Mindfulness-based Stress Reduction in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02136485
• Other study ID #: GN14CH078
• Status: Completed
• Phase: N/A
• Start date: June 2, 2014
• Est. completion date: August 31, 2016

Study information

• Verified date: February 2019
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Mindfulness-based stress reduction (MBSR)
8 sessions of MBSR

Other:
• waiting list control

Locations

Country	Name	City	State
United Kingdom	NHS Centre for Integrative Care	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility, accessibility, and acceptability of MBSR in people with MS	Completion rate	5 months
Secondary	Perceived stress symptoms (PSS)	PSS questionnaire	5 months
Secondary	Health related Quality of Life	EuroQuol 5D (EQ-5D)	5 months
Secondary	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	5 months