Stress Management for High Blood Pressure

Study Overview
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Brief Summary
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The purpose of this research study is to examine the efficacy of two stress management interventions in reducing blood pressure (BP) in patients who have prehypertension (BP between 120/80 and 139/89). It is expected that participants will be better able to control their BP through reducing stress and increasing healthy lifestyle behaviors.

Conditions
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Prehypertension

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction
* Behavioral: Stress Management Education
* Other: American Heart Association Recommended Self-Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unmedicated high blood pressure (SBP of 120-139 or DBP of 80-89) BMI in the range of 19-40 Interest in attempting to control blood pressure through lifestyle modification Exclusion Criteria: pacemakers uncontrolled hypertension (SBP≥140 or DBP≥90) atrial fibrillation myocardial infarction (MI) percutaneous transluminal coronary angioplasty (PTCA) coronary artery bypass graft (CABG) within 6 months of enrollment congestive heart failure uncorrected primary valvular disease hypertrophic or restrictive cardiomyopathy uncorrected thyroid heart disease chronic kidney disease persistent tachyarrhythmia JNC risk category C (target organ damage, diabetes) patients who are pregnant or plan to become pregnant within 9 months patients who are lactating patients unable to comply with assessment procedures patients with alcohol or drug abuse within 12 months patients who consume more than 21 alcoholic drinks per week patients who are current smokers patients who are unable to provide informed consent or who have dementia patients with previous extensive meditation or yoga training patients with blood pressure ≥140/90

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Stress Reduction<br>The Mindfulness-Based Stress Reduction intervention includes eight 2.5-hour weekly group sessions and an all-day retreat. | Behavioral: Mindfulness-Based Stress Reduction<br>* Patients are randomized to an intervention<br>* Other names: MBSR;Other: American Heart Association Recommended Self-Care<br>* All Patients receive AHA Recommended Self-Care<br>|
| Active Comparator: Stress Management Education<br>The Stress Management Education intervention includes eight 2.5-hour weekly group sessions and an all-day retreat. | Behavioral: Stress Management Education<br>* Patients are randomized to an intervention<br>* Other names: SME;Other: American Heart Association Recommended Self-Care<br>* All Patients receive AHA Recommended Self-Care<br>|
| Other: AHA Recommended Self-Care<br>All participants will receive the American Heart Association - Understanding and Controlling Your High Blood Pressure Brochure and information on the Dietary Approach to Stop Hypertension from the National Institutes of Health. These brochures describe ways that individuals can improve their lifestyle through better diet and exercise. Participants will get a chance to try and make healthy lifestyle changes on their own, using this information. | Other: American Heart Association Recommended Self-Care<br>* All Patients receive AHA Recommended Self-Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Clinic Blood Pressure | All clinic blood pressure assessments will be completed in a quiet, climate controlled room according to American Heart Association guidelines. The mean of the three seated readings on the non- dominant arm will be averaged to define clinic blood pressure. | Week 0, Week 4, Week 8, Week 34, and Week 60 | 
| Change in Diastolic Clinic Blood Pressure | All clinic blood pressure assessments will be completed in a quiet, climate controlled room according to American Heart Association guidelines. The mean of the three seated readings on the non- dominant arm will be averaged to define clinic blood pressure. | Week 0, Week 4, Week 8, Week 34, and Week 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour Ambulatory Systolic Blood Pressure | Participants will complete 24-hour Ambulatory Blood Pressure Monitoring with the Oscar 2 oscillometric blood pressure monitor. The Oscar will be programmed to take three blood pressure measurements per hour from 6 AM till 11 PM and two BP measurements per hour from 11 PM to 6 AM. During each reading, participants will be instructed to drop their arms to their sides as soon as they sense the cuff inflating, and to keep it relaxed and still until a few seconds after the deflation has finished. Ambulatory SBP and DBP will be derived by computing the mean of all valid readings obtained during waking hours and nighttime sleep. | Week 0, Week 8, Week 60 | 
| Change in 24-hour Ambulatory Diastolic Blood Pressure | Participants will complete 24-hour Ambulatory Blood Pressure Monitoring with the Oscar 2 oscillometric blood pressure monitor. The Oscar will be programmed to take three blood pressure measurements per hour from 6 AM till 11 PM and two BP measurements per hour from 11 PM to 6 AM. During each reading, participants will be instructed to drop their arms to their sides as soon as they sense the cuff inflating, and to keep it relaxed and still until a few seconds after the deflation has finished. Ambulatory SBP and DBP will be derived by computing the mean of all valid readings obtained during waking hours and nighttime sleep. | Week 0, Week 8, Week 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized clinical trial, Early medical intervention, Intervention studies, Blood pressure, Stress Management