Mindfulness-Based Blood Pressure Reduction: Stage 2a RCT

Hypertension Clinical Trial

— MB-BP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256890
• Other study ID #: 1412001171-3
• Secondary ID: 1UH2AT009145
• Status: Completed
• Phase: N/A
• Start date: June 13, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: January 2021
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 1, 2019
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Prehypertension

Intervention

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.

Locations

Country	Name	City	State
United States	Brown University School of Public Health	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Brown University	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure	Directly assessed as mean of second and third blood pressure readings	6 month follow-up
Primary	Dietary Approaches to Stop Hypertension-consistent diet	Self-report via Willet Food Frequency Questionnaire	6 month follow-up
Secondary	Sustained Attention to Response Task (SART)	Behavioral measure of attention control	6 month follow-up
Secondary	Mindful Attention Awareness Scale (MAAS)	Self-report measure of attention control and mindfulness	6 month follow-up
Secondary	Pittsburgh Stress Battery	Behavioral measure of stress reactivity	6 month follow-up
Secondary	Perceived Stress Scale	Self-report measure of perceived stress	6 month follow-up
Secondary	Heartbeat Detection Task	Behavioral measure of self-awareness	6 month follow-up
Secondary	Multidimensional Assessment of Interoceptive Awareness (MAIA)	Self-report measure of self-awareness	6 month follow-up
Secondary	Physical Activity - self report	Self-report via International Physical Activity Questionnaire (IPAQ)	6 month follow-up
Secondary	Physical Activity - step count	Directly assessed via FitBit step count	6 month follow-up
Secondary	Alcohol consumption	Self-report via Willet Food Frequency Questionnaire	6 month follow-up
Secondary	Body Mass Index	Directly assessed as weight (kg) per height (m) squared, using a validated stadiometer to assess height, and validated scale to measure weight.	6 month follow-up
Secondary	Antihypertensive medication adherence	Directly assessed via eCAP medication adherence devices (Information Mediary Corp., Ottawa, ON, Canada). Please note that eCAP is the device name, and not an acronym.	6 month follow-up
Secondary	Antihypertensive medication use	Directly assessed via medication bottle labels that participants bring to clinic assessments	6 month follow-up
Secondary	Diastolic blood pressure	Directly assessed as mean of second and third readings	6 month follow-up