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

NCT04804800 | Not Yet Recruiting

• 1 other identifier: RC-P0089
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anorexia Nervosa; Dysmorphophobia

Keywords

Anorexia Nervosa; Dysmorphophobia; Body distortions; Multisensory remediation; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• Change in Body Dimensions Estimation task

  Body overestimation bias will be assessed by the Body Dimensions Estimation task.

  6 weeks

Secondary Outcomes (6)

• Change in Body Shape Questionnaire

  6 weeks

• Change in Physical self description questionnaire

  6 weeks

• Change in Body Image Questionnaire

  6 weeks

• Change in Weight gain

  6 weeks

• Change in Eating Disorder Examination Questionnaire

  6 weeks

Study Arms (3)

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).

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.

Other: Experimental group 2 : Virtual Reality + Multi Sensorial Remediation

Interventions

Experimental group 1 : Virtual Reality OTHER

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

Experimental group 1 : Virtual Reality

Experimental group 2 : Virtual Reality + Multi Sensorial Remediation OTHER

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

Experimental group 2 : Virtual Reality + Multi Sensorial Remediation

Eligibility Criteria

• Age: 15 Years - 26 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Female
• Age ≥ 15 to ≤ 26 years old
• Patient hospitalized (full hospitalization or day hospital) in one of the investigative centers for a minimum period of 6 weeks
• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead

MeSH Terms

Conditions

Anorexia Nervosa; Body Dysmorphic Disorders

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Somatoform Disorders

Study Officials

• Vincent Dodin, PhD

  Hôpital Saint-Vincent de Paul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie Lansiaux, PhD, MD

CONTACT

03.20.22.52.69; lansiaux.amelie@ghicl.net

Anne-Sophie Blain, CRA

CONTACT

03.20.22.57.32; blain.anne-sophie@ghicl.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: September 1, 2022
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: January 6, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share