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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Intervention, MBSR therapy<br>Group that receives Mindfulness Based Stress Reduction Therapy immediately after randomization | Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy<br>* 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<br>* Other names: mindfulness meditation;|
| Active Comparator: Delayed Treatment Arm, MBSR Therapy<br>Group that receives Mindfulness Based Stress Reduction Therapy within 3 months of randomization | Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy<br>* 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<br>* Other names: mindfulness meditation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 24 hour ambulatory systolic and diastolic blood pressure at the end of the treatment assessment period compared to the beginning. |  | 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. |  | 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 |  | 24 weeks | 
| The effect of MBSR on ambulatory blood pressure by gender |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness Based Stress Reduction (MBSR), Stress Reduction, hypertension, high blood pressure, ambulatory blood pressure monitoring