Clinical trial NCT03825055: Resilience in Young Adults Newly Diagnosed With Multiple Sclerosis
Official title: Behaviour and Well-Being: A Bio-Psycho-Social Model of Resilience in Young Adults Newly Diagnosed With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: disease-specific variables
biopsychosocial characteristics
resilience
adjustment
quality of life
well-being
young adults
Lead sponsor: Universita di Verona
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Universitaria Integrata Verona
name: Fondazione Italiana Sclerosi Multipla
name: Federico II University
First posted: 2019-01-31
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potentially eligible patients, diagnosed with MS in the 2 years prior to study inclusion, from the catchment area of the Multiple Sclerosis Regional Center of the Azienda Ospedaliera Universitaria Integrata of Verona will be identified during routine visits at the MS Centre of Borgo Roma Hospital Verona and asked to participate in the study.

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.

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.

Primary outcomes:
measure: Level of resilience
timeFrame: at study entry (i.e., within one month from informed consent)
Secondary outcomes:
measure: Level of quality of life
timeFrame: at study entry (i.e., within one month from informed consent)
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona, Policlinico G.B. Rossi
state: Veneto
Study officials:
affiliation: Università di Verona
name: Michela Rimondini, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Università di Verona
name: Alberto Gajofatto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Moss-Morris R, Dennison L, Landau S, Yardley L, Silber E, Chalder T. A randomized controlled trial of cognitive behavioral therapy (CBT) for adjusting to multiple sclerosis (the saMS trial): does CBT work and for whom does it work? J Consult Clin Psychol. 2013 Apr;81(2):251-62. doi: 10.1037/a0029132. Epub 2012 Jun 25.
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citation: 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.