Intervention for Young Adults With Multiple Sclerosis — ESPRIMO  

Multiple Sclerosis Clinical Trial

Official title: ESPRIMO: A Bio-psycho-social Co-created Intervention for Young Adults With Multiple Sclerosis: Study Protocol for a Feasibility Study

Status Completed

Clinical Trial Summary

This study aims to develop - in collaboration with patients with multiple sclerosis (MS)- a psychosocial and physical activity intervention (i.e., ESPRIMO intervention) for young adults with MS targeted at improving patients' health-related quality of life (HRQoL). Further, the study seeks to preliminarily test the effect, feasibility, and acceptability of the ESPRIMO intervention using a pilot sample of young adults with MS.

Given that the ESPRIMO study will be conducted immediately after the COVID-19 emergency, it does not seem reasonable to start the co-creation of the intervention without taking into account the potential impact of this pandemic on the quality of life and well-being of patients with MS and on their management of care. Thus, the investigators seek to better understand the needs of the target population under these particular circumstances.

Clinical Trial Description

Being the most common neurological disease causing disability in young adults, multiple sclerosis (MS) does not only impair physical functions but is also often associated with fatigue, symptoms of depression and anxiety as well as reduced health related quality of life (HRQoL). Especially the first years after the diagnosis can be emotionally challenging and psychological adjustment problematic. Since MS is generally detected between the ages of 20 and 40, a period of great significance for professional and personal development, the adaptation to this chronic disease may become even more challenging.

It is now well established that psychological interventions aiming to support people with MS (e.g., Cognitive Behavioural Therapy, mindfulness-based interventions) do not only have a positive effect on psychological aspects, such as resilience, but also on physiological outcomes (e.g., fatigue, physical vitality) and on the perception of general health.

According to the literature, psychological well-being and HRQoL can be also promoted by regular physical activity and exercise (e.g., walking, ballroom dancing), which present the additional advantage of reducing some physical symptoms of MS. Practicing physical activity in groups enables participants also to socialize and create interpersonal relationships, which in turn may significantly affect patients' psychological well-being and illness perception.

Despite the positive impact of interventions focusing on either physical, psychological or social/interpersonal dimensions, there has been little discussion about the development of comprehensive interventions based on the bio-psycho-social model of disease. Even less attention has been paid to the development of early interventions tailored to young adults' needs and to the engagement of patients in the creation of such programs despite the fact that patient engagement has become a central priority for researchers and policy makers in medicine.

Therefore, the investigators aim to develop - in collaboration with patients with MS - a psychosocial and motor intervention (i.e., ESPRIMO intervention) for young adults with MS targeted at improving patients' HRQoL. Further, the study seeks to preliminarily test the effect, feasibility, and acceptability of the ESPRIMO intervention using a pilot sample of young adults with MS.

In the so-called co-creation phase, the primary aim is to create, together with patients, a bio-psycho-social intervention, following also the preferences and suggestions of healthcare professionals. In the intervention phase, the primary aim is to explore the feasibility of the intervention and its effect in improving their quality of life.

Secondary aims of the study are five-fold: 1) to collect patients' opinions and needs as well as healthcare professionals' perspectives on the preferred characteristics of a bio-psycho-social intervention; 2) to explore the effect of the bio-psycho-social intervention in improving bio-psycho-social aspects, such as quality of life, resilience, fatigue (see primary and secondary outcomes) 3) to investigate potential relationships between these psychological variables at baseline and post-intervention; 4) to assess the differences in effect, patient satisfaction and participation rates according to sociodemographic and clinical characteristics; 5) to examine the reasons for dropouts and possible barriers to participation.

Additionally, considering that the ESPRIMO Study will start shortly after the end of the COVID-19 emergency, the potential impact of this emergency on patients' well-being and quality of life must be taken into account when creating the intervention together with the patients.

Therefore, the investigators aim to explore in a pre-phase the potential impact of the COVID-19 emergency on the psychological status and management of disease and the potential positive resources used to deal with this highly challenging situation. ;

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

• NCT number: NCT04431323
• Study type: Interventional
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Status: Completed
• Phase: N/A
• Start date: May 13, 2020
• Completion date: October 30, 2022