HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga) (HARMONY)
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ClinicalTrials.gov Identifier: NCT00825526 |
Recruitment Status :
Completed
First Posted : January 21, 2009
Last Update Posted : June 1, 2012
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Condition or disease | Intervention/treatment | Phase |
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Hypertension | Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 101 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga) |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | March 2012 |

Arm | Intervention/treatment |
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Experimental: Early Intervention, MBSR therapy
Group that receives Mindfulness Based Stress Reduction Therapy immediately after randomization
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Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy
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:
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Active Comparator: Delayed Treatment Arm, MBSR Therapy
Group that receives Mindfulness Based Stress Reduction Therapy within 3 months of randomization
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Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy
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:
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- 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 ]
- 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 ]
- 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 ]
- 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 ]
- The effect of MBSR on ambulatory blood pressure by gender [ Time Frame: 24 weeks ]

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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825526
Canada, Ontario | |
Sunnybrook Health Sciences Centre | |
Toronto, Ontario, Canada, M4N 3M5 | |
University Health Network | |
Toronto, Ontario, Canada, M5G 2N2 |
Principal Investigator: | Sheldon Tobe, MD, FRCP(C) | Sunnybrook Health Science Centre | |
Study Chair: | Brian Baker, ChB, MB | University Health Network, Toronto | |
Study Chair: | Jane Irvine, D.Phil., C. Psych. | York University | |
Study Chair: | Susan Abbey, MD, FRCP(C) | University Health Network, Toronto | |
Study Chair: | Beth Abramson, MD, FRCPC, FACC | Unity Health Toronto | |
Study Chair: | Martin Myers, MD, FRCPC | Sunnybrook Health Science Centre |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sheldon Tobe, Medical Doctor, Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT00825526 |
Other Study ID Numbers: |
NA 6349 |
First Posted: | January 21, 2009 Key Record Dates |
Last Update Posted: | June 1, 2012 |
Last Verified: | May 2012 |
Mindfulness Based Stress Reduction (MBSR) Stress Reduction hypertension high blood pressure ambulatory blood pressure monitoring |
Hypertension Vascular Diseases Cardiovascular Diseases |