Multiple SclerosisSEmPathyNCT05332951
Study of Empathy in MS
An observational study of Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Multiple sclerosis is a chronic inflammatory disease of the central nervous system whose exact etiology remains unclear, underpinned by multiple pathophysiological mechanisms, and is a cause of significant motor and cognitive disability. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interpersonal Reactivity Index
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Jul 2022to 19 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients followed for multiple sclerosis
Who may be able to join
- Patient aged 18 to 60
- Follow-up for multiple sclerosis meeting the revised McDonalds diagnostic criteria of 2017.
- Patient not objecting to participation in the research.
Who cannot join
- NA
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Study of Empathy in Patients With Multiple Sclerosis
Multiple sclerosis is a chronic inflammatory disease of the central nervous system whose exact etiology remains unclear, underpinned by multiple pathophysiological mechanisms, and is a cause of significant motor and cognitive disability.
Some studies report a prevalence of 40% to 60% of cognitive impairment during the disease, and represents a major factor influencing quality of life in patients with MS.
Read more
Cognitive impairment can affect one or more of the 6 cognitive functions, including social cognition and its three components: theory of mind, or an individual's ability to infer intention and other's behavior, empathy, and social perceptions and knowledge.
To date, few studies have focused on the more specific study of empathy in MS. They seem to suggest the existence of a deficit but rely on small numbers of patients.
There appear to be many confounding factors but their direct relationship to empathy is not clearly established: potentially related comorbidities, such as anxiety and depression that are frequently found in MS patients ; level of education and cognitive reserve; and finally the very characteristics of the disease.
Indeed, data concerning relationship between empathy and the activity or stage of MS seem so far contradictory.
Alexithymia, or inability to express feelings verbally, is a pathology close to empathy deficit, and can affect patients' daily lives in a similar way. Prevalence of alexithymia in MS patients has been shown to be higher than in general population, and its parallel study with empathy seems relevant.
The aim of this study is to assess the level of empathy on a larger scale of MS population and to study various confounding factors known to influence the level of empathy, such as anxiety, depression, level of education but also the characteristics of the disease: its duration of evolution, its stage, its activity, and associated disability.
The investigator team will conduct a prospective observational study in MS patients to assess their level of empathy versus a control population of healthy subjects and study the influence of these different variables.
Read the detailed description
Multiple sclerosis is a chronic inflammatory disease of the central nervous system that affects more than 2.8 million people worldwide and whose diagnosis is most often made around the age of 30. Its prevalence is increasing since the 90s and seems to involve certain susceptibility genes and environmental factors.
This inflammatory disease, whose exact etiology remains unclear, underpinned by multiple pathophysiological mechanisms, is the cause of significant motor and cognitive disability. Indeed, some studies report a prevalence of 40% to 60% of cognitive impairment during the disease, and represents a major factor influencing quality of life in patients with MS.
Defined as a part of cognitive functions, social cognition refers to a set of processes involved in social interactions, including perception, understanding and reasoning about emotions and behaviors of others.
There are usually several components described within social cognition: - theory of mind, or an individual's ability to infer other's intention and behavior, - empathy, which is the ability to react to and understand other's emotion, and - social perceptions and knowledge (from prosody, bodily gestures and facial expressions).
The concept of empathy was first defined in the 19th century by Theodor Lipps, then one of the main representatives of German psychology, under the term "Einfühlung" as a tool for understanding the mental status of the other.
Several works have tried to distinguish between affective and cognitive empathy.
Affective empathy is defined as the affective state produced in response to emotional experiences of others. Cognitive empathy represents the understanding of an external situation from the point of view of the person who lives it by distinguishing the other from oneself. This last component is substantially related to the definition of theory of mind.
Empathy can be assessed via a 28-item IRI (Interpersonal Reactivity Index) self-questionnaire, the most commonly used test in clinical research, the French version of which has been validated on 322 subjects.
To date, few studies have focused on the more specific study of empathy in MS and its two aforementioned components but seem to suggest the existence of a deficit.
There appears to be many confounding factors but their direct relationship to empathy is not clearly established: potentially related comorbidities, such as anxiety and depression that are frequently found in MS patients ; level of education and cognitive reserve; and finally the very characteristics of the disease.
Indeed, data concerning relationship between empathy and the activity or stage of MS seem so far contradictory.
Alexithymia, or inability to express feelings verbally, is a pathology close to empathy deficit, and can affect patients' daily lives in a similar way. Prevalence of alexithymia in MS patients has been shown to be higher than in general population, and its parallel study with empathy seems relevant.
The aim of this study is to assess the level of empathy on a larger scale of MS population and to study various confounding factors known to influence the level of empathy, such as anxiety, depression, level of education but also the characteristics of the disease: its duration of evolution, its stage, its activity, and associated disability.
The investigator team conducted a prospective observational study in MS patients to assess their level of empathy versus a control population of healthy subjects and study the influence of these different variables.
- Conditions
- Multiple Sclerosis
- Being tested
- Interpersonal Reactivity Index
- Keywords
- MS, social cognition, empathy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal Reactivity IndexOther
Questionnaire to be completed by the patient
| Study group | Role | What they receive |
|---|---|---|
| Adult patients followed for multiple sclerosis | Not described Receives: Other: Interpersonal Reactivity Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpersonal Reactivity Index (IRI)
QUestionnaire IRI will be completed by patients
Measured: 5 minutes
Secondary outcomes (5)
alexithymia
Toronto Alexithymia Scale TAS 20 (rated from 20 to 100)
Measured: 5 minutes
anxiety and depression
Hospital Anxiety and Depression Scale HADS will be completed by patients (rated from 0 to 21)
Measured: 5 minutes
cognitive reserve
Cognitive Reserve Index questionnaire CRIq will be completed by patients
Measured: 5 minutes
fatigue
Fatigue Severity Scale (FSS) will be completed by patients (rated from 9 to 63)
Measured: 5 minutes
cognitive deficit
Symbol Digit Modalities Test (SDMT, rated from 0 to 90) to be defined by the investigator
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start4 Jul 2022
- Primary completion19 Dec 2022
- Study completion19 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332951
- Sponsor's protocol ID
- APHP220241
- Other IDs
- 2022-A00713-40
- Acronym
- SEmPathy
- Status last verified
- Jan 2024
- First submitted
- 11 Apr 2022
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Empathy in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05332951
- Acronym / sponsor ID
- SEmPathy / APHP220241
- Conditions
- Multiple Sclerosis
- Keywords
- MS, social cognition, empathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 19 Dec 2022 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multiple sclerosis is a chronic inflammatory disease of the central nervous system whose exact etiology remains unclear, underpinned by multiple pathophysiological mechanisms, and is a cause of significant motor and cognitive disability.
Some studies report a prevalence of 40% to 60% of cognitive impairment during the disease, and represents a major factor influencing quality of life in patients with MS.
Cognitive impairment can affect one or more of the 6 cognitive functions, including social cognition and its three components: theory of mind, or an individual's ability to infer intention and other's behavior, empathy, and social perceptions and knowledge.
To date, few studies have focused on the more specific study of empathy in MS. They seem to suggest the existence of a deficit but rely on small numbers of patients.
There appear to be many confounding factors but their direct relationship to empathy is not clearly established: potentially related comorbidities, such as anxiety and depression that are frequently found in MS patients ; level of education and cognitive reserve; and finally the very characteristics of the disease.
Indeed, data concerning relationship between empathy and the activity or stage of MS seem so far contradictory.
Alexithymia, or inability to express feelings verbally, is a pathology close to empathy deficit, and can affect patients' daily lives in a similar way. Prevalence of alexithymia in MS patients has been shown to be higher than in general population, and its parallel study with empathy seems relevant.
The aim of this study is to assess the level of empathy on a larger scale of MS population and to study various confounding factors known to influence the level of empathy, such as anxiety, depression, level of education but also the characteristics of the disease: its duration of evolution, its stage, its activity, and associated disability.
The investigator team will conduct a prospective observational study in MS patients to assess their level of empathy versus a control population of healthy subjects and study the influence of these different variables.
Detailed description
Multiple sclerosis is a chronic inflammatory disease of the central nervous system that affects more than 2.8 million people worldwide and whose diagnosis is most often made around the age of 30. Its prevalence is increasing since the 90s and seems to involve certain susceptibility genes and environmental factors.
This inflammatory disease, whose exact etiology remains unclear, underpinned by multiple pathophysiological mechanisms, is the cause of significant motor and cognitive disability. Indeed, some studies report a prevalence of 40% to 60% of cognitive impairment during the disease, and represents a major factor influencing quality of life in patients with MS.
Defined as a part of cognitive functions, social cognition refers to a set of processes involved in social interactions, including perception, understanding and reasoning about emotions and behaviors of others.
There are usually several components described within social cognition: - theory of mind, or an individual's ability to infer other's intention and behavior, - empathy, which is the ability to react to and understand other's emotion, and - social perceptions and knowledge (from prosody, bodily gestures and facial expressions).
The concept of empathy was first defined in the 19th century by Theodor Lipps, then one of the main representatives of German psychology, under the term "Einfühlung" as a tool for understanding the mental status of the other.
Several works have tried to distinguish between affective and cognitive empathy.
Affective empathy is defined as the affective state produced in response to emotional experiences of others. Cognitive empathy represents the understanding of an external situation from the point of view of the person who lives it by distinguishing the other from oneself. This last component is substantially related to the definition of theory of mind.
Empathy can be assessed via a 28-item IRI (Interpersonal Reactivity Index) self-questionnaire, the most commonly used test in clinical research, the French version of which has been validated on 322 subjects.
To date, few studies have focused on the more specific study of empathy in MS and its two aforementioned components but seem to suggest the existence of a deficit.
There appears to be many confounding factors but their direct relationship to empathy is not clearly established: potentially related comorbidities, such as anxiety and depression that are frequently found in MS patients ; level of education and cognitive reserve; and finally the very characteristics of the disease.
Indeed, data concerning relationship between empathy and the activity or stage of MS seem so far contradictory.
Alexithymia, or inability to express feelings verbally, is a pathology close to empathy deficit, and can affect patients' daily lives in a similar way. Prevalence of alexithymia in MS patients has been shown to be higher than in general population, and its parallel study with empathy seems relevant.
The aim of this study is to assess the level of empathy on a larger scale of MS population and to study various confounding factors known to influence the level of empathy, such as anxiety, depression, level of education but also the characteristics of the disease: its duration of evolution, its stage, its activity, and associated disability.
The investigator team conducted a prospective observational study in MS patients to assess their level of empathy versus a control population of healthy subjects and study the influence of these different variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients followed for multiple sclerosis | – | Other: Interpersonal Reactivity Index |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients followed for multiple sclerosis
Key inclusion criteria (3 listed)
- Patient aged 18 to 60
- Follow-up for multiple sclerosis meeting the revised McDonalds diagnostic criteria of 2017.
- Patient not objecting to participation in the research.
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal Reactivity IndexQuestionnaire to be completed by the patient | Other | Adult patients followed for multiple sclerosis |
Primary outcome
Interpersonal Reactivity Index (IRI)
Time frame: 5 minutes
QUestionnaire IRI will be completed by patients
5 secondary outcomes
alexithymia
Time frame: 5 minutes
anxiety and depression
Time frame: 5 minutes
cognitive reserve
Time frame: 5 minutes
fatigue
Time frame: 5 minutes
cognitive deficit
Time frame: 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interpersonal Reactivity Index (IRI) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.