Emotional Processing, Family Life, Friendship and Social Integration in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 4
- 主要终点
- Interaction between measures of emotional processing (z score) and functional measures of social interaction
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(patient group):
- •Age 18-45 years;
- •MS diagnosis according to McDonald criteria (Polman et al., 2005);
- •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)
排除标准
- •(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;
研究组 & 干预措施
patient
MS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);
干预措施: Clinical evaluation (Other)
patient
MS diagnosis according to McDonald criteria (Polman et al., 2005). Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);
干预措施: Cognitive evaluation (Other)
Control
healthy subject
干预措施: Cognitive evaluation (Other)
结局指标
主要结局
Interaction between measures of emotional processing (z score) and functional measures of social interaction
时间窗: At inclusion (day 0)
among the 3 groups (impaired MS, no impaired MS and HS)
次要结局
- Correlation between measures of emotional processing with cognitive testing (z scores by domain) and cognitive functioning evaluated by significant other(At inclusion (day 0))
- Correlation between measures of emotional processing and quality of life measures(At inclusion (day 0))
- 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))