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临床试验/NCT04107870
NCT04107870招募中不适用

Efficiency of Virtual Reality Exposure Therapy in the Management of Body Dysmorphic Disorder in Female Adolescents With Anorexia Nervosa: a Randomized, Controlled Superiority Study

CHU de Reims1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
CHU de Reims
入组人数
40
试验地点
1
主要终点
Body Shape Questionnaire

研究概览

简要总结

Anorexia nervosa is defined in DSM V as a quantitative and qualitative dietary restriction resulting in significant weight loss, intense fear of weight gain, altered weight and body shape perception (body dysmorphic disorder) and low self-esteem influenced by weight or body shape. Body dysmorphic disorder is the most difficult symptom to manage in anorexia nervosa and its persistence is a factor associated with relapse.

Virtual reality exposure therapy has proven its effectiveness in the management of post-traumatic stress disorder in the military and is a widely used therapy. The effectiveness of this treatment using new technologies has not yet been studied for the treatment of body dysmorphic disorder in anorexia nervosa and is not used routinely. It could represent an interesting alternative to the physical approach in psychomotor therapy, traditionally offered to patients suffering from anorexia nervosa. It is important to evaluate the effectiveness of virtual reality exposure therapy in the management of body dysmorphic disorder in patients with anorexia nervosa by comparing these two care techniques.

详细描述

The aim of this study is to evaluate the effectiveness of Virtual Reality Exposure Therapy in the management of body dysmorphic disorder in patients with anorexia nervosa, compared to the traditionally proposed body approach in psychomotor therapy.

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
Single (Participant)

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
Female
接受健康志愿者
否

入选标准

  • •Female adolescents aged 13 to 18
  • •with a diagnosis of anorexia nervosa of all types (including purgative and hyperphagic) according to the DSM-V
  • •French as first language
  • •agreed to participate in the study
  • •parental authority holders accepting her participation in the study
  • •affiliated to a social security system
  • •Patients will not be included in the study:
  • •with a somatic severity criterion:
  • •Total aphagia
  • •Body mass index (BMI) < 14kg/m² for those over 17 years of age, BMI < 13.2kg/m² for those aged 15-16 and BMI < 12.7kg/m² for those aged 13-
  • •Confusion
  • •Bradycardia <40/min, Tachycardia
  • •Blood pressure < 80/50mmHg
  • •Hypothermia <35.5°C
  • •Severe metabolic disorders: hypokalemia < 2.5 mmol/l, hyponatremia < 125mmol/l or hypernatremia > 150 mmol/l, hypophosphoremia < 0.5 mmol/l
  • •Acetonuria, hypoglycemia < 0.6g/l
  • •Creatinine elevation > 100micromol/l
  • •Cytolysis > 4N
  • •Leuconeutropenia <1000/mm3
  • •Thrombocytopenia <6000000/mm3
  • •Suicide attempt in the last month before inclusion
  • •Receiving benzodiazepine treatment outside the prescription limits.
  • •Psychotic patients or patients with psychoactive substance addiction according to MINI KID criteria (Sheehan DV et al. Reliability and validity of the Mini International Neuropsychiatric Interview for children and adolescents (MINI Kid). J Clin Psychiatry 2010;71(3):313-326).

排除标准

  • 未提供

研究组 & 干预措施

Virtual Reality Exposure Therapy

Experimental

Female adolescents aged 13 to 18 are proposed virtual reality exposure therapy sessions, accompanied by a cognitive and behavioral therapy (CBT) therapist, to work on their body representations

干预措施: Virtual Reality Exposure Therapy sessions (Behavioral)

Psychomotor Therapy

Active Comparator

Psychomotor therapy sessions are proposed to female adolescents aged 13 to 18 years, ac-companied by a psychomotor therapist, to work on their body representations.

干预措施: Psychomotor therapy sessions (Behavioral)

结局指标

主要结局

Body Shape Questionnaire

时间窗: 12 months

The Body Shape Questionnaire (BSQ) measures concerns about body shape. The BSQ can be divided into 4 sub scores: "avoidance and social shame of body exposure", "body dissatisfaction with lower body parts", "use of laxatives and vomiting to reduce body dissatisfaction" and "inappropriate cognitions and behaviours to control weight".

次要结局

  • Eating Disorder Inventory(12 months)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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