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)
Primary Purpose
Bulimia Nervosa, Binge-Eating Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
experimentation of the virtual reality "RevBED"
Sponsored by
About this trial
This is an interventional other trial for Bulimia Nervosa focused on measuring food craving, virtual reality, eating disorders, bulimia nervosa, binge eating disorder
Eligibility Criteria
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)
Sites / Locations
- CHU Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
patients with bulimia or binge eating disorder
control
Arm Description
patients with bulimia or binge eating disorder
paired healthy controls
Outcomes
Primary Outcome Measures
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")
Secondary Outcome Measures
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")
Heart rate variation
Measurement of cyclical fluctuations with sensor
Pupillometry
Measurement of phase fluctuations of pupil diameters with visual sensor
Electro-Dermal Activity
Measurement of skin conductance fluctuations by amplifying the potential differences between two electrodes in contact with the subject's skin
Heart rate variation
Measurement of cyclical fluctuations with sensor
Pupillometry
Measurement of phase fluctuations of pupil diameters with visual sensor
Electro-Dermal Activity
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
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)
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)
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
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
Full Information
NCT ID
NCT05385653
First Posted
May 2, 2022
Last Updated
April 24, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT05385653
Brief Title
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)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa, Binge-Eating Disorder
Keywords
food craving, virtual reality, eating disorders, bulimia nervosa, binge eating disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cross-sectional, single-center comparative study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with bulimia or binge eating disorder
Arm Type
Experimental
Arm Description
patients with bulimia or binge eating disorder
Arm Title
control
Arm Type
Other
Arm Description
paired healthy controls
Intervention Type
Behavioral
Intervention Name(s)
experimentation of the virtual reality "RevBED"
Other Intervention Name(s)
the use of the scenario in VR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Verbal Rating Scales of food craving (VRS)
Description
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")
Time Frame
Change from the first exploration of virtual rooms to the last exploration (20 minutes)
Secondary Outcome Measure Information:
Title
Verbal Rating Scales of food craving (VRS)
Description
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")
Time Frame
Change from the start of exploration of each virtual rooms to the end (5 minutes)
Title
Heart rate variation
Description
Measurement of cyclical fluctuations with sensor
Time Frame
Change from the first exploration of virtual rooms to the last exploration (20 minutes)
Title
Pupillometry
Description
Measurement of phase fluctuations of pupil diameters with visual sensor
Time Frame
Change from the first exploration of virtual rooms to the last exploration (20 min)
Title
Electro-Dermal Activity
Description
Measurement of skin conductance fluctuations by amplifying the potential differences between two electrodes in contact with the subject's skin
Time Frame
Change from the first exploration of virtual rooms to the last exploration (20 minutes)
Title
Heart rate variation
Description
Measurement of cyclical fluctuations with sensor
Time Frame
Change from the start of exploration of each virtual rooms to the end (5 minutes)
Title
Pupillometry
Description
Measurement of phase fluctuations of pupil diameters with visual sensor
Time Frame
Change from the start of exploration of each virtual rooms to the end (5 minutes)
Title
Electro-Dermal Activity
Description
Measurement of skin conductance fluctuations by amplifying the potential differences between two electrodes in contact with the subject's skin
Time Frame
Change from the start of exploration of each virtual rooms to the end (5 minutes)
Title
Variations of the measurements VRS of the food craving and each of the physiological measurements of the food craving
Description
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.
Time Frame
Change from the start of exploration of each virtual rooms to the end (5 minutes)
Title
Verbal Rating Scales of anxiety (VRS)
Description
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")
Time Frame
Change from the first exploration of virtual rooms to the last exploration (20 minutes)
Title
Verbal Rating Scales of anxiety (VRS)
Description
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")
Time Frame
Change from the start of exploration of each virtual rooms to the end (5 minutes)
Title
Variations of the VRS food craving and of the VRS anxiety of the food craving
Description
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
Time Frame
Change from the start of exploration of each virtual rooms to the end (5 minutes)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélia GAY, MD
Phone
(0)477127750
Ext
+33
Email
aurelia.gay@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène RAINGARD, CRA
Phone
(0)477829703
Ext
+33
Email
helene.raingard@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aurélia GAY, MD
Organizational Affiliation
CHU de Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélia GAY, MD
First Name & Middle Initial & Last Name & Degree
Catherine MASSOUBRE, MD PhD
First Name & Middle Initial & Last Name & Degree
Baptiste RAVEY, MD
First Name & Middle Initial & Last Name & Degree
Vikesh BHOOWABUL, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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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)
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