Pre-therapeutic Validation of the Virtual Reality-based Exposure Scenario for CBT ReVBED for the Induction of Food Craving in Patients With Bulimia and Binge Eating Disorder (BED)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Bulimia Nervosa, Binge-Eating Disorder

Intervention / Treatment
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* Behavioral: experimentation of the virtual reality RevBED


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cross-sectional, single-center comparative study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients with bulimia or binge eating disorder<br>patients with bulimia or binge eating disorder | Behavioral: experimentation of the virtual reality RevBED<br>* ReVBED is a VR-based exposure scenario for CBT for the induction of food craving in patients with bulimia nervosa and binge eating disorder. The use of ReVBED requires no VR experience and only generic and commonly used virtual reality tools (a computer with VR software, a wireless virtual reality headset, two controllers and headphones), all with a CE mark, allowing its users to move in and interact with a specially designed virtual environment. This exhibit scenario takes place in a VR environment built to represent a standard apartment consisting of four exhibit rooms (a bedroom, a teenager's bedroom, a living room and a kitchen) in which the ReVBED user moves sequentially through the scenario. In each room, specific cues of craving are displayed. These cues are not only visual, but also audio, emotional and socio-environmental. A central hall connects the other rooms and serves as a safe place for debriefing, where measures such as craving are assessed.<br>* Other names: the use of the scenario in VR;|
| Other: control<br>paired healthy controls | Behavioral: experimentation of the virtual reality RevBED<br>* ReVBED is a VR-based exposure scenario for CBT for the induction of food craving in patients with bulimia nervosa and binge eating disorder. The use of ReVBED requires no VR experience and only generic and commonly used virtual reality tools (a computer with VR software, a wireless virtual reality headset, two controllers and headphones), all with a CE mark, allowing its users to move in and interact with a specially designed virtual environment. This exhibit scenario takes place in a VR environment built to represent a standard apartment consisting of four exhibit rooms (a bedroom, a teenager's bedroom, a living room and a kitchen) in which the ReVBED user moves sequentially through the scenario. In each room, specific cues of craving are displayed. These cues are not only visual, but also audio, emotional and socio-environmental. A central hall connects the other rooms and serves as a safe place for debriefing, where measures such as craving are assessed.<br>* Other names: the use of the scenario in VR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal Rating Scales of food craving (VRS) | 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) | Change from the first exploration of virtual rooms to the last exploration (20 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal Rating Scales of food craving (VRS) | 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) | Change from the start of exploration of each virtual rooms to the end (5 minutes) | 
| Heart rate variation | Measurement of cyclical fluctuations with sensor | Change from the first exploration of virtual rooms to the last exploration (20 minutes) | 
| Pupillometry | Measurement of phase fluctuations of pupil diameters with visual sensor | Change from the first exploration of virtual rooms to the last exploration (20 min) | 
| Electro-Dermal Activity | Measurement of skin conductance fluctuations by amplifying the potential differences between two electrodes in contact with the subject's skin | Change from the first exploration of virtual rooms to the last exploration (20 minutes) | 
| Heart rate variation | Measurement of cyclical fluctuations with sensor | Change from the start of exploration of each virtual rooms to the end (5 minutes) | 
| Pupillometry | Measurement of phase fluctuations of pupil diameters with visual sensor | Change from the start of exploration of each virtual rooms to the end (5 minutes) | 
| Electro-Dermal Activity | Measurement of skin conductance fluctuations by amplifying the potential differences between two electrodes in contact with the subject's skin | 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 | Correlation between the variations of the VRS measurements and each of the physiological measurements (HRV, pupillometry and EDA) of the food craving induced in patients with bulimia and BED, compared to matched healthy controls. | Change from the start of exploration of each virtual rooms to the end (5 minutes) | 
| Verbal Rating Scales of anxiety (VRS) | Evaluate variation of anxiety assessed by Verbal Rating Scales (VRS : self-assessment from 0 to 10 with 0 = no food craving felt and 10 = maximum food craving felt) | Change from the first exploration of virtual rooms to the last exploration (20 minutes) | 
| Verbal Rating Scales of anxiety (VRS) | Evaluate variation of anxiety assessed by Verbal Rating Scales (VRS) : self-assessment from 0 to 10 with 0 = no food craving felt and 10 = maximum food craving felt) | 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 | Correlation between the variations Food Craving Verbal Rating Scales and Anxiety Verbal Rating Scales (VRS : self-assessment from 0 to 10 with 0 = no felt and 10 = maximum felt) the VRS food craving and VRS anxiety | Change from the start of exploration of each virtual rooms to the end (5 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food craving, virtual reality, eating disorders, bulimia nervosa, binge eating disorder