Contribution of a Virtual Reality Program in the Treatment of Dysmorphophobia for Adolescent Female With Anorexia Nervosa (TERV-TCA)
Primary Purpose
Anorexia Nervosa
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
self-evaluation of the Body Mass Index
Cognitive-behavioral psychotherapies
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa
Eligibility Criteria
Inclusion Criteria:
- Age between 13 et 18 years old
- Female subject
- Females with anorexia nervosa according to the diagnostic criteria of DSM-5
- The patient, the parents or the legal representative (s) have given written consent
- Possessing a social security scheme
Exclusion Criteria:
- Male subject
- Age under 13 years or over 18 years
- Subject presenting a contra-indication to virtual reality
- Subject, or parents who refused to sign informed consent
Sites / Locations
- Assistance Publique Hôpitaux de MarseilleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
The reference treatment of dysmorphophobia used
The reference treatment with the virtual reality
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of non-self Body Mass Index
the self-evaluation of BMI will allow to observe the evolution of the symptom of dysmorphophobia. Explicit and implicit assessment of lean body addiction.
Eating Disorder Inventory 2 (EDI)
The EDI is intended to assess attitudes and behaviors related to eating behavior in 11 sub-scales. the most pathological answer are rated 0
Secondary Outcome Measures
Full Information
NCT ID
NCT03426930
First Posted
February 2, 2018
Last Updated
February 7, 2018
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03426930
Brief Title
Contribution of a Virtual Reality Program in the Treatment of Dysmorphophobia for Adolescent Female With Anorexia Nervosa
Acronym
TERV-TCA
Official Title
Contribution of a Virtual Reality Program in the Treatment of Dysmorphophobia for Adolescent Female With Anorexia Nervosa
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 17, 2018 (Actual)
Primary Completion Date
January 17, 2020 (Anticipated)
Study Completion Date
January 17, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Anorexia nervosa is an eating disorder that begins frequently in adolescence between the ages of 13 and 19, which affects girls with a sex ratio of 10:1, and the prevalence for females varies from 0,3% to 0,9%.
The current therapeutic arsenal has a limited success in the treatment of anorexia nervosa with a long-term mortality rate and a 12-month relapse rate of up to 10% and 40%, respectively.
One of the most difficult symptoms to treat is a body dysmorphic disorder, also called dysmorphophobia, the persistence of this symptom is a major negative prognostic factor.
The main treatment of dysmorphophobia is currently cognitive behavioral therapy (CBT). In most protocols, the technique of progressive exposure face to the mirror is used with low efficiency. Adapted physical activity has recently been proposed in the literature as a tool to improve body perception.
Face of complex management of this major symptom that is dysmorphophobia, some offer to use virtual reality.
It is in this context that the study proposes to study the contribution of virtual reality in the treatment of the body dysmorphic disorder of adolescent patients hospitalized for anorexia nervosa in the department of Child and Adolescent Psychiatry Salvator Hospital in Marseille.
It will be compare the importance and the evolution of the dysmorphophobia between two groups of teenagers hospitalized in Space Arthur for anorexia nervosa: an experimental group receiving the treatment with the contribution of the virtual reality, and a control group receiving the reference treatment of dysmorphophobia used in our unit.
It will be recruit 30 adolescent females with anorexia nervosa according to the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM)-5. The subjects will be divided into 2 groups of 15 teenagers, according to a randomization list, a group with a classic protocol, a group with virtual reality. The subjects with virtual reality will have 5 exposure sessions where they will be able to model their body in view in 1st person and 3rd person, via an Oculus Rift. It will be compare the following parameters: the different scores related to dysmorphophobia according to different questionnaires, the self-evaluation of the Body Mass Index (BMI), in order to observe the evolution of the symptom, then the anxiety relative to the exposure of a BMI higher in order to work the fear of getting fat, the choice of the most pleasant BMI, to evaluate skinny body addiction.
At the end of the study, we hope to highlight the effectiveness of virtual reality to fight against dysmorphophobia, in order to have a better estimate of its body aspect, and to impact the evolution towards the cure in anorexia nervosa in teenage girls. In addition to increasing our knowledge, this could allow to consider new strategies in the management of anorexia nervosa, and why not democratize more virtual reality with adolescents followed in child and adolescent psychiatry.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The reference treatment of dysmorphophobia used
Arm Type
Active Comparator
Arm Title
The reference treatment with the virtual reality
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
self-evaluation of the Body Mass Index
Intervention Description
Evaluation of the Body Mass Index before and after the treatment
Intervention Type
Other
Intervention Name(s)
Cognitive-behavioral psychotherapies
Intervention Description
Cognitive-behavioral psychotherapies before and after the treatment
Primary Outcome Measure Information:
Title
Evaluation of non-self Body Mass Index
Description
the self-evaluation of BMI will allow to observe the evolution of the symptom of dysmorphophobia. Explicit and implicit assessment of lean body addiction.
Time Frame
24 months
Title
Eating Disorder Inventory 2 (EDI)
Description
The EDI is intended to assess attitudes and behaviors related to eating behavior in 11 sub-scales. the most pathological answer are rated 0
Time Frame
24 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 13 et 18 years old
Female subject
Females with anorexia nervosa according to the diagnostic criteria of DSM-5
The patient, the parents or the legal representative (s) have given written consent
Possessing a social security scheme
Exclusion Criteria:
Male subject
Age under 13 years or over 18 years
Subject presenting a contra-indication to virtual reality
Subject, or parents who refused to sign informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flora BAT, PH
Phone
491745850
Ext
+33
Email
flora.bat@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle CHARVIN, Clinical Study Assistant
Phone
491745850
Ext
+33
Email
isabelle.charvin@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier ARNAUD, General Director
Organizational Affiliation
ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flora BAT, PH
Phone
491745860
Ext
+33
Email
flora.bat@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Flora BAT, PH
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Contribution of a Virtual Reality Program in the Treatment of Dysmorphophobia for Adolescent Female With Anorexia Nervosa
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