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Mindfulness-Based Blood Pressure Reduction (MB-BP) Intervention Development (MB-BP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02702258
Recruitment Status : Unknown
Verified July 2017 by Eric Loucks, Brown University.
Recruitment status was:  Active, not recruiting
First Posted : March 8, 2016
Last Update Posted : July 25, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Eric Loucks, Brown University

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 ID #) will utilize a randomized control trial design to further evaluate causation and effect size.


Condition or disease Intervention/treatment Phase
Prehypertension Hypertension Behavioral: MB-BP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness-Based Blood Pressure Reduction (MB-BP) Intervention Development: Effects on Self-Regulation Targets, Including Self Awareness, Emotion Regulation and Attention Control
Study Start Date : February 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MB-BP
This is the primary intervention tested in this single arm trial.
Behavioral: MB-BP
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702258


Locations
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United States, Rhode Island
Brown University School of Public Health
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Eric Loucks, PhD Brown University

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Responsible Party: Eric Loucks, Assistant Professor, Brown University
ClinicalTrials.gov Identifier: NCT02702258    
Other Study ID Numbers: 1412001171-1
1UH2AT009145-01 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individuals interested in utilizing data are welcome to contact the principal investigator with a data analysis proposal.
Keywords provided by Eric Loucks, Brown University:
mindfulness
blood pressure
hypertension
prehypertension
Additional relevant MeSH terms:
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Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases