Mindfulness-Based Blood Pressure Reduction: Stage 2a RCT

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.