Mindfulness to Reduce Ambulatory Hypertension in Atrial Fibrillation (AF)

Mindfulness-based Coaching to Reduce Abnormal Nocturnal Hypertension in Atrial Fibrillation

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.

Study Overview

• Status: Unknown
• Conditions: Hypertension; Atrial Fibrillation; Mindfulness; Cardiovascular Risk Reduction
• Intervention / Treatment: Behavioral: Mindfulness-based coaching; Behavioral: Dietary cardiovascular risk reduction coaching

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul Ritvo, Ph.D; Phone Number: 22396 416-736-2100; Email: pritvo@yorku.ca

Study Locations

• Canada
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Recruiting
      • Southlake Regional Health Centre
      • Sub-Investigator: Yaariv Khaykin, MD
      • Sub-Investigator: Meysam Pirbaglou, MSc
      • Sub-Investigator: Pouria Alipour, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 50-80
• Diagnosed Atrial Fibrillation
• Night time (Sleep Time) Systolic Blood Pressure≥120 OR Daytime (awake) Systolic Blood Pressure ≥ 135
• Able and Willing to sign Informed Consent Form

Exclusion Criteria:

• Scheduled for Surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness meditation coaching; 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.	Behavioral: Mindfulness-based coaching; 16 week mindfulness-based protocol focused on home-based and weekly group practice of mindfulness meditation and mindful movement.
Active Comparator: dietary cardiovascular risk reduction coaching; 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.	Behavioral: Dietary cardiovascular risk reduction coaching; Regular in-person meetings, phone calls, or email from study coordinator instructing them on how to integrate exercise and dietary changes in their lifestyle to reduce their risk of future cardiovascular events.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Night time (Sleep) Systolic Blood Pressure	The primary outcome of this study will be change in ANBP from baseline when compared to subsequent follow-up study time points.	16 weeks
Daytime time (Awake) Systolic Blood Pressure	The primary outcome of this study will be change in daytime ABP from baseline when compared to subsequent follow-up study time points.	16 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nocturnal Dipping	ANBP will be calculated as the percentage of nocturnal drop in systolic blood pressure in relation to its daytime values	16 Weeks
Atrial Tachyarrhythmia Episodes	24-hour Holter monitoring assessments using the MARS® ambulatory ECG system at baseline and 4 months to assess atrial tachyarrhythmia episodes lasting 30 seconds or more	16 Weeks
Hospital Anxiety and Depression Scale (HADS)	14 item self-report questionnaire evaluating anxiety and depression symptoms in medical populations	16 Weeks
Profile of Mood States (POMS-SF)	65 item self-report questionnaire examining mood and changes in mood over a period, POMS, in both original and shorter 37 item format, has been extensively used in clinical settings	16 Weeks
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)	24 item the magnitude and changes over time in mindfulness levels, including its five - observing, describing experience, acting with awareness, non-judging of inner experience, and nonreactivity to inner experience facets.	16 Weeks
SF-12 v2 Health Survey	assesses self reported physical and mental health, providing separate scores for 8 sub-domains of physical and mental health (e.g. physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health).	16 Weeks
Pittsburgh Sleep Quality Index (PSQI)	The instrument, widely used in epidemiological or clinical contexts, is comprised of seven sub-components (i.e. sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, medication use, and daytime dysfunction) leading to a global sleep quality score.	16 Weeks
Cardiac Anxiety Questionnaire (CAQ)	18 item index of HFA, a measure of anxiety sensitivity specific to cardiovascular patients. The CAQ conceptualizes HFA as a 3 dimensional measure, including heart-related fear, avoidance, attention subscales.	16 Weeks

Collaborators and Investigators

• Sponsor: York University
• Collaborators: Southlake Regional Health Centre
• Investigators: Principal Investigator: Paul Ritvo, Ph.D, York Univrsity

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2017
• Primary Completion (Anticipated): August 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Hypertension; Atrial Fibrillation
• Other Study ID Numbers: 0031-1617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No