Clinical trial NCT02702258: Mindfulness-Based Blood Pressure Reduction (MB-BP) Intervention Development - Stage 1 Single Arm Trial
Official title: Mindfulness-Based Blood Pressure Reduction (MB-BP) Stage 1 Single Arm Trial: Acceptability and Feasibility Study; Additionally Exploring the Preliminary Effects on Self-Regulation Targets, Including Self Awareness, Emotion Regulation and Attention Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prehypertension
Hypertension
Keywords: mindfulness
blood pressure
hypertension
prehypertension
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2016-03-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Mindfulness interventions customized for prehypertensive/hypertensive patients have never been investigated. Until methodologically rigorous studies to evaluate customized interventions for hypertension are performed, we will not know if the observed preliminary effects of general mindfulness interventions on blood pressure reduction could be much more effective with a tailored approach. Consequently, we propose 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). This 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), (2) emotion regulation (specifically the Difficulty in Emotion Regulation Scale), and (3) self-awareness (specifically the 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. The grant funding this study is performing a concurrent systematic review of impacts of mindfulness interventions on self-regulation outcomes. Based on the findings from the systematic review, other self-regulation measures will be explored as secondary outcomes.

Specific aims are:

1. To outline and evaluate key active elements of MB-BP. 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 ID #) will utilize a randomized control trial design to further evaluate causation and effect size.

Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Sustained Attention to Response Task
timeFrame: 1 year follow-up
measure: Difficulties in Emotion Regulation Scale
timeFrame: 1 year follow-up
measure: Multidimensional Assessment of Interoceptive Awareness
timeFrame: 1 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Brown University School of Public Health
state: Rhode Island
Study officials:
affiliation: Brown University
name: Eric Loucks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.