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RecruitingNCT04107870ANO-TERVUpdated Mar 8, 2023

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

An interventional study of Virtual Reality Exposure Therapy sessions and Psychomotor therapy sessions in Anorexia Nervosa, sponsored by CHU de Reims. Recruiting at 1 site in France. Open to female participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by CHU de Reims · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2021; still recruiting 5 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
13 Years to 17 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Anorexia Nervosa

Keywords

  • ANOREXIA NERVOSA
  • FEMALE ADOLESCENTS
  • BODY DYSMORPHIC DISORDER
  • VIRTUAL REALITY EXPOSURE THERAPY
03

In context

Anorexia Nervosa

469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.

This study's planned enrollment of 40 is below the median of 46 across 313 interventional studies indexed under Anorexia Nervosa.

Browse Anorexia Nervosa studies →

Lead sponsor

CHU de Reims is the lead sponsor of 276 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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
  • 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
    • (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).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Virtual Reality Exposure Therapy

    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

    Behavioral: Virtual Reality Exposure Therapy sessions

  • Active comparator
    Psychomotor Therapy

    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.

    Behavioral: Psychomotor therapy sessions

Interventions

  • BehavioralVirtual 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

  • BehavioralPsychomotor 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.

06

What researchers measure

Primary outcomes

  1. 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".

    Time frame: 12 months

Secondary outcomes

  1. 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

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04107870
Lead sponsor
CHU de Reims
Responsible party
Sponsor
First posted
Sep 27, 2019
Start date
Jun 20, 2021
Primary completion
Mar 20, 2027 (estimated)
Completion
Sep 20, 2028 (estimated)
Last update
Mar 8, 2023

Study contacts

Julien EUTROPE
Contact
jeutrope@chu-reims.fr
03 26 78 39 56 ext. 0033

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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