Mindfulness-based Stress Reduction in Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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Mindfulness-based Stress Reduction in Multiple Sclerosis - a Randomised Controlled Trial

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Mindfulness-based stress reduction (MBSR)
* Other: waiting list control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBSR<br>8 weekly sessions each lasting 2.5 hours | Behavioral: Mindfulness-based stress reduction (MBSR)<br>* 8 sessions of MBSR<br>|
| Other: Control<br>Control arm - waiting list control, once the intervention group has completed MBSR the control group will be invited to participate in MBSR | Other: waiting list control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility, accessibility, and acceptability of MBSR in people with MS | Completion rate | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived stress symptoms (PSS) | PSS questionnaire | 5 months | 
| Health related Quality of Life | EuroQuol 5D (EQ-5D) | 5 months | 
| Multiple Sclerosis Quality of Life Inventory (MSQLI) | 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 |