HypertensionNCT07679984
Evaluating the Effects of a Mindfulness Intervention on Health Outcomes in Individuals With Hypertension
A study testing Mindfulness in Motion in people with Hypertension and Essential (Primary) Hypertension, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of adding the Mindfulness in Motion (MIM) program to usual primary care for people with high blood pressure. MIM is a facilitated, 8-week online program that teaches simple ways to manage stress using mindfulness practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Essential (Primary) Hypertension
- What is being tested?
- Mindfulness in Motion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age >18 years old.
- Established patient at OSU Family Medicine
- Diagnosis of primary essential hypertension
- Ability and willingness to participate in all Mindfulness in Motion (MIM) study activities.
- Ability and willingness to download MyCap, the smartphone app that securely links participant study responses to the REDCap study project.
- WiFi connectivity or LTE to allow use of MIM smartphone app and MyCap when not at OSU clinical site.
Who cannot join
- Inability to read and/or understand English (MIM intervention, study consent and questionnaires in English).
- Established mindfulness practice.
- Diagnosis of secondary hypertension with identifiable underlying causes including:
- Chronic kidney disease
- Renal artery stenosis
- Primary aldosteronism
Show all 14Show fewer
- Cushing's syndrome
- Pheochromocytoma
- Obstructive sleep apnea
- Medication induced hypertension (e.g., steroids, NSAIDs)
- Pregnancy related hypertension
- Current severe alcohol or substance abuse disorder.
- Participants with documented cognitive disorder that limits the ability to independently participate in MIM program, read, understand, and/or complete the surveys; i.e. dementia, Alzheimer's or biological tests.
- Participants with major psychiatric disorders not controlled by medication or other psychiatric treatments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Beth Steinberg, PhD, RN, 614-406-7067, beth.steinberg@osumc.edu
Sienna Andres, B.S., 380-283-6479, sienna.andres@osumc.edu
About this study
The purpose of this study is to evaluate the effectiveness of adding the Mindfulness in Motion (MIM) program to usual primary care for people with high blood pressure. MIM is a facilitated, 8-week online program that teaches simple ways to manage stress using mindfulness practices. The program also includes the use of a companion smartphone app throughout the 12-month study period. In this study, investigators will compare people who receive their usual care and take part in the MIM program with those who receive usual care alone to see if it helps improve blood pressure, weight, stress, sleep, and overall well-being. Over 12 months, participants will be asked to complete short questionnaires about stress, sleep, and resilience four times via a smartphone, tablet, or computer.
Read the detailed description
Hypertension is a major modifiable risk factor for cardiovascular disease, and effective blood pressure reduction significantly reduces the risk of stroke, myocardial infarction, and heart failure. Current clinical treatment guidelines prioritize lifestyle modification as first-line therapy for a diagnosis of hypertension. The American Heart Association (AHA) has acknowledged mind-body medicine approaches, specifically meditation-based practices, as potential supportive strategies for cardiovascular risk reduction among patients with cardiovascular risk factors and diagnoses. Complementary medicine includes a range of therapies aimed at supporting behavior change, stress reduction, self-management, and overall well-being. However, utilization of these practices remains relatively low among individuals with cardiovascular disease and cardiovascular risk factors, largely due to limited awareness of their potential benefits and practical barriers such as travel requirements and time commitment. The expansion of virtual and app based complementary practices has the potential to address key implementation barriers, including travel burden and scheduling constraints, while supporting scalable and sustained engagement.
Mindfulness-based practices, increasingly offered virtually and via smartphone applications, have shown promise for adults with elevated blood pressure and hypertension. Studies that have implemented mindfulness based interventions, ranging from one to 12 sessions, have reported clinically significant reductions in systolic and diastolic blood pressure, as well as improvements in related psychosocial outcomes such as stress, anxiety, and depression. Emerging evidence suggests that blood pressure improvements are, in part, affected by lifestyle behaviors, including improved dietary choices, medication adherence, and decreased stress.
For over two decades, Mindfulness in Motion (MIM), has been studied as an educational, community-based 8-week program that has shown significant improvements in psychosocial outcomes, such as burnout, stress, and resiliency for healthcare professionals, persons with multiple sclerosis, cancer survivors, inner-city children under economic stress, college students, and community first responders. The purpose of this study is to evaluate the effectiveness of Mindfulness in Motion (MIM), an evidence-based mindfulness intervention delivered virtually and supported by a companion smartphone application, among patients diagnosed with hypertension, compared with usual care. Individual outcomes will be assessed at four time points: baseline, at the conclusion of the 8 week virtual MIM intervention (2 month assessment), at four months following completion of the virtual 8-week intervention (6 month assessment) and again at 10 months following completion of the virtual 8-week intervention (12 month assessment). Individual outcomes will include self report measures of perceived stress, resilience, and sleep. Physiological outcome measures including body mass index (BMI), and systolic and diastolic blood pressure will be collected at baseline and again at the end of the 12-month study period. MIM attendance at the 8-weekly virtual sessions, monthly mindfulness refresher sessions, and MIM app usage, per participant per day and over the 12 month period, will be measured.
- Conditions
- Hypertension, Essential (Primary) Hypertension
- Being tested
- Mindfulness in Motion
- Keywords
- hypertension, primary care, mindfulness, stress, resilience, sleep, blood pressure
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness in MotionBehavioural
Mindfulness in Motion (MIM) is an 8-week evidence-based program designed as an intervention to help participants learn practical burnout/stress reduction and resiliency building techniques. Delivered in a virtual, synchronous group format one hour per week, MIM includes didactic instruction, community-building group discussion, mindfulness, and gentle yoga. Each session focuses on a specific theme with topics that include Willingness to Daily Practice, Cultivating Mindful Sleep, Vision of Self, Supported by the Breath, Mindful Eating and Yoga, Movement Through Balance, Awareness of Sensation, Clarity and Release, and Staying Grounded \& Moving Forward. Participants are highly encouraged to engage in 10-20 minutes of individual self-practice at least five times per week. A companion MIM smartphone app offers daily mindfulness, movement, and reflective practices.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness in Motion plus Usual Care (Intervention Group) | Experimental | Not described Receives: Behavioral: Mindfulness in Motion |
| Usual Care (Control Group) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and Diastolic Blood Pressure
Blood pressure, obtained at each Family Medicine ambulatory appointment, is the force exerted by circulating blood against the walls of blood vessels due to heart's pumping action. It is measured in mmHg. The upper number is the measurement during the heartbeat (systolic) and the lower number is while the heart is at rest (diastolic). In the office, this measurement will be taken manually by trained medical assistants using GE Healthcare CRITIKON DURA-CUF reusable cuff and 767-Series wall/mobile sphygmomanometer in clinic and recorded in the patient's electronic medical record.
Measured: At baseline and at the end of the 12-month study
Height/Weight_BMI
Body Mass Index (BMI) is an auto calculation in the electronic medical record reflecting the indirect measure of body fat derived by dividing weight in kilograms by height in meters, squared. For adults 20 years of age and older, a BMI below 18.5 is considered underweight, a BMI between 18.5 and 24.9 is considered a healthy weight, a BMI of 25.0 to 29.9 is defined as overweight, and a BMI greater than 30.0 is defined as obesity.
Measured: At baseline and at the end of the 12-month study period
Secondary outcomes (3)
Perceived Stress Scale-10
The Perceived Stress Scale-10 (PSS-10) is a 10-item self-report measure of perceived stress. It is a measure of the degree to which situations in one's life are appraised as stressful over the past month. The 4-point Likert Scale includes responses of 0 (never), 1 (almost never), 2 (sometimes), 3 (fairly often), and 4 (very often). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Measured: At baseline, at 2-months, 6-months, and at the end of the 12-month study period.
Connor-Davidson Resilience Scale-10
The Connor-Davidson Resilience Scale-10 (CD-RISC-10) is a 10-item self-report assessment of a person's ability to bounce back after adversity. A 5-point Likert Scale for each statement ranges from 0 (Not True at All), 1 (Rarely True), 2 (Sometimes True), 3 (Often True), 4 (True Nearly All of the Time). A respondent's total score can range from 0 to 40 with higher scores indicating higher resilience.
Measured: At baseline, 2-month assessment, 6-month assessment, and at end of the 12-month study period.
PROMIS Sleep Disturbance Scale
The PROMIS Sleep Disturbance Scale (SDS) scale is a standardized, self reported measure designed to assess perceived sleep quality and difficulty. The 8-item short form evaluates sleep impairment over the past 7 days; question responses are formatted on a 5-point Likert scale ranges from 1 (Not at all) to 5 (Very Much). Participant raw scores can range from 6 to 30 with higher scores indicating increased sleep disturbance.
Measured: At baseline, 2-month assessment, 6-month assessment, and at the end of the 12-month study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Steinberg, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679984
- Sponsor's protocol ID
- 20261358
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of a Mindfulness Intervention on Health Outcomes in Individuals With Hypertension
- ClinicalTrials.gov ID
- NCT07679984
- Acronym / sponsor ID
- 20261358
- Conditions
- Hypertension, Essential (Primary) Hypertension
- Keywords
- hypertension, primary care, mindfulness, stress, resilience, sleep, blood pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 1 Jul 2026 (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 purpose of this study is to evaluate the effectiveness of adding the Mindfulness in Motion (MIM) program to usual primary care for people with high blood pressure. MIM is a facilitated, 8-week online program that teaches simple ways to manage stress using mindfulness practices. The program also includes the use of a companion smartphone app throughout the 12-month study period. In this study, investigators will compare people who receive their usual care and take part in the MIM program with those who receive usual care alone to see if it helps improve blood pressure, weight, stress, sleep, and overall well-being. Over 12 months, participants will be asked to complete short questionnaires about stress, sleep, and resilience four times via a smartphone, tablet, or computer.
Detailed description
Hypertension is a major modifiable risk factor for cardiovascular disease, and effective blood pressure reduction significantly reduces the risk of stroke, myocardial infarction, and heart failure. Current clinical treatment guidelines prioritize lifestyle modification as first-line therapy for a diagnosis of hypertension. The American Heart Association (AHA) has acknowledged mind-body medicine approaches, specifically meditation-based practices, as potential supportive strategies for cardiovascular risk reduction among patients with cardiovascular risk factors and diagnoses. Complementary medicine includes a range of therapies aimed at supporting behavior change, stress reduction, self-management, and overall well-being. However, utilization of these practices remains relatively low among individuals with cardiovascular disease and cardiovascular risk factors, largely due to limited awareness of their potential benefits and practical barriers such as travel requirements and time commitment. The expansion of virtual and app based complementary practices has the potential to address key implementation barriers, including travel burden and scheduling constraints, while supporting scalable and sustained engagement.
Mindfulness-based practices, increasingly offered virtually and via smartphone applications, have shown promise for adults with elevated blood pressure and hypertension. Studies that have implemented mindfulness based interventions, ranging from one to 12 sessions, have reported clinically significant reductions in systolic and diastolic blood pressure, as well as improvements in related psychosocial outcomes such as stress, anxiety, and depression. Emerging evidence suggests that blood pressure improvements are, in part, affected by lifestyle behaviors, including improved dietary choices, medication adherence, and decreased stress.
For over two decades, Mindfulness in Motion (MIM), has been studied as an educational, community-based 8-week program that has shown significant improvements in psychosocial outcomes, such as burnout, stress, and resiliency for healthcare professionals, persons with multiple sclerosis, cancer survivors, inner-city children under economic stress, college students, and community first responders. The purpose of this study is to evaluate the effectiveness of Mindfulness in Motion (MIM), an evidence-based mindfulness intervention delivered virtually and supported by a companion smartphone application, among patients diagnosed with hypertension, compared with usual care. Individual outcomes will be assessed at four time points: baseline, at the conclusion of the 8 week virtual MIM intervention (2 month assessment), at four months following completion of the virtual 8-week intervention (6 month assessment) and again at 10 months following completion of the virtual 8-week intervention (12 month assessment). Individual outcomes will include self report measures of perceived stress, resilience, and sleep. Physiological outcome measures including body mass index (BMI), and systolic and diastolic blood pressure will be collected at baseline and again at the end of the 12-month study period. MIM attendance at the 8-weekly virtual sessions, monthly mindfulness refresher sessions, and MIM app usage, per participant per day and over the 12 month period, will be measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness in Motion plus Usual Care (Intervention Group) | Experimental | Behavioral: Mindfulness in Motion |
| Usual Care (Control Group) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >18 years old.
- Established patient at OSU Family Medicine
- Diagnosis of primary essential hypertension
- Ability and willingness to participate in all Mindfulness in Motion (MIM) study activities.
- Ability and willingness to download MyCap, the smartphone app that securely links participant study responses to the REDCap study project.
Key exclusion criteria (14 listed)
- Inability to read and/or understand English (MIM intervention, study consent and questionnaires in English).
- Established mindfulness practice.
- Diagnosis of secondary hypertension with identifiable underlying causes including:
- Current severe alcohol or substance abuse disorder.
- Participants with documented cognitive disorder that limits the ability to independently participate in MIM program, read, understand, and/or complete the surveys; i.e. dementia, Alzheimer's or biological tests.
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 |
|---|---|---|
| Mindfulness in MotionMindfulness in Motion (MIM) is an 8-week evidence-based program designed as an intervention to help participants learn practical burnout/stress reduction and resiliency building techniques. Delivered in a virtual, synchronous group format one hour per week, MIM includes didactic instruction, community-building group discussion, mindfulness, and gentle yoga. Each session focuses on a specific theme with topics that include Willingness to Daily Practice, Cultivating Mindful Sleep, Vision of Self, Supported by the Breath, Mindful Eating and Yoga, Movement Through Balance, Awareness of Sensation, Clarity and Release, and Staying Grounded \& Moving Forward. Participants are highly encouraged to engage in 10-20 minutes of individual self-practice at least five times per week. A companion MIM smartphone app offers daily mindfulness, movement, and reflective practices. | Behavioural | Mindfulness in Motion plus Usual Care (Intervention Group) |
Primary outcome
Systolic and Diastolic Blood Pressure
Time frame: At baseline and at the end of the 12-month study
Blood pressure, obtained at each Family Medicine ambulatory appointment, is the force exerted by circulating blood against the walls of blood vessels due to heart's pumping action. It is measured in mmHg. The upper number is the measurement during the heartbeat (systolic) and the lower number is while the heart is at rest (diastolic). In the office, this measurement will be taken manually by trained medical assistants using GE Healthcare CRITIKON DURA-CUF reusable cuff and 767-Series wall/mobile sphygmomanometer in clinic and recorded in the patient's electronic medical record.
Height/Weight_BMI
Time frame: At baseline and at the end of the 12-month study period
Body Mass Index (BMI) is an auto calculation in the electronic medical record reflecting the indirect measure of body fat derived by dividing weight in kilograms by height in meters, squared. For adults 20 years of age and older, a BMI below 18.5 is considered underweight, a BMI between 18.5 and 24.9 is considered a healthy weight, a BMI of 25.0 to 29.9 is defined as overweight, and a BMI greater than 30.0 is defined as obesity.
3 secondary outcomes
Perceived Stress Scale-10
Time frame: At baseline, at 2-months, 6-months, and at the end of the 12-month study period.
Connor-Davidson Resilience Scale-10
Time frame: At baseline, 2-month assessment, 6-month assessment, and at end of the 12-month study period.
PROMIS Sleep Disturbance Scale
Time frame: At baseline, 2-month assessment, 6-month assessment, and at the end of the 12-month study period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness in Motion in people with Hypertension and Essential (Primary) Hypertension, run by Ohio State 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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 6 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beth Steinberg, PhD, RN (614-406-7067, beth.steinberg@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and Diastolic Blood Pressure (time frame: At baseline and at the end of the 12-month study). 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?
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 6 Jul 2026.