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).
Does MBSR have a significant BP-lowering effect on awake and 24 h ABP?
Is MBSR a safe and feasible complementary treatment for high BP?
Is there interest in the general population to participate in a meditation/stress reduction programme to lower high BP?
Results of this trial will contribute to the development of non-pharmacological treatment approaches to HTN.
If a positive outcome is achieved, the HARMONY Study could highlight MBSR as a new paradigm for delivering lifestyle therapy.
If successful, the next phase of the project will incorporate additional lifestyle intervention components to MBSR therapy (such as sodium and weight loss counselling), with the goal of ultimately building a standardised lifestyle therapy programme to which physicians can refer their hypertensive patients to the future.
Strengths and limitations of this study
First study to examine a standardised stress reduction group therapy, already funded in part by the Ontario Health Insurance Plan, for the management of high BP.
Large sample size and use of randomised controlled trial format minimises bias and maximises the opportunity to detect any BP-lowering effect of MBSR.
Due to the silent nature of high BP, the lack of immediate positive perceptible feedback when BP is lowered may hamper the reinforcement necessary to make permanent lifestyle changes.