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Mindfulness-based Stress Reduction in Multiple Sclerosis

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NHS Trust

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Behavioral: Mindfulness-based stress reduction (MBSR)
Other: waiting list control

Study type

Interventional

Funder types

Other

Identifiers

NCT02136485
GN14CH078

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 2 patient groups

MBSR
Experimental group
Description:
8 weekly sessions each lasting 2.5 hours
Treatment:
Behavioral: Mindfulness-based stress reduction (MBSR)
Control
Other group
Description:
Control arm - waiting list control, once the intervention group has completed MBSR the control group will be invited to participate in MBSR
Treatment:
Other: waiting list control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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