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

November 12, 2022 updated by: Michela Rimondini, Universita di Verona

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Veneto
      • Verona, Veneto, Italy, 37134
        • Azienda Ospedaliera Universitaria Integrata Verona, Policlinico G.B. Rossi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of resilience
Time Frame: 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.
at study entry (i.e., within one month from informed consent)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of quality of life
Time Frame: 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.
at study entry (i.e., within one month from informed consent)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universita di Verona

Collaborators

Fondazione Italiana Sclerosi Multipla
Federico II University
Azienda Ospedaliera Universitaria Integrata Verona

Investigators

  • Principal Investigator: Michela Rimondini, PhD, Universita di Verona
  • Principal Investigator: Alberto Gajofatto, MD, PhD, Universita di Verona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2019

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

January 30, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 12, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2029CESC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for the primary and secondary outcome measures (resilience, quality of life) will be made available upon reasonable request.

IPD Sharing Time Frame

Data can be made available upon reasonable request when data are published (6 months after publication).

IPD Sharing Access Criteria

Requestors will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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