A Telemedicine Mindfulness-based Intervention for People With Multiple
Improving the Quality of Life of People With Multiple Sclerosis and Their Caregivers With a Telemedicine Mindfulness-Based Intervention
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Telemedicine mindfulness-based intervention
Compared with
- Psycho-education intervention
What it measured
Main measures
Evidence of an improved quality of life in patients with multiple sclerosis as measured by The Multiple Sclerosis Quality of Life-54 (MSQOL-54)
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
Quality of life (reported by participants)Evidence of an improved quality of life in caregivers as measured by the Short-Form-36 (SF-36)
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
Quality of life (reported by participants)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)
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
Mood and sleep
Other measures (5)
Evidence of an attained mindfulness level in patients with multiple sclerosis and in caregivers as measured by the Langer Mindfulness Scale (LMS)
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
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)
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
Mood and sleepEvidence of a decrease of sleep disturbance and fatigue and a better quality of sleep in patients with multiple sclerosis as measured by actigraphy unit
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
FatigueMood and sleepEvidence of a decrease in fatigue in patients with multiple sclerosis and in caregivers as measured by the Modified Fatigue Impact Scale (MFIS)
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
FatigueEvidence of a decrease in caregiver burden as measured by the Zarit Burden Interview (ZBI)
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
Who could take part
Relapsing and progressive · 18 to 90
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
A telemedicine meditation intervention for people with multiple sclerosis and their caregivers: study protocol for a randomized controlled trial.Trials · 2016
Results
Cavalera C, Rovaris M, Mendozzi L, Pugnetti L, Garegnani M, Castelnuovo G, Molinari E, Pagnini F. Online meditation training for people with multiple sclerosis: A randomized controlled trial. Mult Scler. 2019 Apr;25(4):610-617. doi: 10.1177/1352458518761187. Epub 2018 Feb 27.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.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.Background
Teasdale JD, Segal Z, Williams JM. How does cognitive therapy prevent depressive relapse and why should attentional control (mindfulness) training help? Behav Res Ther. 1995 Jan;33(1):25-39. doi: 10.1016/0005-7967(94)e0011-7.Background
Manzoni GM, Pagnini F, Gorini A, Preziosa A, Castelnuovo G, Molinari E, Riva G. Can relaxation training reduce emotional eating in women with obesity? An exploratory study with 3 months of follow-up. J Am Diet Assoc. 2009 Aug;109(8):1427-32. doi: 10.1016/j.jada.2009.05.004.Background
Vickrey BG, Hays RD, Harooni R, Myers LW, Ellison GW. A health-related quality of life measure for multiple sclerosis. Qual Life Res. 1995 Jun;4(3):187-206. doi: 10.1007/BF02260859.Background
Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002 Oct;59(10):877-83. doi: 10.1001/archpsyc.59.10.877.Background
Isaksson AK, Ahlstrom G. Managing chronic sorrow: experiences of patients with multiple sclerosis. J Neurosci Nurs. 2008 Jun;40(3):180-91.Background
Gay MC, Vrignaud P, Garitte C, Meunier C. Predictors of depression in multiple sclerosis patients. Acta Neurol Scand. 2010 Mar;121(3):161-70. doi: 10.1111/j.1600-0404.2009.01232.x. Epub 2010 Jan 12.
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History
Started
Sept 2014
Main results due
Nov 2016
Finished
Dec 2016