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临床试验/NCT05018260
NCT05018260已完成不适用

Attention Bias Modification Versus Attention Control in Treatment of Social Anxiety

Tel Aviv University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Change from baseline - the Liebowitz Social Anxiety Scale (LSAS) - Diagnostic Interview scores

研究概览

简要总结

The purpose of this study is to compare the clinical efficacy of treatment using gaze contingent music reward therapy (GC-MRT) with attention control treatment based on a similar paradigm, for social anxiety disorder (SAD)

详细描述

This study examines the possibility that the effectiveness shown for GC-MRT in the treatment of SAD leans on attention control rather than bias modification. Therefore half of the participants will receive the classic GC-MRT course of treatment while the other half a version of the task with non-emotional stimuli (geometric shapes).

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

particiapants, investigators and outcome assessors are blind to allocation

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

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).

结局指标

主要结局

Change from baseline - the Liebowitz Social Anxiety Scale (LSAS) - Diagnostic Interview scores

时间窗: at baseline, one week after end of intervention

The Liebowitz Social Anxiety Scale (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. The minimum and maximum values of the LSAS total score are 0 and 144, respectively, with higher scores mean worse outcome. 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

  • Clinical Global Impression(at baseline, one week after end of intervention)
  • Change from baseline - the Social Phobia Inventory scores(at baseline, one week after end of intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yair Bar-Haim

Professor

Tel Aviv University

研究点 (2)

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