A Telemedicine Mindfulness-based Intervention for People With Multiple Sclerosis and Their Caregivers

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Telemedicine mindfulness-based intervention; Behavioral: Psycho-education intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02364505

23042013205901

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 156 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of relapsing-remitting or secondary progressive multiple sclerosis.
• Ability to communicate and to understand tasks.
• No change of disease-modifying treatment in the 3 months before the enrolment.
• No clinical relapses or use of steroid treatment during the 4 weeks before the enrolment.
• Availability of a personal computer, smartphone or tablet (compatible with the software).
• Provided informed consent for study participation.

Exclusion criteria

• Being a person who lives with the multiple sclerosis patient and provides him/her with most care and assistance
• Ability to communicate and to understand tasks
• Availability of a personal computer, smartphone or tablet (compatible with the software).
• Provided informed consent for study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 2 patient groups

Telemedicine mindfulness intervention

Experimental group

Description:

Participants are assigned to a telemedicine mindfulness intervention group. The protocol lasts 8 weeks and it is composed by one online course session each week and home exercises. The course sessions, with a synchronous communication, will be conducted by a trainer, through teleconferences, that will explain how to practice the exercises to develop mindfulness attitude, following the mindfulness-based intervention-multiple sclerosis protocol. Subjects will be able to take part of these sessions everywhere, through a computer, tablet o mobile. During these sessions, individuals will interact with the trainer with teleconference or textual communications.

Treatment:

Behavioral: Telemedicine mindfulness-based intervention

Psycho-education control group

Active Comparator group

Description:

Psycho-education control group, provided with a telemedicine approach. Subject in this group will use a similar software than the experimental intervention, with identical time efforts required. Software contents will be psycho-educative.

Treatment:

Behavioral: Psycho-education intervention