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

Brown University

Status: Completed

Conditions: Hypertension; Prehypertension

Treatments: Other: Enhanced Usual Care Control; Behavioral: MB-BP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03859076

5UH3AT009145-04 (U.S. NIH Grant/Contract)

1412001171-2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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119 participants in 2 patient groups

MB-BP Intervention

Experimental group

Description:

MB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions & a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, & specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, & stress reactivity. Students learn a range of mindfulness skills (body scan exercises, meditation and yoga). Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified; for those without a physician, the investigator works to provide access within health insurance constraints.

Treatment:

Behavioral: MB-BP

Enhanced Usual Care Control

Active Comparator group

Description:

Those in the control group receive an educational brochure from the American Heart Association (product code 50-1731) and a validated home blood pressure monitor (Omron, Model PB786N), that has an evidence-based approach to lower blood pressure. All participants who have uncontrolled hypertension (blood pressure >140/90 mmHg) will be offered to have their physicians notified, if not already being overseen for it. For participants with uncontrolled hypertension who do not have a physician, the investigator works to provide access within constraints of their health insurance. Additionally, participants randomized to the control group are asked to refrain from engaging in any type of formal mindfulness practice more than weekly during the first six months of study involvement.

Treatment:

Other: Enhanced Usual Care Control