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Completed

NCT Number: NCT00825526

HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga)

The purpose of this study is to determine if Mindfulness Based Stress Reduction (MBSR) is an effective intervention for lowering blood pressure in early unmedicated hypertensives.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 20 to 75 years
  • Hypertension by ABPM at baseline (daytime > 135/85 mmHg or 24-hour ABPM > 130/80 mmHg)

Exclusion criteria

  • Use of antihypertensive within 6 months of the screening ABPM.
  • Screening office BP > 180/100 and ABPM > 160/100 mmHg.
  • Diabetes
  • Secondary hypertension
  • Renal disease (GFR < 60 ml/min or overt nephropathy)
  • History of heart attack
  • Stroke or TIA or
  • Re-vascularization procedure.
  • Active malignant disease (except non-melanoma skin cancer)
  • Epileptic seizure 6 months before the screening visit.
  • Congestive heart failure
  • Severe liver disease
  • Pregnancy or lactation period
  • Participation in a clinical trial or receipt of investigational compound or treatment in the 3 months prior to the initial screening visit.
  • Planned elective surgery during the study period except for cataract surgery

Treatment and study plan

Mindfulness Based Stress Reduction (MBSR) Therapy

Behavioral

The objectives of MBSR therapy are to 1) understand their personal response to stress and 2) develop techniques to change the way these patients respond and cope with stress

Other names: stress reduction therapy, Jon Kabat-Zinn, mindfulness meditation

Primary outcomes

  1. The primary outcome is the difference in 24-hour systolic and diastolic blood pressure between the treatment and wait-list group for the 12-week primary assessment period.

    Time frame: 12 weeks

Secondary outcomes

  1. Changes in 24 hour ambulatory systolic and diastolic blood pressure at the end of the treatment assessment period compared to the beginning.

    Time frame: 12 weeks

  2. Between and within group comparisons of MBSR on blood pressure at different times of the day including daytime, night time and work time.

    Time frame: 24 weeks

  3. The proportion of patients achieving blood pressure targets (24-hour ABPM<130/80 mmHg, daytime ABPM<135/85 mmHg) at the end of the Primary Outcome period

    Time frame: 24 weeks

  4. The effect of MBSR on ambulatory blood pressure by gender

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • University Health Network, Toronto

Registry information

Acronym: HARMONY

Important dates

Study start
2008
Primary completion
2012
First posted
Jan 21, 2009
Registry last updated
Jun 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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