Intervention for Young Adults With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): ESPRIMO
Intervention type(s): Behavioral
Intervention description(s): Participants will receive the intervention during Phase 2.
The intervention is based on the cognitive behavioral, the third-wave (mindfulness and acceptance and commitment therapy), and the positive psychology approach.
The frequency of the intervention and the specific content and aims of the psychological and physical intervention will be based on the results of the surveys and the focus group discussion (Pre-phase and Phase 1). In order to maximize the benefit of the integrated intervention, all the three components of the interventions (i.e., psychological, motor exercise and social components) will be administered in the same time period.
A preliminary theoretical framework of the intervention will be created prior to the survey phase according to the literature in the field. Specific aspects of this preliminary framework will be discussed during the co-creation phase and adapted after the analysis of the qualitative results.
Intervention model: Single Group Assignment
Intervention model description: ESPRIMO is a feasibility study using a participatory design.
It is composed of a pre-phase and three main consequential phases:
Pre-phase: Exploring the psychological impact of COVID-19 on young adults with MS using a cross-sectional web-based survey for patients with MS;
Phase 1 (Co-creation of the intervention): initial co-creation phase aiming to develop a biopsychosocial intervention (the so-called ESPRIMO intervention) targeted at young adults with MS, using cross-sectional web-based surveys for young adults with MS and healthcare providers as well as focus groups with patients;
Phase 2 (intervention): aiming to test preliminary effect, feasibility, and acceptability of the ESPRIMO intervention in a sample of young patients with MS; Phase 3 (Fine tuning of the intervention): evaluation of the results by the ESPRIMO Board (composed of four young adults with MS and three healthcare professionals) and subsequent fine-tuning of the ESPRIMO intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: quality of life; young adults; biopsychosocial intervention