Meditation + AF Education for Atrial Fibrillation

(MEND-AF2 Trial)

Overseen By Linda Ottoboni, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Low cardiac function, Life expectancy, Hospitalized, Mindfulness, Cognitive impairment

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: 6

Duration: 6 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this project is to determine whether the entire intervention (Mindfulness meditation, AF education, and weekly phone visits) that is nurse delivered to individuals with paroxysmal atrial fibrillation is more effective than a combination, single or no intervention in the reduction of overall AF symptoms, anxiety, and negative illness perception; or the improvement of quality of life (QOL) and functional status.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for Atrial Fibrillation?

Mindfulness-Based Stress Reduction (MBSR) has been shown to improve quality of life and reduce stress in patients with various chronic conditions, including anxiety and depression, which may indirectly benefit those with atrial fibrillation by reducing stress-related triggers. ^{1 2 3 4 5}

Is meditation and mindfulness-based stress reduction safe for humans?

Mindfulness-based stress reduction (MBSR) is generally considered safe for humans and has been used for various conditions like stress, depression, anxiety, and chronic pain without significant safety concerns. ^{1 6 7 8 9}

How is the meditation treatment for atrial fibrillation different from other treatments?

The meditation treatment for atrial fibrillation is unique because it focuses on reducing stress and anxiety through mindfulness practices, which can help manage heart rhythm issues by lowering stress-related hormones. Unlike traditional medical treatments, this approach uses techniques like meditation and yoga to improve mental well-being and potentially reduce the frequency of atrial fibrillation episodes. ^{1 2 3 10 11}

Research Team

Linda Ottoboni, PhD

Principal Investigator

Clinician and research scientist

Eligibility Criteria

This trial is for adults with Paroxysmal Atrial Fibrillation (PAF) who've had symptoms in the last 6 months. Participants must be able to engage in weekly phone calls, attend two video/phone sessions six weeks apart, and understand English. Those with severe heart failure, short life expectancy, recent hospitalization for other illnesses, prior mindfulness practice or cognitive issues cannot join.

Inclusion Criteria

Able to participate in weekly phone calls

Able to read and understand English

Able to attend two video visit/phone sessions that are 6 weeks apart

Exclusion Criteria

You have been diagnosed with severe heart problems.

You are expected to live for less than 6 months.

You were in the hospital for a different illness in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mindfulness meditation, AF education, and weekly phone visits for symptom management

6 weeks

6 weekly phone visits

Follow-up

Participants are monitored for changes in AF symptom burden, anxiety, and quality of life

12 months

Treatment Details

Interventions

• AF Education
• Meditation
• Phone Calls

Trial Overview The study tests if a nurse-led program combining Mindfulness meditation, AF education, and weekly phone check-ins can reduce AF symptoms and anxiety while improving quality of life compared to partial or no intervention. The effectiveness of each component alone will also be evaluated.

Participant Groups

Group I: Weekly Phone Calls Experimental Treatment 1 Intervention

Each week for the six-week intervention, the researcher will contact the participant by phone at an agreed upon time and will discuss any questions, issues or concerns that are voiced by the participant within 5-15 minutes.

Group II: Mindfulness Meditation and Phone Calls Experimental Treatment 2 Interventions

Each participant watches an mindfulness meditation introductory video in the initial session and then is asked to practice for 10 minutes each day using a guided audio, which includes a different topic each week. The time duration of the guided meditations increases to 15 minutes each day during Weeks 3-6. Each week for the six-week intervention, the researcher will contact the participant by phone at an agreed upon time and will discuss any questions, issues or concerns that are voiced by the participant within 5-15 minutes.

Group III: Mindfulness Meditation Practice Experimental Treatment 1 Intervention

Each participant watches an mindfulness meditation introductory video in the initial session and then is asked to practice for 10 minutes each day using a guided audio, which includes a different topic each week. The time duration of the guided meditations increases to 15 minutes each day during Weeks 3-6.

Group IV: Meditation and Education and Phone Calls Experimental Treatment 3 Interventions

Each participant watches an mindfulness meditation introductory video in the initial session and then is asked to practice for 10 minutes each day using a guided audio, which includes a different topic each week. Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week. The time duration of the guided meditations increases to 15 minutes each day during Weeks 3-6. Each week for the six-week intervention, the researcher will contact the participant by phone at an agreed upon time and will discuss any questions, issues or concerns that are voiced by the participant within 5-15 minutes.

Group V: AF education Experimental Treatment 1 Intervention

Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week.

Group VI: AF Education and Weekly Phone Calls Experimental Treatment 2 Interventions

Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week. Each week for the six-week intervention, the researcher will contact the participant by phone at an agreed upon time and will discuss any questions, issues or concerns that are voiced by the participant within 5-15 minutes.

Group VII: AF Education and Mindfulness Meditation Experimental Treatment 2 Interventions

Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week. Each participant watches an mindfulness meditation introductory video in the initial session and then is asked to practice for 10 minutes each day using a guided audio, which includes a different topic each week. The time duration of the guided meditations increases to 15 minutes each day during Weeks 3-6.

Group VIII: Usual Care Active Control 1 Intervention

patient receives same care as patients not enrolled in study intervention

Meditation is already approved in United States, European Union for the following indications:

Approved in United States as Mindfulness Meditation for:

• Chronic Low Back Pain

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

• Chronic Pain Management
• Stress Reduction

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

An abbreviated Mindfulness-Based Stress Reduction (MBSR) program consisting of 6 weekly 75-minute sessions can effectively be implemented during staff lunch breaks, making it a practical training option for healthcare providers and clinic staff.

This adapted MBSR program is not only feasible but also well-accepted, suggesting it could enhance the well-being of healthcare workers in a workplace setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. Hazlett-Stevens, H.[2021]

Meditation practices have been shown to significantly improve psychosocial factors, quality of life, and reduce heart failure symptom burden in patients, based on a review of six studies involving 320 heart failure patients.

Despite the positive findings, the studies varied widely in their design and outcome measures, highlighting the need for more standardized and larger trials to better understand the effects of meditation on heart failure outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation interventions among heart failure patients: An integrative review. Viveiros, J., Chamberlain, B., O'Hare, A., et al.[2022]

Mindfulness-based stress reduction (MBSR) is increasingly recommended by healthcare providers for its benefits in managing conditions like anxiety, depression, chronic pain, and insomnia.

Incorporating MBSR techniques into daily medical practice can help physicians reduce their own stress and prevent burnout, promoting overall wellness in both patients and providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demystifying mindfulness. Lawson, K.[2011]

A 10-week mindfulness-based stress reduction (MBSR) program significantly improved psychological distress in women with conditions like multiple chemical sensitivity, chronic fatigue syndrome, and fibromyalgia, as shown by a large sample of 50 participants compared to 26 control subjects.

Improvements were statistically significant both immediately after the program and at a three-month follow-up, indicating that MBSR can be an effective complementary intervention for managing symptoms in these chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled study of the effect of a mindfulness-based stress reduction technique in women with multiple chemical sensitivity, chronic fatigue syndrome, and fibromyalgia. Sampalli, T., Berlasso, E., Fox, R., et al.[2021]

Mindfulness-based stress reduction (MBSR) has been shown to effectively reduce stress levels in healthy individuals, as indicated by a review of ten studies, although most of these studies were of low quality.

MBSR not only reduces stress but also enhances traits like empathy and self-compassion, while showing similar efficacy to standard relaxation training, highlighting the need for more rigorous research to confirm its specific benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for stress management in healthy people: a review and meta-analysis. Chiesa, A., Serretti, A.[2022]

The Journeys to Wellness trial successfully adapted the standard 8-week mindfulness-based stress reduction (MBSR) program into a workshop and teleconference format (tMBSR) for 63 kidney transplant candidates, showing high attendance and satisfaction rates among participants.

Participants in the tMBSR group reported significantly higher expectations of the intervention's usefulness for managing their health (83%) compared to the tSupport group (43%), indicating a positive reception and potential efficacy of the mindfulness training for improving quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-adapted mindfulness-based stress reduction (tMBSR) for patients awaiting kidney transplantation: Trial design, rationale and feasibility. Reilly-Spong, M., Reibel, D., Pearson, T., et al.[2022]

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

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Meditation interventions among heart failure patients: An integrative review. [2022]

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

Design and methods for a pilot study of a phone-delivered, mindfulness-based intervention in patients with implantable cardioverter defibrillators. [2021]

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

Demystifying mindfulness. [2011]

5. Iran pubmed.ncbi.nlm.nih.gov

Effect of Mindfulness Based Stress Reduction on Quality of Life (SF-36) and Spirometry Parameters, in Chemically Pulmonary Injured Veterans. [2018]

6. New Zealand pubmed.ncbi.nlm.nih.gov

A controlled study of the effect of a mindfulness-based stress reduction technique in women with multiple chemical sensitivity, chronic fatigue syndrome, and fibromyalgia. [2021]

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

Mindfulness-based stress reduction for stress management in healthy people: a review and meta-analysis. [2022]

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

Telephone-adapted mindfulness-based stress reduction (tMBSR) for patients awaiting kidney transplantation: Trial design, rationale and feasibility. [2022]

9. India pubmed.ncbi.nlm.nih.gov

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

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

Nontraditional Cardiac Rehabilitation in Korean Patients with Coronary Artery Disease. [2022]

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

A pilot study of a mindfulness based stress reduction program in adolescents with implantable cardioverter defibrillators or pacemakers. [2018]