Recruiting

Mindfulness

Sponsor:

York University

Code:

NCT03910192

Conditions

Atrial Fibrillation

Hypertension

Mindfulness

Cardiovascular Risk Reduction

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Mindfulness-based coaching

Dietary cardiovascular risk reduction coaching

Study Details

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.

Conditions

Atrial Fibrillation

Hypertension

Mindfulness

Cardiovascular Risk Reduction

Study ID

NCT03910192

Start date

Mar 14, 2017

Status verified date

Apr, 2019

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Aug 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Mindfulness-based coaching

16 week mindfulness-based protocol focused on home-based and weekly group practice of mindfulness meditation and mindful movement.

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.

Primary outcome measure

  • Night time (Sleep) Systolic Blood Pressure [ Time Frame: 16 weeks ]
  • Daytime time (Awake) Systolic Blood Pressure [ Time Frame: 16 Weeks ]

Central Contacts and Locations

Central contacts

Paul Ritvo, Ph.D

416-736-2100pritvo@yorku.ca

Locations

Southlake Regional Health Centre

Recruiting

Newmarket, Ontario, Canada, L3Y 2P9

Contacts

Paul Ritvo, PhD

4165808021pritvo@yorku.ca

Principal Investigator:

Paul Ritvo, PhD

More Information

Sponsor

York University

Last update posted

Apr 10, 2019

Last verified

Apr, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by York University on 2019-04-10.