Multiple Sclerosis Clinical Trial
Official title:
Improving the Quality of Life of People With Multiple Sclerosis and Their Caregivers With a Telemedicine Mindfulness-Based Intervention
The aim of the project is to investigate the impact of a multiple sclerosis specific telemedicine mindfulness-based Intervention on the quality of life of people with multiple sclerosis and their caregivers.
The mindfulness protocol will be modified according to multiple sclerosis clinical
peculiarities and implemented with a multimedia web-based software.
The project will be divided in two parts. During the first phase of the project, a standard
mindfulness-based stress reduction protocol will be modified according to clinical
peculiarities and specific needs of people with multiple sclerosis. In the meanwhile, a
multimedia software with these teaching will be developed, so that the training could be
available online, from home. The protocol and the software will be tested for ergonomics in a
pilot, qualitative, study.
In the second phase, a randomized clinical trial will be performed. One-hundred and twenty
multiple sclerosis patients-caregivers couples will be randomly allocated in the experimental
or to the control group. Subjects in the experimental group will attend the telemedicine
mindfulness intervention, while controls will join a psycho-educational telemedicine program.
At baseline, post-treatment and at a 6-month follow-up, participants will be assessed for
quality of life, anxiety, depression, quality of sleep and mindfulness level. A subgroup of
subjects will be assessed with actigraphs, for an objective evaluation of their sleep and
physical activity. Experimental subjects will be assessed for participation and engagement to
the treatment. Data will be analyzed with a complex longitudinal design, considering both
within and between groups comparisons.
The dissemination process will involve scientific publication on neurological and
psychological journals, a book, scientific meeting presentations and communication to general
media. If there will be a positive effect of the mindfulness software, it will be diffused to
multiple sclerosis clinics and associations.
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