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临床试验/NCT03426930
NCT03426930Unknown不适用

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

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Evaluation of non-self Body Mass Index

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Evaluation of non-self Body Mass Index

时间窗: 24 months

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)

时间窗: 24 months

The EDI is intended to assess attitudes and behaviors related to eating behavior in 11 sub-scales. the most pathological answer are rated 0

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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