Stress Management for High Blood Pressure
试验速览
- 阶段
- 不适用
- 入组人数
- 141
- 试验地点
- 4
- 主要终点
- Change in Systolic Clinic Blood Pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mindfulness-Based Stress Reduction
The Mindfulness-Based Stress Reduction intervention includes eight 2.5-hour weekly group sessions and an all-day retreat.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: American Heart Association Recommended Self-Care (Other)
结局指标
主要结局
Change in Systolic Clinic Blood Pressure
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
David M. Fresco
Professor
Kent State University