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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)

Primary Purpose

Anorexia Nervosa

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual Reality Exposure Therapy sessions
Psychomotor therapy sessions
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anorexia Nervosa focused on measuring ANOREXIA NERVOSA, FEMALE ADOLESCENTS, BODY DYSMORPHIC DISORDER, VIRTUAL REALITY EXPOSURE THERAPY

Eligibility Criteria

13 Years - 17 Years (Child)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Damien JOLLYRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality Exposure Therapy

Psychomotor Therapy

Arm 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

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.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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

Full Information

First Posted
September 26, 2019
Last Updated
March 7, 2023
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT04107870
Brief Title
Efficiency of Virtual Reality Exposure Therapy in the Management of Body Dysmorphic Disorders in Female Adolescents With Anorexia Nervosa
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2021 (Actual)
Primary Completion Date
March 20, 2027 (Anticipated)
Study Completion Date
September 20, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
ANOREXIA NERVOSA, FEMALE ADOLESCENTS, BODY DYSMORPHIC DISORDER, VIRTUAL REALITY EXPOSURE THERAPY

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Exposure Therapy
Arm Type
Experimental
Arm 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
Arm Title
Psychomotor Therapy
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure Therapy sessions
Intervention 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
Intervention Type
Behavioral
Intervention Name(s)
Psychomotor therapy sessions
Intervention 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.
Primary Outcome Measure Information:
Title
Body Shape Questionnaire
Description
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 Outcome Measure Information:
Title
Eating Disorder Inventory
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
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 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julien EUTROPE
Phone
03 26 78 39 56
Ext
0033
Email
jeutrope@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien EUTROPE
Phone
03 26 78 39 56
Ext
0033
Email
jeutrope@chu-reims.fr

12. IPD Sharing Statement

Learn more about this trial

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

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