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Clinical Trials/NCT05385653
NCT05385653
Recruiting
Not Applicable

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

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country60 target enrollmentJune 29, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bulimia Nervosa
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
60
Locations
1
Primary Endpoint
Verbal Rating Scales of food craving (VRS)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 29, 2023
End Date
September 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

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)

Outcomes

Primary Outcomes

Verbal Rating Scales of food craving (VRS)

Time Frame: 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 Outcomes

  • 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 start of exploration of each virtual rooms to the end (5 minutes))
  • Pupillometry(Change from the start of exploration of each virtual rooms to the end (5 minutes))
  • Electro-Dermal Activity(Change from the start of exploration of each virtual rooms to the end (5 minutes))
  • 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))
  • 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))
  • Verbal Rating Scales of anxiety (VRS)(Change from the start of exploration of each virtual rooms to the end (5 minutes))

Study Sites (1)

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