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

Hypertension Clinical Trial

— HARMONY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825526
• Other study ID #: NA 6349
• Status: Completed
• Phase: N/A
• First received: January 19, 2009
• Last updated: May 31, 2012
• Start date: July 2008

Study information

• Verified date: May 2012
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Changes in 24 hour ambulatory systolic and diastolic blood pressure at the end of the treatment assessment period compared to the beginning.		12 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	The effect of MBSR on ambulatory blood pressure by gender		24 weeks	No

External Links

•   Overview of MBSR program