Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa

NCT ID: NCT04804800

Last Updated: 2022-01-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2026-05-31

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.

Conditions

Anorexia Nervosa; Dysmorphophobia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental group 1 : Virtual Reality

The patients benefit from the care recommended by the HAS, the virtual reality program and time for relaxation and body scan (1 hour).

Group Type: EXPERIMENTAL

Experimental group 1 : Virtual Reality

Intervention Type: OTHER

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 Remediation

The patients benefit from the care recommended by the HAS, the virtual reality and the multisensory remediation programs, and also the body scan.

Group Type: EXPERIMENTAL

Experimental group 2 : Virtual Reality + Multi Sensorial Remediation

Intervention Type: OTHER

Patients benefit from the care recommended by the HAS, the virtual reality program, the multisensory remediation, and also the body scan.

Interventions

Experimental group 1 : Virtual Reality

Patients benefit from the care recommended by the HAS, the virtual reality program and time for relaxation and body scan.

Intervention Type: OTHER

Experimental group 2 : Virtual Reality + Multi Sensorial Remediation

Patients benefit from the care recommended by the HAS, the virtual reality program, the multisensory remediation, and also the body scan.

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Dodin, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint-Vincent de Paul

Central Contacts

Amélie Lansiaux, PhD, MD

Role: CONTACT

lansiaux.amelie@ghicl.net

03.20.22.52.69

Anne-Sophie Blain, CRA

Role: CONTACT

blain.anne-sophie@ghicl.net

03.20.22.57.32

Other Identifiers

RC-P0089

Identifier Type: -

Identifier Source: org_study_id