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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	101 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
Official Title:	HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga)
Study Start Date :	July 2008
Actual Primary Completion Date :	March 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. 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. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :

1. Changes in 24 hour ambulatory systolic and diastolic blood pressure at the end of the treatment assessment period compared to the beginning. [ Time Frame: 12 weeks ]
2. Between and within group comparisons of MBSR on blood pressure at different times of the day including daytime, night time and work time. [ Time Frame: 24 weeks ]
3. 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 [ Time Frame: 24 weeks ]
4. The effect of MBSR on ambulatory blood pressure by gender [ Time Frame: 24 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

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	St. Michael's Hospital, Toronto
Study Chair:	Martin Myers, MD, FRCPC	Sunnybrook Health Science Centre

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Overview of MBSR program 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Sheldon Tobe, Medical Doctor, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00825526 History of Changes
Other Study ID Numbers:	NA 6349
First Posted:	January 21, 2009
Last Update Posted:	June 1, 2012
Last Verified:	May 2012

Keywords provided by Sheldon Tobe, Sunnybrook Health Sciences Centre:

Mindfulness Based Stress Reduction (MBSR); Stress Reduction; hypertension; high blood pressure; ambulatory blood pressure monitoring

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases