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Mindfulness-based Stress Reduction in Multiple Sclerosis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02136485
Enrollment
50
Registered
2014-05-13
Start date
2014-06-02
Completion date
2016-08-31
Last updated
2019-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

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.

Interventions

BEHAVIORALMindfulness-based stress reduction (MBSR)

8 sessions of MBSR

Sponsors

University of Glasgow
CollaboratorOTHER
NHS Greater Glasgow and Clyde
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Feasibility, accessibility, and acceptability of MBSR in people with MS5 monthsCompletion rate

Secondary

MeasureTime frameDescription
Perceived stress symptoms (PSS)5 monthsPSS questionnaire
Health related Quality of Life5 monthsEuroQuol 5D (EQ-5D)
Multiple Sclerosis Quality of Life Inventory (MSQLI)5 monthsMeasure of a) fatigue, b) chronic pain, c) sexual function, d) urinary function, e) bowel function, f) visual impairment, g) cognitive function, h) emotional distress

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026