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

N/ANot Yet RecruitingNCT07679984

Ohio State University140 enrolled

Overview

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.

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.

Interventions

Mindfulness in MotionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: At baseline and at the end of the 12-month study period

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: At baseline, 2-month assessment, 6-month assessment, and at the end of the 12-month study period.