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

May 31, 2012 updated by: Sheldon Tobe, Sunnybrook Health Sciences Centre
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 12 weeks
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.
Time Frame: 12 weeks
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.
Time Frame: 24 weeks
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
Time Frame: 24 weeks
24 weeks
The effect of MBSR on ambulatory blood pressure by gender
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA 6349

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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