Mindfulness-Based Blood Pressure Reduction (MB-BP) Intervention Development - Stage 1 Single Arm Trial

NCT02702258 | Completed DMC

• 2 other identifiers: 1412001171-11UH2AT009145-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Specific aims are:

1. 1.To outline and evaluate key active elements of the Mindfulness-Based Blood Pressure Reduction (MB-BP) intervention. This aim will be achieved using (a) focus groups of participants undergoing the MB-BP intervention, (b) discussion with experts (including cardiologists, epidemiologists, mindfulness experts, mindfulness intervention instructors) prior to, and following pilot testing of MBHT in participants, and (c) clinical judgment of the investigators performing the intervention.
2. 2.To evaluate impacts of MB-BP on target engagement (pre-post change in effect size) and longevity of target engagement (follow-up time-points). Follow-up time periods include 10 weeks, 6 months and 1 year.

Conditions

Prehypertension; Hypertension

Keywords

mindfulness; blood pressure; hypertension; prehypertension

Outcome Measures

Primary Outcomes (3)

• Sustained Attention to Response Task

  The Sustained Attention Test is a computer-based task designed to measure a person's ability to withhold responses to infrequent and unpredictable stimuli during a period of rapid and rhythmic responding to frequent stimuli.

  1 year follow-up

• Difficulties in Emotion Regulation Scale

  This is a brief, 36-item, self-report questionnaire designed to assess multiple aspects of emotion dysregulation.

  1 year follow-up

• Multidimensional Assessment of Interoceptive Awareness

  This measure assesses interoceptive awareness across multiple domains such as awareness of body sensations, trusting body sensations, and mind-body integration.

  1 year follow-up

Study Arms (1)

MB-BP

EXPERIMENTAL

This is the primary intervention tested in this single arm trial.

Behavioral: MB-BP

Interventions

MB-BP BEHAVIORAL

MB-BP (Mindfulness-Based Blood Pressure Reduction) customizes Mindfulness-Based Stress Reduction (MBSR) to participants with prehypertension/hypertension. MB-BP will consist of nine 2.5-hour weekly group sessions and an 7.5-hour one-day session. Some of the unique areas of MB-BP are education on hypertension risk factors, hypertension health effects, and specific mindfulness modules focused on awareness of blood pressure determinants such as diet, physical activity, antihypertensive 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.

MB-BP

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).
• 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 (1)

• Loucks EB, Nardi WR, Gutman R, Kronish IM, Saadeh FB, Li Y, Wentz AE, Webb J, Vago DR, Harrison A, Britton WB. Mindfulness-Based Blood Pressure Reduction (MB-BP): Stage 1 single-arm clinical trial. PLoS One. 2019 Nov 27;14(11):e0223095. doi: 10.1371/journal.pone.0223095. eCollection 2019.

  PMID: 31774807 RESULT

Related Links

• Mindfulness-Based Blood Pressure Reduction (MB-BP): Stage 1 single-arm clinical trial

MeSH Terms

Conditions

Prehypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eric Loucks, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 8, 2016
• Study Start: February 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)