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
Trials January 4, 2016 DOI: 10.1186/s13063-015-1136-9 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial (study protocol) Peer reviewed |
|---|---|
| Sample size | 120 |
| Population | Men and women with a diagnosis of relapsing-remitting or secondary progressive multiple sclerosis, and their caregivers |
| Duration | 2-month intervention; assessments at baseline, week 8 (intervention conclusion), and week 27 (6-month follow-up) |
| Topics | Meditation |
| Registration | NCT02364505 |
| Key findings | The protocol proposes that a 2-month, MS-specific telemedicine meditation intervention may improve quality of life, anxiety, and depression in people with multiple sclerosis and their caregivers, compared with an online psycho-education control condition with equal contact time. The authors state that the trial will increase understanding of meditation as part of an MS treatment plan. No results are reported. |
Abstract
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. 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. 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. Clinical Trials Register NCT02364505. https://clinicaltrials.gov/ct2/show/NCT02364505.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cited by 3
- Effect of mindfulness yoga on anxiety and depression in early breast cancer patients received adjuvant chemotherapy: a randomized clinical trial Journal of Cancer Research and Clinical Oncology July 5, 2022
- Online meditation training for people with multiple sclerosis: A randomized controlled trial. Multiple Sclerosis Journal April 2019
- Can the Mindful Awareness and Resilience Skills for Adolescents (MARS-A) Program Be Provided Online? Voices from the Youth. Children August 28, 2018
Cites 5
- Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, and Zen Meditation for Depression, Anxiety, Pain, and Psychological Distress Journal of Psychiatric Practice July 1, 2012
- The experience of meditation for people with amyotrophic lateral sclerosis and their caregivers - a qualitative analysis. Psychology, Health & Medicine September 2016
- Examination of the factor structure and concurrent validity of the Langer Mindfulness/Mindlessness Scale. Assessment October 27, 2010
- MS quality of life, depression, and fatigue improve after mindfulness training: a randomized trial. Neurology September 1, 2010
- The Effect of Mindfulness-Based Therapy on Anxiety and Depression: A Meta-Analytic Review Journal of Consulting and Clinical Psychology April 1, 2010