Emotional Processing, Family Life, Friendship and Social Integration in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— EMOSOCIAL-MS  

Official title:

Emotional Processing, Family Life, Friendship and Social Integration in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708927
• Other study ID #: CHUBX 2015/11
• Status: Completed
• Phase: N/A
• Start date: March 3, 2016
• Est. completion date: January 28, 2019

Study information

• Verified date: February 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In addition to the physical, cognitive and psychological symptoms experienced by individuals with Multiple Sclerosis (MS), there is new research which indicates that some individuals with MS have a deficit in emotional processing, specifically, facial affect recognition. Emotional processing is defined as "a central aspect of social cognition". Models of social cognition indicate that emotional processing is an essential component of interpersonal relationships. The failure to accurately perceive other's emotions has been shown to lead to difficulty in social relationships, misinterpreting other's affect, and consequently, inappropriate responding.

However, even though a significant number of individuals with MS have impairments in emotional processing, we do not yet have an understanding of how these impairments affect the social functioning of individuals with MS, including the impact of these deficits on family structure. It is well-known that MS impacts one's social functioning including factors such as employment, daily living activities and interpersonal relationships. Recently a strong correlation was observed between reduced social participation in MS and quality of life. There is evidence to suggest that emotional processing deficits lie at the heart of this reduced social participation in persons with MS, leading to decreased social functioning and thus reduced quality of life. However, to date, this hypothesis has not been tested.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 28, 2019
• Est. primary completion date: January 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria (patient group):

• Age 18-45 years;

• MS diagnosis according to McDonald criteria (Polman et al., 2005);

• RRMS;

• Disease duration < 15 years;

• Fluent French speaker;

• Have a significant other (family members or close friends) who was willing to complete the informant questionnaire BAFQ;

• Being affiliated to health insurance;

• Having signed an informed consent (later than the day of inclusion and before any examination required by research).

Inclusion Criteria (healthy control):

• Age 18-45 years

• Fluent French speaker;

• Have a significant other (family members or close friends) who was willing to complete the informant questionnaire BAFQ.

• Being affiliated to health insurance

• Having signed an informed consent (later than the day of inclusion and before any examination required by research)

Exclusion Criteria (patient group):

• Other progressive neurological disease;

• psychiatric comorbidity including severe depression according to Diagnostic and Statistical Manual-IV (DSM-IV);

• alcohol or other addiction to toxic;

• EDSS> 6;

• Disabling visual or motor problems preventing participation to neuropsychological assessments;

• relapse since less than one month;

• change of disease-modifying therapy or psychotropic drug since less than three month;

• change of psychotropic drug since less than one month;

• Prior neuropsychological testing with the same tests less than one year prevents the participant to participate at this study.

• Illiteracy, is unable to count or to read;

• Being under guardianship.

• Pregnant or breastfeeding women;

Exclusion Criteria (healthy control):

• History of neurological disease;

• family history of MS;

• psychiatric comorbidity including severe depression according to DSMIV;

• alcohol or other toxic addiction;

• usage of psychotropic drugs;

• Known cognitive complaint or neuropsychological affection;

• Prior neuropsychological testing with the same tests less than one year prevents the participant to participate at this study.

• Illiteracy, is unable to count or to read;

• Being under guardianship.

• Pregnant or breastfeeding women;

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Clinical evaluation
• Clinical assessment : Expanded Disability Status Scale (EDSS), ambulation test. Medications will be recorded.
• Cognitive evaluation
• Neuropsychological, psychological, social and social cognitive evaluation

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	CHU de Dijon	Dijon

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	FONDATION POUR L'AIDE A LA RECHERCHE SUR LA SCLEROSE EN PLAQUES

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interaction between measures of emotional processing (z score) and functional measures of social interaction	among the 3 groups (impaired MS, no impaired MS and HS)	At inclusion (day 0)
Secondary	Correlation between measures of emotional processing with cognitive testing (z scores by domain) and cognitive functioning evaluated by significant other	(BAFQ)	At inclusion (day 0)
Secondary	Correlation between measures of emotional processing and quality of life measures	(MUSIQoL questionnaire).	At inclusion (day 0)
Secondary	Impact of the cognitive impairment on the relationship of emotional processing (z score) with interpersonal relationships (family, friendship, marital) and society integration and social functioning.		At inclusion (day 0)