Telephone-based Mindfulness Training to Reduce Blood Pressure in Black Women With Hypertension in the Jackson Heart Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure
研究概览
简要总结
High blood pressure is a powerful risk factor for heart disease. Black women are more likely to have high blood pressure than white women or Hispanic women. Even when they are aware they have high blood pressure, many people struggle to keep their blood pressure controlled. Research shows a connection between life stress and high blood pressure and heart disease outcomes. Mindfulness training programs can help people regulate their emotions and cope with stress. Research shows that mindfulness programs can also lower blood pressure. This study will compare two programs: MIND-BP, a Zoom-based mindfulness training group; and BOOST, a Zoom-based support group. The aims of the study are to test if the MIND-BP program leads to greater reductions in blood pressure, stress and depressive symptoms than the BOOST program in Black women with high blood pressure who are participating in the Jackson Heart Study. The primary outcome measure is 6-month change in systolic blood pressure. The secondary outcome measures are 6-month changes in perceived stress and depressive symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participant in Jackson Heart Study
- •Willing to be randomized and comply with all aspects of protocol
- •Willing to be audio-recorded during group sessions.
排除标准
- •Positive cognitive screen (MMSE <19)
- •Severe depressive symptoms (CES-D ≥16)
- •Pregnant or planning to become pregnant in the next 6 months
- •Current participation in another trial
- •Arm circumference >45 cm and <22 cm
研究组 & 干预措施
MIND-BP
Participants who are randomly assigned to receive the MIND-BP program, a virtually delivered mindfulness training group.
干预措施: MIND-BP (Behavioral)
BOOST
Participants who are randomly assigned to receive the BOOST program, a virtually delivered mindfulness training group.
干预措施: BOOST (Behavioral)
结局指标
主要结局
Change in Systolic Blood Pressure
时间窗: Baseline, Month 6
Change in average systolic blood pressure (SBP) from 7 consecutive days of home blood pressure monitoring.
次要结局
- Perceived Stress Scale (PSS-10) Score at Month 3(Month 3)
- Center for Epidemiological Studies Depression (CES-D) Score at Month 3(Month 3)
- Number of Participants with Uncontrolled Hypertension at Month 6(Month 6)
- Center for Epidemiological Studies Depression (CES-D) Score at Baseline(Baseline)
- Center for Epidemiological Studies Depression (CES-D) Score at Month 6(Month 6)
- Number of Participants with Uncontrolled Hypertension at Baseline(Baseline)
- Number of Participants with Uncontrolled Hypertension at Month 3(Month 3)
- Perceived Stress Scale (PSS-10) Score at Baseline(Baseline)
- Perceived Stress Scale (PSS-10) Score at Month 6(Month 6)