Mindfulness for Newly Diagnosed Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Multiple Sclerosis (MS) is a chronic neurological disease often diagnosed in a person's 20s
      or 30s, at a time when most people are starting careers and families. In relapsing remitting
      (RR) MS new neurological symptoms suddenly develop over hours to days during relapses, and
      they do not start to resolve for days to weeks. Relapse symptoms may not completely
      disappear, such that disability accumulates over time. Further, most persons with RRMS will
      enter a progressive phase years after diagnosis. It is unpredictable when the transition to
      the progressive phase will occur and how quickly this progression will happen. Thus,
      receiving an MS diagnosis is a highly stressful event. Persons with MS (PwMS) often suffer
      from mood symptoms, which can further impair quality of life (QOL).

      PwMS need support and the skills to effectively cope with the distress that comes with the
      uncertainty of a new MS diagnosis, as well as to minimize or prevent the onset of negative
      mood symptoms. One promising approach is mindfulness - a mental state of paying attention
      with intention, and accepting the present moment as it is without judgment. Scientific
      evidence supports the use of mindfulness based interventions (MBIs) in other chronic diseases
      to reduce stress, anxiety and depression, leading to improved physical function and QOL. MBIs
      decreased stress-related symptoms and the levels of stress hormones in the blood. As such,
      MBIs have the potential to lessen the negative consequences of stress in newly diagnosed
      PwMS.
    

Detailed description: 
      The investigators aim to assess if an MBI can reduce the negative impact of an MS diagnosis
      by improving coping skills. The investigator predicts that it will reduce perceived stress as
      well as stress markers in the blood, thus increasing overall QOL for newly diagnosed PwMS.

      In this study, the investigator will randomly assign newly diagnosed PwMS to either MBI or
      standard treatment. The investigator administers the MBI under the format of the Mindfulness
      Ambassador Council (MAC), which was developed by the non-profit organization, Mindfulness
      Without Borders (MWB, www.mindfulnesswithoutborders.org). This intervention will consist of
      group meetings led by a mindfulness coach once a week for an hour over 10 weeks. We will
      include in the study PwMS that have been diagnosed with RRMS within the last year. We will
      assess measures of coping, mood symptoms and QOL before the intervention, after 10 weeks (or
      equivalent time for the standard treatment group) and then again 6 months later, to ensure
      any benefit continues over time.

      First and foremost, PwMS will benefit from this type of research. This project could lead to
      a non-pharmacological, cost-effective intervention to help cope with the uncertainty that
      comes with an MS diagnosis as well as improves mood symptoms, psychosocial functioning and
      QOL, currently and over the long-term.

      Sharing the results of this study will be a priority for us. We will present our results at
      national and international meetings as well as submit for journal publication. We will share
      our findings with other health care practitioners and with the lay public through community
      presentations and possible media releases.
    

Intervention name(s): Mindfulness Behavioural Intervention (MBI) group
Intervention type(s): Behavioral
Intervention description(s): While every MBI session is different, in general they will help you develop skills in focused attention, and emotional and behavioural regulation in a group environment made up of other people with MS who may share common experiences with you. MBI sessions are group-based which means you will be attending the sessions with other people who are also in this study and facilitated by trained personnel .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Mindfulness