Clinical trial NCT04804800: Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Dysmorphophobia
Keywords: Anorexia Nervosa
Dysmorphophobia
Body distortions
Multisensory remediation
Virtual Reality
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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%)
* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Change in Body Dimensions Estimation task
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Body Shape Questionnaire
timeFrame: 6 weeks
measure: Change in Physical self description questionnaire
timeFrame: 6 weeks
measure: Change in Body Image Questionnaire
timeFrame: 6 weeks
measure: Change in Weight gain
timeFrame: 6 weeks
measure: Change in Eating Disorder Examination Questionnaire
timeFrame: 6 weeks
measure: Anxiety measured by the State-Trait Anxiety Inventory (STAI-Etat-Trait)
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital Saint-Vincent de Paul
name: Vincent Dodin, PhD
role: PRINCIPAL_INVESTIGATOR
References: