Clinical trial NCT00825526: HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga)
Official title: HARMONY Study (Hypertension Analysis of Stress Reduction Using Mindfulness Meditation and Yoga)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Mindfulness Based Stress Reduction (MBSR)
Stress Reduction
hypertension
high blood pressure
ambulatory blood pressure monitoring
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2009-01-21
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in 24 hour ambulatory systolic and diastolic blood pressure at the end of the treatment assessment period compared to the beginning.
timeFrame: 12 weeks
measure: Between and within group comparisons of MBSR on blood pressure at different times of the day including daytime, night time and work time.
timeFrame: 24 weeks
measure: 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
timeFrame: 24 weeks
measure: The effect of MBSR on ambulatory blood pressure by gender
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Sunnybrook Health Science Centre
name: Sheldon Tobe, MD, FRCP(C)
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Brian Baker, ChB, MB
role: STUDY_CHAIR
affiliation: York University
name: Jane Irvine, D.Phil., C. Psych.
role: STUDY_CHAIR
affiliation: University Health Network, Toronto
name: Susan Abbey, MD, FRCP(C)
role: STUDY_CHAIR
affiliation: Unity Health Toronto
name: Beth Abramson, MD, FRCPC, FACC
role: STUDY_CHAIR
affiliation: Sunnybrook Health Science Centre
name: Martin Myers, MD, FRCPC
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.