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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Intervention, MBSR therapy | Experimental | Group that receives Mindfulness Based Stress Reduction Therapy immediately after randomization |
|
| Delayed Treatment Arm, MBSR Therapy | Active Comparator | Group that receives Mindfulness Based Stress Reduction Therapy within 3 months of randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) Therapy | Behavioral | 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 |
| Measure | Description | 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 |
| Measure | Description | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheldon Tobe, MD, FRCP(C) | Sunnybrook Health Science Centre | Principal Investigator |
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada | ||
| University Health Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24038797 | Derived | 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. | |
| 22396225 | Derived |
| Label | URL |
|---|---|
| Overview of MBSR program | View source |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| D013812 | Therapeutics |
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| 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 |
| Toronto |
| Ontario |
| M5G 2N2 |
| Canada |
| 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. |