RevBED: 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)

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05385653

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bulimia Nervosa Binge-Eating Disorder	Behavioral: experimentation of the virtual reality "RevBED"	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cross-sectional, single-center comparative studyCross-sectional, single-center comparative study

Masking:

None (Open Label)

Primary Purpose:

Other

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patients with bulimia or binge eating disorder 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

Arm

Intervention/Treatment

Experimental: patients with bulimia or binge eating disorder

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"

Other Names:

the use of the scenario in VR

Outcome Measures

Primary Outcome Measures

Verbal Rating Scales of food craving (VRS) [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")

Secondary Outcome Measures

Verbal Rating Scales of food craving (VRS) [Change from the start of exploration of each virtual rooms to the end (5 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")
Heart rate variation [Change from the first exploration of virtual rooms to the last exploration (20 minutes)]
Measurement of cyclical fluctuations with sensor
Pupillometry [Change from the first exploration of virtual rooms to the last exploration (20 min)]
Measurement of phase fluctuations of pupil diameters with visual sensor
Electro-Dermal Activity [Change from the first exploration of virtual rooms to the last exploration (20 minutes)]
Measurement of skin conductance fluctuations by amplifying the potential differences between two electrodes in contact with the subject's skin
Heart rate variation [Change from the start of exploration of each virtual rooms to the end (5 minutes)]
Measurement of cyclical fluctuations with sensor
Pupillometry [Change from the start of exploration of each virtual rooms to the end (5 minutes)]
Measurement of phase fluctuations of pupil diameters with visual sensor
Electro-Dermal Activity [Change from the start of exploration of each virtual rooms to the end (5 minutes)]
Measurement of skin conductance fluctuations by amplifying the potential differences between two electrodes in contact with the subject's skin
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)]
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.
Verbal Rating Scales of anxiety (VRS) [Change from the first exploration of virtual rooms to the last exploration (20 minutes)]
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")
Verbal Rating Scales of anxiety (VRS) [Change from the start of exploration of each virtual rooms to the end (5 minutes)]
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")
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)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)