Clinical trial NCT03607773: Mindfulness for Newly Diagnosed Multiple Sclerosis
Official title: Mindfulness Group Intervention for Newly Diagnosed Persons With Multiple Sclerosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Mindfulness
Lead sponsor: London Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
First posted: 2018-07-31
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Recently diagnosed with RRMS;
2. Must be within 1 year of an RRMS diagnosis at the time of the first MBI session;
3. Between 18-59 years of age inclusive; and
4. Fluent in English.

Exclusion Criteria:

1. Have bipolar disorder, schizophrenia, post-traumatic stress disorder, dissociation disorders or untreated depression or other psychiatric disease (at the PI's discretion) that could affect the study outcomesa major psychiatric disease such as bipolar disorder, schizophrenia or untreated severe major depressive disorder;
2. Use of marijuana more than 3x per week, or have other substance abuse, as determined by the PI;
3. Diagnosed with other neurological disorder(s) that would prevent participation in the intervention; or
4. Unable to attend at least 80% (8 of 10) of the MBI sessions (missing more than 20% of the sessions will result in removal from the study).

Primary outcomes:
measure: Change in coping skills
timeFrame: Within 1 month Pre-MBI sessions; Within 1 month Post-MBI sessions; 6 months post-MBI sessions.
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Sarah A Morrow, M.D.
role: PRINCIPAL_INVESTIGATOR
References: