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

Primary Purpose

Anorexia Nervosa, Dysmorphophobia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental group 1 : Virtual Reality
Experimental group 2 : Virtual Reality + Multi Sensorial Remediation
Sponsored by
Lille Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anorexia Nervosa focused on measuring Anorexia Nervosa, Dysmorphophobia, Body distortions, Multisensory remediation, Virtual Reality

Eligibility Criteria

15 Years - 26 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control group

    Experimental group 1 : Virtual Reality

    Experimental group 2 : Virtual Reality + Multi Sensorial Remediation

    Arm Description

    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.

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.
    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).
    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).
    Change in Weight gain
    Weight gain will be measured by weighting.
    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.
    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.

    Full Information

    First Posted
    March 16, 2021
    Last Updated
    January 5, 2022
    Sponsor
    Lille Catholic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04804800
    Brief Title
    Virtual Reality Place in the Management of Body Dysmorphia Disorders in Anorexia Nervosa
    Acronym
    PROSANOR
    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

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    May 2025 (Anticipated)
    Study Completion Date
    May 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lille Catholic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anorexia Nervosa, Dysmorphophobia
    Keywords
    Anorexia Nervosa, Dysmorphophobia, Body distortions, Multisensory remediation, Virtual Reality

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Experimental group 1 : Virtual Reality
    Arm Type
    Experimental
    Arm Description
    The patients benefit from the care recommended by the HAS, the virtual reality program and time for relaxation and body scan (1 hour).
    Arm Title
    Experimental group 2 : Virtual Reality + Multi Sensorial Remediation
    Arm Type
    Experimental
    Arm Description
    The patients benefit from the care recommended by the HAS, the virtual reality and the multisensory remediation programs, and also the body scan.
    Intervention Type
    Other
    Intervention Name(s)
    Experimental group 1 : Virtual Reality
    Intervention Description
    Patients benefit from the care recommended by the HAS, the virtual reality program and time for relaxation and body scan.
    Intervention Type
    Other
    Intervention Name(s)
    Experimental group 2 : Virtual Reality + Multi Sensorial Remediation
    Intervention Description
    Patients benefit from the care recommended by the HAS, the virtual reality program, the multisensory remediation, and also the body scan.
    Primary Outcome Measure Information:
    Title
    Change in Body Dimensions Estimation task
    Description
    Body overestimation bias will be assessed by the Body Dimensions Estimation task.
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Change in Body Shape Questionnaire
    Description
    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.
    Time Frame
    6 weeks
    Title
    Change in Physical self description questionnaire
    Description
    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).
    Time Frame
    6 weeks
    Title
    Change in Body Image Questionnaire
    Description
    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).
    Time Frame
    6 weeks
    Title
    Change in Weight gain
    Description
    Weight gain will be measured by weighting.
    Time Frame
    6 weeks
    Title
    Change in Eating Disorder Examination Questionnaire
    Description
    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.
    Time Frame
    6 weeks
    Title
    Anxiety measured by the State-Trait Anxiety Inventory (STAI-Etat-Trait)
    Description
    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.
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    26 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amélie Lansiaux, PhD, MD
    Phone
    03.20.22.52.69
    Email
    lansiaux.amelie@ghicl.net
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anne-Sophie Blain, CRA
    Phone
    03.20.22.57.32
    Email
    blain.anne-sophie@ghicl.net
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vincent Dodin, PhD
    Organizational Affiliation
    Hôpital Saint-Vincent de Paul
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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