Social and Moral Cognition in Multiple Sclerosis
COSMOS
1 other identifier
interventional
90
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Dec 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2023
CompletedFirst Submitted
Initial submission to the registry
March 12, 2024
CompletedFirst Posted
Study publicly available on registry
March 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedMarch 20, 2024
March 1, 2024
1.4 years
March 12, 2024
March 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Moral dilemma judgments
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
3 hours
Secondary Outcomes (12)
Explicit time perspective inventory test
3 hours
Implicit time perspective inventory test
3 hours
Dot Probe Task
3 hours
Level of moral permissibility
3 hours
Level of emotional reactivity
3 hours
- +7 more secondary outcomes
Study Arms (2)
Multiple sclerosis patients
OTHERMS patients with the relapsing-remitting form (RRMS) and Expanded Disability Status Scale (EDSS) ≤ 4
Control participants
OTHERPatients without global cognitive impairment
Interventions
The demographic questionnaire collects demographic information: gender, age, level of education, laterality, history of psychiatric or neurological disorders. The moral judgment task consists in completing 20 vignettes of moral dilemmas. Cognitive disorders will be assessed using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery. If the patient has taken the BICAMS battery recently (less than 6 months), and with no change in pathology since then, the results of these tests will be used in this study. Affective disorders will be assessed using the following tests: * The Beck Depression Inventory-Fast Screen (BDI-FS) to assess the level of depression, * State trait anxiety inventory-Y (STAI-Y) to assess anxiety, * Toronto Alexithymia Scale-20 (TAS-20)to assess alexithymia, * The Empathy Quotient-8 (EQ-8) to assess participants' level of empathy, * The Dot Probe Task to assess participants' emotional information processing style.
This questionnaire collects key information on the participant's pathology: clinical form, date of first symptoms, diagnosis, last attack, as well as latest EDSS and functional scores.
The MoCA is a screening tool for neurocognitive impairment, designed primarily to detect milder impairment. The MoCA is a short-answer questionnaire that includes a number of tasks to be completed by the individual. The items assessed are grouped into six subsections: short-term memory, visuospatial skills, executive functions, attention, concentration, working memory, language and orientation in time and space. The tests proposed are often more complex than those found in the mini-mental state examination (MMSE).
Eligibility Criteria
You may qualify if:
- Men or women aged 18 to 55.
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hôpital Saint-Vincent-de-Paul - Neurologie
Lille, France
Hôpital Saint-Philibert - Neurologie
Lomme, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Béatrice DEGRAEVE
Catholic University of Lille Faculty of Letters and Humanities
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2024
First Posted
March 19, 2024
Study Start
December 19, 2023
Primary Completion
April 30, 2025
Study Completion
October 30, 2025
Last Updated
March 20, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share