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Mindfulness meditation coaching for High Blood Pressure (AF Trial)
N/A
Waitlist Available
Led By Paul Ritvo, Ph.D
Research Sponsored by York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
AF Trial Summary
The aim of this study is to evaluate the effectiveness of a 16 week mindfulness-based coaching program compared to a cardiovascular risk reduction education program. Both groups will undergo 24-hour ambulatory blood pressure monitoring, along with assessments of psychological measures (see bellow) at study baseline, midpoint (8 weeks), and conclusion (16 weeks). In addition, both groups will also undergo 24-hour Holter monitoring assessments at study beginning and conclusion to assess possible episodes of atrial tachyarrhythmia during the assessed interval.
Eligible Conditions
- High Blood Pressure
- Atrial Fibrillation
- Mindfulness
- Cardiovascular Risk Reduction
AF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Daytime time (Awake) Systolic Blood Pressure
Night time (Sleep) Systolic Blood Pressure
Secondary outcome measures
Tachyarrhythmia
Cardiac Anxiety Questionnaire (CAQ)
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)
+5 moreAF Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness meditation coachingExperimental Treatment1 Intervention
Mindfulness-based coaching - participants will receive instructions on (a) mindfulness meditation and gentle mindful movement through home-based and in-class participation at the Southlake Cardiovascular Rehabilitation Clinic and (b) personal coaching support. The health coach will further assist participants through either face-to-face or telephone-based discussions. They will meet with the health coach at mutually-agreed upon on times for designated time periods.
Group II: dietary cardiovascular risk reduction coachingActive Control1 Intervention
Cardiovascular risk reduction education - No change to standard of care where participants will receive instructions (in person or by phone call) on how to integrate exercise and dietary changes in your lifestyle to reduce your risk of future cardiovascular events. These instructions will be centered around the DASH dietary practices.
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Who is running the clinical trial?
York UniversityLead Sponsor
58 Previous Clinical Trials
17,426 Total Patients Enrolled
Southlake Regional Health CentreOTHER
17 Previous Clinical Trials
5,638 Total Patients Enrolled
Paul Ritvo, Ph.DPrincipal InvestigatorYork Univrsity
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