Mindfulness-Based Blood Pressure Reduction (MB-BP) Intervention Development

Mindfulness interventions customized for prehypertensive/hypertensive patients have never
been investigated. Until methodologically rigorous studies to evaluate customized
interventions for hypertension are performed, we will not know if the observed preliminary
effects of general mindfulness interventions on blood pressure reduction could be much more
effective with a tailored approach. Consequently, we propose 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). This 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), (2) emotion regulation (specifically the Difficulty in Emotion
Regulation Scale), and (3) self-awareness (specifically the 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. The grant funding this study is
performing a concurrent systematic review of impacts of mindfulness interventions on
self-regulation outcomes. Based on the findings from the systematic review, other
self-regulation measures will be explored as secondary outcomes.

Specific aims are:

1. To outline and evaluate key active elements of MB-BP. This aim will be achieved using
(a) focus groups of participants undergoing the MB-BP intervention, (b) discussion with
experts (including cardiologists, epidemiologists, mindfulness experts, mindfulness
intervention instructors) prior to, and following pilot testing of MBHT in participants,
and (c) clinical judgment of the investigators performing the intervention.

2. To evaluate impacts of MB-BP on target engagement (pre-post change in effect size) and
longevity of target engagement (follow-up time-points). Follow-up time periods include
10 weeks, 6 months and 1 year.

This study is a prospective single-arm trial during the intervention development phase.
Following this phase, after the intervention has been further developed, a subsequent study
(with a different clinicaltrials.gov ID #) will utilize a randomized control trial design to
further evaluate causation and effect size.

Inclusion Criteria:

- Hypertension/prehypertension (≥120 mmHg systolic, ≥80 mmHg diastolic pressure or
taking antihypertensive medication).

- 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.