Mindfulness-Based Blood Pressure Reduction: Stage 2a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Systolic blood pressure
研究概览
简要总结
The primary aim is to evaluate impacts of a behavioral intervention called "Mindfulness-Based Blood Pressure Reduction" (MB-BP) vs. enhanced usual care control on systolic blood pressure at 6 months, via a randomized controlled trial.
详细描述
Effects of mindfulness interventions customized for prehypertensive/hypertensive patients are poorly understood. Until methodologically rigorous studies to evaluate customized interventions for hypertension are performed, it will be unknown whether the observed preliminary effects of general mindfulness interventions on blood pressure reduction could be much more effective with a tailored approach. Consequently, this study proposes to conduct a behavioral intervention study to evaluate whether Mindfulness-Based Stress Reduction (MBSR) customized to prehypertensive and hypertensive patients has the potential to provide clinically relevant reductions in blood pressure. This customized intervention is called Mindfulness-Based Blood Pressure Reduction (MB-BP). The study follows the NIH Stage Model for Behavioral Intervention Development, where targets likely proximally affected by the intervention are identified, that should also have effect on the longer-term outcomes (e.g. blood pressure, mortality). The selected targets, consistent with theoretical frameworks and early evidence how mindfulness interventions could influence mental and physical health outcomes, are measures of self-regulation including (1) attention control (specifically the Sustained Attention Response Task and Mindful Attention Awareness Scale), (2) emotion regulation (specifically the Pittsburgh Stress Battery and the Perceived Stress Scale), and (3) self-awareness (specifically the Heart Beat Detection Task and Multidimensional Assessment of Interoceptive Awareness). Based on the degree of target engagement, MB-BP can be further customized to better engage with the targets as needed.
Specific aims are as follows.
The primary aim is to evaluate impacts of MB-BP vs. enhanced usual care control on systolic blood pressure at 6 months. Follow-up time periods include 10 weeks and 6 months.
Secondary aims include evaluating impacts of MB-BP vs. enhanced usual care control on self-regulation mechanistic target engagement, including (1) attention control (specifically the Sustained Attention Response Task and Mindful Attention Awareness Scale), (2) emotion regulation (specifically the Pittsburgh Stress Battery and the Perceived Stress Scale), and (3) self-awareness (specifically the Heart Beat Detection Task and Multidimensional Assessment of Interoceptive Awareness). Further secondary aims include evaluating impacts of MB-BP vs. active control on medical regimen adherence, including (1) physical activity, (2) Dietary Approaches to Stop Hypertension (DASH)-consistent diet, (3) alcohol consumption, (4) body mass index, and (5) antihypertensive medication use and adherence. Secondary blood pressure outcomes include diastolic blood pressure.
This study is a randomized controlled trial, with blinding of staff performing participant assessments and data analysts performing statistical analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will implement blinding of staff performing participant assessments and data analysts performing statistical analyses. The principal investigator will be blinded to group allocation, except for participants that he is involved with instructing in the MB-BP intervention (there are multiple instructors). The prinicipal investigator has no access to the master data file. Equipoise is emphasized for all staff who interact with participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertension/prehypertension (≥120 mmHg systolic, ≥80 mmHg diastolic pressure or taking antihypertensive medication). Preference is given to recruiting uncontrolled hypertensives (≥140 mmHg systolic or ≥90 mmHg diastolic pressure)
- •Able to speak, read, and write in English.
- •All adults (≥18 years of age), genders and racial/ethnic groups are eligible to be included.
排除标准
- •Current regular meditation practice (>once/week)
- •Serious medical illness precluding regular class attendance
- •Current substance abuse, suicidal ideation or eating disorder
- •History of bipolar or psychotic disorders or self-injurious behaviors.
- •These participants are excluded because they may disrupt group participation, require additional or specialized treatment, or are already participating in practices similar to the intervention.
结局指标
主要结局
Systolic blood pressure
时间窗: 6 month follow-up
Directly assessed as mean of second and third blood pressure readings
Dietary Approaches to Stop Hypertension-consistent diet
时间窗: 6 month follow-up
Self-report via Willet Food Frequency Questionnaire
次要结局
- Alcohol consumption(6 month follow-up)
- Heartbeat Detection Task(6 month follow-up)
- Sustained Attention to Response Task (SART)(6 month follow-up)
- Mindful Attention Awareness Scale (MAAS)(6 month follow-up)
- Pittsburgh Stress Battery(6 month follow-up)
- Perceived Stress Scale(6 month follow-up)
- Multidimensional Assessment of Interoceptive Awareness (MAIA)(6 month follow-up)
- Physical Activity - step count(6 month follow-up)
- Diastolic blood pressure(6 month follow-up)
- Physical Activity - self report(6 month follow-up)
- Antihypertensive medication adherence(6 month follow-up)
- Body Mass Index(6 month follow-up)
- Antihypertensive medication use(6 month follow-up)