Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Interpretation Bias Modification Training for Social Anxiety Disorder (SAD)

5 août 2026 mis à jour par: University of Wisconsin, Milwaukee

Computerized Interpretation Bias Modification Training for Social Anxiety Disorder

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.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Réel)

50

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Wisconsin
      • Milwaukee, Wisconsin, États-Unis, 53211
        • University of Wisconsin-Milwaukee

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Cognitive Bias Modification for Interpretation Bias (CBM-I)
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.
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.
Comparateur actif: Stress Management Psychoeducation (SMP) Group
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.
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Brief Fear of Negative Evaluation (BFNE)
Délai: 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)
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)
Délai: 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)
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)
Délai: Pre-training (baseline); 2-week follow-up (2 weeks after completion of the 2-week intervention)
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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Word Sentence Association Paradigm (WSAP)
Délai: 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)
The WSAP task was used to evaluate interpretation bias in response to ambiguous situations. During the task, participants indicate whether a presented word (either negative or benign) is related or unrelated to a subsequently presented ambiguous sentence. The scenarios included both social and general situations. The percentage of endorsement responses was calculated separately for each trial type: social-threat, social-benign, general-threat, and general benign.
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
Délai: 2 weeks of training period
Daily diary was used to evaluate participants' daily social interactions and changes in social anxiety symptoms. Participants in both groups received a text message to complete the daily diary survey each evening over the 2-week period of training. The survey first asked participants to report the social interactions they had experienced that day, followed by questions assessing anxiety, avoidance, negative self-perception, fear of negative judgment, and satisfaction related to the most stressful social interaction.
2 weeks of training period
Credibility and Expectancy Questionnaire (CEQ)
Délai: After the 1st training session
The CEQ is a self-report measure that assesses participants' perceptions of the credibility of an intervention their expectations regarding its outcomes. This measure was used to evaluate the feasibility of the CBM-I intervention.
After the 1st training session
Treatment Acceptability Questionnaire (TAQ)
Délai: 2-week follow-up (2 weeks after completion of the 2-week intervention)
The TAQ is a 5-item self-report measures that evaluates participants' perceptions of an intervention's acceptability, ethicality, acceptability of side effects, pleasantness and comfort of the intervention.
2-week follow-up (2 weeks after completion of the 2-week intervention)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

26 septembre 2024

Achèvement primaire (Réel)

8 décembre 2025

Achèvement de l'étude (Réel)

8 décembre 2025

Dates d'inscription aux études

Première soumission

17 juillet 2026

Première soumission répondant aux critères de contrôle qualité

5 août 2026

Première publication (Réel)

7 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 août 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • UWM 25.022

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner