NCT04107870 Efficiency of Virtual Reality Exposure Therapy in the Management of Body Dysmorphic Disorders in Female Adolescents With Anorexia Nervosa
| NCT ID | NCT04107870 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHU de Reims |
| Condition | Anorexia Nervosa |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-06-20 |
| Primary Completion | 2027-03-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2021-06-20 with a primary completion date of 2027-03-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Anorexia nervosa is defined in DSM V as a quantitative and qualitative dietary restriction resulting in significant weight loss, intense fear of weight gain, altered weight and body shape perception (body dysmorphic disorder) and low self-esteem influenced by weight or body shape. Body dysmorphic disorder is the most difficult symptom to manage in anorexia nervosa and its persistence is a factor associated with relapse. Virtual reality exposure therapy has proven its effectiveness in the management of post-traumatic stress disorder in the military and is a widely used therapy. The effectiveness of this treatment using new technologies has not yet been studied for the treatment of body dysmorphic disorder in anorexia nervosa and is not used routinely. It could represent an interesting alternative to the physical approach in psychomotor therapy, traditionally offered to patients suffering from anorexia nervosa. It is important to evaluate the effectiveness of virtual reality exposure therapy in the management of body dysmorphic disorder in patients with anorexia nervosa by comparing these two care techniques.
Eligibility Criteria
Inclusion criteria : * Female adolescents aged 13 to 18 * with a diagnosis of anorexia nervosa of all types (including purgative and hyperphagic) according to the DSM-V * French as first language * agreed to participate in the study * parental authority holders accepting her participation in the study * affiliated to a social security system Patients will not be included in the study: * with a somatic severity criterion: * Total aphagia * Body mass index (BMI) \< 14kg/m² for those over 17 years of age, BMI \< 13.2kg/m² for those aged 15-16 and BMI \< 12.7kg/m² for those aged 13-14. * Confusion * Bradycardia \<40/min, Tachycardia * Blood pressure \< 80/50mmHg * Hypothermia \<35.5°C * Severe metabolic disorders: hypokalemia \< 2.5 mmol/l, hyponatremia \< 125mmol/l or hypernatremia \> 150 mmol/l, hypophosphoremia \< 0.5 mmol/l * Acetonuria, hypoglycemia \< 0.6g/l * Creatinine elevation \> 100micromol/l * Cytolysis \> 4N * Leuconeutropenia \<1000/mm3 * Thrombocytopenia \<6000000/mm3 * Suicide attempt in the last month before inclusion * Receiving benzodiazepine treatment outside the prescription limits. * Psychotic patients or patients with psychoactive substance addiction according to MINI KID criteria (Sheehan DV et al. Reliability and validity of the Mini International Neuropsychiatric Interview for children and adolescents (MINI Kid). J Clin Psychiatry 2010;71(3):313-326).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04107870 clinical trial?
This trial is open to female participants only, aged 13 Years or older, up to 17 Years, studying Anorexia Nervosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04107870 currently recruiting?
Yes, NCT04107870 is actively recruiting participants. Contact the research team at jeutrope@chu-reims.fr for enrollment information.
Where is the NCT04107870 trial being conducted?
This trial is being conducted at Reims, France.
Who is sponsoring the NCT04107870 clinical trial?
NCT04107870 is sponsored by CHU de Reims. The trial plans to enroll 40 participants.