- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02136485
Mindfulness-based Stress Reduction in Multiple Sclerosis
Mindfulness-based Stress Reduction in Multiple Sclerosis - a Randomised Controlled Trial
This application concerns a proposed randomised controlled trial evaluating the use of Mindfulness-based stress reduction (MBSR) in people with Multiple Sclerosis (MS) in secondary care.
MS is an inherently stressful condition, and stress is thought to exacerbate MS. Mental health problems are common in MS, can impair quality of life, and lead to higher rates of suicide.
Prior research has shown that cognitive behavioural therapy (CBT) can help mitigate stress and diminish disease activity in MS, but effects are short-lived and there is thus a need to explore whether other psychological approaches might be more beneficial in this regard.
MBSR is another psychological stress reduction technique that is thought to operate differently to CBT, via cultivating a state of "meta-cognitive awareness" and has shown to be helpful when used in other long term conditions, such as chronic pain and anxiety, whilst Mindfulness-based cognitive therapy (MBCT - a derivative of MBSR) is effective in treating recurrent depression. All of these conditions are common in MS. However, mindfulness based interventions have not been well studied in MS.
The investigators propose to carry out a feasibility study to assess how acceptable and accessible MBSR is as a stress reduction technique in people with MS. The investigators would seek up to 50 participants who would then be randomly assigned to receive MBSR or their usual care. The investigators would seek measurements of health and wellbeing before, immediately following, and 3 months following the MBSR intervention. This would include basic demographic information (age, gender, ethnicity), measures of mental health, and physical health, as well as qualitative semi-structured interviews with selected participants. After this we would offer MBSR to the control group.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Glasgow, United Kingdom, G12 0XP
- NHS Centre for Integrative Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Having at baseline a Neurologist confirmed diagnosis of MS
- Can understand spoken and written English
- Score of less than or equal to 7 on the Expanded Disability Status Scale
Exclusion Criteria:
- Potentially life threatening physical or mental health comorbidities or conditions expected to significantly limit participation and adherence
- Current receipt of another form of psychological intervention (non-pharmacological)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MBSR
8 weekly sessions each lasting 2.5 hours
|
8 sessions of MBSR
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Other: Control
Control arm - waiting list control, once the intervention group has completed MBSR the control group will be invited to participate in MBSR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility, accessibility, and acceptability of MBSR in people with MS
Time Frame: 5 months
|
Completion rate
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived stress symptoms (PSS)
Time Frame: 5 months
|
PSS questionnaire
|
5 months
|
Health related Quality of Life
Time Frame: 5 months
|
EuroQuol 5D (EQ-5D)
|
5 months
|
Multiple Sclerosis Quality of Life Inventory (MSQLI)
Time Frame: 5 months
|
Measure of a) fatigue, b) chronic pain, c) sexual function, d) urinary function, e) bowel function, f) visual impairment, g) cognitive function, h) emotional distress
|
5 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Simpson R, Simpson S, Wood K, Mercer SW, Mair FS. Using normalisation process theory to understand barriers and facilitators to implementing mindfulness-based stress reduction for people with multiple sclerosis. Chronic Illn. 2019 Dec;15(4):306-318. doi: 10.1177/1742395318769354. Epub 2018 Apr 26. No abstract available.
- Simpson R, Mair FS, Mercer SW. Mindfulness-based stress reduction for people with multiple sclerosis - a feasibility randomised controlled trial. BMC Neurol. 2017 May 16;17(1):94. doi: 10.1186/s12883-017-0880-8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN14CH078
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Mindfulness-based stress reduction (MBSR)
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-
Ottawa Hospital Research InstituteCanadian Cancer Society (CCS)CompletedCancer | Chronic Pain | Painful Neuropathy | Worries; Pain or DisabilityCanada
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University of AarhusCopenhagen University Hospital, HvidovreCompletedAn Adapted Mindfulness-based Stress Reduction Program for Psycho-socially Vulnerable Pregnant Women.Pregnancy, High RiskDenmark
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University of SheffieldCompleted
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Northwestern UniversityAmerican Cancer Society, Inc.; Robert H. Lurie Cancer CenterCompleted
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Universität Duisburg-EssenMinisterium für Schule und Weiterbildung, Land Nordrhein-Westfalen; Ministerium...CompletedChild Development | Burnout Syndrome | MindfulnessGermany
-
National Taiwan University HospitalUnknownMindfulness-based Stress ReductionTaiwan
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University of ManitobaWorkers Compensation Board of Manitoba; Catholic Health Corporation of ManitobaUnknownBurnout, Professional | Emotional Stress | Work Related Illnesses | Burnout SyndromeCanada
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University Medical Center GroningenCompletedOvarian CancerNetherlands
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Carnegie Mellon UniversityCompletedInflammation | Stress