title: A telemedicine meditation intervention for people with multiple sclerosis and their caregivers: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Mindfulness-based interventions, modified and shortened versions of meditation teachings, have proved to be effective in the improvement of quality of life in many clinical conditions, including chronic diseases. Preliminary results available in the literature and in clinical experience indicate a high potential for this treatment for the reduction of psychological suffering in people with chronic diseases.
  
  
  METHODS
  This randomized controlled trial will investigate the impact of a multiple sclerosis (MS) specific telemedicine meditation intervention on the quality of life of people with multiple sclerosis and their caregivers. This trial will recruit 120 patients, men and women, with a diagnosis of relapsing-remitting or secondary progressive MS and their caregivers to participate in a 2-month intervention. Patients will undergo assessments of quality of life, anxiety, depression, quality of sleep, mindfulness and fatigue levels conducted at baseline, at week 8 (conclusion of the intervention) and at week 27 (6 months follow-up). Caregivers will complete assessments conducted at the same time for the same areas, plus caregiver burden. The intervention condition will consist of 2 hours/week of online meditation in a group setting led by a trainer, plus 1 hour/week of individual exercises. The control condition will incorporate a psycho-education online program and will require the same contact time commitment as the intervention condition.
  
  
  CONCLUSIONS
  Primary outcome measures will consist of assessments of quality of life, anxiety, and depression level. Assessments of mindfulness level, quality of sleep and fatigue level will be considered secondary outcome measures. This investigation will increase understanding of the role of meditation as part of a treatment plan for people with MS and their caregivers. Overall, this study design has the potential to lead to effective meditation intervention strategies for this population and improve their quality of life.
  
  
  BACKGROUND
  Clinical Trials Register NCT02364505. https://clinicaltrials.gov/ct2/show/NCT02364505.
authors.affiliation: Department of Psychology, Catholic University of the Sacred Heart of Milan, via Nirone 15 - 20123, Milan, Italy. cesare.cavalera@gmail.com.
authors.forename: Cesare
authors.initials: C
authors.lastname: Cavalera
authors.affiliation: Department of Psychology, Catholic University of the Sacred Heart of Milan, via Nirone 15 - 20123, Milan, Italy. francesco.pagnini@unicatt.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Pagnini
authors.affiliation: Multiple Sclerosis Rehabilitation Unit, Istituto di Ricovero e Cura a Carattere Scientifico S. Maria Nascente, don C. Gnocchi Foundation, Via Capecelatro 66, Milan, 20148, Italy. mrovaris@dongnocchi.it.
authors.forename: Marco
authors.initials: M
authors.lastname: Rovaris
authors.affiliation: Multiple Sclerosis Rehabilitation Unit, Istituto di Ricovero e Cura a Carattere Scientifico S. Maria Nascente, don C. Gnocchi Foundation, Via Capecelatro 66, Milan, 20148, Italy. lmendozzi@dongnocchi.it.
authors.forename: Laura
authors.initials: L
authors.lastname: Mendozzi
authors.affiliation: Laboratory of Clinical Neurophysiology, Istituto di Ricovero e Cura a Carattere Scientifico S. Maria Nascente, don C. Gnocchi Foundation, Via Capecelatro 66, Milan, 20148, Italy. lpugnetti@dongnocchi.it.
authors.forename: Luigi
authors.initials: L
authors.lastname: Pugnetti
authors.affiliation: Laboratory of Clinical Neurophysiology, Istituto di Ricovero e Cura a Carattere Scientifico S. Maria Nascente, don C. Gnocchi Foundation, Via Capecelatro 66, Milan, 20148, Italy. mgaregnani@dongnocchi.it.
authors.forename: Massimo
authors.initials: M
authors.lastname: Garegnani
authors.affiliation: Department of Psychology, Catholic University of the Sacred Heart of Milan, via Nirone 15 - 20123, Milan, Italy. enrico.molinari@unicatt.it.
authors.forename: Enrico
authors.initials: E
authors.lastname: Molinari
mesh_terms: D017028:Caregivers / Q000523:psychology*; D002985:Clinical Protocols; D003627:Data Interpretation, Statistical; D005260:Female; D006801:Humans; D008297:Male; D019122:Meditation; D009103:Multiple Sclerosis / Q000523:psychology / Q000628:therapy*; D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D018401:Sample Size; D017216:Telemedicine