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Completed

NCT Number: 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)

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.

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Key information

Conditions

Bulimia Nervosa Binge-Eating Disorder Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Saint-Etienne

Saint-Etienne, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: the use of the scenario in VR

Primary outcomes

  1. 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

  1. Verbal Rating Scales of food craving (VRS)

    Time frame: 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")

  2. Heart rate variation

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

    Measurement of cyclical fluctuations with sensor

  3. Pupillometry

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

    Measurement of phase fluctuations of pupil diameters with visual sensor

  4. Electro-Dermal Activity

    Time frame: 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

  5. Heart rate variation

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

    Measurement of cyclical fluctuations with sensor

  6. Pupillometry

    Time frame: 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

  7. Electro-Dermal Activity

    Time frame: 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

  8. Variations of the measurements VRS of the food craving and each of the physiological measurements of the food craving

    Time frame: 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.

  9. Verbal Rating Scales of anxiety (VRS)

    Time frame: 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")

  10. Verbal Rating Scales of anxiety (VRS)

    Time frame: 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")

  11. Variations of the VRS food craving and of the VRS anxiety of the food craving

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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

Acronym: RevBED

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 23, 2022
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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