Pre-therapeutic Validation of the VR-based Exposure Scenario for CBT "ReVBEB" for the Induction of Food Craving in Patients With Bulimia and Binge Eating Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Verbal Rating Scales of food craving (VRS)
研究概览
简要总结
Food craving is a major therapeutic issue in Eating Disorders with binge eating: the Bulimia Nervosa and the Binge Eating Disorder (BED). Food craving is linked to compulsive eating and its apprehension is currently based on classic Cognitive and Behavioural Therapies (CBT). However, it remains difficult to induce in therapy and a significant number of patients do not respond to classic CBTs. The development of exposure scenarios for CBT in virtual reality (VR) has allowed a gain in efficacy and in particular therapeutic effects lasting longer after treatment. Nevertheless, the stimuli used are often simple food visuals and insufficiently consider the many factors influencing food craving (physical, psychological, socio-environmental...) and VR immersion is still limited by the use of 3D laptops (fixed) rather than wireless headsets.
详细描述
Eating Disorders-specialized clinicians from Saint-Etienne University Hospital Center (CHU) and VR-specialized engineers from National School of Engineering of Saint-Etienne (ENISE) therefore collaborated in the creation of ReVBED, a VR-based exposure scenario for CBT for the induction of food craving in eating disorders with binge eating. ReVBED offers successive exposures to multimodal stimuli in a coherent scenario and in an immersive virtual environment via a wireless VR headset.
Our first objective is to validate the effectiveness of our scenario in inducing food craving in patients with bulimia and BED.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients: who meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for Bulimia Nervosa or Binge Eating Disorder
- •Controls: paired to patients on age and level of education
排除标准
- •Patients and controls:
- •Under legal protection measure (guardianship, curatorship or safeguard of justice)
- •Having a treatment being established and / or not stabilized (declarative) able to alter the physiological data recorded and the answers to the self-questionnaires
- •Having one or more sensory deficit(s) or disorder(s) incompatible with the use of VR equipment (declarative)
- •Patients: who have already benefited from specific care targeting food craving (declarative) Controls: with a score greater than or equal to 88 on the Bulimia Test (BULIT)
结局指标
主要结局
Verbal Rating Scales of food craving (VRS)
时间窗: Change from the first exploration of virtual rooms to the last exploration (20 minutes)
Evaluate variation in food craving assessed by Verbal Rating Scales (VRS) : self-assessment from 0 to 10 with 0 = "no food craving felt" and 10 = "maximum food craving felt")
次要结局
- Verbal Rating Scales of food craving (VRS)(Change from the start of exploration of each virtual rooms to the end (5 minutes))
- Heart rate variation(Change from the start of exploration of each virtual rooms to the end (5 minutes))
- Pupillometry(Change from the start of exploration of each virtual rooms to the end (5 minutes))
- Electro-Dermal Activity(Change from the start of exploration of each virtual rooms to the end (5 minutes))
- Variations of the measurements VRS of the food craving and each of the physiological measurements of the food craving(Change from the start of exploration of each virtual rooms to the end (5 minutes))
- Variations of the VRS food craving and of the VRS anxiety of the food craving(Change from the start of exploration of each virtual rooms to the end (5 minutes))
- Verbal Rating Scales of anxiety (VRS)(Change from the start of exploration of each virtual rooms to the end (5 minutes))