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临床试验/NCT06318923
NCT06318923Unknown不适用

Social and Moral Cognition in Multiple Sclerosis

Lille Catholic University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年12月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
Moral dilemma judgments

研究概览

简要总结

Multiple Sclerosis (MS) is a chronic, progressive disease that affects young adults (aged between 20 and 40) and has a major impact on patients' quality of life. Cognitive disorders in MS are common, affecting 40-60% of patients. Among these disorders, the presence of social cognition disorders is common. Within social cognition, the moral judgment has been an object of research in order to understand the determinants of moral decision-making: how and why individuals make moral choices with regard to a set of prescriptions and social norms. Compared to control subjects, MS patients show a decrease in moral permissiveness, as well as an increase in moral relativity and emotional reactivity. Thus, it would seem that MS patients issue more deontological choices (lower moral permissiveness). Given that these patients also exhibit empathy deficits and higher alexithymia, these patterns are surprising. Indeed, in other clinical populations, low empathic abilities and high alexithymia are linked to utilitarian rather than deontological moral judgments.

The objective of this project is to analyze the process of decision-making carried out by patients during moral dilemma situations in comparison with control individuals and verify whether the presence of a positivity bias could explain the more deontological choices made by some patients. Indeed, some work has shown that older individuals make more deontological moral judgments than younger adults. These results are also observed with young individuals when their future temporal perspectives have been experimentally constrained.

详细描述

Among the explanatory factors of interest, motivational factors (future temporal perspectives and emergence of a positivity bias), as well as cognitive and affective factors (by means of neuropsychological assessment) and neurophysiological factors (by means of electrodermal response) will be investigated.

From a clinical point of view, a change in decision-making concerning choices with a strong emotional valence can have an impact on patients' daily lives and their course of care. Indeed, MS patients regularly have to make crucial choices about their treatment and care. A modification of decision-making patterns in these situations would represent a major challenge. A good understanding of these patterns will thus contribute to the development of appropriate management procedures to mitigate the impact on patients' daily lives.

研究设计

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

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Men or women aged 18 to
  • Understanding and able to express themselves in French.
  • Characteristics according to groups:
  • MS patient group:
  • relapsing-remitting form (RRMS)
  • with EDSS ≤ 4
  • with no significant motor, cerebellar or somesthesic disorders of the upper limbs or visual disorders (specific EDSS parameter ≤ 2)
  • absence of relapse in the last 6 weeks
  • Control groups:
  • absence of known global cognitive deterioration.
  • Understanding and signing of the informed consent and information letter concerning participation in the study.
  • Beneficiary of health insurance coverage.

排除标准

  • People with previous neurological pathologies, head trauma with loss of consciousness, known psychiatric pathologies (excluding anxiety-depressive syndrome), serious general illnesses, perceptual or dysarthric disorders preventing verbal communication or reading,
  • Severe cognitive impairment in MS patients, i.e. an SDMT score < -2.5 if the BICAMS battery is present in the patient's file and is less than 6 months old.
  • Severe depressive syndrome, with a BDI-FS score > 10
  • People with sensory disorders (visual and auditory) that interfere with neuropsychological testing;
  • Major sensory disorders or cerebellar syndrome
  • Sensory deficits (visual or auditory)
  • Treatment with psychotropic drugs
  • Adults under guardianship, curatorship, persons deprived of liberty.
  • Pregnant or breast-feeding women

研究组 & 干预措施

Multiple sclerosis patients

Other

MS patients with the relapsing-remitting form (RRMS) and Expanded Disability Status Scale (EDSS) ≤ 4

干预措施: Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment (Other)

Multiple sclerosis patients

Other

MS patients with the relapsing-remitting form (RRMS) and Expanded Disability Status Scale (EDSS) ≤ 4

干预措施: MS questionnaire (Other)

Control participants

Other

Patients without global cognitive impairment

干预措施: Socio-demographic questionnaire, moral judgment task, cognitive tests, psychoaffective assessment (Other)

Control participants

Other

Patients without global cognitive impairment

干预措施: MONTREAL COGNITIVE ASSESSMENT (MoCA) test (Other)

结局指标

主要结局

Moral dilemma judgments

时间窗: 3 hours

The measure will be carried out using a series of 20 vignettes.These vignettes present different scenarios of fictional moral dilemmas, and the subject must make a choice. This test therefore results in 20 binary measures, which can be separated according to the type of scenario. In this task, for each vignette, the type of choice made is measured, along with levels of moral permissibility, subjective emotional reactivity and moral relativity. For this scale: Type of choice: binary yes/no (utilitarian/deontological) ; reflects an answer type (no better or worse outcome) Moral permissibility: Likert Scale from 0 to 10 ; reflects an answer type (no better or worse outcome) Subjective emotional reactivity : Likert Scale from 0 to 10 ; reflects an answer type (no better or worse outcome) Subjective emotional r

次要结局

  • Moral relativity level(3 hours)
  • State-Trait Anxiety Inventory(3 hours)
  • Level of moral permissibility(3 hours)
  • Level of emotional reactivity(3 hours)
  • Toronto Alexithymia Scale (TAS)-20(3 hours)
  • Explicit time perspective inventory test(3 hours)
  • Implicit time perspective inventory test(3 hours)
  • The Beck Depression Inventory(3 hours)
  • Empathy quotient-8 (EQ-8)(3 hours)
  • Electrodermal response(3 hours)
  • Dot Probe Task(3 hours)
  • Brief International Cognitive Assessment for Multiple Sclerosis(3 hours)

研究者

发起方
Lille Catholic University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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