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临床试验/NCT03825055
NCT03825055已完成不适用

Behaviour and Well-Being: A Bio-Psycho-Social Model of Resilience in Young Adults Newly Diagnosed With Multiple Sclerosis

Universita di Verona1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2019年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
试验地点
1
主要终点
Level of resilience

研究概览

简要总结

This study aims to fill the gap of knowledge on the biopsychosocial (BPS) characteristics and resilience of young adults newly diagnosed with Multiple Sclerosis, to evaluate the relationship among these variables, and to develop a BPS model of resilience.

详细描述

Multiple sclerosis (MS) is the most common neurological disease causing disability in young adults and is widely recognized as a major stress factor. Several studies have shown that the first years after the diagnosis are distressing in terms of adjustment to the disease and that MS negatively affects patients' psychological wellbeing, quality of life (QoL), and social functioning (Kern et al., 2013; Moss-Morris et al., 2013; Pagnini et al., 2014). Nevertheless, up to know, the link between disease-specific variables at diagnosis, resilience, and psychological adjustment of MS patients remains largely unexplored, especially in adolescents and young adults.

This study aims to fill the gap of knowledge on the biopsychosocial (BPS) characteristics and resilience of young adults newly diagnosed with MS, to evaluate the relationship among these variables, and to develop a BPS model of resilience.

Biological and clinical characteristics of young adults newly diagnosed with MS in the University Hospital of Verona will be investigated by collecting clinical information, performing neurological examinations, brain and cervical spinal cord magnet resonance imaging (MRI), and analyzing cerebrospinal fluid and blood biomarkers (i.e. measures of inflammation, axonal damage, oxidative stress and microRNAs (miRNAs) expression), body composition, gut microbiota, and movement/perceptual markers. Psychosocial characteristics (e.g., psychological distress, illness perception, mindfulness trait, and coping strategies), QoL, psychological wellbeing and resilience will be assessed by self-report questionnaires. Comparative statistics (i.e., ANOVA or unpaired samples t-test, correlation and regression analyses) will be applied to evaluate the relationship among biological, psychological and social factors.

The results of this study are expected not only to allow a comprehensive and new understanding of the determinants of resilience and adjustment in MS patients at this crucial stage of life but also to inform resilience interventions, tailored to adolescents' and young patients' specific needs, aiming to reduce the risk of maladaptive reactions to the disease and to improve the psychological well-being and their quality of life.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • MS diagnosis in the 2 years prior to study inclusion, according to the revised McDonald Criteria (Thompson et al., 2018);
  • MRI of the brain in the 6 months prior to or within one month after screening visit according to a standardized protocol (including pre- and post-contrast volumetric T1-weighted, 3D Fluid Attenuated Inversion Recovery (FLAIR), and 3D Double Inversion Recovery (DIR) sequences for brain imaging, and sagittal and axial pre- and post-contrast volumetric T1-weighted, T2-weighted and short tau inversion recovery (STIR) sequences for spinal cord imaging)
  • Italian speakers.

排除标准

  • Clinically relevant cognitive deficits as evaluated by the treating neurologist
  • Treatment with any disease-modifying therapy (DMT) for MS at inclusion and by completion of study procedures (maximum two months from consent); steroids administration up to 30 days prior to inclusion is allowed.

结局指标

主要结局

Level of resilience

时间窗: at study entry (i.e., within one month from informed consent)

Connor-Davidson Resilience Scale (CD-RISC; Connor \& Davidson, 2003), designed to assess resilience features in adolescents and adults. The CD-RISC is composed of 25 items and evaluated on a 5-point Likert scale (ranging from 0 "not true at all" to 4 "true nearly all of the time"), with higher scores reflecting higher levels of resilience.

次要结局

  • Level of quality of life(at study entry (i.e., within one month from informed consent))

研究者

发起方
Universita di Verona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michela Rimondini

Associate Professor in Clinical Psychology

Universita di Verona

研究点 (1)

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