Clinical trial NCT02708927: Emotional Processing, Family Life, Friendship and Social Integration in Patients With Multiple Sclerosis
Official title: Emotional Processing, Family Life, Friendship and Social Integration in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: social integration
cognitive impairment
emotional processing
quality of life
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: FONDATION POUR L'AIDE A LA RECHERCHE SUR LA SCLEROSE EN PLAQUES
First posted: 2016-03-15
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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;

Primary outcomes:
measure: Interaction between measures of emotional processing (z score) and functional measures of social interaction
timeFrame: At inclusion (day 0)
Secondary outcomes:
measure: Correlation between measures of emotional processing with cognitive testing (z scores by domain) and cognitive functioning evaluated by significant other
timeFrame: At inclusion (day 0)
measure: Correlation between measures of emotional processing and quality of life measures
timeFrame: At inclusion (day 0)
measure: 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.
timeFrame: At inclusion (day 0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Dijon
country: France
facility: CHU de Dijon
Study officials:
affiliation: University Hospital, Bordeaux
name: Bruno BROCHET, Prof
role: PRINCIPAL_INVESTIGATOR
References: