Safety and Feasibility of Virtual Reality Therapy for Functional Neurological Symptom/Conversion Disorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Adherence
研究概览
简要总结
The purpose of this study is to design and test the safety and feasibility of virtual reality technologies and experiences of egocentric avatar embodiment in the application of physical and cognitive behavior therapy in functional neurological symptom/conversion disorder. Investigators hypothesize that patients will safely use and accept this modality of treatment and will show evidence of a decrease in symptom frequency.
详细描述
This is a treatment development trial, participants randomly assigned to active treatment will be enrolled in embodied Virtual Reality therapy. The therapy will be based on principals of exposure and behavioral shaping therapies and mirror visual feedback therapy. The therapy will be delivered over 8 sessions and modified as indicated by clinical feedback. A fixed protocol will be developed with exact methods to be used to be determined. After a fixed protocol has been established, a treatment manual will be created to use in further controlled trials.
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
- Single (Participant)
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
- •Adults 18-65 years, who are diagnosed with functional neurologic symptom or conversion disorder. If diagnosis of seizure type then video EEG with diagnosis confirmed by board-certified neurologist with subspecialty training in epilepsy and clinical neurophysiology using the criteria of the International Classification of the Epilepsies is required. If diagnosis of motor type, documented and clinically established levels of diagnostic certainty (Williams,1995) confirmed by 2 neurologists is required.
- •Participants must have at least one symptom per month in the month prior to enrollment
- •Fluency in English spoken language
排除标准
- •Nonfluency or inability to communicate in English spoken language
- •Inability to participate or attend biweekly 30 minute session over 14 weeks
- •Frank psychosis
- •Active self harm urges
- •Serious medical illness
- •Active substance or alcohol use or dependence that could interfere with participation
- •Diagnoses of mental retardation, dementia or delirium
- •Pregnant women
结局指标
主要结局
Adherence
时间窗: Number of sessions attended over 12 weeks
Number of sessions attended over 12 weeks recorded by therapist
次要结局
- Global Assessment of Functioning (GAF)(baseline, 6weeks, then 6,9,12 months)
- Generalized Anxiety Disorder 7-item (GAD-7) scale(baseline, biweekly for 6weeks then 6,9,12 months)
- Frequency and severity of functional symptoms(baseline, biweekly for 6 weeks then 6,9,12 months)
- Frequency of adverse events(baseline, biweekly for 6 weeks then 6,9,12 months)
- General Self-Efficacy Scale(baseline, biweekly for 6weeks, then 6,9,12 months)
- Patient Health Questionnaire-9 (PHQ-9)(baseline, biweekly for 6weeks then 6,9,12 months)
- Oxford Handicap Scale(baseline, 6weeks, then 6,9,12 months)
研究者
Kim Bullock, MD
Clinical Associate Professor
Stanford University