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

Sunnybrook Health Sciences Centre101 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

101

Conditions

Hypertension

Interventions

Mindfulness Based Stress Reduction (MBSR) TherapyBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 20 to 75 years 2. Hypertension by ABPM at baseline (daytime \> 135/85 mmHg or 24-hour ABPM \> 130/80 mmHg) Exclusion Criteria: 1. Use of antihypertensive within 6 months of the screening ABPM. 2. Screening office BP \> 180/100 and ABPM \> 160/100 mmHg. 3. Diabetes 4. Secondary hypertension 5. Renal disease (GFR \< 60 ml/min or overt nephropathy) 6. History of heart attack 7. Stroke or TIA or 8. Re-vascularization procedure. 9. Active malignant disease (except non-melanoma skin cancer) 10. Epileptic seizure 6 months before the screening visit. 11. Congestive heart failure 12. Severe liver disease 13. Pregnancy or lactation period 14. Participation in a clinical trial or receipt of investigational compound or treatment in the 3 months prior to the initial screening visit. 15. Planned elective surgery during the study period except for cataract surgery

Locations (2)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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