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

Completed · Not applicable

Conditions studied: Prehypertension, Hypertension

In brief

Specific aims are: 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. 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. This study is a prospective single-arm trial during the intervention development phase. Following this phase, after the intervention has been further developed, a subsequent study (with a different clinicaltrials.gov identification #) will utilize a randomized control trial design to further evaluate causation and effect size.

Key facts

Study ID

NCT02702258

Run by

Brown University

People needed

48

Starts

2016-02-01

Expected to finish

2017-10-01

Last updated by the study team

2020-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Brown University School of Public Health — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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