Mindfulness-Based Stress Reduction for Multiple Sclerosis

Overseen By Robert Simpson

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Robert Simpson

Disqualifiers: Cognitive impairment, Severe mental health, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This project aims to implement and investigate a mindfulness-based stress reduction (MBSR) in people with multiple sclerosis (PwMS). The main objective is to implement MBSR intervention for PwMS in a major tertiary care clinic for PwMS. We will iteratively refine the intervention as required based on stakeholder feedback and any other emergent contextual findings. Participants will be asked to take part in an 8-week MBSR course and report changes in anxiety, depression, quality of life, emotional regulation, self-compassion, mindfulness, and health services use.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on mindfulness practices, so you may not need to change your medication routine.

What data supports the effectiveness of the treatment Mindfulness-Based Stress Reduction (MBSR) for Multiple Sclerosis?

Research shows that Mindfulness-Based Stress Reduction (MBSR) can improve the quality of life, reduce psychological distress, and enhance cognitive functioning in people with Multiple Sclerosis. Participants in studies reported benefits like better sleep, less stress, and improved relationships after undergoing MBSR. ^{1 2 3 4 5}

Is Mindfulness-Based Stress Reduction (MBSR) safe for humans?

Mindfulness-Based Stress Reduction (MBSR) is generally considered safe for humans and has been used for various conditions like depression, anxiety, and chronic pain. Some participants may initially experience an increase in awareness of their condition, which can be unpleasant, but this is often followed by greater acceptance and self-compassion. ^{1 2 4 6 7}

How is Mindfulness-Based Stress Reduction (MBSR) treatment different from other treatments for Multiple Sclerosis?

Mindfulness-Based Stress Reduction (MBSR) is unique because it is a non-drug therapy that focuses on meditation and mindfulness to help improve quality of life, reduce stress, and enhance cognitive functioning in people with Multiple Sclerosis. Unlike traditional treatments that may focus on medication, MBSR emphasizes mental and emotional well-being through practices like meditation and mindful movement. ^{1 2 4 6 7}

Eligibility Criteria

This trial is for adults aged 18 to 60 with Multiple Sclerosis or related conditions, who can understand English and are willing to participate in an online Mindfulness-Based Stress Reduction (MBSR) course.

Inclusion Criteria

I have been diagnosed with MS or a similar condition.

I can understand spoken and written English.

I am willing to participate in a mindfulness course.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take part in an 8-week Mindfulness-Based Stress Reduction (MBSR) course

8 weeks

Weekly online sessions

Follow-up

Participants are monitored for changes in anxiety, depression, quality of life, and other measures

3 months

Follow-up assessments at 8 weeks and 3 months

Treatment Details

Interventions

• Mindfulness-Based Stress Reduction

Trial Overview The study tests the effects of an 8-week MBSR program on anxiety, depression, quality of life, emotional regulation, self-compassion, mindfulness, and health services use among people with Multiple Sclerosis.

Participant Groups

Group I: Mindfulness-Based Stress Reduction Experimental Treatment 1 Intervention

8-week Mindfulness-Based Stress Reduction course

Mindfulness-Based Stress Reduction is already approved in United States, European Union for the following indications:

Approved in United States as Mindfulness-Based Stress Reduction for:

• Chronic Low Back Pain

Approved in European Union as Mindfulness-Based Stress Reduction for:

• Chronic Pain Management
• Stress Reduction

Who Is Running the Clinical Trial?

Robert Simpson

Lead Sponsor

Trials

3

Recruited

210+

Findings from Research

A systematic review of 18 studies found that Mindfulness Based Stress Reduction (MBSR) therapy significantly improves the conditions of patients with chronic illnesses such as cancer, hypertension, and diabetes.

MBSR offers a promising alternative treatment method that helps patients manage their diseases more effectively, although more research is needed to fully understand its mechanisms and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. Niazi, AK., Niazi, SK.[2022]

References

1. Iran pubmed.ncbi.nlm.nih.gov

The Effect of Mindfulness-Based Stress Reduction (MBSR) Therapy on Quality of Life in Women with Multiple Sclerosis, Ahvaz, Iran. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Optimising mindfulness-based stress reduction for people with multiple sclerosis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Meditation as an adjunct to the management of multiple sclerosis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The Effectiveness of Mindfulness-Based Stress Reduction on Psychological Distress and Cognitive Functioning in Patients with Multiple Sclerosis: a Pilot Study. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Perceived stress in multiple sclerosis: the potential role of mindfulness in health and well-being. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for people with multiple sclerosis - a feasibility randomised controlled trial. [2019]