Extrait

Background and study aims: Multiple sclerosis (MS) is an incurable, chronic disease of the central nervous system. There is a substantial literature on the challenges of adjusting to MS but few have taken into account the differential challenges for people with relapsing remitting MS and those with a progressive form of the illness. This study focuses on people with progressive type of MS. Mindfulness based courses have been shown to effectively reduce anxiety, depression and pain in patients with chronic physical illnesses. The aim of this study is to assess the effectiveness of an easy to access mindfulness based cognitive therapy (MBCT) course, which aims to reduce distress for people affected by primary or secondary progressive MS. Who can participate? You can take part in this study if you have primary or secondary progressive MS, and if you have Internet access. Also, you can take part if you haven't received any formal training in mindfulness methods and if you are not currently receiving any other psychological treatment. This is because we would like to see whether our course is helpful and we won't be able to do so if you have completed similar courses before or if you are receiving additional psychological help. Unfortunately, you won't be able to take part in this study if you have severe problems with concentration because some elements of the course require good attention. Also, in case you are highly distressed, this type of treatment might not be the most appropriate for you. We will discuss these issues with you over the phone before the start of the course and we may suggest an alternative approach for you. What does the study involve? The research project will involve a comparison between an 8-week mindfulness course group and a waiting-list (control) group. You will be randomised into one of the two groups and depending on the group you are assigned to you will either join the mindfulness course straight away or in case you are assigned to waiting list group, you will have the chance to join a mindfulness course in 5 months time. The sessions of the mindfulness course will take place once a week for about an hour. Angeliki will facilitate the sessions and 4 more people with progressive MS will take part in the course with you. You will not have to travel for these sessions. The course will be delivered through videoconferences. As part of the programme we will ask you to practice mindfulness meditation regularly using the CDs we will provide you. We will record the sessions so that we can check that Angeliki is conducting the sessions in exactly the way that was planned. Further, we will ask participants of both groups to fill in questionnaires at three times; a month before the programme starts for the mindfulness course group, when the course finishes and 20 weeks after the course has finished. Participants of the waiting list group will be asked to refrain from taking part in any other mindfulness course during this period. These questionnaires will take about an hour to fill in. You can complete these questionnaires through a website. If you have been assigned to the waiting group, you will not require filling in any extra questionnaires when you start your mindfulness course. At the end of the course, you will be invited to meet with an independent researcher who will ask you about your experiences and your views about the programme. He will arrange a convenient time with you to conduct an informal interview on the telephone for about one hour. The interviewer will not be a member of the team involved in this project. The independent researcher will tape-record your interview and transcribe it omitting your name or any other identifiable information before giving the transcripts to the research team to study it at a later date. Then we will delete the recordings of the interviews. If you want to take part in the mindfulness programme but do not want to do this interview you do not have to. You can also change your mind if you agree to do the interview but decide you no longer want to at a later date. What are the possible benefits and risks of participating? We cannot promise the study will help you but the evidence so far show that mindfulness courses are helpful for people with chronic conditions. Further the information we get will help us make the course more relevant to the needs of people with progressive MS. The main disadvantage of taking part is simply the time and effort it will take. It is also possible that exploring issues to do with your illness may be difficult for you. However, mindfulness approaches are designed to help people to feel better and we don't expect that people will feel any worse as a result of taking part. If, through taking part in the research, it becomes clear that you are having any major difficulties (e.g. with depression) we will refer you to further sources of support. Where is the study run from? King's College London, UK When is the study starting and how long is it expected to run for? The study started in November 2012 and will end in November 2013. Participants will be recruited between November 2012 and May 2013. Who is funding the study? MS Society, UK. Who is the main contact? Angeliki Bogosian [email protected]

Critère d'inclusion

• Primary and secondary progressive multiple sclerosis

Liens

• ictrp
• isrctn