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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

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.

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Early Intervention, MBSR therapy

Group that receives Mindfulness Based Stress Reduction Therapy immediately after randomization

Group Type EXPERIMENTAL

Mindfulness Based Stress Reduction (MBSR) Therapy

Intervention Type 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

Delayed Treatment Arm, MBSR Therapy

Group that receives Mindfulness Based Stress Reduction Therapy within 3 months of randomization

Group Type ACTIVE_COMPARATOR

Mindfulness Based Stress Reduction (MBSR) Therapy

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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stress reduction therapy Jon Kabat-Zinn mindfulness meditation

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes