Mindfulness to Reduce Ambulatory Hypertension in Atrial Fibrillation

Not Applicable

• Conditions: Mindfulness; Cardiovascular Risk Reduction; Atrial Fibrillation; Hypertension
• Interventions: Behavioral: Dietary cardiovascular risk reduction coaching; Behavioral: Mindfulness-based coaching

• Registration Number: NCT03910192
• Lead Sponsor: York University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-14
• Status Verified: 2019-04
• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-08
• Last Update Submitted: 2019-04-08
• Study First Posted: 2019-04-10
• Last Update Posted: 2019-04-10
• Primary Completion: 2019-08-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dietary cardiovascular risk reduction coaching	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.
Mindfulness meditation coaching	Mindfulness-based 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Atrial Tachyarrhythmia Episodes	16 Weeks	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
Hospital Anxiety and Depression Scale (HADS)	16 Weeks	14 item self-report questionnaire evaluating anxiety and depression symptoms in medical populations
SF-12 v2 Health Survey	16 Weeks	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).
Profile of Mood States (POMS-SF)	16 Weeks	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
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF)	16 Weeks	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.
Nocturnal Dipping	16 Weeks	ANBP will be calculated as the percentage of nocturnal drop in systolic blood pressure in relation to its daytime values
Pittsburgh Sleep Quality Index (PSQI)	16 Weeks	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.
Cardiac Anxiety Questionnaire (CAQ)	16 Weeks	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.

Trial Locations

Locations (1)

Southlake Regional Health Centre; 🇨🇦 Newmarket, Ontario, Canada