Visual Mismatch Negativity in Attention Bias Modifcation Treatment for Social and Generalized Anxiety- an ERP Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline - The Generalized Anxiety Disorder Severity Scale
研究概览
简要总结
this study examines the emergence of the visual mismatch negativity (vMMN) ERP component in response to deviations from the embedded contingency in attention bias modification treatment (ABMT) for social and generalized anxiety, and the interaction between vMMN emergence and clinical improvement.
***As of September 2017, recruitment of SAD participants has concluded.
详细描述
all participants, suffering from either social anxiety disorder or generalized anxiety disorder, will receive 6 sessions of ABMT, adapted for an oddball paradigm. two of the sessions will also include simultaneous EEG measurement. the goal of the study is to determine the emergence of vMMN in response to trials deviating the embedded contingency and to examine the correlation between vMMN emergence and clinical improvement of anxiety symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older 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) or Generalized Anxiety Disorder according to the DSM-IV
- •SP/GAD as the primary diagnosis: In cases of co-morbidity, SP/GAD 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
- •A diagnosis of psychotic or bipolar disorders.
- •A diagnosis of a neurological disorder (i.e., epilepsy, brain injury).
- •Drug or alcohol abuse.
- •A pharmacological treatment that is not stabilized in the past 3 months.
- •Another psychotherapeutic treatment.
- •Change in treatment during the study.
- •Poor judgment capacity (i.e., children under 18 and special populations).
结局指标
主要结局
Change from baseline - The Generalized Anxiety Disorder Severity Scale
时间窗: 1 week after treatment completion and 2 months after treatment completion
The Generalized Anxiety Disorder Severity Scale (GADSS) is a 6-item interview assessment that evaluates the severity of each of the DSM-IV symptoms of generalized anxiety disorder. It begins with a target worry list to identify situations that are the focus of worry, and continues with six 5-point-scale items to evaluate levels of generalized anxiety severity.
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores
时间窗: 1 week after treatment completion and 2 months after treatment completion
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.
次要结局
- Change from baseline - the Social Phobia Inventory scores(1 week after treatment completion and 2 months after treatment completion)
- Change from baseline - the GAD-7(1 week after treatment completion and 2 months after treatment completion)
- Change from baseline - the Penn State Worry Questionnaire(1 week after treatment completion and 2 months after treatment completion)
研究者
Yair Bar-Haim
Professor
Tel Aviv University