BVR-100 and BES-100 Validation Trial: A Randomized, Double-Blind, Parallel-Group, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 12
- 主要终点
- Measurement of Intervention Credibility Assessed With the Credibility Score, at Baseline
研究概览
简要总结
This study is to compare two Virtual Reality (VR)-based interventions, BVR-100 and BES-100, for the treatment of Social Anxiety Disorder (SAD).
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)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female, aged 18 or above.
- •Subject has English fluency and literacy.
- •Subject meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5) criteria for Social Anxiety Disorder
- •Subject has a total Liebowitz Social Anxiety Scale (LSAS) score at Screening of ≥ 70.
排除标准
- •Subject has significant visual, auditory or balance impairment
- •Subject has history of photosensitive epilepsy or seizure disorder
- •Subject has history of motion sickness or medical condition predisposing to nausea or dizziness.
- •Subject has injuries, inflammation or infection affecting the eyes, ears or face that would make the use of the hardware uncomfortable.
- •Subject has, current or lifetime history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, major neurocognitive disorder, neurodevelopmental disorder of greater than mild severity or of a severity that impacts the subject's ability to consent, follow study directions, or otherwise safely participate in the study; posttraumatic stress disorder, major depressive disorder (MDD) with psychotic features, borderline or antisocial personality disorder
- •Subject has met DSM-5-based criteria for Alcohol or Substance Use Disorder (other than nicotine or caffeine) within one (1) year prior to Screening.
- •Subject has received ketamine, esketamine, arketamine, or psychedelic therapies (eg, psilocybin, methylenedioxymethamphetamine [MDMA]) for MDD or any psychiatric condition within one (1) year prior to Screening.
- •In the opinion of the Investigator: (a) study participation may pose a significant or undue risk to the subject; (b) the subject is unlikely to successfully complete all of the requirements of the study per protocol; or (c) study participation may adversely impact the integrity of the data or the validity of the study results.
结局指标
主要结局
Measurement of Intervention Credibility Assessed With the Credibility Score, at Baseline
时间窗: Baseline
The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The first three items load onto the credibility factor. Higher scores suggest better experience, lower scores suggest poor experience.Credibility score is calculated by taking the sum of score of the first 3 items of the CEQ scale ranging from 3 to 27.
Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 6
时间窗: 6 weeks
The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The first three items load onto the credibility factor. Higher scores suggest better experience, lower scores suggest poor experience.Credibility score is calculated by taking the sum of score of the first 3 items of the CEQ scale ranging from 3 to 27.
Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 8
时间窗: 8 weeks
The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The first three items load onto the credibility factor. Higher scores suggest better experience, lower scores suggest poor experience.Credibility score is calculated by taking the sum of score of the first 3 items of the CEQ scale ranging from 3 to 27.
Measurement of Intervention Credibility Assessed With Expectancy Score, at Baseline
时间窗: Baseline
The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The final three items load onto the expectancy factor. Higher scores suggest better experience, lower scores suggest poor experience.Expectancy score is calculated by taking the sum of score of the last 3 items of the CEQ scale ranging from 3 to 27.
Measurement of Intervention Credibility Assessed With the Expectancy Score, at Week 6
时间窗: 6 weeks
The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The final three items load onto the expectancy factor. Higher scores suggest better experience, lower scores suggest poor experience.Expectancy score is calculated by taking the sum of score of the last 3 items of the CEQ scale ranging from 3 to 27.
Measurement of Intervention Credibility Assessed With the ExpectancyScore, at Week 8
时间窗: 8 weeks
The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The final three items load onto the expectancy factor. Higher scores suggest better experience, lower scores suggest poor experience.Expectancy score is calculated by taking the sum of score of the last 3 items of the CEQ scale ranging from 3 to 27.
次要结局
- Subject Retention Rate at Week 6(6 weeks)
- Subject Retention Rate at Week 8(8 weeks)
- Summary of Time-on-Task(8 weeks)