Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 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 the clinical efficacy and neuro-cognitive mechanisms of Gaze-Contingent Usic Reward Therapy for social anxiety disorder, compared with treatment with SSRIs or waitlist control.
详细描述
Attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. The purpose of this study is to determine whether giving gaze-contingent feedback is an effective treatment for social anxiety disorder, compared to treatment with SSRI (Escitelopram) and a waitlist control. A secondary purpose is to explore the unique neuro-cognitive mechanisms of this treatment, using eye-tracking, MRI and fMRI measurements. Participants will be assessed using clinical interviews and self-rated questionnaires before, during and after 12 weeks of treatment or wait. Outcome measures will be social anxiety symptoms, as well as dwell time on threat in eye-tracking paradigms tested in previous studies, and BOLD signals in MRI measurements. Neuro-cognitive mechanisms will be explored as potential mediators of clinical efficacy.
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
- Double (Investigator, Outcomes Assessor)
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) according to the DSM-IV.
- •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.
- •No current pharmaco-therapy.
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.
- •Any current pharmacological treatment.
- •Any current psychotherapeutic treatment.
- •Change in treatment during the study.
- •Poor judgment capacity (i.e., children under 18 and special populations).
研究组 & 干预措施
Gaze Contingent Music Reward Therapy
Participants will receive gaze-contingent feedback according to their viewing patterns, over a course of 12 weeks.
干预措施: Gaze Contingent Music Reward Therapy (Behavioral)
Selective Serotonin Reuptake Inhibitors
Participants will receive 10-20 mg of Escitalopram over a course of 12 weeks.
干预措施: Escitalopram (Drug)
Waitlist Control
Participants will wait for treatment for 12 weeks, then receive GC-MRT for 12 weeks.
干预措施: Waitlist (Behavioral)
结局指标
主要结局
Change from baseline - the Liebowitz Social Anxiety Scale - Diagnostic Interview scores
时间窗: 6 weeks into intervention, 1 week after intervention 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(At baseline, at weeks 2,4,6,8,10 of the intervention or wait period, 1 week after intervention completion)
- Clinical Global Impression(6 weeks into intervention, 1 week after intervention completion)
研究者
Yair Bar-Haim
Professor
Tel Aviv University