Stress Management for High Blood Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2020-05-31

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.

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Detailed Description

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Conditions

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Prehypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Mindfulness-Based Stress Reduction

The Mindfulness-Based Stress Reduction intervention includes eight 2.5-hour weekly group sessions and an all-day retreat.

Group Type EXPERIMENTAL

Mindfulness-Based Stress Reduction

Intervention Type BEHAVIORAL

Patients are randomized to an intervention

American Heart Association Recommended Self-Care

Intervention Type OTHER

All Patients receive AHA Recommended Self-Care

Stress Management Education

The Stress Management Education intervention includes eight 2.5-hour weekly group sessions and an all-day retreat.

Group Type ACTIVE_COMPARATOR

Stress Management Education

Intervention Type BEHAVIORAL

Patients are randomized to an intervention

American Heart Association Recommended Self-Care

Intervention Type OTHER

All Patients receive AHA Recommended Self-Care

AHA Recommended Self-Care

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.

Group Type OTHER

American Heart Association Recommended Self-Care

Intervention Type OTHER

All Patients receive AHA Recommended Self-Care

Interventions

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Mindfulness-Based Stress Reduction

Patients are randomized to an intervention

Intervention Type BEHAVIORAL

Stress Management Education

Patients are randomized to an intervention

Intervention Type BEHAVIORAL

American Heart Association Recommended Self-Care

All Patients receive AHA Recommended Self-Care

Intervention Type OTHER

Other Intervention Names

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MBSR SME

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No