Evidence map›Paper›PMID 26729330›Full record

Trial reportTrials2016

A telemedicine meditation intervention for people with multiple sclerosis and their caregivers: study protocol for a randomized controlled trial.

Cesare Cavalera, Francesco Pagnini, Marco Rovaris, Laura Mendozzi, Luigi Pugnetti, Massimo Garegnani, Enrico Molinari

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02364505 (Improving the Quality of Life of People With Multiple Sclerosis and Their Caregivers With a Telemedicine Mindfulness-Based Intervention), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02364505 nacompletednot on this map

Improving the Quality of Life of People With Multiple Sclerosis and Their Caregivers With a Telemedicine Mindfulness-Based Intervention

TypeinterventionalSponsorFondazione Don Carlo Gnocchi ETSRan2014 to 2016Enrolled156ConditionsMultiple SclerosisArmsTelemedicine mindfulness-based intervention, Psycho-education intervention
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Longitudinal associations between mindfulness and well-being in people with multiple sclerosis.International journal of clinical and health psychology : IJCHP · 2019
    Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Cesare CavaleraDepartment of Psychology, Catholic University of the Sacred Heart of Milan, via Nirone 15 - 20123, Milan, Italy. cesare.cavalera@gmail.com.
Francesco PagniniDepartment of Psychology, Catholic University of the Sacred Heart of Milan, via Nirone 15 - 20123, Milan, Italy. francesco.pagnini@unicatt.it.
Marco RovarisMultiple 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.
Laura MendozziMultiple 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.
Luigi PugnettiLaboratory 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.
Massimo GaregnaniLaboratory 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.
Enrico MolinariDepartment of Psychology, Catholic University of the Sacred Heart of Milan, via Nirone 15 - 20123, Milan, Italy. enrico.molinari@unicatt.it.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMindfulness-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/

designThis 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. DISCUSSION: 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.

trial registrationClinical Trials Register NCT02364505. https://clinicaltrials.gov/ct2/show/NCT02364505.

Indexed as

Clinical ProtocolsMeditationTelemedicineCaregiversData Interpretation, StatisticalFemaleHumansMaleMultiple SclerosisOutcome Assessment, Health CareQuality of LifeSample Size

Identifiers

PMID26729330
PMCPMC4700623

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.