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Emotional Processing, Family Life, Friendship and Social Integration in Patients With Multiple Sclerosis (EMOSOCIAL-MS)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical evaluation
Cognitive evaluation
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring social integration, cognitive impairment, emotional processing, quality of life

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • CHU de Bordeaux
  • CHU de Dijon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

patient

Control

Arm Description

MS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);

healthy subject

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Correlation between measures of emotional processing with cognitive testing (z scores by domain) and cognitive functioning evaluated by significant other
(BAFQ)
Correlation between measures of emotional processing and quality of life measures
(MUSIQoL questionnaire).
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.

Full Information

First Posted
March 10, 2016
Last Updated
February 1, 2019
Sponsor
University Hospital, Bordeaux
Collaborators
FONDATION POUR L'AIDE A LA RECHERCHE SUR LA SCLEROSE EN PLAQUES
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1. Study Identification

Unique Protocol Identification Number
NCT02708927
Brief Title
Emotional Processing, Family Life, Friendship and Social Integration in Patients With Multiple Sclerosis
Acronym
EMOSOCIAL-MS
Official Title
Emotional Processing, Family Life, Friendship and Social Integration in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 3, 2016 (Actual)
Primary Completion Date
January 28, 2019 (Actual)
Study Completion Date
January 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
FONDATION POUR L'AIDE A LA RECHERCHE SUR LA SCLEROSE EN PLAQUES

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
social integration, cognitive impairment, emotional processing, quality of life

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient
Arm Type
Experimental
Arm Description
MS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);
Arm Title
Control
Arm Type
Experimental
Arm Description
healthy subject
Intervention Type
Other
Intervention Name(s)
Clinical evaluation
Intervention Description
• Clinical assessment : Expanded Disability Status Scale (EDSS), ambulation test. Medications will be recorded.
Intervention Type
Other
Intervention Name(s)
Cognitive evaluation
Intervention Description
• Neuropsychological, psychological, social and social cognitive evaluation
Primary Outcome Measure Information:
Title
Interaction between measures of emotional processing (z score) and functional measures of social interaction
Description
among the 3 groups (impaired MS, no impaired MS and HS)
Time Frame
At inclusion (day 0)
Secondary Outcome Measure Information:
Title
Correlation between measures of emotional processing with cognitive testing (z scores by domain) and cognitive functioning evaluated by significant other
Description
(BAFQ)
Time Frame
At inclusion (day 0)
Title
Correlation between measures of emotional processing and quality of life measures
Description
(MUSIQoL questionnaire).
Time Frame
At inclusion (day 0)
Title
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.
Time Frame
At inclusion (day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno BROCHET, Prof
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France

12. IPD Sharing Statement

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

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