Bulimia NervosaRevBEDNCT05385653
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)
A study testing experimentation of the virtual reality "RevBED" in people with Bulimia Nervosa and Binge-Eating Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bulimia Nervosa, Binge-Eating Disorder
- What is being tested?
- experimentation of the virtual reality "RevBED"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2023to 28 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Bulimia Nervosa, Binge-Eating Disorder
- Being tested
- experimentation of the virtual reality "RevBED"
- Keywords
- food craving, virtual reality, eating disorders, bulimia nervosa, binge eating disorder
- Medical subject headings
- Bulimia Nervosa, Binge-Eating Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimentation of the virtual reality "RevBED"Behavioural
Also called the use of the scenario in VR
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.
| Study group | Role | What they receive |
|---|---|---|
| patients with bulimia or binge eating disorder | Experimental | patients with bulimia or binge eating disorder Receives: Behavioral: experimentation of the virtual reality "RevBED" |
| control | Other | paired healthy controls Receives: Behavioral: experimentation of the virtual reality "RevBED" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: Change from the first exploration of virtual rooms to the last exploration (20 minutes)
Secondary outcomes (11)
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")
Measured: Change from the start of exploration of each virtual rooms to the end (5 minutes)
Heart rate variation
Measurement of cyclical fluctuations with sensor
Measured: Change from the first exploration of virtual rooms to the last exploration (20 minutes)
Pupillometry
Measurement of phase fluctuations of pupil diameters with visual sensor
Measured: Change from the first exploration of virtual rooms to the last exploration (20 min)
Electro-Dermal Activity
Measurement of skin conductance fluctuations by amplifying the potential differences between two electrodes in contact with the subject's skin
Measured: Change from the first exploration of virtual rooms to the last exploration (20 minutes)
Heart rate variation
Measurement of cyclical fluctuations with sensor
Measured: Change from the start of exploration of each virtual rooms to the end (5 minutes)
Pupillometry
Measurement of phase fluctuations of pupil diameters with visual sensor
Measured: Change from the start of exploration of each virtual rooms to the end (5 minutes)
Electro-Dermal Activity
Measurement of skin conductance fluctuations by amplifying the potential differences between two electrodes in contact with the subject's skin
Measured: 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
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.
Measured: Change from the start of exploration of each virtual rooms to the end (5 minutes)
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")
Measured: Change from the first exploration of virtual rooms to the last exploration (20 minutes)
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")
Measured: 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
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
Measured: Change from the start of exploration of each virtual rooms to the end (5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start29 Jun 2023
- Primary completion22 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cross-sectional, single-center comparative study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélia GAY, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385653
- Sponsor's protocol ID
- 21CH086
- Other IDs
- ANSM
- Acronym
- RevBED
- Status last verified
- Nov 2023
- First submitted
- 2 May 2022
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05385653
- Acronym / sponsor ID
- RevBED / 21CH086
- Conditions
- Bulimia Nervosa, Binge-Eating Disorder
- Keywords
- food craving, virtual reality, eating disorders, bulimia nervosa, binge eating disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-sectional, single-center comparative study
| Arm | Type | Receives |
|---|---|---|
| patients with bulimia or binge eating disorder | Experimental | Behavioral: experimentation of the virtual reality "RevBED"patients with bulimia or binge eating disorder |
| control | Other | Behavioral: experimentation of the virtual reality "RevBED"paired healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimentation of the virtual reality "RevBED"Also: the use of the scenario in VRReVBED 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. | Behavioural | control, patients with bulimia or binge eating disorder |
Primary outcome
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")
11 secondary outcomes
Verbal Rating Scales of food craving (VRS)
Time frame: Change from the start of exploration of each virtual rooms to the end (5 minutes)
Heart rate variation
Time frame: Change from the first exploration of virtual rooms to the last exploration (20 minutes)
Pupillometry
Time frame: Change from the first exploration of virtual rooms to the last exploration (20 min)
Electro-Dermal Activity
Time frame: Change from the first exploration of virtual rooms to the last exploration (20 minutes)
Heart rate variation
Time frame: Change from the start of exploration of each virtual rooms to the end (5 minutes)
Pupillometry
Time frame: Change from the start of exploration of each virtual rooms to the end (5 minutes)
Electro-Dermal Activity
Time frame: 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
Time frame: Change from the start of exploration of each virtual rooms to the end (5 minutes)
Verbal Rating Scales of anxiety (VRS)
Time frame: Change from the first exploration of virtual rooms to the last exploration (20 minutes)
Verbal Rating Scales of anxiety (VRS)
Time frame: 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
Time frame: Change from the start of exploration of each virtual rooms to the end (5 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélia GAY, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimentation of the virtual reality "RevBED" in people with Bulimia Nervosa and Binge-Eating Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Rating Scales of food craving (VRS) (time frame: Change from the first exploration of virtual rooms to the last exploration (20 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.