HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga) - Full Text View

Sponsor:	Sunnybrook Health Sciences Centre
Collaborator:	University Health Network, Toronto
Information provided by (Responsible Party):	Sheldon Tobe, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00825526

Purpose

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	Intervention
Hypertension	Behavioral: Mindfulness Based Stress Reduction (MBSR) Therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga)

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
The effect of MBSR on ambulatory blood pressure by gender [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	July 2008
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 20 to 75 years
Hypertension by ABPM at baseline (daytime > 135/85 mmHg or 24-hour ABPM > 130/80 mmHg)

Exclusion Criteria:

Use of antihypertensive within 6 months of the screening ABPM.
Screening office BP > 180/100 and ABPM > 160/100 mmHg.
Diabetes
Secondary hypertension
Renal disease (GFR < 60 ml/min or overt nephropathy)
History of heart attack
Stroke or TIA or
Re-vascularization procedure.
Active malignant disease (except non-melanoma skin cancer)
Epileptic seizure 6 months before the screening visit.
Congestive heart failure
Severe liver disease
Pregnancy or lactation period
Participation in a clinical trial or receipt of investigational compound or treatment in the 3 months prior to the initial screening visit.
Planned elective surgery during the study period except for cataract surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825526

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

Additional Information:

Overview of MBSR program This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Sheldon Tobe, Doctor, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT00825526 History of Changes
Other Study ID Numbers:	NA 6349
Study First Received:	January 19, 2009
Last Updated:	January 8, 2012
Health Authority:	Canada: Ethics Review Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on February 09, 2012