Mindfulness-based Stress Reduction in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: waiting list control; Behavioral: Mindfulness-based stress reduction (MBSR)

• Registration Number: NCT02136485
• Lead Sponsor: NHS Greater Glasgow and Clyde

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-01
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-13
• Study Start: 2014-06-02
• Primary Completion: 2016-08-31
• Study Completion: 2016-08-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Feasibility, accessibility, and acceptability of MBSR in people with MS	5 months	Completion rate

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NHS Centre for Integrative Care; 🇬🇧 Glasgow, United Kingdom