A Randomized Controlled Efficacy Trial of a Telemedicine-based Virtual Reality Clinic for the Treatment of Phobias
2026年4月23日 更新者：University of South Florida
Doxy.me VR vs. Telemental Health-Based Exposure Therapy: Phase II
The goal of this clinical trial is to learn if a telemedicine-based virtual reality clinic (Doxy.me VR) works to treat dog, spider, and snake phobias in adults. The main questions it aims to answer are:
Does Doxy.me VR decrease the severity of phobias better than traditional telemedicine-based treatment? Does this work because it feels more realistic than telemedicine alone?
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
240
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。
学习联系方式
- 姓名：Maureen Jacobs Plaisimond
- 电话号码：813-396-0060
- 邮箱：MCOM-VRStudy@usf.edu
学习地点
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Florida
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Tampa、Florida、美国、33613
- University of South Florida
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接触：
- Maureen Jacobs Plaisimond
- 电话号码：813-396-0060
- 邮箱：MCOM-VRStudy@usf.edu
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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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
Individuals will be eligible if they: (1) are an adult (≥18 years old); (2) have a self-reported fear of dogs, snakes, and/or spiders; (3) score 89 ≥ on the FSQ OR 24 ≥ on the SNAQ OR 147 ≥ on the DPQ; and (4) have access to the internet AND a computer OR smartphone with video conferencing capabilities.
Exclusion Criteria:
Individuals will be ineligible to participate if they: (1) are participating in ongoing mental health therapy from a non-study therapist; (2) changed psychiatric medication use within the past 6 weeks; (3) report active auditory, visual, and/or tactile hallucinations via the DART Psychosis Module screening question; (4) report active health conditions requiring upcoming planned or likely hospitalization or intensive treatment that will prevent them from participating; (5) report active legal proceedings that might lead to incarceration during the study period that would prevent them from participating; (6) report an unstable housing situation (eg., eviction or homelessness); (7) have experienced photosensitive seizures within the prior 6 months; (8) endorse more than 20% of symptom validity questions.
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 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：Telemedicine-based Virtual Reality Exposure Therapy
This group will receive exposure therapy in a telemedicine-based Virtual Reality Clinic using virtual reality snakes, dogs, or spiders.
The VR stimuli range from small to medium to large and have four activity levels: idle, calm, energetic, and aggressive.
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Participants will complete 7 60-minute exposure therapy sessions in a Virtual Reality Clinic using Virtual Reality stimuli and progress to in vivo exposures. Other Name: |
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有源比较器：Standard Telemedicine-Based Exposure Therapy
This group will receive exposure therapy via Doxy.me
telemedicine platform using photos and videos of snakes, dogs, or spiders.
The photo/video stimuli range from small to medium to large and have four activity levels: idle, calm, energetic, and aggressive.
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Participants will complete 7 60-minute exposure therapy sessions using photos/videos and progress to in vivo exposures.
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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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Phobia symptom severity
大体时间：Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Severity Measure for Specific Phobia (SMSP) is a 10-item self-report questionnaire that assesses the severity of specific phobia symptoms relative to an individual's feared stimulus.
Total scores range from 0 to 4 with higher scores indicating higher phobia severity.
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Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Dog Phobia Severity
大体时间：Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Dog Phobia Questionnaire (DPQ) is a 27-item, self-report questionnaire assessing the severity of dog phobia symptoms.
Scores range from 27 to 189 with higher scores indicating higher phobia severity.
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Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Snake Phobia Severity
大体时间：Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Snake Anxiety Questionnaire (SNAQ) is a 30-item self-report questionnaire assessing the severity of snake phobia symptoms.
Scores range from 0 to 30 with higher scores indicating higher phobia severity.
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Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Spider Phobia Severity
大体时间：Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Fear of Spiders Questionnaire (FSQ) is an 18-item self-report questionnaire assessing the severity of spider phobia symptoms.
Scores range from 18 to 126 with higher scores indicating higher phobia severity.
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Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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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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Specific Phobia Diagnosis
大体时间：Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Diagnostic Assessment Research Tool (DART) is a modular semi structured interview corresponding with the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5).
Study therapists administer the DART Specific Phobia Module, which provides designations of Absent, Subthreshold, and Present.
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Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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General Anxiety
大体时间：Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure of anxiety symptom severity.
Scores range from 0 to 15 with higher scores indicating higher anxiety severity.
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Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Depression Severity
大体时间：Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Patient Health Questionnaire-8 (PHQ-8) is an 8-item self-report measure of depression symptom severity.
Scores range from 0 to 27 with higher scores indicating higher depression severity.
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Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Quality of Life Level
大体时间：Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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The Quality of Life Scale (QOLS) is a 16-item self-report measure of quality of life.
Scores range from 16 to 112 with higher scores indicating better quality of life.
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Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Level of Telepresence
大体时间：Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
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The iGroup Presence Questionnaire (iPQ) is a 14-item self-report questionnaire of telepresence.
Scores on each subscale range from 0-6 with higher scores indicating more presence.
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Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
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Cybersickness Severity
大体时间：Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
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The Cybersickness in Virtual Reality Questionnaire (CSQ-VR) is an 6-item measure of nausea, vestibular, and oculomotor cybersickness experienced in virtual reality.
Scores range from 6 to 27 with higher scores indicating higher levels of cybersickness.
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Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
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Level of Working (Therapeutic) Alliance
大体时间：4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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The Working Alliance Inventory (WAI-SR) is a 12-item client-rated measure of therapeutic alliance.
Total scores range from 1 to 5 with higher scores indicating a better therapeutic alliance.
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4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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Satisfaction with Therapy
大体时间：4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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The Satisfaction with Therapy and Therapist Scale-Revised (STTS-R) is a 13-item self-report questionnaire that assesses client satisfaction with treatment.
Scores range from 0 to 60 with higher scores indicating higher satisfaction.
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4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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System Usability
大体时间：4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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The System Usability Scale (SUS) is a 10-item self-report measure of the usability of a particular software system, platform, or app.
Scores range from 0-100 with higher scores indicating better usability.
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4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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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。
调查人员
- 首席研究员：Brian E. Bunnell, PhD、University of South Florida
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 (估计的)
2026年4月1日
初级完成 (估计的)
2027年12月1日
研究完成 (估计的)
2028年1月1日
研究注册日期
首次提交
2026年4月23日
首先提交符合 QC 标准的
2026年4月23日
首次发布 (实际的)
2026年4月30日
研究记录更新
最后更新发布 (实际的)
2026年4月30日
上次提交的符合 QC 标准的更新
2026年4月23日
最后验证
2026年2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.