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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy

• Registration Number: NCT00825526
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-01-19
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-21
• Primary Completion: 2012-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-31
• Last Update Posted: 2012-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Early Intervention, MBSR therapy	Mindfulness Based Stress Reduction (MBSR) Therapy	Group that receives Mindfulness Based Stress Reduction Therapy immediately after randomization
Delayed Treatment Arm, MBSR Therapy	Mindfulness Based Stress Reduction (MBSR) Therapy	Group that receives Mindfulness Based Stress Reduction Therapy within 3 months of randomization

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

University Health Network; 🇨🇦 Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada