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NCT Number: NCT02136485

Mindfulness-based Stress Reduction in Multiple Sclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS Centre for Integrative Care

Glasgow, G12 0XP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mindfulness-Based Stress Reduction (MBSR)

Behavioral

8 sessions of MBSR

Waiting list control

Other

Primary outcomes

  1. Feasibility, accessibility, and acceptability of MBSR in people with MS

    Time frame: 5 months

    Completion rate

Secondary outcomes

  1. Perceived stress symptoms (PSS)

    Time frame: 5 months

    PSS questionnaire

  2. Health related Quality of Life

    Time frame: 5 months

    EuroQuol 5D (EQ-5D)

  3. 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

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • University of Glasgow

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 13, 2014
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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