Mindfulness-based Stress Reduction in Multiple Sclerosis

NCT02136485 | Completed

• 1 other identifier: GN14CH078
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

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

  Completion rate

  5 months

Secondary Outcomes (3)

• Perceived stress symptoms (PSS)

  5 months

• Health related Quality of Life

  5 months

• Multiple Sclerosis Quality of Life Inventory (MSQLI)

  5 months

Study Arms (2)

MBSR

EXPERIMENTAL

8 weekly sessions each lasting 2.5 hours

Behavioral: Mindfulness-based stress reduction (MBSR)

Control

OTHER

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

Other: waiting list control

Interventions

Mindfulness-based stress reduction (MBSR) BEHAVIORAL

8 sessions of MBSR

MBSR

waiting list control OTHER

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

NHS Centre for Integrative Care

Glasgow, G12 0XP, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29699410 DERIVED

• 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.

  PMID: 28511703 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 13, 2014
• Study Start: June 2, 2014
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: March 1, 2019

Record last verified: 2019-02

Locations

GB (1)