Mindfulness-Based Blood Pressure Reduction: Stage 2a RCT

NCT03256890 | Completed DMC

• 2 other identifiers: 1412001171-31UH2AT009145
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Prehypertension

Keywords

mindfulness; blood pressure; hypertension; prehypertension; self regulation; Science of Behavior Change; attention control; self awareness; emotion regulation

Outcome Measures

Primary Outcomes (2)

• Systolic blood pressure

  Directly assessed as mean of second and third blood pressure readings

  6 month follow-up

• Dietary Approaches to Stop Hypertension-consistent diet

  Self-report via Willet Food Frequency Questionnaire

  6 month follow-up

Secondary Outcomes (13)

• Sustained Attention to Response Task (SART)

  6 month follow-up

• Mindful Attention Awareness Scale (MAAS)

  6 month follow-up

• Pittsburgh Stress Battery

  6 month follow-up

• Perceived Stress Scale

  6 month follow-up

• Heartbeat Detection Task

  6 month follow-up

Study Arms (2)

MB-BP Intervention

EXPERIMENTAL

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. Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified; for those without a physician, we work to provide access within health insurance constraints.

Behavioral: MB-BP Intervention

Enhanced Usual Care Control

ACTIVE COMPARATOR

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.

Other: Enhanced Usual Care Control

Interventions

MB-BP Intervention BEHAVIORAL

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.

MB-BP Intervention

Enhanced Usual Care Control OTHER

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.

Enhanced Usual Care Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brown University: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02912, United States

Location

Related Publications (4)

• Loucks EB, Kronish IM, Saadeh FB, Scarpaci MM, Proulx JA, Gutman R, Britton WB, Schuman-Olivier Z. Adapted Mindfulness Training for Interoception and Adherence to the DASH Diet: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2339243. doi: 10.1001/jamanetworkopen.2023.39243.

  PMID: 37917063 DERIVED

• Loucks EB, Kronish IM, Saadeh FB, Scarpaci MM, Proulx JA, Gutman R, Britton WB, Schuman-Olivier Z. Effects of Adapted Mindfulness Training on Interoception and Adherence to the Dietary Approaches to Stop Hypertension (DASH) Diet: The MB-BP Randomized Clinical Trial. medRxiv [Preprint]. 2023 May 15:2023.05.10.23289818. doi: 10.1101/2023.05.10.23289818.

  PMID: 37292774 DERIVED

• Loucks EB, Schuman-Olivier Z, Saadeh FB, Scarpaci MM, Nardi WR, Proulx JA, Gutman R, King J, Britton WB, Kronish IM. Effect of Adapted Mindfulness Training in Participants With Elevated Office Blood Pressure: The MB-BP Study: A Randomized Clinical Trial. J Am Heart Assoc. 2023 Jun 6;12(11):e028712. doi: 10.1161/JAHA.122.028712. Epub 2023 May 23.

  PMID: 37218591 DERIVED

• 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.

  PMID: 35594968 DERIVED

MeSH Terms

Conditions

Hypertension; Prehypertension; Self-Control; Emotional Regulation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Social Behavior; Behavior

Study Officials

• Eric B Loucks, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will implement blinding of staff performing participant assessments and data analysts performing statistical analyses. The principal investigator will be blinded to group allocation, except for participants that he is involved with instructing in the MB-BP intervention (there are multiple instructors). The prinicipal investigator has no access to the master data file. Equipoise is emphasized for all staff who interact with participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 22, 2017
• Study Start: June 13, 2017
• Primary Completion: December 18, 2018
• Study Completion: July 1, 2019
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

US (1)