Clinical trial NCT03859076: UH3 Phase - Mindfulness-Based Blood Pressure Reduction (MB-BP) : Stage 2a RCT
Official title: Mindfulness Based Blood Pressure Reduction: Stage 2a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Prehypertension
Keywords: mindfulness
blood pressure
hypertension
prehypertension
self regulation
Science of Behavior Change
attention control
self awareness
emotion regulation
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2019-03-01
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-Regulation Primary Outcome: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Heartbeat Detection Task
timeFrame: Baseline, 10 weeks, 6 months
measure: Interoceptive Awareness fMRI Task
timeFrame: Baseline, 10-week follow-up
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline, 10 weeks, 6 months
measure: Pittsburgh Stress Battery
timeFrame: Baseline, 10 weeks, 6 months
measure: Perceived Stress Scale (PSS-14)
timeFrame: Baseline, 10 weeks, 6 months
measure: Anxiety Symptoms - self-report
timeFrame: Baseline, 10 weeks, 6 months
measure: Depressive Symptoms - self-report
timeFrame: Baseline, 10 weeks, 6 months
measure: Sustained Attention to Response Task (SART)
timeFrame: 6 month follow-up
measure: Self-Compassion
timeFrame: 6 months
measure: Self-Efficacy
timeFrame: Baseline, 10 weeks, 6 months
measure: Dietary Approaches to Stop Hypertension (DASH)-consistent diet
timeFrame: 6 month follow-up
measure: Alcohol consumption - self report
timeFrame: 6 month-follow up
measure: Electronically-Measured Antihypertensive Medication Adherence
timeFrame: 6 months
measure: Body Mass Index
timeFrame: Baseline, 10 weeks, 6 months
measure: Physical Activity - self report
timeFrame: Baseline, 10 weeks, 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown Mindfulness Center
state: Rhode Island
Study officials:
affiliation: Brown University
name: Eric B Loucks, PhD
role: PRINCIPAL_INVESTIGATOR
References: