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临床试验/NCT03160443
NCT03160443Unknown不适用

Impact of Neuropsychological Alteration of Decision-making Abilities on the Functioning of Patients With Eating Disorders

University Hospital, Montpellier2 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2017年5月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
340
试验地点
2
主要终点
Level of functional impairment assessed by the Work and Social Adjustment Scale (WSAS)

研究概览

简要总结

Eating disorders are multifactorial disorders currently conceptualized in a biopsychosocial model, but pathophysiology remains relatively unknown, and robust etiological models to guide treatment are therefore lacking. Different endophenotypes and neurocognitive vulnerability factors have been found in eating disorders including decision making abnormalities. The investigators hypothesize that decision making abnormalities are associated with a lower level of functioning and quality of life which could lead to social and interpersonal difficulties. The investigators also hypothesize that these anomalies are associated with a particular clinical profile (more restrictive profile, more hyperactivity, less insight on the disease and desire for care ...).

详细描述

The investigators will recruit a total of 340 patients with an eating disorder in the university hospital of Montpellier.

  • Participation consists of a one-day visit with a multidisciplinary assessment. No action is specific to research. This is the usual management of patients with eating disorders addressed to our department.
  • An ancillary study will be proposed, if the patient is addressed by his general practitioner for an annual evaluation. This second visit will be exactly the same as the initial visit.

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 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with an eating disorder according to Diagnostic and Statistical Manuel of Mental disorders-V (DSM-V) criteria
  • Patient aged from 15 to 65 years
  • Patient who performs the day-hospital evaluation
  • Patient affiliated to a French social security system
  • Patient able to understand the nature, the aim and the methodology of the study
  • For minor one of the legal guardians gave his consent

排除标准

  • Patient in an unstable somatic state (eg severe metabolic disorder making impossible or unreliable neuropsychological assessments)
  • Patient's refusal to participate
  • Patient on protective measures (guardianship or trusteeship)
  • Pregnant or nursing women. A dosage of beta human chorionic gonadotropin (βHCG) will be performed to ensure the absence of pregnancy.

结局指标

主要结局

Level of functional impairment assessed by the Work and Social Adjustment Scale (WSAS)

时间窗: Baseline

We aim to investigate the link between decision-making and daily functioning of patients with eating disorder.

次要结局

  • Level of functional impairment assessed by the clinician with the FAST scale(Baseline)
  • Level of functional impairment assessed by the clinician with the Functional Assessment Staging Test (FAST) scale(Baseline)
  • Quality of life assessed by the Eating disorder quality of life (EDQOL) scale.(Baseline)
  • Score to decision making test (Iowa gambling task)(At 12 months if patient is included in the ancillary study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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