Ignite Creation Date:
2024-05-06 @ 10:26 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03256890
Status:
COMPLETED
Last Update Posted:
2021-01-26
First Post:
2017-08-03
Brief Title:
Mindfulness-Based Blood Pressure Reduction Stage 2a RCT
Sponsor:
Brown University
Organization:
Brown University
Study Overview
Official Title:
Mindfulness-Based Blood Pressure Reduction Stage 2a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MB-BP
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
Detailed Description:
Effects of mindfulness interventions customized for prehypertensivehypertensive patients are poorly understood Until methodologically rigorous studies to evaluate customized interventions for hypertension are performed it will be unknown whether the observed preliminary effects of general mindfulness interventions on blood pressure reduction could be much more effective with a tailored approach Consequently this study proposes 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 The 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 eg 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 and Mindful Attention Awareness Scale 2 emotion regulation specifically the Pittsburgh Stress Battery and the Perceived Stress Scale and 3 self-awareness specifically the Heart Beat Detection Task and 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
Specific aims are as follows
The primary aim is to evaluate impacts of MB-BP vs enhanced usual care control on systolic blood pressure at 6 months Follow-up time periods include 10 weeks and 6 months
Secondary aims include evaluating impacts of MB-BP vs enhanced usual care control on self-regulation mechanistic target engagement including 1 attention control specifically the Sustained Attention Response Task and Mindful Attention Awareness Scale 2 emotion regulation specifically the Pittsburgh Stress Battery and the Perceived Stress Scale and 3 self-awareness specifically the Heart Beat Detection Task and Multidimensional Assessment of Interoceptive Awareness Further secondary aims include evaluating impacts of MB-BP vs active control on medical regimen adherence including 1 physical activity 2 Dietary Approaches to Stop Hypertension DASH-consistent diet 3 alcohol consumption 4 body mass index and 5 antihypertensive medication use and adherence Secondary blood pressure outcomes include diastolic blood pressure
This study is a randomized controlled trial with blinding of staff performing participant assessments and data analysts performing statistical analyses
Specific aims are as follows
The primary aim is to evaluate impacts of MB-BP vs enhanced usual care control on systolic blood pressure at 6 months Follow-up time periods include 10 weeks and 6 months
Secondary aims include evaluating impacts of MB-BP vs enhanced usual care control on self-regulation mechanistic target engagement including 1 attention control specifically the Sustained Attention Response Task and Mindful Attention Awareness Scale 2 emotion regulation specifically the Pittsburgh Stress Battery and the Perceived Stress Scale and 3 self-awareness specifically the Heart Beat Detection Task and Multidimensional Assessment of Interoceptive Awareness Further secondary aims include evaluating impacts of MB-BP vs active control on medical regimen adherence including 1 physical activity 2 Dietary Approaches to Stop Hypertension DASH-consistent diet 3 alcohol consumption 4 body mass index and 5 antihypertensive medication use and adherence Secondary blood pressure outcomes include diastolic blood pressure
This study is a randomized controlled trial with blinding of staff performing participant assessments and data analysts performing statistical analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1UH2AT009145 | NIH | None | httpsreporternihgovquickSearch1UH2AT009145 |