Contribution of a Virtual Reality Program in the Treatment of Dysmorphophobia for Adolescent Female With Anorexia Nervosa

NCT ID: NCT03426930

Last Updated: 2018-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-17
• Study Completion Date: 2021-01-17

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.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The reference treatment of dysmorphophobia used

Group Type: ACTIVE_COMPARATOR

self-evaluation of the Body Mass Index

Intervention Type: OTHER

Evaluation of the Body Mass Index before and after the treatment

Cognitive-behavioral psychotherapies

Intervention Type: OTHER

Cognitive-behavioral psychotherapies before and after the treatment

The reference treatment with the virtual reality

Group Type: EXPERIMENTAL

self-evaluation of the Body Mass Index

Intervention Type: OTHER

Evaluation of the Body Mass Index before and after the treatment

Cognitive-behavioral psychotherapies

Intervention Type: OTHER

Cognitive-behavioral psychotherapies before and after the treatment

Interventions

self-evaluation of the Body Mass Index

Evaluation of the Body Mass Index before and after the treatment

Intervention Type: OTHER

Cognitive-behavioral psychotherapies

Cognitive-behavioral psychotherapies before and after the treatment

Intervention Type: OTHER

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Olivier ARNAUD, General Director

Role: STUDY_DIRECTOR

ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Flora BAT, PH

Role: CONTACT

flora.bat@ap-hm.fr

491745850 ext. +33

Isabelle CHARVIN, Clinical Study Assistant

Role: CONTACT

isabelle.charvin@ap-hm.fr

491745850 ext. +33

Facility Contacts

Flora BAT, PH

Role: primary

flora.bat@ap-hm.fr

491745860 ext. +33

Other Identifiers

2017-A02836-47

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017-40

Identifier Type: -

Identifier Source: org_study_id