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| Name | Class |
|---|---|
| Catholic University of the Sacred Heart | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine mindfulness intervention | Experimental | 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. |
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| Psycho-education control group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine mindfulness-based intervention | Behavioral | Comparison of telemedicine mindfulness intervention with telemedicine psycho-education control group |
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| Measure | Description | Time Frame |
|---|---|---|
| Evidence of an improved quality of life in patients with multiple sclerosis as measured by The Multiple Sclerosis Quality of Life-54 (MSQOL-54) | All subjects will be assigned to psychometric assessment | First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention |
| Evidence of an improved quality of life in caregivers as measured by the Short-Form-36 (SF-36) | All subjects will be assigned to psychometric assessment | First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention |
| Evidence of a decrease of anxiety and depression in patients with multiple sclerosis and in caregivers as measured by the Hospital Anxiety and Depression Scale (HADS) | All subjects will be assigned to psychometric assessment | First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of an attained mindfulness level in patients with multiple sclerosis and in caregivers as measured by the Langer Mindfulness Scale (LMS) | All subjects will be assigned to psychometric assessment | first assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Francesco Pagnini | Milan | Mi | 20871 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20876468 | Background | Grossman P, Kappos L, Gensicke H, D'Souza M, Mohr DC, Penner IK, Steiner C. MS quality of life, depression, and fatigue improve after mindfulness training: a randomized trial. Neurology. 2010 Sep 28;75(13):1141-9. doi: 10.1212/WNL.0b013e3181f4d80d. | |
| 21601010 | Background | Whitebird RR, Kreitzer MJ, Lewis BA, Hanson LR, Crain AL, Enstad CJ, Mehta A. Recruiting and retaining family caregivers to a randomized controlled trial on mindfulness-based stress reduction. Contemp Clin Trials. 2011 Sep;32(5):654-61. doi: 10.1016/j.cct.2011.05.002. Epub 2011 May 12. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Psycho-education intervention | Behavioral | 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. |
|
| Evidence of a decrease of sleep disturbance and better quality of sleep in patients with multiple sclerosis and in caregivers as measured by the Medical Outcomes Study Sleep Measure (MOSssm) | All subjects will be assigned to psychometric assessment | First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention |
| Evidence of a decrease of sleep disturbance and fatigue and a better quality of sleep in patients with multiple sclerosis as measured by actigraphy unit | 40 subjects will receive an actigraphy, a non-invasive method of monitoring human rest/activity cycles, that can be worn to measure gross motor activity | First assessment includes the entires two weeks preceding the start of the intervention (baseline condition); second assessment includes the entire two weeks after the end of the intervention |
| Evidence of a decrease in fatigue in patients with multiple sclerosis and in caregivers as measured by the Modified Fatigue Impact Scale (MFIS) | All subjects will be assigned to psychometric assessment | First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention |
| Evidence of a decrease in caregiver burden as measured by the Zarit Burden Interview (ZBI) | All subjects will be assigned to psychometric assessment | First assessment: two weeks before the start of the intervention (baseline condition); second assessment: one week after the end of the intervention; third assessment: 6-months follow-up after the end of the intervention |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |