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) (RevBED)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Binge-Eating Disorder; Bulimia Nervosa
• Intervention / Treatment: Behavioral: experimentation of the virtual reality "RevBED"

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurélia GAY, MD; Phone Number: +33 (0)477127750; Email: aurelia.gay@chu-st-etienne.fr
• Study Contact Backup: Name: Hélène RAINGARD, CRA; Phone Number: +33 (0)477829703; Email: helene.raingard@chu-st-etienne.fr

Study Locations

• France
  • Saint-Etienne, France
    • Recruiting
    • CHU Saint-Etienne
    • Sub-Investigator: Baptiste RAVEY, MD
    • Principal Investigator: Aurélia GAY, MD
    • Sub-Investigator: Catherine MASSOUBRE, MD PhD
    • Sub-Investigator: Vikesh BHOOWABUL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with bulimia or binge eating disorder	Behavioral: experimentation of the virtual reality "RevBED"; 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.; Other Names: the use of the scenario in VR
Other: control; paired healthy controls	Behavioral: experimentation of the virtual reality "RevBED"; 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.; Other Names: the use of the scenario in VR

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Aurélia GAY, MD, CHU DE SAINT-ETIENNE

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: virtual reality; eating disorders; food craving; bulimia nervosa; binge eating disorder
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bulimia Nervosa
• Other Study ID Numbers: 21CH086; ANSM (Other Identifier: 2024-A00286-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No