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Clinical Trials/NCT02136485
NCT02136485
Completed
N/A

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

NHS Greater Glasgow and Clyde1 site in 1 country50 target enrollmentJune 2, 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
NHS Greater Glasgow and Clyde
Enrollment
50
Locations
1
Primary Endpoint
Feasibility, accessibility, and acceptability of MBSR in people with MS
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2, 2014
End Date
August 31, 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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)

Outcomes

Primary Outcomes

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

Time Frame: 5 months

Completion rate

Secondary Outcomes

  • Perceived stress symptoms (PSS)(5 months)
  • Health related Quality of Life(5 months)
  • Multiple Sclerosis Quality of Life Inventory (MSQLI)(5 months)

Study Sites (1)

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