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

CompletedNot a drug-phase studyMS (type not specified)NCT02136485

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Mindfulness-based stress reduction (MBSR)
  • waiting list control

What it measured

Main measures

  • Feasibility, accessibility, and acceptability of MBSR in people with MS

    5 months

    Feasibility

Other measures (3)

  • Perceived stress symptoms (PSS)

    5 months

  • Health related Quality of Life

    5 months

    Quality of life (reported by participants)
  • Multiple Sclerosis Quality of Life Inventory (MSQLI)

    5 months

    Thinking and memoryFatigueBladder, bowel and sexual functionPainQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

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)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jun 2014

    2. Main results due

      Aug 2016

    3. Finished

      Aug 2016

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