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
- 119
- 试验地点
- 2
- 主要终点
- Self-Regulation Primary Outcome: Multidimensional Assessment of Interoceptive Awareness (MAIA)
研究概览
简要总结
The primary aim is to identify the impacts of a behavioral intervention called "Mindfulness-Based Blood Pressure Reduction" (MB-BP) vs. enhanced usual care on the primary self-regulation target, specifically an assay of self-related processes (Multidimensional Assessment of Interoceptive Awareness) (MAIA) 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.
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
- •Elevated blood pressure or hypertension defined as ≥120 mmHg systolic or ≥80 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
- •Exclusion criteria follow standard guidelines and recommendations:
- •current regular mindfulness meditation practice (>once/week)
- •serious medical illness or cognitive condition (e.g., dementia) precluding regular class attendance and/or participation
- •current substance abuse, suicidal ideation or eating disorder
- •history of bipolar or psychotic disorders or self-injurious behaviors.
结局指标
主要结局
Self-Regulation Primary Outcome: Multidimensional Assessment of Interoceptive Awareness (MAIA)
时间窗: 6 month follow-up
a validated measure of body awareness - a 32 item self-report measure composed of the following 8 subscales: (i) Noticing, (ii) Not-Distracting, (iii) Not-Worrying, (iv) Attention Regulation, (v) Emotional Awareness, (vi) Self-Regulation, (vii) Body Listening, and (viii) Trusting. Individuals rate items using a 6 point Likert scale from 0 ('Never') to 5 ('Always'). Total scores are obtained through reverse coding items 5, 6, 7, 8, 9 and summing all items. Higher scores indicate higher levels of positive awareness.
次要结局
- Heartbeat Detection Task(Baseline, 10 weeks, 6 months)
- Pittsburgh Stress Battery(Baseline, 10 weeks, 6 months)
- Anxiety Symptoms - self-report(Baseline, 10 weeks, 6 months)
- Depressive Symptoms - self-report(Baseline, 10 weeks, 6 months)
- Interoceptive Awareness fMRI Task(Baseline, 10-week follow-up)
- Difficulties in Emotion Regulation Scale (DERS)(Baseline, 10 weeks, 6 months)
- Perceived Stress Scale (PSS-14)(Baseline, 10 weeks, 6 months)
- Sustained Attention to Response Task (SART)(6 month follow-up)
- Self-Compassion(6 months)
- Self-Efficacy(Baseline, 10 weeks, 6 months)
- Dietary Approaches to Stop Hypertension (DASH)-consistent diet(6 month follow-up)
- Alcohol consumption - self report(6 month-follow up)
- Electronically-Measured Antihypertensive Medication Adherence(6 months)
- Body Mass Index(Baseline, 10 weeks, 6 months)
- Physical Activity - self report(Baseline, 10 weeks, 6 months)