Efficacy of Attention Bias Modification vs. Placebo for Social Anxiety Disorder
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Dot-Probe Attention Bias Modification (ABM), Placebo Training.
- Кому может быть актуально
- Состояния в реестре: Social Anxiety Disorder (SAD), Attention Bias Modification Treatment (ABMT), Placebo Effect. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Израиль
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Официальное название
Placebo Effects in Dot-Probe Attention Bias Modification (ABM) Among Adults With Social Anxiety Disorder.
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое 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. - Поведенческое 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.
Первичные конечные точки
- Change in social anxiety symptoms [Срок оценки: 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.]
Вторичные конечные точки (8)
- Change in reaction-time-based attention bias measured in miliseconds [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline one-week before treatment begins]
- Change in depressive symptoms [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Израиль · 1 центр
- Tel Aviv university — Tel Aviv
Идентификаторы
NCT: NCT07666776 · ABM_P