At a glance
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ESPRIMO: A Bio-psycho-social Co-created Intervention for Young Adults With Multiple Sclerosis: Study Protocol for a Feasibility Study
In Brief
A clinical study evaluating ESPRIMO for Multiple Sclerosis. Completed, enrolled 53 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.