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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Yair Bar-Haim, PhD
- Número de telefone: 97236405465
- E-mail: yair1@tauex.tau.ac.il
Estude backup de contato
- Nome: Lital Kohn, MA
- Número de telefone: 97236405465
- E-mail: litalkohn@tauex.tau.ac.il
Locais de estudo
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Tel Aviv, Israel
- Recrutamento
- Tel Aviv University
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Contato:
- Yuval Regev, masters
- Número de telefone: +97245-333-4472
- E-mail: yuvalregev4@mail.tau.ac.il
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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.
Outros nomes:
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Comparador de 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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in social anxiety symptoms
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in reaction-time-based attention bias measured in miliseconds
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Yair Bar-Haim, PhD, Tel Aviv University
Datas de registro do estudo
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- ABM_P
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