UH3 Phase - Mindfulness-Based Blood Pressure Reduction (MB-BP) : Stage 2a RCT

Mindfulness Based Blood Pressure Reduction: Stage 2a Randomized Controlled Trial

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.