Clinical trial NCT03256890: Mindfulness-Based Blood Pressure Reduction: 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: 2017-08-22
Enrollment: 82
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 evaluate impacts of a behavioral intervention called "Mindfulness-Based Blood Pressure Reduction" (MB-BP) vs. enhanced usual care control on systolic blood pressure 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Systolic blood pressure
timeFrame: 6 month follow-up
measure: Dietary Approaches to Stop Hypertension-consistent diet
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Sustained Attention to Response Task (SART)
timeFrame: 6 month follow-up
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: 6 month follow-up
measure: Pittsburgh Stress Battery
timeFrame: 6 month follow-up
measure: Perceived Stress Scale
timeFrame: 6 month follow-up
measure: Heartbeat Detection Task
timeFrame: 6 month follow-up
measure: Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: 6 month follow-up
measure: Physical Activity - self report
timeFrame: 6 month follow-up
measure: Physical Activity - step count
timeFrame: 6 month follow-up
measure: Alcohol consumption
timeFrame: 6 month follow-up
measure: Body Mass Index
timeFrame: 6 month follow-up
measure: Antihypertensive medication adherence
timeFrame: 6 month follow-up
measure: Antihypertensive medication use
timeFrame: 6 month follow-up
measure: Diastolic blood pressure
timeFrame: 6 month follow-up
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University School of Public Health
state: Rhode Island
Study officials:
affiliation: Brown University
name: Eric B Loucks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polcari JJ, Cali RJ, Nephew BC, Lu S, Rashkovskii M, Wu J, Saadeh F, Loucks E, King JA. Effects of the Mindfulness-Based Blood Pressure Reduction (MB-BP) program on depression and neural structural connectivity. J Affect Disord. 2022 Aug 15;311:31-39. doi: 10.1016/j.jad.2022.05.059. Epub 2022 May 17.