Evaluating the Effects of a Mindfulness Intervention on Health Outcomes in Individuals With Hyper… (NCT07679984) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluating the Effects of a Mindfulness Intervention on Health Outcomes in Individuals With Hypertension
United States140 participantsStarted 2026-10-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Systolic and Diastolic Blood Pressure
Timeframe: At baseline and at the end of the 12-month study
2
Height/Weight_BMI
Timeframe: At baseline and at the end of the 12-month study period
. 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.
. Participants with major psychiatric disorders not controlled by medication or other psychiatric treatments.