跳至主要内容
临床试验/NCT05682417
NCT05682417招募中不适用

Impact of Body Schema Distortion on Remission and Weight Regain in Anorexia Nervosa

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年9月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
2
主要终点
Overestimation of the body schema

研究概览

简要总结

Anorexia nervosa is a predominantly female eating disorder that most often appears in adolescence. The latter leads to strict and voluntary food deprivation for several months or even years. The lifetime prevalence of anorexia is 1.4% in women and 0.2% in men.

Ultimately, only half of people treated for anorexia nervosa in adolescence recover, 30% simply improve, 21% suffer from chronic disorders and 5 to 6% die. At the same time, between a quarter and half of patients abandon their current treatment, including during hospitalization. Relapses occur during the evolution of anorexia nervosa. Even more worrying, mortality is highest the year following the patient's discharge from hospital. This appears to be due to somatic complications in more than half of cases (most often cardiac arrest), to suicide in 27% of cases.

Researchers are still trying to clarify the mechanisms involved in the emergence and persistence of this disorder. The objective is to obtain more verified and faster cures. However, the obstacles to successful treatment are mainly due to the denial of disorders and thinness.

From a neurocognitive perspective, the representation one has of one's body is underpinned by two types of representations, i.e. body image and body schema.

It has long been shown that body image is altered in anorexia nervosa. More recently, authors have shown that the distortion of the body representation was however more extensive and also affected the body schema. Patients find themselves too fat despite obvious thinness and move through space as if this were really the case.

Worryingly, these distortions in bodyschema seem to persist after therapeutic management. Despite the potential role of body-scheme distortions in maintaining the disorder, as well as the risk of relapse, the difficulties in assessing body-scheme are significant. Indeed, recovery in these pathologies is often determined according to the Body Mass Index, self-declaration and questionnaires evaluating body image, again limiting the verification of the resorption of distortions in the body schema.

Investigators have therefore developed the systematic, ergonomic and simplified evaluation of the body schema in patients suffering from anorexia nervosa at the time of diagnosis in an expert center, but also during follow-up evaluations thanks to the use of an evaluation platform of the body schema, i.e. the body in brain platform, developed by the LIP/PC2S laboratory and the SATT Linksium which allows the evaluation of the body schema.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patient over 15 years old
  • Patient with a BMI <18.5
  • Patient suffering from anorexia nervosa (DSM V, 2013)
  • Patient agreeing to participate in the study with signed informed consent (Or whose parents/holder of parental authority have signed the informed consent)
  • Patient affiliated to a Social Security plan or beneficiary of such a plan

排除标准

  • Adult patients protected by a legal protection measure (guardianship, curatorship, etc.)
  • Patients participating in another research that may interfere with this research
  • Patients with acute and co-occurring psychiatric comorbidities (suicidal crisis, delusions)
  • Patients not fluent in French
  • Pregnant, parturient or breastfeeding women (on questioning of the patient)
  • Persons deprived of their liberty by a judicial or administrative decision
  • Persons admitted to a health or social establishment for purposes other than research
  • Patients with any current pathology or history of psychotic disorders, migraine, epilepsy, balance disorders, vertigo, visual disorders, proprioceptive disorders and/or neuromuscular disorders.

结局指标

主要结局

Overestimation of the body schema

时间窗: Baseline (T0); 6 months after baseline (T+6); 12 months after baseline (T+12)

Overestimation of the body schema (in percentage) assessed by the body schema assessment platform (MOVE tool, motion assessment in virtual reality). Overestimation of the body schema (percentage of distortion) will be compared to normal values, and then compared with the percentages at T+6 and T+12.

次要结局

  • Eating behavior assessed by the EDE-Q questionnaire(Baseline T0; 6 months; 12 months)
  • Weight/height ratio, expressed by body mass index (BMI)(Baseline T0; 6 months; 12 months)
  • Body overstatement(Baseline T0; 6 months; 12 months)
  • Alexithymia score(Baseline T0; 6 months; 12 months)
  • Eating behavior assessed by the EDI-2 questionnaire(Baseline T0; 6 months; 12 months)
  • Cognitive rigidity score(Baseline T0; 6 months; 12 months)
  • Body dissatisfaction score(Baseline T0; 6 months; 12 months)
  • Level of anxiety(Baseline T0; 6 months; 12 months)
  • Level of Depression(Baseline T0; 6 months; 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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