Pilot Study of Virtual Reality for Providing Exposure Therapy to Children
2018年4月23日 更新者：Minnesota HealthSolutions
Low-Cost, Virtual Reality System to Increase Access to Exposure Therapy for Anxiety and Obsessive Compulsive Disorders
Drs. from the Mayo Clinic Rochester will plan and execute a feasibility study of the phase I prototype version of the Virtual Reality exposure therapy system.
Dr. X, who has significant experience in evaluating patient experiences and opinions of technologies intended to change behavior, will oversee a qualitative study to examine the prototype system.
Twenty children with generalized anxiety disorder with perfectionism who have received less than 3 treatment sessions and a parent will be recruited to pilot the Virtual Reality system.
研究概览
详细说明
Twenty children with generalized anxiety disorder (perfectionism) who have received less than 3 treatment sessions and a parent will be recruited to pilot the Virtual Reality system.
Participants will be identified through the Mayo Clinic Pediatric Anxiety Disorders Clinic (PADC) using purposive sampling methods.
Each patient will participate in a single (up to) 2-hour visit, allowing for breaks as needed.
Staff from Mayo Clinic HealthCare Policy & Research experienced in qualitative data analysis and not involved with the patients' medical care or development of the prototype system will conduct the study visits.
During the first 30 minutes the patient and parent will be introduced to the Virtual Reality system and the rationale for this feasibility study.
Next, a therapist from the PADC, all of whom are experienced exposure therapists, will lead the patient through exposure exercises using the Virtual Reality system for up to 30 minutes.
During the next period, up to 30 minutes, the therapist will go to a different room and the patient, with support from their parent, will complete exposure exercises using the Virtual Reality system that the therapist directed them to complete.
During the exposures the interviewer will observe, code and record the patient's interaction with the Virtual Reality system.
The data from the Virtual Reality system will be automatically transmitted to a cloud service running on a local laptop to study the effectiveness of the system's automatic logging capabilities.
For the remaining time (up to 30 minutes) the interviewer will interview the patient about his or her experience with the Virtual Reality system and then will ask for observations and opinions from the parent.
研究类型
介入性
注册 (实际的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
7年 至 12年 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- diagnosis of Generalized Anxiety Disorder with perfectionism and have received less than three treatment sessions
Exclusion Criteria:
- too young to safely and effectively participate with the study materials
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Pilot virtual reality
Children with anxiety will have a single visit to test the virtual reality system and measure its affects on their anxiety ratings.
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Exposure to a virtual reality vignette with anxiety rating to support exposure therapy
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Qualitative response to the system as assessed by observation while using the system and interview following use.
大体时间：through study completion, an average of one day study visit
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Twenty participants will provide qualitative data about their experience using the system.
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through study completion, an average of one day study visit
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Anxiety as assessed by the Subjective Units of Distress Scale
大体时间：through study completion, an average of one day study visit
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Anxiety for each of the twenty participants will be assessed using SUDS prior to and after each time repeating the exposure.
Participants will self-select how many times to repeat the exposure during the one day study visit.
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through study completion, an average of one day study visit
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年9月1日
初级完成 (实际的)
2018年1月31日
研究完成 (实际的)
2018年1月31日
研究注册日期
首次提交
2017年6月1日
首先提交符合 QC 标准的
2017年7月1日
首次发布 (实际的)
2017年7月5日
研究记录更新
最后更新发布 (实际的)
2018年4月24日
上次提交的符合 QC 标准的更新
2018年4月23日
最后验证
2018年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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