A Bio-Psycho-Social Co-created Intervention for Young Adults With Multiple Sclerosis (ESPRIMO): Rationale and Study Protocol for a Feasibility Study

Abstract

BackgroundMultiple sclerosis (MS), the most common neurological disease that causes disability in youth, does not only affect physical functions but is also associated with cognitive impairment, fatigue, depression, and anxiety and can significantly impact health-related quality of life (HRQoL). Since MS is generally diagnosed at a young age—a period of great significance for personal, relational, and professional development—adaptation can become highly challenging. Therefore, enhancing the competence of young people to adaptively cope with these potential challenges is of utmost importance in order to promote their potentialities and talents. It has been shown that psychological interventions targeting MS patients can enhance resilience and HRQoL and that regular physical activity (PA) and social engagement can improve psychological well-being. However, literature on the development of global interventions based on the bio-psycho-social model of the disease is missing. Even less attention has been paid to interventions dedicated to young adults with MS (YawMS) and to the involvement of patients in the development of such programs.AimsIn collaboration with MS patients, this study aims to develop a bio-psycho-social intervention (ESPRIMO) for YawMS, aiming to improve their HRQoL and to explore its feasibility, acceptability, and effects.MethodsTo tailor the intervention to the specific needs of YawMS, “patient engagement principles” will be adopted in the co-creation phase, performing a web survey and focus groups with patients and healthcare professionals. In the intervention phase, a pilot sample of 60 young adults with MS will be enrolled. The co-created intervention, composed of group sessions over a 12-week period, will cover psycho-social strategies and include physical activities. Adopting a longitudinal, pre–post evaluation design, self-report questionnaires measuring HRQoL and other bio-psycho-social features (e.g., resilience, well-being, mindfulness traits, self-efficacy, perceived social support, psychological symptoms, illness perception, committed action, fatigue, attitudes, subjective norms, perceived behavioral control, motivation, perception of autonomy support for PA, barriers and intentions to PA) will be administered, the quantity and quality of PA will be measured, and a questionnaire developed by the authors will be used to evaluate the feasibility and acceptability of the ESPRIMO intervention.

“If You Can’t Control the Wind, Adjust Your Sail”: Tips for Post-Pandemic Benefit Finding from Young Adults Living with Multiple Sclerosis. A Qualitative Study

“…As regards the qualitative analyses, participants' answers were grouped in an Excel file and later analyzed using inductive thematic analysis [36]. Two raters (SP, VD) independently read all quotes and created an initial list of codes.…”

“…According to the inclusion criteria of the ESPRIMO project, the definition of the age range for "young adults" from 18 to 45 years has been made on the basis of the clinical onset of MS (i.e., 20-40 years) and the course of the disease. Thus, our study focuses on a subgroup of MS patients who could be considered "young" given the disease history [36,37]. Regarding the second aim of the current research, we divided the sample into two sub-groups (i.e., ages 18-30, ages 31-45) and compared the frequencies of the theme and sub-themes between the groups using Pearson chi-squared test for independence of contingency tables, and the permutation approach was performed to adjust for cells with rare frequencies, where appropriate.…”

“…As stated in the introduction, the clinical purpose of this qualitative exploration was to develop patient-generated tips based on meaning-making and benefit finding to help other young adults with MS to face the pandemic and, more in general, their illness and its impact on their quality of life. Indeed, the present study is part of the ESPRIMO project that aims to improve the quality of life of yawMS through the collaboration between patients living with the disease, clinicians, and researchers [36]. Figure 2 presents patients' tips by drawing on the metaphor underlying the ESPRIMO logo, namely a sailing boat navigating in a storm, that symbolically values the resilience potential of vulnerable populations (i.e., if you are in the middle of a storm, you cannot control the wind, and you are navigating a fragile boat, all you can do is adjust the sails and use the wind in your favour).…”

“…As part of the "ESPRIMO" project [36], the present study was approved by the Ethical Committee of the Verona Hospital (Prog. 2676CESC) and registered on ClinicalTrials (ClinicalTrials.govID: NCT04431323).…”

Family Functioning and Multiple Sclerosis: Study Protocol of a Multicentric Italian Project

“…All those aspects together can have a significant impact on families, negatively affecting marital relationships and parental bonding. Partners and children of patients with MS find themselves dealing with a number of significant challenges, which can have negative consequences on their well-being and quality of life (Steck, 2000;Ehrensperger et al, 2008;Kouzoupis et al, 2010;Donisi et al, 2021).…”