NCT05291429已完成不适用
Study to Identify if OVR Health's VR-Kit is Safe to Use and Helps Individuals to Improve Focus, Attention and Reduce Worry & Rumination.
Oxford VR2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年2月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Safety of virtual reality device and reduction in worry and rumination (Perseverative Thinking score )
研究概览
简要总结
This is a randomized-controlled interventional treatment study with three arms of comparable demographics to evaluate the safety and efficacy of OVR Health's VR experience to improve control over the focus of attention and reduce worry and rumination in individuals who have reported problems with these issues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over 18 years old
- •Must be in good general health
- •Self-reported with the following symptoms (as assessed by questions and questionnaires in study material):
- •Finding it hard to let go of difficult thoughts.
- •Looking out for signs of a potential threat in their environment (or in their body) that unhelpfully maintains their problem.
- •Engaging in repetitive, unhelpful patterns of negative thinking (worry & rumination). • These may be due to a diagnosis of a mental health condition, but this is not required for entry into the study.
- •Good understanding of written and spoken English
- •Willing and able to give informed consent
- •Willing and able to follow the study protocol
- •Willing and able to use VR headset at home
- •WiFi connection to connect VR headset at home
- •Willing and able to return VR headset
排除标准
- •Current diagnosis of epilepsy, dementia, or another neurological disease that may prevent the use of VR hardware and software
- •Individuals with suicidal or self-harm thoughts
- •Significant visual, auditory, or balance impairment
- •Insufficient comprehension of English
- •Primary diagnosis of alcohol or substance abuse disorder, or personality disorder • Significant learning disability
- •Current active suicidal plans or self-harm (in which case participant will be referred to appropriate crisis service)
- •Receiving current alternative psychotherapy treatment
- •Unwilling to provide consent
- •Unwilling to follow the study protocol
结局指标
主要结局
Safety of virtual reality device and reduction in worry and rumination (Perseverative Thinking score )
时间窗: 5 weeks
Changes in perceived safety using the Perseverative Thinking score (Scale 0-4).
Safety of virtual reality device and reduction in worry and rumination (PHQ9)
时间窗: 5 weeks
Changes in perceived safety using the PHQ9 questionnaire (Scale 0-3).
次要结局
- Impact of coaching on virtual reality intervention effectiveness (PHQ9)(5 weeks)
- Impact of coaching on virtual reality intervention effectiveness (Perseverative Thinking scor)(5 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and PrednisoneMultiple MyelomaNCT00507416Millennium Pharmaceuticals, Inc.502
已完成
4 期
Different Application Rates of Crisaborole Ointment 2% in Adults With Mild to Moderate Atopic DermatitisDermatitis, AtopicNCT03868098Innovaderm Research Inc.31
已完成
3 期
Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)Dry Eye DiseaseNCT05360966Aerie Pharmaceuticals467
已完成
3 期
Study Evaluating the Safety and Efficacy of AR-15512Dry Eye DiseaseNCT05285644Aerie Pharmaceuticals465
已完成
2 期
Safety and Efficacy of Intravitreal Fluocinolone Acetonide Implants in Patients With Diabetic Macular EdemaDiabetic Macular EdemaNCT00576459Bausch & Lomb Incorporated40