Mindfulness-based Stress Reduction in Multiple Sclerosis

February 27, 2019 updated by: NHS Greater Glasgow and Clyde

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Glasgow, United Kingdom, G12 0XP
        • NHS Centre for Integrative Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MBSR
8 weekly sessions each lasting 2.5 hours
8 sessions of MBSR
Other: Control
Control arm - waiting list control, once the intervention group has completed MBSR the control group will be invited to participate in MBSR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility, accessibility, and acceptability of MBSR in people with MS
Time Frame: 5 months
Completion rate
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived stress symptoms (PSS)
Time Frame: 5 months
PSS questionnaire
5 months
Health related Quality of Life
Time Frame: 5 months
EuroQuol 5D (EQ-5D)
5 months
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
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2014

Primary Completion (Actual)

August 31, 2016

Study Completion (Actual)

August 31, 2016

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 9, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Actual)

March 1, 2019

Last Update Submitted That Met QC Criteria

February 27, 2019

Last Verified

February 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on Mindfulness-based stress reduction (MBSR)

3
Subscribe