NCT03426930

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2021

Completed
Last Updated

February 8, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

February 2, 2018

Last Update Submit

February 7, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    24 months

  • 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

    24 months

Study Arms (2)

The reference treatment of dysmorphophobia used

ACTIVE COMPARATOR
Other: self-evaluation of the Body Mass IndexOther: Cognitive-behavioral psychotherapies

The reference treatment with the virtual reality

EXPERIMENTAL
Other: self-evaluation of the Body Mass IndexOther: Cognitive-behavioral psychotherapies

Interventions

Evaluation of the Body Mass Index before and after the treatment

The reference treatment of dysmorphophobia usedThe reference treatment with the virtual reality

Cognitive-behavioral psychotherapies before and after the treatment

The reference treatment of dysmorphophobia usedThe reference treatment with the virtual reality

Eligibility Criteria

Age13 Years - 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Jean-Olivier ARNAUD, General Director

    ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE

    STUDY DIRECTOR

Central Study Contacts

Flora BAT, PH

CONTACT

Isabelle CHARVIN, Clinical Study Assistant

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2018

First Posted

February 8, 2018

Study Start

January 17, 2018

Primary Completion

January 17, 2020

Study Completion

January 17, 2021

Last Updated

February 8, 2018

Record last verified: 2018-02

Locations