Ignite Creation Date:
2024-05-06 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03607773
Status:
COMPLETED
Last Update Posted:
2021-03-23
First Post:
2018-07-12
Brief Title:
Mindfulness for Newly Diagnosed Multiple Sclerosis
Sponsor:
Sarah Morrow
Organization:
London Health Sciences Centre
Study Overview
Official Title:
Mindfulness Group Intervention for Newly Diagnosed Persons With Multiple Sclerosis A Pilot Study
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIMS
Brief Summary:
Multiple Sclerosis MS is a chronic neurological disease often diagnosed in a persons 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
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 wwwmindfulnesswithoutbordersorg 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
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 wwwmindfulnesswithoutbordersorg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None