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

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ClinicalTrials.gov Identifier: NCT00825526
Recruitment Status : Completed
First Posted : January 21, 2009
Last Update Posted : June 1, 2012
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Sheldon Tobe, Sunnybrook Health Sciences Centre

Study Description
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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

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Arms and Interventions
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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825526


Locations
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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
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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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Additional Information:
Overview of MBSR program  This link exits the ClinicalTrials.gov site

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

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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    Key Record Dates
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:
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Hypertension
Vascular Diseases
Cardiovascular Diseases