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Efficiency of Virtual Reality Exposure Therapy in the Management of Body Dysmorphic Disorders in Female Adolescents With Anorexia Nervosa (ANO-TERV)

C

CHU de Reims

Status

Enrolling

Conditions

Anorexia Nervosa

Treatments

Behavioral: Virtual Reality Exposure Therapy sessions
Behavioral: Psychomotor therapy sessions

Study type

Interventional

Funder types

Other

Identifiers

NCT04107870
PR19054

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Virtual Reality Exposure Therapy
Experimental group
Description:
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
Treatment:
Behavioral: Virtual Reality Exposure Therapy sessions
Psychomotor Therapy
Active Comparator group
Description:
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.
Treatment:
Behavioral: Psychomotor therapy sessions

Trial contacts and locations

1

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Central trial contact

Julien EUTROPE

Data sourced from clinicaltrials.gov

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