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

This study has been completed.
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Sheldon Tobe, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00825526
First received: January 19, 2009
Last updated: May 31, 2012
Last verified: May 2012
  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:


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 ]

Enrollment: 101
Study Start Date: July 2008
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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided by Sunnybrook Health Sciences Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sheldon Tobe, Medical 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: May 31, 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 September 18, 2014