Meditation + AF Education for Atrial Fibrillation

(MEND-AF2 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Linda Ottoboni, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Approved in 2 Jurisdictions

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.

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.

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Stanford Health Care Stanford, CA

Who Is Running the Clinical Trial?

Stanford University Lead Sponsor

References