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NCT Number: NCT04107870

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

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.

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Key information

Conditions

Anorexia Nervosa Body Dysmorphic Disorders Feeding and Eating Disorders Mental Disorders Somatoform Disorders

Age range

13 year–17 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Virtual Reality Exposure Therapy sessions

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Body Shape Questionnaire

    Time frame: 12 months

    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".

Secondary outcomes

  1. Eating Disorder Inventory

    Time frame: 12 months

    Eating Disorder Inventory (EDI-2) is a self questionnaire to assess the severity of symptoms of eating disorders and to evaluate their changes

Study contacts

Contact information is provided by the study sponsor or research team.

Julien EUTROPE

CONTACT

[email protected]

03 26 78 39 56 ext. 0033

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Official study 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

Acronym: ANO-TERV

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Sep 27, 2019
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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