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)

NCT05385653 | Completed

• 2 other identifiers: 21CH086ANSM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bulimia Nervosa; Binge-Eating Disorder

Keywords

food craving; virtual reality; eating disorders; bulimia nervosa; binge eating disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Verbal Rating Scales of food craving (VRS)

  Change from the start of exploration of each virtual rooms to the end (5 minutes)

• Heart rate variation

  Change from the first exploration of virtual rooms to the last exploration (20 minutes)

• Pupillometry

  Change from the first exploration of virtual rooms to the last exploration (20 min)

• Electro-Dermal Activity

  Change from the first exploration of virtual rooms to the last exploration (20 minutes)

• Heart rate variation

  Change from the start of exploration of each virtual rooms to the end (5 minutes)

Study Arms (2)

patients with bulimia or binge eating disorder

EXPERIMENTAL

patients with bulimia or binge eating disorder

Behavioral: experimentation of the virtual reality "RevBED"

control

OTHER

paired healthy controls

Behavioral: experimentation of the virtual reality "RevBED"

Interventions

experimentation of the virtual reality "RevBED" BEHAVIORAL

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.

Also known as: the use of the scenario in VR

control; patients with bulimia or binge eating disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aurélia GAY, MD

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-sectional, single-center comparative study

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 23, 2022
• Study Start: June 29, 2023
• Primary Completion: May 22, 2024
• Study Completion: May 28, 2024
• Last Updated: September 3, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)