Stress Management for High Blood Pressure
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Kent State University
- Enrollment
- 141
- Locations
- 4
- Primary Endpoint
- Change in Systolic Clinic Blood Pressure
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Mindfulness-Based Stress Reduction
The Mindfulness-Based Stress Reduction intervention includes eight 2.5-hour weekly group sessions and an all-day retreat.
Intervention: Mindfulness-Based Stress Reduction (Behavioral)
Mindfulness-Based Stress Reduction
The Mindfulness-Based Stress Reduction intervention includes eight 2.5-hour weekly group sessions and an all-day retreat.
Intervention: American Heart Association Recommended Self-Care (Other)
Stress Management Education
The Stress Management Education intervention includes eight 2.5-hour weekly group sessions and an all-day retreat.
Intervention: Stress Management Education (Behavioral)
Stress Management Education
The Stress Management Education intervention includes eight 2.5-hour weekly group sessions and an all-day retreat.
Intervention: American Heart Association Recommended Self-Care (Other)
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.
Intervention: American Heart Association Recommended Self-Care (Other)
Outcomes
Primary Outcomes
Change in Systolic Clinic Blood Pressure
Time Frame: Week 0, Week 4, Week 8, Week 34, and Week 60
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.
Change in Diastolic Clinic Blood Pressure
Time Frame: Week 0, Week 4, Week 8, Week 34, and Week 60
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.
Secondary Outcomes
- Change in 24-hour Ambulatory Systolic Blood Pressure(Week 0, Week 8, Week 60)
- Change in 24-hour Ambulatory Diastolic Blood Pressure(Week 0, Week 8, Week 60)
Investigators
David M. Fresco
Professor
Kent State University