HypertensionMB-BPNCT03256890
Mindfulness-Based Blood Pressure Reduction: Stage 2a RCT
A study testing MB-BP Intervention in people with Hypertension and Prehypertension, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Prehypertension
- What is being tested?
- MB-BP Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2017to 1 Jul 2019
- 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). Preference is given to recruiting uncontrolled hypertensives (≥140 mmHg systolic or ≥90 mmHg diastolic pressure)
- 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: Stage 2a Randomized Controlled Trial
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.
Read the detailed description
Effects of mindfulness interventions customized for prehypertensive/hypertensive 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 (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 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.
- Conditions
- Hypertension, Prehypertension
- Being tested
- MB-BP Intervention, Enhanced Usual Care Control
- Keywords
- mindfulness, blood pressure, hypertension, prehypertension, self regulation, Science of Behavior Change, attention control, self awareness, emotion regulation
- Medical subject headings
- Hypertension, Prehypertension, Self-Control, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB-BP InterventionBehavioural
MB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions and a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, and specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive 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. Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified, if not already overseen for uncontrolled hypertension; those without a physician are worked with to provide access within health insurance constraints.
Enhanced Usual Care ControlOther
Control group participants receive an educational brochure from American Heart Association entitled "Understanding and Controlling Your High Blood Pressure Brochure" (product code 50-1639). Every participant is provided with a validated home blood pressure monitor (Omron, Model PB786N), that as an evidence-based approach to lower blood pressure, would be considered "enhanced usual care" at this time. All participants who have uncontrolled hypertension (blood pressure >140/90 mmHg) will be offered to have their physicians notified, if not already being overseen for uncontrolled hypertension. For participants with uncontrolled hypertension who do not have a physician, we work participants to provide access within constraints of their health insurance.
| Study group | Role | What they receive |
|---|---|---|
| MB-BP Intervention | Experimental | MB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions and a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, and specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, and stress reactivity. Students learn a range of mindfulness skills including body scan exercises, meditation and yoga. Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified; for those without a physician, we work to provide access within health insurance constraints. Receives: Behavioral: MB-BP Intervention |
| Enhanced Usual Care Control | Active comparator | Control group participants receive an educational brochure from American Heart Association entitled "Understanding and Controlling Your High Blood Pressure Brochure" (product code 50-1639). Every participant is provided with a validated home blood pressure monitor (Omron, Model PB786N), that as an evidence-based approach to lower blood pressure, would be considered "enhanced usual care" at this time. All participants who have uncontrolled hypertension (blood pressure >140/90 mmHg) will be offered to have their physicians notified, if not already being overseen for uncontrolled hypertension. For participants with uncontrolled hypertension who do not have a physician, we work participants to provide access within constraints of their health insurance. Receives: Other: Enhanced Usual Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Directly assessed as mean of second and third blood pressure readings
Measured: 6 month follow-up
Dietary Approaches to Stop Hypertension-consistent diet
Self-report via Willet Food Frequency Questionnaire
Measured: 6 month follow-up
Secondary outcomes (13)
Sustained Attention to Response Task (SART)
Behavioral measure of attention control
Measured: 6 month follow-up
Mindful Attention Awareness Scale (MAAS)
Self-report measure of attention control and mindfulness
Measured: 6 month follow-up
Pittsburgh Stress Battery
Behavioral measure of stress reactivity
Measured: 6 month follow-up
Perceived Stress Scale
Self-report measure of perceived stress
Measured: 6 month follow-up
Heartbeat Detection Task
Behavioral measure of self-awareness
Measured: 6 month follow-up
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Self-report measure of self-awareness
Measured: 6 month follow-up
Physical Activity - self report
Self-report via International Physical Activity Questionnaire (IPAQ)
Measured: 6 month follow-up
Physical Activity - step count
Directly assessed via FitBit step count
Measured: 6 month follow-up
Alcohol consumption
Self-report via Willet Food Frequency Questionnaire
Measured: 6 month follow-up
Body Mass Index
Directly assessed as weight (kg) per height (m) squared, using a validated stadiometer to assess height, and validated scale to measure weight.
Measured: 6 month follow-up
Antihypertensive medication adherence
Directly assessed via eCAP medication adherence devices (Information Mediary Corp., Ottawa, ON, Canada). Please note that eCAP is the device name, and not an acronym.
Measured: 6 month follow-up
Antihypertensive medication use
Directly assessed via medication bottle labels that participants bring to clinic assessments
Measured: 6 month follow-up
Diastolic blood pressure
Directly assessed as mean of second and third readings
Measured: 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start13 Jun 2017
- Primary completion18 Dec 2018
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 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
- Sponsor
- Investigators
- Eric B Loucks, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256890
- Sponsor's protocol ID
- 1412001171-3
- Other IDs
- 1UH2AT009145
- Acronym
- MB-BP
- Status last verified
- Jan 2021
- First submitted
- 3 Aug 2017
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu F, Brewer LC, Neves VV, Scarpaci MM, Saadeh FB, Proulx JA, Loucks EB. Impact of the mindfulness-based blood pressure reduction (MB-BP) program on cardiovascular health: A randomized clinical trial. Am J Prev Cardiol. 2026 Mar 28;27:101584. doi: 10.1016/j.ajpc.2026.101584. eCollection 2026 Jun.
PubMed 42291030Loucks EB, Kronish IM, Saadeh FB, Scarpaci MM, Proulx JA, Gutman R, Britton WB, Schuman-Olivier Z. Adapted Mindfulness Training for Interoception and Adherence to the DASH Diet: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2339243. doi: 10.1001/jamanetworkopen.2023.39243.
PubMed 37917063Loucks EB, Kronish IM, Saadeh FB, Scarpaci MM, Proulx JA, Gutman R, Britton WB, Schuman-Olivier Z. Effects of Adapted Mindfulness Training on Interoception and Adherence to the Dietary Approaches to Stop Hypertension (DASH) Diet: The MB-BP Randomized Clinical Trial. medRxiv [Preprint]. 2023 May 15:2023.05.10.23289818. doi: 10.1101/2023.05.10.23289818.
PubMed 37292774Loucks EB, Schuman-Olivier Z, Saadeh FB, Scarpaci MM, Nardi WR, Proulx JA, Gutman R, King J, Britton WB, Kronish IM. Effect of Adapted Mindfulness Training in Participants With Elevated Office Blood Pressure: The MB-BP Study: A Randomized Clinical Trial. J Am Heart Assoc. 2023 Jun 6;12(11):e028712. doi: 10.1161/JAHA.122.028712. Epub 2023 May 23.
PubMed 37218591Polcari JJ, Cali RJ, Nephew BC, Lu S, Rashkovskii M, Wu J, Saadeh F, Loucks E, King JA. Effects of the Mindfulness-Based Blood Pressure Reduction (MB-BP) program on depression and neural structural connectivity. J Affect Disord. 2022 Aug 15;311:31-39. doi: 10.1016/j.jad.2022.05.059. Epub 2022 May 17.
PubMed 35594968
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Blood Pressure Reduction: Stage 2a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03256890
- Acronym / sponsor ID
- MB-BP / 1412001171-3
- Conditions
- Hypertension, Prehypertension
- Keywords
- mindfulness, blood pressure, hypertension, prehypertension, self regulation, Science of Behavior Change, attention control, self awareness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 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
- 13 Jun 2017 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 22 Aug 2017 (actual)
- 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.
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 prehypertensive/hypertensive 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 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MB-BP Intervention | Experimental | Behavioral: MB-BP InterventionMB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions and a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, and specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, and stress reactivity. Students learn a range of mindfulness skills including body scan exercises, meditation and yoga. Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified; for those without a physician, we work to provide access within health insurance constraints. |
| Enhanced Usual Care Control | Active comparator | Other: Enhanced Usual Care ControlControl group participants receive an educational brochure from American Heart Association entitled "Understanding and Controlling Your High Blood Pressure Brochure" (product code 50-1639). Every participant is provided with a validated home blood pressure monitor (Omron, Model PB786N), that as an evidence-based approach to lower blood pressure, would be considered "enhanced usual care" at this time. All participants who have uncontrolled hypertension (blood pressure >140/90 mmHg) will be offered to have their physicians notified, if not already being overseen for uncontrolled hypertension. For participants with uncontrolled hypertension who do not have a physician, we work participants to provide access within constraints of their health insurance. |
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). Preference is given to recruiting uncontrolled hypertensives (≥140 mmHg systolic or ≥90 mmHg diastolic pressure)
- 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 (5 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-BP InterventionMB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions and a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, and specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive 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. Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified, if not already overseen for uncontrolled hypertension; those without a physician are worked with to provide access within health insurance constraints. | Behavioural | MB-BP Intervention |
| Enhanced Usual Care ControlControl group participants receive an educational brochure from American Heart Association entitled "Understanding and Controlling Your High Blood Pressure Brochure" (product code 50-1639). Every participant is provided with a validated home blood pressure monitor (Omron, Model PB786N), that as an evidence-based approach to lower blood pressure, would be considered "enhanced usual care" at this time. All participants who have uncontrolled hypertension (blood pressure >140/90 mmHg) will be offered to have their physicians notified, if not already being overseen for uncontrolled hypertension. For participants with uncontrolled hypertension who do not have a physician, we work participants to provide access within constraints of their health insurance. | Other | Enhanced Usual Care Control |
Primary outcome
Systolic blood pressure
Time frame: 6 month follow-up
Directly assessed as mean of second and third blood pressure readings
Dietary Approaches to Stop Hypertension-consistent diet
Time frame: 6 month follow-up
Self-report via Willet Food Frequency Questionnaire
13 secondary outcomes
Sustained Attention to Response Task (SART)
Time frame: 6 month follow-up
Mindful Attention Awareness Scale (MAAS)
Time frame: 6 month follow-up
Pittsburgh Stress Battery
Time frame: 6 month follow-up
Perceived Stress Scale
Time frame: 6 month follow-up
Heartbeat Detection Task
Time frame: 6 month follow-up
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time frame: 6 month follow-up
Physical Activity - self report
Time frame: 6 month follow-up
Physical Activity - step count
Time frame: 6 month follow-up
Alcohol consumption
Time frame: 6 month follow-up
Body Mass Index
Time frame: 6 month follow-up
Antihypertensive medication adherence
Time frame: 6 month follow-up
Antihypertensive medication use
Time frame: 6 month follow-up
Diastolic blood pressure
Time frame: 6 month follow-up
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 26 Jan 2021.
- Derived from this study: PubMed 42291030Wu F, Brewer LC, Neves VV, Scarpaci MM, Saadeh FB, Proulx JA, Loucks EB. Impact of the mindfulness-based blood pressure reduction (MB-BP) program on cardiovascular health: A randomized clinical trial. Am J Prev Cardiol. 2026 Mar 28;27:101584. doi: 10.1016/j.ajpc.2026.101584. eCollection 2026 Jun.
- Derived from this study: PubMed 37917063Loucks EB, Kronish IM, Saadeh FB, Scarpaci MM, Proulx JA, Gutman R, Britton WB, Schuman-Olivier Z. Adapted Mindfulness Training for Interoception and Adherence to the DASH Diet: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2339243. doi: 10.1001/jamanetworkopen.2023.39243.
- Derived from this study: PubMed 37292774Loucks EB, Kronish IM, Saadeh FB, Scarpaci MM, Proulx JA, Gutman R, Britton WB, Schuman-Olivier Z. Effects of Adapted Mindfulness Training on Interoception and Adherence to the Dietary Approaches to Stop Hypertension (DASH) Diet: The MB-BP Randomized Clinical Trial. medRxiv [Preprint]. 2023 May 15:2023.05.10.23289818. doi: 10.1101/2023.05.10.23289818.
- Derived from this study: PubMed 37218591Loucks EB, Schuman-Olivier Z, Saadeh FB, Scarpaci MM, Nardi WR, Proulx JA, Gutman R, King J, Britton WB, Kronish IM. Effect of Adapted Mindfulness Training in Participants With Elevated Office Blood Pressure: The MB-BP Study: A Randomized Clinical Trial. J Am Heart Assoc. 2023 Jun 6;12(11):e028712. doi: 10.1161/JAHA.122.028712. Epub 2023 May 23.
- Derived from this study: PubMed 35594968Polcari JJ, Cali RJ, Nephew BC, Lu S, Rashkovskii M, Wu J, Saadeh F, Loucks E, King JA. Effects of the Mindfulness-Based Blood Pressure Reduction (MB-BP) program on depression and neural structural connectivity. J Affect Disord. 2022 Aug 15;311:31-39. doi: 10.1016/j.jad.2022.05.059. Epub 2022 May 17.
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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 B 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 Intervention in people with Hypertension and Prehypertension, 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 5 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 26 Jan 2021. 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?
Systolic blood pressure (time frame: 6 month follow-up). The study lists 2 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 NCT03256890, which also lists 5 linked publications.
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 26 Jan 2021.