Resilience in Young Adults Newly Diagnosed With Multiple Sclerosis

NCT ID: NCT03825055

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 51 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-26
• Study Completion Date: 2022-03-31

Brief 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.

Detailed 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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Young patients with MS

young adults (i.e., 18-45 years) newly diagnosed with MS (Case-Only)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role: collaborator

Fondazione Italiana Sclerosi Multipla

OTHER

Sponsor Role: collaborator

Federico II University

OTHER

Sponsor Role: collaborator

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Michela Rimondini

Associate Professor in Clinical Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michela Rimondini, PhD

Role: PRINCIPAL_INVESTIGATOR

Università di Verona

Alberto Gajofatto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Università di Verona

Locations

Azienda Ospedaliera Universitaria Integrata Verona, Policlinico G.B. Rossi

Verona, Veneto, Italy

Countries

Italy

References

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Reference Type: BACKGROUND

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Gajofatto A, Donisi V, Busch IM, Gobbin F, Butturini E, Calabrese M, Carcereri de Prati A, Cesari P, Del Piccolo L, Donadelli M, Fabene P, Fochi S, Gomez-Lira M, Magliozzi R, Malerba G, Mariotti R, Mariotto S, Milanese C, Romanelli MG, Sbarbati A, Schena F, Mazzi MA, Rimondini M. Biopsychosocial model of resilience in young adults with multiple sclerosis (BPS-ARMS): an observational study protocol exploring psychological reactions early after diagnosis. BMJ Open. 2019 Aug 2;9(8):e030469. doi: 10.1136/bmjopen-2019-030469.

Reference Type: DERIVED

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Other Identifiers

2029CESC

Identifier Type: -

Identifier Source: org_study_id