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

Sunnybrook Health Sciences Centre

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00825526

NA 6349

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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101 participants in 2 patient groups

Early Intervention, MBSR therapy

Experimental group

Description:

Group that receives Mindfulness Based Stress Reduction Therapy immediately after randomization

Treatment:

Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy

Delayed Treatment Arm, MBSR Therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy