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Recruiting NCT07666776

Efficacy of Attention Bias Modification vs. Placebo for Social Anxiety Disorder

No phase Interventional Social Anxiety Disorder (SAD) Attention Bias Modification Treatment (ABMT) Placebo Effect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dot-Probe Attention Bias Modification (ABM), Placebo Training.
Who it may be relevant to
Registry conditions: Social Anxiety Disorder (SAD), Attention Bias Modification Treatment (ABMT), Placebo Effect. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Placebo Effects in Dot-Probe Attention Bias Modification (ABM) Among Adults With Social Anxiety Disorder.

Overview

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.

Detailed description

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.

Interventions

  • Behavioral Dot-Probe Attention Bias Modification (ABM)
    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.
  • Behavioral Placebo Training
    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.

Primary outcome measures

  • Change in social anxiety symptoms [Time frame: 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.]
Secondary outcome measures (8)
  • Change in reaction-time-based attention bias measured in miliseconds [Time frame: 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.]
  • Change in reaction-time-based attention bias variability [Time frame: 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.]
  • Change in eye-tracking-based attention bias [Time frame: 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.]
  • Change in eye-tracking-based attention bias variability [Time frame: 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.]
  • Treatment Expectancy and Credibility [Time frame: Baseline one-week before treatment begins]
  • Change in depressive symptoms [Time frame: 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.]
  • Change in Generalized Anxiety Symptoms [Time frame: 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.]
  • Self report change in social anxiety symptoms [Time frame: 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Israel · 1 center
  • Tel Aviv university — Tel Aviv

Identifiers

NCT: NCT07666776 · ABM_P

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗