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Mindfulness for Newly Diagnosed Multiple Sclerosis (MIMS)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness Behavioural Intervention (MBI) group
Sponsored by
Sarah Morrow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Mindfulness

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • London Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Mindfulness Behavioural Intervention (MBI) group

Control group

Arm Description

10 one-hour mindfulness sessions

Standard of care.

Outcomes

Primary Outcome Measures

Change in coping skills
Brief COPE measure - was developed to assess a broad range of coping responses.28 questions with a 1-4 point scale for a total range of 28-116 with a lower score indicating better coping skills. This will be assessed at three time points and then aggregated to arrive at one reported value that represents "change in coping skills". This is indicated as an integer. Ex. Pre-MBI = 70 and Post-MBI = 50 and 6mo Post-MBI = 50 then the aggregated score would be -20.

Secondary Outcome Measures

Full Information

First Posted
July 12, 2018
Last Updated
March 19, 2021
Sponsor
Sarah Morrow
Collaborators
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03607773
Brief Title
Mindfulness for Newly Diagnosed Multiple Sclerosis
Acronym
MIMS
Official Title
Mindfulness Group Intervention for Newly Diagnosed Persons With Multiple Sclerosis: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 19, 2018 (Actual)
Primary Completion Date
January 20, 2020 (Actual)
Study Completion Date
January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sarah Morrow
Collaborators
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The PI will not know which group each participant has been randomized to, nor will the study coordinator. One study team member, who is leading the Mindfulness sessions, will be unblinded.
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Behavioural Intervention (MBI) group
Arm Type
Active Comparator
Arm Description
10 one-hour mindfulness sessions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Behavioural Intervention (MBI) group
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Change in coping skills
Description
Brief COPE measure - was developed to assess a broad range of coping responses.28 questions with a 1-4 point scale for a total range of 28-116 with a lower score indicating better coping skills. This will be assessed at three time points and then aggregated to arrive at one reported value that represents "change in coping skills". This is indicated as an integer. Ex. Pre-MBI = 70 and Post-MBI = 50 and 6mo Post-MBI = 50 then the aggregated score would be -20.
Time Frame
Within 1 month Pre-MBI sessions; Within 1 month Post-MBI sessions; 6 months post-MBI sessions.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Recently diagnosed with RRMS; Must be within 1 year of an RRMS diagnosis at the time of the first MBI session; Between 18-59 years of age inclusive; and Fluent in English. Exclusion Criteria: 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; Use of marijuana more than 3x per week, or have other substance abuse, as determined by the PI; Diagnosed with other neurological disorder(s) that would prevent participation in the intervention; or 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah A Morrow, M.D.
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Mindfulness for Newly Diagnosed Multiple Sclerosis

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