Clinical trial NCT04107870: Efficiency of Virtual Reality Exposure Therapy in the Management of Body Dysmorphic Disorders in Female Adolescents With Anorexia Nervosa
Official title: Efficiency of Virtual Reality Exposure Therapy in the Management of Body Dysmorphic Disorder in Female Adolescents With Anorexia Nervosa: a Randomized, Controlled Superiority Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Keywords: ANOREXIA NERVOSA
FEMALE ADOLESCENTS
BODY DYSMORPHIC DISORDER
VIRTUAL REALITY EXPOSURE THERAPY
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The aim of this study is to evaluate the effectiveness of Virtual Reality Exposure Therapy in the management of body dysmorphic disorder in patients with anorexia nervosa, compared to the traditionally proposed body approach in psychomotor therapy.

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).

Primary outcomes:
measure: Body Shape Questionnaire
timeFrame: 12 months
Secondary outcomes:
measure: Eating Disorder Inventory
timeFrame: 12 months
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: