NCT03859076

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2020

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

1.7 years

First QC Date

February 20, 2019

Last Update Submit

January 11, 2021

Conditions

HypertensionPrehypertension

Keywords

mindfulnessblood pressurehypertensionprehypertensionself regulationScience of Behavior Changeattention controlself awarenessemotion regulation

Outcome Measures

Primary Outcomes (1)

  • Self-Regulation Primary Outcome: Multidimensional Assessment of Interoceptive Awareness (MAIA)

    a validated measure of body awareness - a 32 item self-report measure composed of the following 8 subscales: (i) Noticing, (ii) Not-Distracting, (iii) Not-Worrying, (iv) Attention Regulation, (v) Emotional Awareness, (vi) Self-Regulation, (vii) Body Listening, and (viii) Trusting. Individuals rate items using a 6 point Likert scale from 0 ('Never') to 5 ('Always'). Total scores are obtained through reverse coding items 5, 6, 7, 8, 9 and summing all items. Higher scores indicate higher levels of positive awareness.

    6 month follow-up

Secondary Outcomes (15)

  • Heartbeat Detection Task

    Baseline, 10 weeks, 6 months

  • Interoceptive Awareness fMRI Task

    Baseline, 10-week follow-up

  • Difficulties in Emotion Regulation Scale (DERS)

    Baseline, 10 weeks, 6 months

  • Pittsburgh Stress Battery

    Baseline, 10 weeks, 6 months

  • Perceived Stress Scale (PSS-14)

    Baseline, 10 weeks, 6 months

  • +10 more secondary outcomes

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 \& a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, \& specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, \& stress reactivity. Students learn a range of mindfulness skills (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, the investigator works to provide access within health insurance constraints.

Behavioral: MB-BP

Enhanced Usual Care Control

ACTIVE COMPARATOR

Those in the control group receive an educational brochure from the American Heart Association (product code 50-1731) and a validated home blood pressure monitor (Omron, Model PB786N), that has an evidence-based approach to lower blood pressure. 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 it. For participants with uncontrolled hypertension who do not have a physician, the investigator works to provide access within constraints of their health insurance. Additionally, participants randomized to the control group are asked to refrain from engaging in any type of formal mindfulness practice more than weekly during the first six months of study involvement.

Other: Enhanced Usual Care Control

Interventions

MB-BPBEHAVIORAL

MB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions \& a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, \& specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, \& stress reactivity. Students learn a range of mindfulness skills (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, the investigator works to provide access within health insurance constraints.

MB-BP Intervention
Enhanced Usual Care ControlOTHER

Those in the control group receive an educational brochure from the American Heart Association (product code 50-1731) and a validated home blood pressure monitor (Omron, Model PB786N), that has an evidence-based approach to lower blood pressure. 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 it. For participants with uncontrolled hypertension who do not have a physician, the investigator works to provide access within constraints of their health insurance. Additionally, participants randomized to the control group are asked to refrain from engaging in any type of formal mindfulness practice more than weekly during the first six months of study involvement.

Enhanced Usual Care Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown Mindfulness Center

Providence, Rhode Island, 02903, United States

Location

Related Publications (3)

  • 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: 37917063DERIVED

  • 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: 37292774DERIVED

  • 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: 37218591DERIVED

MeSH Terms

Conditions

HypertensionPrehypertensionSelf-ControlEmotional Regulation

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSocial BehaviorBehavior

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

February 20, 2019

First Posted

March 1, 2019

Study Start

December 13, 2018

Primary Completion

August 31, 2020

Study Completion

November 12, 2020

Last Updated

January 13, 2021

Record last verified: 2021-01

Locations

US(1)