Efficiency of Virtual Reality Exposure Therapy in the Management of Body Dysmorphic Disorders in Female Adolescents With Anorexia Nervosa

Anorexia Nervosa Clinical Trial

— ANO-TERV  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04107870
• Other study ID #: PR19054
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2021
• Est. completion date: September 20, 2028

Study information

• Verified date: March 2023
• Source: CHU de Reims
• Contact: Julien EUTROPE
• Phone: 03 26 78 39 56
• Email: jeutrope[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 20, 2028
• Est. primary completion date: March 20, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 17 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Body Dysmorphic Disorders

Intervention

Behavioral:
• Virtual Reality Exposure Therapy sessions
Female adolescents aged 13 to 18 are proposed virtual reality exposure therapy sessions, accompanied by a cognitive and behavioral therapy (CBT) therapist, to work on their body representations
• Psychomotor therapy sessions
Psychomotor therapy sessions are proposed to female adolescents aged 13 to 18 years, ac-companied by a psychomotor therapist, to work on their body representations.

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Shape Questionnaire	The Body Shape Questionnaire (BSQ) measures concerns about body shape. The BSQ can be divided into 4 sub scores: "avoidance and social shame of body exposure", "body dissatisfaction with lower body parts", "use of laxatives and vomiting to reduce body dissatisfaction" and "inappropriate cognitions and behaviours to control weight".	12 months
Secondary	Eating Disorder Inventory	Eating Disorder Inventory (EDI-2) is a self questionnaire to assess the severity of symptoms of eating disorders and to evaluate their changes	12 months