Stress Management for High Blood Pressure

Kent State University

Status: Unknown

Conditions: Prehypertension

Treatments: Behavioral: Stress Management Education; Behavioral: Mindfulness-Based Stress Reduction; Other: American Heart Association Recommended Self-Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02371317

KentSU

Details and patient eligibility

About

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.

Enrollment: 141 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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141 participants in 3 patient groups

Mindfulness-Based Stress Reduction

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness-Based Stress Reduction

Other: American Heart Association Recommended Self-Care

Stress Management Education

Active Comparator group

Description:

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

Treatment:

Behavioral: Stress Management Education

Other: American Heart Association Recommended Self-Care

AHA Recommended Self-Care

Other group

Description:

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.

Treatment:

Other: American Heart Association Recommended Self-Care