Anorexia NervosaPROSANORNCT04804800
Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa
A study testing Experimental group 1 : Virtual Reality and Experimental group 2 : Virtual Reality + Multi Sensorial Remediation in people with Anorexia Nervosa and Dysmorphophobia, run by Lille Catholic University.
Trial summary
Body distortions are responsible for anorexic behavior reinforcing loops. It is necessary to target this behavior and develop appropriate therapies taking into account the perceptual (implicit) and conceptual (explicit) phenomenon of body representations. Read more about this study
- Who is it for?
- Ages 15 to 26 years, women only
- Conditions the study is for
- Anorexia Nervosa, Dysmorphophobia
- What is being tested?
- Experimental group 1 : Virtual Reality and Experimental group 2 : Virtual Reality + Multi Sensorial Remediation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to May 2026
- 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 15 to 26 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Female
- Age ≥ 15 to ≤ 26 years old
- Anorexic nervosa eating disorder according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5). As patients are hospitalized for anorexic nervosa, the medical diagnosis of each care center participating in the inclusions will be trusted
- Patient hospitalized (full hospitalization or day hospital) in one of the investigative centers for a minimum period of 6 weeks
- 14 ≤ BMI ≤ 18.5 for adult patients. For minors, Cole's curves will be used. The Body mass index (BM)I should be between the 1st percentile and the 10th percentile (if the weight curve shows a clear break indicating abnormal weight loss). For example, for a 15-year-old girl, the BMI should be between 14.5 and 16.8.
- Presence of body distortion (BSC ≥ 20%)
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- French language mastery
- Affiliation to a social security system
- Signature of informed consent to participate in this study by the patient and by her parents in the case of underage patients
Who cannot join
- Associated major mental disorders (psychotic disorders, bipolar disorders, major depression)
- Neurological disorders (pyramidal or extrapyramidal syndromes)
- Substance addiction (drugs, alcohol)
- Any disorder likely to impair the reasoning, discernment or judgment abilities
- Psychological incapacity to answer the questionnaires
- Medical contraindication to the practice of physical activity (identical contraindication to people without anorexia. In fact, appropriate physical activity is prescribed in anorexic patients in order to reduce the cardiovascular risks, osteopenia or anxiety and allow them to become aware of an adapted physical practice (reduction of anarchic physical hyperactivity)
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- Participation in other research programs or psychomotor treatments in parallel
- Pregnant or breastfeeding woman
- Persons under guardianship, curatorship or legal protection
- Blindness, eye infections, mask wounds, poorly balanced epilepsy, psychiatric disorders incompatible with virtual reality
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa : Comparison of the Recommended Management and Virtual Reality Care Programs With or Without Multisensory Remedy
Body distortions are responsible for anorexic behavior reinforcing loops. It is necessary to target this behavior and develop appropriate therapies taking into account the perceptual (implicit) and conceptual (explicit) phenomenon of body representations.
The main originality of the proposed program consists on combining virtual visual impulses and multisensory recalibration (touch, proprioception, vestibular sensations) in order to compare the body distortions evolution in anorexic patients with or without a multimodal care program including Virtual Reality from its own body scan, coupled or not to a multisensory remediation.
Read the detailed description
Rapid weight loss associated with mental anorexia leads to dysmorphophobia and body distortions. Patients perceive themselves to be bigger than they really are. Body distortions are responsible for anorexic behavior reinforcing loops. It is then necessary to target this behavior and develop appropriate therapies taking into account the perceptual (implicit) and conceptual (explicit) phenomenon of body representations.
The current treatment programs which are recommended by the Haute Autorité de Santé (HAS) in France focus on the somatic, nutritional, individual and family psychological aspects. These recommendations hardly mention the bodily distortion phenomenon which frequently leads patients to relapse into the disease.
The 3D body scanner enables to get awareness of the body through visual feedback allowing the patient to get a reassuring overview of her weight development.
This projects aims to combine virtual visual impulses and multisensory recalibration (touch, proprioception, vestibular sensations) in order to compare the body distortions evolution in anorexic patients with or without a multimodal care program including Virtual Reality from its own body scan coupled or not to a multisensory remediation.
- Conditions
- Anorexia Nervosa, Dysmorphophobia
- Being tested
- Experimental group 1 : Virtual Reality, Experimental group 2 : Virtual Reality + Multi Sensorial Remediation
- Keywords
- Anorexia Nervosa, Dysmorphophobia, Body distortions, Multisensory remediation, Virtual Reality
- Medical subject headings
- Anorexia Nervosa, Body Dysmorphic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental group 1 : Virtual RealityOther
Patients benefit from the care recommended by the HAS, the virtual reality program and time for relaxation and body scan.
Experimental group 2 : Virtual Reality + Multi Sensorial RemediationOther
Patients benefit from the care recommended by the HAS, the virtual reality program, the multisensory remediation, and also the body scan.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The patients benefit from the care recommended by the HAS. They benefit from psychological interviews, psychiatric follow-up, dietetic follow-up, family interviews and therapy. Body therapies (physiotherapy, massage, fascia therapy, psychomotor skills, dance therapy, etc.) may also take place. Patients will also benefit from relaxation and body scan. |
| Experimental group 1 : Virtual Reality | Experimental | The patients benefit from the care recommended by the HAS, the virtual reality program and time for relaxation and body scan (1 hour). Receives: Other: Experimental group 1 : Virtual Reality |
| Experimental group 2 : Virtual Reality + Multi Sensorial Remediation | Experimental | The patients benefit from the care recommended by the HAS, the virtual reality and the multisensory remediation programs, and also the body scan. Receives: Other: Experimental group 2 : Virtual Reality + Multi Sensorial Remediation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Dimensions Estimation task
Body overestimation bias will be assessed by the Body Dimensions Estimation task.
Measured: 6 weeks
Secondary outcomes (6)
Change in Body Shape Questionnaire
The womens body image concerns will be evaluated by the Body Shape Questionnaire. This 34-items questionnaire is scored from 1 (= never) to 6 (= always) to obtain a global score.
Measured: 6 weeks
Change in Physical self description questionnaire
The Physical self description will be measured by the Physical Self Description Questionnaire (PSQD). This questionnaire estimates 11 sub-dimensions of the physical self from 70 items on a continuum ranging from 1 (very negative perception) to 6 (very positive perception).
Measured: 6 weeks
Change in Body Image Questionnaire
Patients bodily satisfaction will be assessed by the Body Image Questionnaire. This questionnaire consists of 19 items scored on 5 points. It gives a total body satisfaction score between 19 and 95 and 4 scores relative to 4 different factors (accessibility/closure, satisfaction/dissatisfaction, active/passive, serenity/tension).
Measured: 6 weeks
Change in Weight gain
Weight gain will be measured by weighting.
Measured: 6 weeks
Change in Eating Disorder Examination Questionnaire
Eating disorders will be assessed by the Eating Disorder Examination Questionnaire (EDE-Q). This questionnaire is divided into several sub-scores: restriction, dietary concerns, body shape concerns and weight concerns. It has 30 items scored from 0 (= no day) to 6 (= every day). A score for each subscale and an overall score can be obtained.
Measured: 6 weeks
Anxiety measured by the State-Trait Anxiety Inventory (STAI-Etat-Trait)
Anxiety will be measured by the STAI-Etat-Trait . Each of the dimensions (STAI-state and Stai-trait) are measured by 20 items scored from 1 (= no or never) to 4 (= yes or almost always) which is summarized by a score.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study startSep 2022 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study presents three groups of patients : * The control group : The patients benefit from the care recommended by the HAS, relaxation times and body scan. * The experimental group 1 : The patients benefit from the care recommended by the HAS, the virtual reality program and relaxation times and body scan. * The experimental group 2 : The patients benefit from the care recommended by the HAS, the virtual reality program, the multi-sensory remediation and relaxation times and body scan.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Dodin, PhD, Principal investigator, Hôpital Saint-Vincent de Paul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804800
- Sponsor's protocol ID
- RC-P0089
- Acronym
- PROSANOR
- Status last verified
- Jan 2022
- First submitted
- 16 Mar 2021
- Last updated
- 6 Jan 2022
- 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 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa : Comparison of the Recommended Management and Virtual Reality Care Programs With or Without Multisensory Remedy
- ClinicalTrials.gov ID
- NCT04804800
- Acronym / sponsor ID
- PROSANOR / RC-P0089
- Conditions
- Anorexia Nervosa, Dysmorphophobia
- Keywords
- Anorexia Nervosa, Dysmorphophobia, Body distortions, Multisensory remediation, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Mar 2021 (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.
Body distortions are responsible for anorexic behavior reinforcing loops. It is necessary to target this behavior and develop appropriate therapies taking into account the perceptual (implicit) and conceptual (explicit) phenomenon of body representations.
The main originality of the proposed program consists on combining virtual visual impulses and multisensory recalibration (touch, proprioception, vestibular sensations) in order to compare the body distortions evolution in anorexic patients with or without a multimodal care program including Virtual Reality from its own body scan, coupled or not to a multisensory remediation.
Detailed description
Rapid weight loss associated with mental anorexia leads to dysmorphophobia and body distortions. Patients perceive themselves to be bigger than they really are. Body distortions are responsible for anorexic behavior reinforcing loops. It is then necessary to target this behavior and develop appropriate therapies taking into account the perceptual (implicit) and conceptual (explicit) phenomenon of body representations.
The current treatment programs which are recommended by the Haute Autorité de Santé (HAS) in France focus on the somatic, nutritional, individual and family psychological aspects. These recommendations hardly mention the bodily distortion phenomenon which frequently leads patients to relapse into the disease.
The 3D body scanner enables to get awareness of the body through visual feedback allowing the patient to get a reassuring overview of her weight development.
This projects aims to combine virtual visual impulses and multisensory recalibration (touch, proprioception, vestibular sensations) in order to compare the body distortions evolution in anorexic patients with or without a multimodal care program including Virtual Reality from its own body scan coupled or not to a multisensory remediation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study presents three groups of patients : * The control group : The patients benefit from the care recommended by the HAS, relaxation times and body scan. * The experimental group 1 : The patients benefit from the care recommended by the HAS, the virtual reality program and relaxation times and body scan. * The experimental group 2 : The patients benefit from the care recommended by the HAS, the virtual reality program, the multi-sensory remediation and relaxation times and body scan.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The patients benefit from the care recommended by the HAS. They benefit from psychological interviews, psychiatric follow-up, dietetic follow-up, family interviews and therapy. Body therapies (physiotherapy, massage, fascia therapy, psychomotor skills, dance therapy, etc.) may also take place. Patients will also benefit from relaxation and body scan. |
| Experimental group 1 : Virtual Reality | Experimental | Other: Experimental group 1 : Virtual RealityThe patients benefit from the care recommended by the HAS, the virtual reality program and time for relaxation and body scan (1 hour). |
| Experimental group 2 : Virtual Reality + Multi Sensorial Remediation | Experimental | Other: Experimental group 2 : Virtual Reality + Multi Sensorial RemediationThe patients benefit from the care recommended by the HAS, the virtual reality and the multisensory remediation programs, and also the body scan. |
Who may qualify
- Ages
- 15 to 26 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Female
- Age ≥ 15 to ≤ 26 years old
- Anorexic nervosa eating disorder according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5). As patients are hospitalized for anorexic nervosa, the medical diagnosis of each care center participating in the inclusions will be trusted
- Patient hospitalized (full hospitalization or day hospital) in one of the investigative centers for a minimum period of 6 weeks
- 14 ≤ BMI ≤ 18.5 for adult patients. For minors, Cole's curves will be used. The Body mass index (BM)I should be between the 1st percentile and the 10th percentile (if the weight curve shows a clear break indicating abnormal weight loss). For example, for a 15-year-old girl, the BMI should be between 14.5 and 16.8.
Key exclusion criteria (10 listed)
- Associated major mental disorders (psychotic disorders, bipolar disorders, major depression)
- Neurological disorders (pyramidal or extrapyramidal syndromes)
- Substance addiction (drugs, alcohol)
- Any disorder likely to impair the reasoning, discernment or judgment abilities
- Psychological incapacity to answer the questionnaires
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 |
|---|---|---|
| Experimental group 1 : Virtual RealityPatients benefit from the care recommended by the HAS, the virtual reality program and time for relaxation and body scan. | Other | Experimental group 1 : Virtual Reality |
| Experimental group 2 : Virtual Reality + Multi Sensorial RemediationPatients benefit from the care recommended by the HAS, the virtual reality program, the multisensory remediation, and also the body scan. | Other | Experimental group 2 : Virtual Reality + Multi Sensorial Remediation |
Primary outcome
Change in Body Dimensions Estimation task
Time frame: 6 weeks
Body overestimation bias will be assessed by the Body Dimensions Estimation task.
6 secondary outcomes
Change in Body Shape Questionnaire
Time frame: 6 weeks
Change in Physical self description questionnaire
Time frame: 6 weeks
Change in Body Image Questionnaire
Time frame: 6 weeks
Change in Weight gain
Time frame: 6 weeks
Change in Eating Disorder Examination Questionnaire
Time frame: 6 weeks
Anxiety measured by the State-Trait Anxiety Inventory (STAI-Etat-Trait)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- 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.
Vincent Dodin, PhD principal investigator
Hôpital Saint-Vincent de Paul
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group 1 : Virtual Reality and Experimental group 2 : Virtual Reality + Multi Sensorial Remediation in people with Anorexia Nervosa and Dysmorphophobia, run by Lille Catholic University.
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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amélie Lansiaux, PhD, MD (03.20.22.52.69, lansiaux.amelie@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Dimensions Estimation task (time frame: 6 weeks). 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 6 Jan 2022.