Ignite Creation Date:
2024-05-06 @ 8:17 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02702258
Status:
COMPLETED
Last Update Posted:
2020-08-05
First Post:
2016-03-03
Brief Title:
Mindfulness-Based Blood Pressure Reduction MB-BP Intervention Development - Stage 1 Single Arm Trial
Sponsor:
Brown University
Organization:
Brown University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-08
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:
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 clinicaltrialsgov identification will utilize a randomized control trial design to further evaluate causation and effect size
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 clinicaltrialsgov identification will utilize a randomized control trial design to further evaluate causation and effect size
Detailed Description:
Mindfulness interventions customized for prehypertensivehypertensive 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 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 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 clinicaltrialsgov ID will utilize a randomized control trial design to further evaluate causation and effect size
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 clinicaltrialsgov ID will utilize a randomized control trial design to further evaluate causation and effect size
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 1UH2AT009145-01 | NIH | None | httpsreporternihgovquickSearch1UH2AT009145-01 |