Doxy.me VR vs. Telemental Health-Based Exposure Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Phobia symptom severity
研究概览
简要总结
The purpose of this study is to assess the feasibility of conducting a randomized controlled efficacy trial comparing the delivery of exposure therapy via a telemedicine-based virtual reality clinic (Doxy.me VR) vs. standard telemental health (TMH) to adults with intense fear of dogs, snakes, and/or spiders. The secondary purpose is to preliminarily examine the efficacy of using Doxy.me VR vs. TMH in reducing phobia severity.
详细描述
This study aims to assess the feasibility of conducting a randomized controlled efficacy trial comparing the delivery of exposure therapy via a telemedicine-based virtual reality clinic (Doxy.me VR) vs. standard telemental health (TMH) to adults with intense fear of dogs, snakes, and/or spiders. This study will use feasibility randomized controlled efficacy trial design. This single-site trial will include up to 60 adults with self-reported fear of dogs, snakes, and/or spiders who will be randomly assigned via the REDCap Randomization Module using a 1:1 allocation ratio to receive 12 sessions of exposure therapy over the course of 3 months via standard telemental health (TMH; n=15) vs. Doxy.me VR (n=15), a telemedicine-based virtual reality clinic.
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
- 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
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Is an adult ≥ 18 years old
- •Has a self-reported fear of dogs, snakes, and/or spiders
- •Indicates Subthreshold or Present Specific Phobia symptoms as determined by the study therapist via administration of the Diagnostic Assessment Research Tool (DART) Specific Phobia Module
- •Has access to the internet AND a computer OR smartphone with video conferencing capabilities
- •Will reside in the state of Florida for the duration of the study
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Is participating in ongoing mental health therapy from a non-study therapist
- •Has had changes to psychotropic medication use within six weeks preceding enrollment in the trial
- •Reports active suicidal and/or homicidal intent or plan as determined by the study therapist via administration of the Diagnostic Assessment Research Tool (DART) Risk Assessment Module
- •Reports active auditory, visual, and/or tactile hallucinations via the Diagnostic Assessment Research Tool (DART) Psychosis Module screening question
- •Reports having a diagnosis of photosensitive epilepsy by a medical doctor or a history of experiencing seizures that they believe were caused by photosensitivity
研究组 & 干预措施
Standard Telemedicine 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.
干预措施: Telemedicine Exposure Therapy Using Photos and Videos (Behavioral)
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.
干预措施: Telemedicine-Based Virtual Reality Exposure Therapy (Behavioral)
结局指标
主要结局
Phobia symptom severity
时间窗: 3 Month Follow-Up
The Severity Measure for Specific Phobia (SMSP) will be used to assess changes in phobia symptom severity at the 3 Month Follow-Up. Each item on the measure is rated on a 5-point scale (0=Never; 1=Occasionally; 2=Half of the time; 3=Most of the time, and 4=All of the time). The total score can range from 0 to 40 with higher scores indicating greater severity of specific phobia. The clinician will use an average total score, which reduces the overall score to a 5-point scale, which allows the clinician to think of the severity of the individual's specific phobia in terms of none (0), mild (1), moderate (2), severe (3), or extreme (4).
次要结局
未报告次要终点