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Mindfulness-based Stress Reduction in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mindfulness-based stress reduction (MBSR)
waiting list control
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • NHS Centre for Integrative Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

MBSR

Control

Arm Description

8 weekly sessions each lasting 2.5 hours

Control arm - waiting list control, once the intervention group has completed MBSR the control group will be invited to participate in MBSR

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Perceived stress symptoms (PSS)
PSS questionnaire
Health related Quality of Life
EuroQuol 5D (EQ-5D)
Multiple Sclerosis Quality of Life Inventory (MSQLI)
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

Full Information

First Posted
May 1, 2014
Last Updated
February 27, 2019
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT02136485
Brief Title
Mindfulness-based Stress Reduction in Multiple Sclerosis
Official Title
Mindfulness-based Stress Reduction in Multiple Sclerosis - a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 2, 2014 (Actual)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
August 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBSR
Arm Type
Experimental
Arm Description
8 weekly sessions each lasting 2.5 hours
Arm Title
Control
Arm Type
Other
Arm Description
Control arm - waiting list control, once the intervention group has completed MBSR the control group will be invited to participate in MBSR
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based stress reduction (MBSR)
Intervention Description
8 sessions of MBSR
Intervention Type
Other
Intervention Name(s)
waiting list control
Primary Outcome Measure Information:
Title
Feasibility, accessibility, and acceptability of MBSR in people with MS
Description
Completion rate
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Perceived stress symptoms (PSS)
Description
PSS questionnaire
Time Frame
5 months
Title
Health related Quality of Life
Description
EuroQuol 5D (EQ-5D)
Time Frame
5 months
Title
Multiple Sclerosis Quality of Life Inventory (MSQLI)
Description
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
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
NHS Centre for Integrative Care
City
Glasgow
ZIP/Postal Code
G12 0XP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29699410
Citation
Simpson R, Simpson S, Wood K, Mercer SW, Mair FS. Using normalisation process theory to understand barriers and facilitators to implementing mindfulness-based stress reduction for people with multiple sclerosis. Chronic Illn. 2019 Dec;15(4):306-318. doi: 10.1177/1742395318769354. Epub 2018 Apr 26. No abstract available.
Results Reference
derived
PubMed Identifier
28511703
Citation
Simpson R, Mair FS, Mercer SW. Mindfulness-based stress reduction for people with multiple sclerosis - a feasibility randomised controlled trial. BMC Neurol. 2017 May 16;17(1):94. doi: 10.1186/s12883-017-0880-8.
Results Reference
derived

Learn more about this trial

Mindfulness-based Stress Reduction in Multiple Sclerosis

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