Application of Virtual Reality Technology to Treatment of Social Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in anxiety as assessed by the Liebowitz Social Anxiety Scale (LSAS)
研究概览
简要总结
The purpose of this study is to compare CBT VR exposure + VR social skills treatment to CBT Imaginal exposure + mindfulness, in reducing the severity of social anxiety in adults with autism and social anxiety (SA), to identify characteristics associated with benefitting from the CBT-VR treatment and to assess acceptability and feasibility of the VR intervention for patients receiving it and use findings to improve methods and to prepare for a community based pragmatic trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autism Spectrum Disorder (ASD) (diagnosed by a qualified professional)
- •verbal and literate in English or Spanish
- •average or greater intellectual ability, based on history and interview
- •able to operate a computer (Windows or Mac).
排除标准
- •current or historical severe mental illness such as schizophrenia, bipolar disorder, or severe depression
- •intellectual disability or a learning disability that would interfere with participating (e.g., unable to read)
- •unable use the technology or do not have access to the technology
- •unable to read
研究组 & 干预措施
Virtual Reality (VR) assisted Cognitive Behavior Therapy (CBT)
干预措施: CBT (Behavioral)
Virtual Reality (VR) assisted Cognitive Behavior Therapy (CBT)
干预措施: VR (Device)
CBT alone
干预措施: CBT (Behavioral)
结局指标
主要结局
Change in anxiety as assessed by the Liebowitz Social Anxiety Scale (LSAS)
时间窗: Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment))
This is a 24 item questionnaire, each is assessed in 2 ways measuring both fear/anxiety and avoidance related to specific social situations, giving a total of 48 ratings across the scale. The questions are scored from 0 (none) to 3 (severe) for a score range of 0-144 higher score indicating worse outcome.
Change in anxiety as assessed by the Social Phobia Scale (SPS)
时间窗: Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment)
This is a 20 item questionnaire and each is scored on a likert scale from 0-4, maximum score of 80 , higher score indicating worse outcome
Change in anxiety as assessed by the Social Interaction Anxiety Scale (SIAS)
时间窗: Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment)
This is a 20 item questionnaire and each is scored on a likert scale from 0(not at all characteristic of me)-4(Extremely characteristic of me), maximum score of 80,higher score indicating worse outcome
Change in anxiety as assessed by the The Severity Measure for Social Anxiety Disorder (SMSAD) scale
时间窗: Baseline, 3 weeks, 6 weeks, 9 weeks, 12 weeks, post treatment (about 4 weeks after end of treatment)
This is a 10 item questionnaire and each is scored from 0(never) to 4(all of the time) for a maximum score of 40, higher score indicating worse outcome
次要结局
未报告次要终点
研究者
Katherine A. Loveland
Professor
The University of Texas Health Science Center, Houston