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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03825055
Study type Observational
Source Universita di Verona
Contact
Status Completed
Phase
Start date February 26, 2019
Completion date March 31, 2022

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