BPS-ARMS: Resilience in Young Adults Newly Diagnosed With Multiple Sclerosis

Sponsor

Universita di Verona (Other)

Overall Status

Recruiting

CT.gov ID

NCT03825055

Collaborator

Azienda Ospedaliera Universitaria Integrata Verona (Other), Fondazione Italiana Sclerosi Multipla (Other), Federico II University (Other)

150

Enrollment

Location

36.1

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Feb 26, 2019

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Young patients with MS young adults (i.e., 18-45 years) newly diagnosed with MS (Case-Only)

Outcome Measures

Primary Outcome Measures

Level of resilience [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.

Secondary Outcome Measures

Level of quality of life [at study entry (i.e., within one month from informed consent)]
Italian version of the MSQOL-54 (Solari et al., 1999). The MSQOL-54 is a multidimensional health-related Quality of Life measure that combines both generic and MS-specific items, such as fatigue and cognitive function (Vickrey et al, 1995, 1997; Solari et al., 1999). The instrument generates 12 scores (physical function, role limitations-physical, role limitations-emotion, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall QoL, and sexual function) along with two summary scores (i.e., physical health and mental health) derived from a weighted combination of scale scores. There are also two single-item measures: satisfaction with sexual function and change in health.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.