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)

Bulimia Nervosa Clinical Trial

— RevBED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05385653
• Other study ID #: 21CH086
• Secondary ID: ANSM
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2023
• Est. completion date: September 2027

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Aurélia GAY, MD
• Phone: (0)477127750
• Email: aurelia.gay[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Feeding and Eating Disorders

Intervention

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.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Heart rate variation	Measurement of cyclical fluctuations with sensor	Change from the first exploration of virtual rooms to the last exploration (20 minutes)
Secondary	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)
Secondary	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)
Secondary	Heart rate variation	Measurement of cyclical fluctuations with sensor	Change from the start of exploration of each virtual rooms to the end (5 minutes)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)