NCT03256890

Mindfulness-Based Blood Pressure Reduction: Stage 2a RCT

Mindfulness-Based Blood Pressure Reduction: Stage 2a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• Prehypertension

Interventions

Type	Name	Description
BEHAVIORAL	MB-BP Intervention	MB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions and a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, and specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, and stress reactivity. Students learn a range of mindfulness skills including body scan exercises, meditation and yoga. Homework consists of practicing skills for ≥45 min/day, 6 days/week. Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified, if not already overseen for uncontrolled hypertension; those without a physician are worked with to provide access within health insurance constraints.
OTHER	Enhanced Usual Care Control	Control group participants receive an educational brochure from American Heart Association entitled "Understanding and Controlling Your High Blood Pressure Brochure" (product code 50-1639). Every participant is provided with a validated home blood pressure monitor (Omron, Model PB786N), that as an evidence-based approach to lower blood pressure, would be considered "enhanced usual care" at this time. 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 uncontrolled hypertension. For participants with uncontrolled hypertension who do not have a physician, we work participants to provide access within constraints of their health insurance.

Timeline

• Start date: 2017-06-13
• Primary completion: 2018-12-18
• Completion: 2019-07-01
• First posted: 2017-08-22
• Last updated: 2021-01-26

Locations

1 site across 1 country: United States