Gaze Contingent Feedback in Treatment of SAD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores
研究概览
简要总结
The purpose of this study is to determine whether giving gaze-contingent feedback is an effective attention modification procedure, helping in the treatment of social anxiety disorder (SAD)
详细描述
The study examines giving social anxious participants gaze-contingent feedback as a novel attention training procedure. Half of the participants will receive contingent feedback while the other half would receive non-contingent "placebo" feedback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A signed consent form
- •Men and women between the ages of 18 and
- •Meeting a current diagnosis of Social Anxiety Disorder (SP) according to the DSM-IV
- •A minimum of a 1-year duration of SP
- •SP as the primary diagnosis: In cases of co-morbidity, SP will be deemed as the most distressing and clinically significant condition among the co-morbid disorders
- •Stable pharmaco-therapy: Participants receiving a pharmacological treatment who are taking a stable medication for at least 3 months before the beginning of the procedure.
排除标准
- •Psychotic episode in the past or the present time.
- •Co-morbidity with any neurological disorder (i.e., epilepsy, brain injury).
- •Another psychotherapeutic treatment during the study.
- •Usage of neuroleptic medication.
- •Change in medication status during the study.
- •Substantial usage of drugs or alcohol in the present time.
- •Poor judgment capacity (i.e., children under 18 and special populations).
结局指标
主要结局
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores
时间窗: post treatment (1 week after treatment completion) and 3-month follow up
The LSAS is a 24-item scale, each item corresponding to a situation selected on the basis of clinical experience. Each item is rated on a severity scale ranging from 0 to 3 with regard to the passing week, measuring separately two components of social anxiety, specifically, fear/anxiety and avoidance of social interaction and performance situations. Although the assessor may request and ask for further detail and adjust the rating based on clinical experience, this option is not often exercised, and inter-rater agreement is not considered to be a relevant concern. It has been shown to have strong psychometric properties, including high internal consistency, strong convergent and discriminative validity and high test-retest reliability.
次要结局
- Change from baseline - the Social Phobia Inventory scores(post treatment (1 week after treatment completion) and 3-month follow up)
研究者
Yair Bar-Haim
Professor of Psychology and Neuroscience School of Psychological Sciences Sagol School of Neuroscience Tel Aviv University
Tel Aviv University