 70% of participants will complete 4 or more of the six training sessions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
Last Updated

August 7, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

July 17, 2026

Last Update Submit

August 5, 2026

Conditions

Keywords

interpretation biascognitive trainingcomputerized interventionsocial anxiety disorder

Outcome Measures

Primary Outcomes (3)

  • Brief Fear of Negative Evaluation (BFNE)

    The BFNE is a 12-item questionnaire, evaluating the level of apprehension and distress about expected negative evaluation. The BFNE was used to assess the cognitive symptoms of social anxiety disorder.

    Pre-training (baseline); Post-training (approximately 1-2 days after completion of the 2-week intervention); 2-week follow-up (2 weeks after completion of the 2-week intervention)

  • Liebowitz Social Anxiety Scale- Self-report Version (LSAS-SR)

    The LSAS-SR is a 24-item scale that assesses the severity of social anxiety symptoms across two subscales: the level of anxiety (emotional reaction) and the level of avoidance (behavioral reaction). In the current study, the two subscales will be analyzed separately to evaluate the effects of the intervention on the emotional and behavioral symptoms of social anxiety.

    Pre-training (baseline); Post-training (approximately 1-2 days after completion of the 2-week intervention); 2-week follow-up (2 weeks after completion of the 2-week intervention)

  • Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)

    DIAMOND is a semi-structured diagnostic interview to assess DSM-5 psychiatric disorders and has demonstrated good reliability and validity. For the current study, only the social anxiety disorder module was administered at pre-training and follow-up assessments.

    Pre-training (baseline); 2-week follow-up (2 weeks after completion of the 2-week intervention)

Secondary Outcomes (4)

  • Word Sentence Association Paradigm (WSAP)

    Pre-training (baseline); Post-training (approximately 1-2 days after completion of the 2-week intervention); 2-week follow-up (2 weeks after completion of the 2-week intervention)

  • Daily Diary

    2 weeks of training period

  • Credibility and Expectancy Questionnaire (CEQ)

    After the 1st training session

  • Treatment Acceptability Questionnaire (TAQ)

    2-week follow-up (2 weeks after completion of the 2-week intervention)

Study Arms (2)

Cognitive Bias Modification for Interpretation Bias (CBM-I)

EXPERIMENTAL

CBM-I is designed to modify negative interpretation bias, a core cognitive characteristic of social anxiety disorder. During the training, participants will complete sentence fragments by filling in missing letters, guiding them to interpret ambiguous social scenarios in a benign way. Participants will complete the training three times per week for two weeks.

Behavioral: Interpretation Bias Modification Training

Stress Management Psychoeducation (SMP) Group

ACTIVE COMPARATOR

The Stress Management Psychoeducation (SMP) group will also receive a cognitive training intervention involving the completion of sentence fragments by filling in missing letters. However, the training content will focus on stress management strategies, such as relaxation techniques and organizational skills, rather than interpretation bias modification. Participants in the SMP group will also complete the training three times per week for two weeks.

Behavioral: Stress Management Psychoeducation

Interventions

Interpretation Bias Modification Training aims to help participants interpret ambiguous social scenarios in a benign way, with the goal of reducing social anxiety symptoms. Individuals with social anxiety disorder tend to interpret ambiguous social situations negatively or catastrophize mildly negative events. This intervention targets this core cognitive characteristic by repeatedly training more adaptive interpretation. Cognitive training is delivered through mobile devices, increasing accessibility and cost-effectiveness while allowing participants to complete the intervention remotely.

Cognitive Bias Modification for Interpretation Bias (CBM-I)

Stress Management Psychoeducation (SMP) is used as a credible comparison condition to evaluate whether CBM-I has specific therapeutic effects on reducing social anxiety symptoms. The SMP condition follows the same training format as CBM-I, in which participants complete fragmented sentences by filling in missing letters. However, the training content focuses on stress management strategies rather than modifying maladaptive interpretations of ambiguous social situations.

Stress Management Psychoeducation (SMP) Group

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of SAD based on the DIAMOND screening interview
  • Moderate or severe symptoms of SAD as assessed by the Liebowitz Social Anxiety Scale (LSAS score of \>= 30)
  • Ages 18-60
  • English as a primary language
  • Possession of a mobile device for access to training and text message for daily diary

You may not qualify if:

  • Self-report 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 as measured by Diagnostic History Scale
  • Current psychotherapy for SAD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin-Milwaukee

Milwaukee, Wisconsin, 53211, United States

Location

Related Publications (10)

  • Mobini S, Mackintosh B, Illingworth J, Gega L, Langdon P, Hoppitt L. Effects of standard and explicit cognitive bias modification and computer-administered cognitive-behaviour therapy on cognitive biases and social anxiety. J Behav Ther Exp Psychiatry. 2014 Jun;45(2):272-9. doi: 10.1016/j.jbtep.2013.12.002. Epub 2013 Dec 31.

    PMID: 24412966BACKGROUND
  • Beard C, Amir N. A multi-session interpretation modification program: changes in interpretation and social anxiety symptoms. Behav Res Ther. 2008 Oct;46(10):1135-41. doi: 10.1016/j.brat.2008.05.012. Epub 2008 Jun 27.

    PMID: 18675400BACKGROUND
  • Beard C. Cognitive bias modification for anxiety: current evidence and future directions. Expert Rev Neurother. 2011 Feb;11(2):299-311. doi: 10.1586/ern.10.194.

    PMID: 21306216BACKGROUND
  • Amir N, Prouvost C, Kuckertz JM. Lack of a benign interpretation bias in social anxiety disorder. Cogn Behav Ther. 2012;41(2):119-29. doi: 10.1080/16506073.2012.662655. Epub 2012 Apr 30.

    PMID: 22545788BACKGROUND
  • Patel TA, Schubert FT, Hom MA, Cougle JR. Correlates of treatment seeking in individuals with social anxiety disorder: Findings from a nationally representative sample. J Anxiety Disord. 2022 Oct;91:102616. doi: 10.1016/j.janxdis.2022.102616. Epub 2022 Aug 6.

    PMID: 36007388BACKGROUND
  • Liu H, Li X, Han B, Liu X. Effects of cognitive bias modification on social anxiety: A meta-analysis. PLoS One. 2017 Apr 6;12(4):e0175107. doi: 10.1371/journal.pone.0175107. eCollection 2017.

    PMID: 28384301BACKGROUND
  • Heinrichs N, Hofmann SG. Information processing in social phobia: a critical review. Clin Psychol Rev. 2001 Jul;21(5):751-70. doi: 10.1016/s0272-7358(00)00067-2.

    PMID: 11434229BACKGROUND
  • Cougle JR, Wilver NL, Day TN, Summers BJ, Okey SA, Carlton CN. Interpretation Bias Modification Versus Progressive Muscle Relaxation for Social Anxiety Disorder: A Web-Based Controlled Trial. Behav Ther. 2020 Jan;51(1):99-112. doi: 10.1016/j.beth.2019.05.009. Epub 2019 May 24.

    PMID: 32005343BACKGROUND
  • Clark DM, McManus F. Information processing in social phobia. Biol Psychiatry. 2002 Jan 1;51(1):92-100. doi: 10.1016/s0006-3223(01)01296-3.

    PMID: 11801234BACKGROUND
  • Amir N, Taylor CT. Interpretation training in individuals with generalized social anxiety disorder: a randomized controlled trial. J Consult Clin Psychol. 2012 Jun;80(3):497-511. doi: 10.1037/a0026928. Epub 2012 Jan 16.

    PMID: 22250851BACKGROUND

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two groups: active training group (Interpretation Bias Modification Group; IBM) or placebo training group (stress management psychoeducation group; SMP). All participants will complete the cognitive training three times a week for two weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2026

First Posted

August 7, 2026

Study Start

September 26, 2024

Primary Completion

December 8, 2025

Study Completion

December 8, 2025

Last Updated

August 7, 2026

Record last verified: 2026-07

Locations