Hypertension
Conditions
Keywords
Mindfulness Based Stress Reduction (MBSR), Stress Reduction, hypertension, high blood pressure, ambulatory blood pressure monitoring
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.
Interventions
BEHAVIORALMindfulness 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
Sponsors
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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. | 12 weeks |
Secondary
| 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. | 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. | 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 | 24 weeks |
| The effect of MBSR on ambulatory blood pressure by gender | 24 weeks |
Countries
Canada
Outcome results
None listed