Clinical trial NCT05385653: 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)
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
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia Nervosa
Binge-Eating Disorder
Keywords: food craving
virtual reality
eating disorders
bulimia nervosa
binge eating disorder
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cross-sectional, single-center comparative study
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Verbal Rating Scales of food craving (VRS)
timeFrame: Change from the first exploration of virtual rooms to the last exploration (20 minutes)
Secondary outcomes:
measure: Verbal Rating Scales of food craving (VRS)
timeFrame: Change from the start of exploration of each virtual rooms to the end (5 minutes)
measure: Heart rate variation
timeFrame: Change from the first exploration of virtual rooms to the last exploration (20 minutes)
measure: Pupillometry
timeFrame: Change from the first exploration of virtual rooms to the last exploration (20 min)
measure: Electro-Dermal Activity
timeFrame: Change from the first exploration of virtual rooms to the last exploration (20 minutes)
measure: Heart rate variation
timeFrame: Change from the start of exploration of each virtual rooms to the end (5 minutes)
measure: Pupillometry
timeFrame: Change from the start of exploration of each virtual rooms to the end (5 minutes)
measure: Electro-Dermal Activity
timeFrame: Change from the start of exploration of each virtual rooms to the end (5 minutes)
measure: Variations of the measurements VRS of the food craving and each of the physiological measurements of the food craving
timeFrame: Change from the start of exploration of each virtual rooms to the end (5 minutes)
measure: Verbal Rating Scales of anxiety (VRS)
timeFrame: Change from the first exploration of virtual rooms to the last exploration (20 minutes)
measure: Verbal Rating Scales of anxiety (VRS)
timeFrame: Change from the start of exploration of each virtual rooms to the end (5 minutes)
measure: Variations of the VRS food craving and of the VRS anxiety of the food craving
timeFrame: Change from the start of exploration of each virtual rooms to the end (5 minutes)
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Aurélia GAY, MD
role: PRINCIPAL_INVESTIGATOR
References: