An interventional study of Experimental group 1 : Virtual Reality and Experimental group 2 : Virtual Reality + Multi Sensorial Remediation in Anorexia Nervosa and Dysmorphophobia, sponsored by Lille Catholic University. Not yet recruiting. Open to female participants aged 15 Years to 26 Years. Per ClinicalTrials.gov, last updated 2022-01-06.
Sponsored by Lille Catholic University · Not applicable, Interventional, and Diagnostic
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.
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.
469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
This study's planned enrollment of 150 is above the median of 46 across 313 interventional studies indexed under Anorexia Nervosa.
Browse Anorexia Nervosa studies →Lille Catholic University is the lead sponsor of 112 studies on the registry; 24 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Other: Experimental group 1 : Virtual Reality
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
Patients benefit from the care recommended by the HAS, the virtual reality program and time for relaxation and body scan.
Patients benefit from the care recommended by the HAS, the virtual reality program, the multisensory remediation, and also the body scan.
Change in Body Dimensions Estimation task
Body overestimation bias will be assessed by the Body Dimensions Estimation task.
Time frame: 6 weeks
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.
Time frame: 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).
Time frame: 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).
Time frame: 6 weeks
Change in Weight gain
Weight gain will be measured by weighting.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2022; primary completion for May 2025, 32 months later.
Of 151 non-industry interventional studies with no phase under Anorexia Nervosa, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 63. This study's planned 32 months is below that.
Counting every sponsor, half of 151 studies reached it within 43 months; a quarter within 24 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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