- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07666776
Efficacy of Attention Bias Modification vs. Placebo for Social Anxiety Disorder
Placebo Effects in Dot-Probe Attention Bias Modification (ABM) Among Adults With Social Anxiety Disorder.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This study examines whether a computerized attention-training intervention called attention bias modification (ABM) can reduce symptoms of social anxiety disorder (SAD) in adults, and whether symptom improvement is specifically related to changes in attentional processing or to nonspecific factors such as expectancy and placebo effects.
Social Anxiety Disorder is characterized by persistent fear of social situations and negative evaluation by others. Previous research suggests that individuals with SAD tend to direct their attention toward socially threatening information, such as angry facial expressions. ABM was developed to reduce these attentional biases by training individuals to shift attention away from threat-related stimuli. However, findings regarding the clinical efficacy of ABM have been mixed, and some studies suggest that symptom improvement may also result from placebo-related factors, including treatment expectancy and engagement with the intervention.
In this randomized controlled trial, 90 adults diagnosed with Social Anxiety Disorder will be assigned to one of three study conditions: (1) active dot-probe ABM training, (2) placebo computerized training, or (3) a wait-list control group. Participants in the active and placebo training groups will complete eight computerized training sessions over four weeks.
The study will assess changes in social anxiety symptoms before and after the intervention using clinical interviews, self-report questionnaires, and computerized attention tasks. In addition, the study will examine attention bias and attention bias variability (ABV), using both reaction-time-based and eye-tracking-based measures, to better understand changes in attentional processing over time. Treatment expectancy and perceived credibility of the intervention will also be evaluated.
The hypothesis is that participants receiving active ABM training and placebo training will show greater reductions in social anxiety symptoms compared to the wait-list control group, and that participants in the active condition will show greater reduction in symptoms than the placebo condition. The study further hypothesizes that only the active ABM condition will produce significant changes in attention bias and attentional bias variability. Overall, the study aims to clarify the specific and nonspecific mechanisms underlying symptom improvement following Attention Bias Modification interventions for Social Anxiety Disorder.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yair Bar-Haim, PhD
- Numéro de téléphone: 97236405465
- E-mail: yair1@tauex.tau.ac.il
Sauvegarde des contacts de l'étude
- Nom: Lital Kohn, MA
- Numéro de téléphone: 97236405465
- E-mail: litalkohn@tauex.tau.ac.il
Lieux d'étude
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Tel Aviv, Israël
- Recrutement
- Tel Aviv University
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Contact:
- Yuval Regev, masters
- Numéro de téléphone: +97245-333-4472
- E-mail: yuvalregev4@mail.tau.ac.il
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adults aged 18-65 years
- Primary diagnosis of generalized Social Anxiety Disorder based on clinical evaluation, the MINI International Neuropsychiatric Interview (MINI), and a Liebowitz Social Anxiety Scale (LSAS) score greater than 50
- Normal or corrected-to-normal vision without color blindness
- Sufficient Hebrew proficiency to complete clinical interviews, self-report questionnaires, and computerized cognitive tasks
Exclusion Criteria:
- Previous participation in attention bias modification training using a dot-probe task
- Previous participation in eye-tracking-based attention training
- Current diagnosis of Post-Traumatic Stress Disorder
- Current or past diagnosis of psychotic disorder or bipolar disorder
- Neurological disorder (e.g., epilepsy or traumatic brain injury)
- Severe suicidal ideation
- Current substance or alcohol use disorder
- Concurrent pharmacological or psychosocial treatment, unless medication has been stable for at least 45 days
- Pregnancy
- Uncorrected visual impairment or use of multifocal glasses
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Active ABM Training
Mechanized Dot-Probe Attention Bias Modification (ABM) training attention away from threat faces.
Participants identify the direction of an arrowehead presented at the location of neutral faces.
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Participants complete a computerized dot-probe attention training task designed to train attention away from threat-related stimuli.
During each trial, angry and neutral facial expressions are presented simultaneously, followed by a probe that consistently appears in the location of the neutral face.
Participants complete eight training sessions over four weeks.
Autres noms:
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Comparateur placebo: Placebo Training
Mechanized Intervention: Placebo Training, presenting a single, centered, non-face oval shape in each trial.
Participants identify the direction of an arrowehead centrally presented.
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Participants complete a computerized task matched to the active training condition in duration, structure, and task demands, but without exposure to emotional stimuli or attentional training contingencies.
The task is designed to control for nonspecific factors such as expectancy and engagement.
Participants complete eight sessions over four weeks.
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Aucune intervention: Wait-List Control
No Intervention / Wait-List, assessments at the same intervals as the active and placebo conditions without intervention in between.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in social anxiety symptoms
Délai: a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Change in social anxiety symptom severity from baseline to post-intervention as measured by the Liebowitz Social Anxiety Scale (LSAS).
Min-Max values 0-80, higher scores mean worse outcome.
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a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in reaction-time-based attention bias measured in miliseconds
Délai: a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Change in attention bias derived from reaction-time performance on the dot-probe task.
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a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Change in reaction-time-based attention bias variability
Délai: a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Change in attention bias variability derived from reaction-time performance on the dot-probe task.
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a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Change in eye-tracking-based attention bias
Délai: a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Change in attention bias measured using eye-tracking during a free-viewing task with threat-related and neutral facial stimuli.
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a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Change in eye-tracking-based attention bias variability
Délai: a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Change in attention bias variability measured using eye-tracking during a free-viewing task with threat-related and neutral facial stimuli.
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a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Treatment Expectancy and Credibility
Délai: Baseline one-week before treatment begins
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Participant-rated treatment expectancy and perceived credibility assessed using the Credibility/Expectancy Questionnaire (CEQ).
0-9 scale and 0% - 100%.
Higher scores indicate greater treatment credibility and greater expectation of improvement.
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Baseline one-week before treatment begins
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Change in depressive symptoms
Délai: a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Change in depressive symptom severity measured using the Patient Health Questionnaire-9 (PHQ-9).
Scale range 0-20, higher scores mean worse outcome.
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a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Change in Generalized Anxiety Symptoms
Délai: a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Change in generalized anxiety symptoms measured using the Generalized Anxiety Disorder-7 scale (GAD-7).
Scores range 0-21, higher scores mean worse outcome.
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a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Self report change in social anxiety symptoms
Délai: a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Change insocial anxiety symptom severity measured using the Social Phobia Inventory (SPIN).
Scores range 0-68, higher scores mean worse outcome.
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a) Baseline one-week before treatment begins; b) an average of 2 weeks following treatment completion. Total time frame (baseline-post) an average of 6 weeks.
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Yair Bar-Haim, PhD, Tel Aviv University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ABM_P
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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