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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mindfulness-based stress reduction (MBSR) can assist people with multiple sclerosis (MS) in managing stress and improving well-being. The researchers aim to determine if an 8-week MBSR course can positively affect anxiety, depression, and overall quality of life for individuals with MS. Participants should have a diagnosis of MS or a related condition and be willing to join the course. The trial focuses on refining the MBSR approach based on feedback to better support individuals with MS. As an unphased trial, it offers a unique opportunity to contribute to innovative approaches that may enhance the quality of life for those with MS.

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 prior data suggests that this mindfulness-based stress reduction is safe for people with multiple sclerosis?

Research has shown that Mindfulness-Based Stress Reduction (MBSR) is generally safe for people with multiple sclerosis (MS). Studies indicate that MBSR can help reduce stress, anxiety, and depression, which are common in those with MS. No major safety concerns have been associated with MBSR. As a non-invasive practice, it does not involve surgery or medication, making it manageable for most individuals.

However, some studies note that not everyone continues with the program, and some participants drop out. These issues relate more to personal commitment than to safety. Overall, MBSR offers a safe way to manage stress and improve well-being for people with MS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Mindfulness-Based Stress Reduction (MBSR) is unique because it offers a non-pharmaceutical approach to managing multiple sclerosis (MS), which is typically treated with medications like immunomodulators and corticosteroids. Unlike these drugs, MBSR focuses on stress management through meditation and awareness techniques, which can improve mental well-being and potentially reduce MS symptoms. Researchers are excited about MBSR because it empowers patients to actively engage in their own health management without the side effects often associated with medication. This holistic approach could complement existing treatments by targeting stress, a known trigger for MS flare-ups.

What evidence suggests that Mindfulness-Based Stress Reduction is effective for multiple sclerosis?

Research has shown that Mindfulness-Based Stress Reduction (MBSR), which participants in this trial will undergo, can improve emotional well-being and reduce stress, depression, and anxiety in people with multiple sclerosis (MS). Studies have found that MBSR can enhance the quality of life for those with MS. For instance, one study discovered that MBSR helped lower stress levels and increase emotional strength. However, some benefits, such as reduced stress, might diminish a few months after completing the program. Mindfulness-based programs like MBSR are considered effective for managing stress-related symptoms in MS, though maintaining the program can sometimes be challenging. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6386630/

Impact of mindfulness-based stress reduction for people ... Preliminary findings suggest that either MBSR or MS Education may improve perceived stress, emotional wellbeing, depression, anxiety, fatigue, and resilience ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6942645/

The Effect of Mindfulness-Based Stress Reduction (MBSR) ... The present study aimed to determine the effect of Mindfulness-Based Stress Reduction (MBSR) therapy on the quality of life in women with Multiple sclerosis in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01419301

Mindfulness Based Stress Reduction in Multiple Sclerosis ... See Delay Results Type in the Results Data Element definitions for more information. ... Mindfulness based stress reduction (MBSR) is program based on daily ...

4. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-017-0880-8

Mindfulness-based stress reduction for people with multiple ... At three-months post-MBSR (study endpoint) improvements in perceived stress were diminished to a small effect size (ES 0.26; p = 0.39), were ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/09638288.2021.1964622

Mindfulness-based interventions for people with multiple ... Mindfulness-based interventions (MBIs) are effective treatments for stress, anxiety, and depression in PwMS. However, low adherence and high attrition may ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9643979/

A systematic review and meta-analysis exploring the efficacy ... The aim of this study was to evaluate via meta-analysis the efficacy of Mindfulness-based interventions (MBIs) for improving QoL in PwMS.

7. nature.com nature.com/articles/s41598-024-62960-w

A single-arm, open-label pilot study of neuroimaging ... A recent survey showed that 100% of MS patients rely on at least one complementary or integrative health intervention to address unmet ...