PrehypertensionMB-BPNCT02702258
Mindfulness-Based Blood Pressure Reduction (MB-BP) Intervention Development - Stage 1 Single Arm Trial
A study testing MB-BP in people with Prehypertension and Hypertension, run by Brown University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prehypertension, Hypertension
- What is being tested?
- MB-BP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University School of Public Health
Providence, Rhode Island, 02912
About this study
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
Specific aims are:
- 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.
- 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.
Read the 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:
- 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.
- 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.
- Conditions
- Prehypertension, Hypertension
- Being tested
- MB-BP
- Keywords
- mindfulness, blood pressure, hypertension, prehypertension
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-BPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MB-BP | Experimental | This is the primary intervention tested in this single arm trial. Receives: Behavioral: MB-BP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrehypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Eric Loucks, Brown University
- Investigators
- Eric Loucks, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702258
- Sponsor's protocol ID
- 1412001171-1
- Other IDs
- 1UH2AT009145-01
- Acronym
- MB-BP
- Status last verified
- Aug 2020
- First submitted
- 3 Mar 2016
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Individuals interested in utilizing data are welcome to contact the principal investigator with a data analysis proposal.
Publications
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.
PubMed 31774807
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02702258
- Acronym / sponsor ID
- MB-BP / 1412001171-1
- Conditions
- Prehypertension, Hypertension
- Keywords
- mindfulness, blood pressure, hypertension, prehypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Feb 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific aims are:
- 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.
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MB-BP | Experimental | Behavioral: MB-BPThis is the primary intervention tested in this single arm trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MB-BPMB-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. | Behavioural | MB-BP |
Primary outcome
Sustained Attention to Response Task
Time frame: 1 year follow-up
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.
Difficulties in Emotion Regulation Scale
Time frame: 1 year follow-up
This is a brief, 36-item, self-report questionnaire designed to assess multiple aspects of emotion dysregulation.
Multidimensional Assessment of Interoceptive Awareness
Time frame: 1 year follow-up
This measure assesses interoceptive awareness across multiple domains such as awareness of body sensations, trusting body sensations, and mind-body integration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Results publication: PubMed 31774807Loucks 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.
- Mindfulness-Based Blood Pressure Reduction (MB-BP): Stage 1 single-arm clinical trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individuals interested in utilizing data are welcome to contact the principal investigator with a data analysis proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Loucks, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MB-BP in people with Prehypertension and Hypertension, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Attention to Response Task (time frame: 1 year follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02702258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.