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Hypertension Analysis of stress Reduction using Mindfulness meditatiON and Yoga (The HARMONY Study): study protocol of a randomised control trial
  1. Kimberly Blom1,
  2. Maxine How1,
  3. Monica Dai2,
  4. Brian Baker3,
  5. Jane Irvine4,
  6. Susan Abbey3,
  7. Beth L Abramson5,
  8. Martin Myers1,
  9. Nancy Perkins1,
  10. Sheldon W Tobe1
  1. 1Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
  2. 2Queen's University, Kingston, Ontario, Canada
  3. 3Department of Psychiatry, University Health Network, Toronto, Ontario, Canada
  4. 4Department of Psychology, York University, Toronto, Ontario, Canada
  5. 5Department of Medicine, St. Michael's Hospital, Toronto, Ontario, Canada
  1. Correspondence to Kimberly Blom; kimberly.blom{at}sunnybrook.ca

Abstract

Introduction Hypertension (HTN) is a leading risk factor for preventable cardiovascular disease, with over one in five adults affected worldwide. Lifestyle modification is a key strategy for the prevention and treatment of HTN. Stress has been associated with greater cardiovascular risk, and stress management is a recommended intervention for hypertensives. Stress reduction through relaxation therapies has been shown to have an effect on human physiology, including lowering blood pressure (BP). However, individualised behavioural interventions are resource intensive, and group stress management approaches have not been validated for reducing HTN. The HARMONY Study is a pilot randomised controlled trial designed to determine if mindfulness-based stress reduction (MBSR), a standardised group therapy, is an effective intervention for lowering BP in stage 1 unmedicated hypertensives.

Methods and analysis Men and women unmedicated for HTN with mean daytime ambulatory blood pressure (ABP) ≥135/85 mm Hg or 24 h ABP ≥130/80 mm Hg are included in the study. Subjects are randomised to receive MBSR immediately or after a wait-list control period. The primary outcome measure is mean awake and 24 h ABP. The primary objective of the HARMONY Study is to compare ABP between the treatment and wait-list control arm at the 12-week primary assessment period. Results from this study will determine if MBSR is an effective intervention for lowering BP in early unmedicated hypertensives.

Ethics and dissemination This research project was approved by the Sunnybrook Research Ethics Board and the University Health Network Research Ethics Board (Toronto, Canada). Planned analyses are in full compliance with the principles of the Declaration of Helsinki. Data collection will be completed by early spring 2012. Primary and secondary analysis will commence immediately after data monitoring is completed; dissemination plans include preparing publications for submission during the summer of 2012.

Trial registration number This study is registered with http://clinicaltrials.gov (NCT00825526).

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

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Footnotes

  • To cite: Blom K, How M, Dai M, et al. Hypertension Analysis of stress Reduction using Mindfulness meditatiON and Yoga (The HARMONY Study): study protocol of a randomised control trial. BMJ Open 2012;2:e000848. doi:10.1136/bmjopen-2012-000848

  • Contributors ST and BB conceptualised the study, and MD, MM, SA, BLA, NP and JI assisted with the study design. KB, MH and MD collected data, which were overseen by NP. KB and MH cleaned the collected data, preformed interim analyses and interpreted interim results. ST is the guarantor. KB, MD, MH and ST wrote and revised the article, as well as designed figures. NP, BB, MM, SA, BLA and JI critically revised the draft for important intellectual content. All authors approved the final version to be published.

  • Funding This work was supported by Heart and Stroke Foundation of Ontario (NA 6349). The Heart and Stroke Foundation of Ontario played no role in the study design, data collection, writing of this article or the decision to submit it for publication.

  • Competing interests None.

  • Ethics approval Ethics approval was provided by Sunnybrook Research Ethics Board and University Health Network Research Ethics Board.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional data available.

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