A new randomized and controlled trial is recruiting multiple sclerosis (MS) patients to investigate the effect of a mindfulness-based telemedicine intervention program on patients and their caregivers. The clinical study’s protocol was recently published in the journal Trials, titled “A telemedicine meditation intervention for people with multiple sclerosis and their caregivers: study protocol for a randomized controlled trial.“
MS, one of the most common diseases of the central nervous system (brain and spinal cord), today afflicts more than 2.3 million people worldwide. MS symptoms vary widely but often include blurred vision, weak limbs, tingling sensations, unsteadiness, and fatigue. For some people, MS is characterized by periods of relapse and remission, while for others it has a progressive pattern. For everyone, MS makes life unpredictable.
Psychological interventions have been found to be effective in the reduction of distress, anxiety, and depression, and also in reducing MS symptoms. Mindfulness-based interventions, modified and shortened versions of meditation teachings, are known to improve the quality of life in many clinical conditions, including chronic diseases, but further studies are required.
The trial (NCT02364505) aims to create and test a multimedia software that can teach meditation at home, following the specific requirements of MS patients (i.e., emphasizing music meditation and relaxation exercises). The study will also investigate the effects of such telemedicine mindfulness training on the life quality of MS caregivers. The researchers will also assess whether patients undergoing the meditation protocol show a change in their sleep patterns, which might also reflect an improved quality of life.
A total of 120 patients with relapsing-remitting or secondary progressive MS and their caregivers will be recruited for the trial. All patients will be assessed for their quality of life, depression, quality of sleep, and anxiety, mindfulness, and fatigue levels. These variables will be examined at study entry, at week eight (end of the intervention), and again at a six-month follow-up. Caregivers will be assessed for the same variables as MS patients, plus caregiver burden.
The intervention is based on two hours per week of online meditation in a group setting, which will be led by a trainer, and one hour per week of individual exercises. The control condition will involve a psycho-education online program and will require the same time commitment.
According to the researchers, this intervention has the potential to become an easily accessed, freely available online resource to improve the quality of life of people diagnosed with MS and their caregivers.
For more information about this clinical trial, taking place in Italy, and how to participate, please visit this link.