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Evaluating the Effects of a Mindfulness Intervention on Health Outcomes in Individuals With Hypertension

2026年7月1日 更新者:Beth Steinberg、Ohio State University
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.

研究概览

地位

尚未招聘

详细说明

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.

研究类型

介入性

注册 (估计的)

140

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Ohio
      • Columbus、Ohio、美国、43210
        • The Ohio State University Wexner Medical Center
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Age >18 years old.
  2. Established patient at OSU Family Medicine
  3. Diagnosis of primary essential hypertension
  4. Ability and willingness to participate in all Mindfulness in Motion (MIM) study activities.
  5. Ability and willingness to download MyCap, the smartphone app that securely links participant study responses to the REDCap study project.
  6. WiFi connectivity or LTE to allow use of MIM smartphone app and MyCap when not at OSU clinical site.

Exclusion Criteria:

  1. Inability to read and/or understand English (MIM intervention, study consent and questionnaires in English).
  2. Established mindfulness practice.
  3. Diagnosis of secondary hypertension with identifiable underlying causes including:

    • Chronic kidney disease
    • Renal artery stenosis
    • Primary aldosteronism
    • Cushing's syndrome
    • Pheochromocytoma
    • Obstructive sleep apnea
    • Medication induced hypertension (e.g., steroids, NSAIDs)
    • Pregnancy related hypertension
  4. Current severe alcohol or substance abuse disorder.
  5. 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.
  6. Participants with major psychiatric disorders not controlled by medication or other psychiatric treatments.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Mindfulness in Motion plus Usual Care (Intervention Group)
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.
无干预:Usual Care (Control Group)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Systolic and Diastolic Blood Pressure
大体时间: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.
At baseline and at the end of the 12-month study
Height/Weight_BMI
大体时间: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.
At baseline and at the end of the 12-month study period

次要结果测量

结果测量
措施说明
大体时间
Perceived Stress Scale-10
大体时间:At baseline, at 2-months, 6-months, and at the end of the 12-month study period.
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.
At baseline, at 2-months, 6-months, and at the end of the 12-month study period.
Connor-Davidson Resilience Scale-10
大体时间:At baseline, 2-month assessment, 6-month assessment, and at end of the 12-month study period.
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.
At baseline, 2-month assessment, 6-month assessment, and at end of the 12-month study period.
PROMIS Sleep Disturbance Scale
大体时间:At baseline, 2-month assessment, 6-month assessment, and at the end of the 12-month study period.
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.
At baseline, 2-month assessment, 6-month assessment, and at the end of the 12-month study period.

其他结果措施

结果测量
措施说明
大体时间
Mindfulness in Motion Attendance
大体时间:At the end of the 12-month study period
Intervention Group percentage of attendance of the 8-weekly virtual sessions.
At the end of the 12-month study period
Mindfulness in Motion App Usage total time per 12-month study period
大体时间:At the end of the 12-month study period.
Intervention group Mindfulness in Motion app usage, total time over 12 months in minutes/hours per participant.
At the end of the 12-month study period.
Mindfulness in Motion mean app usage per day
大体时间:At the end of the 12-month study period.
Intervention group Mindfulness in Motion app usage, mean per day per participant in minutes.
At the end of the 12-month study period.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2028年5月1日

研究注册日期

首次提交

2026年6月22日

首先提交符合 QC 标准的

2026年6月26日

首次发布 (实际的)

2026年7月1日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年7月1日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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