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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2N2
      • University Health Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Intervention, MBSR therapy; Group that receives Mindfulness Based Stress Reduction Therapy immediately after randomization	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; Other Names: stress reduction therapy; Jon Kabat-Zinn; mindfulness meditation
Active Comparator: Delayed Treatment Arm, MBSR Therapy; Group that receives Mindfulness Based Stress Reduction Therapy within 3 months of randomization	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; Other Names: stress reduction therapy; Jon Kabat-Zinn; mindfulness meditation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: University Health Network, Toronto
• Investigators: Principal Investigator: Sheldon Tobe, MD, FRCP(C), Sunnybrook Health Science Centre; Study Chair: Brian Baker, ChB, MB, University Health Network, Toronto; Study Chair: Jane Irvine, D.Phil., C. Psych., York University; Study Chair: Susan Abbey, MD, FRCP(C), University Health Network, Toronto; Study Chair: Beth Abramson, MD, FRCPC, FACC, Unity Health Toronto; Study Chair: Martin Myers, MD, FRCPC, Sunnybrook Health Science Centre

Publications and helpful links

General Publications

• Blom K, Baker B, How M, Dai M, Irvine J, Abbey S, Abramson BL, Myers MG, Kiss A, Perkins NJ, Tobe SW. Hypertension analysis of stress reduction using mindfulness meditation and yoga: results from the HARMONY randomized controlled trial. Am J Hypertens. 2014 Jan;27(1):122-9. doi: 10.1093/ajh/hpt134. Epub 2013 Sep 14.
• Blom K, How M, Dai M, Baker B, Irvine J, Abbey S, Abramson BL, Myers M, Perkins N, Tobe SW. Hypertension Analysis of stress Reduction using Mindfulness meditatiON and Yoga (The HARMONY Study): study protocol of a randomised control trial. BMJ Open. 2012 Mar 5;2(2):e000848. doi: 10.1136/bmjopen-2012-000848. Print 2012.

Helpful Links

• Overview of MBSR program

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: January 19, 2009
• First Submitted That Met QC Criteria: January 20, 2009
• First Posted (Estimate): January 21, 2009

Study Record Updates

• Last Update Posted (Estimate): June 1, 2012
• Last Update Submitted That Met QC Criteria: May 31, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: ambulatory blood pressure monitoring; hypertension; Stress Reduction; high blood pressure; Mindfulness Based Stress Reduction (MBSR)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: NA 6349