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

NCT07679984 | Not Yet Recruiting

• 1 other identifier: 20261358
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Essential (Primary) Hypertension

Keywords

hypertension; primary care; mindfulness; stress; resilience; sleep; blood pressure

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (3)

• Perceived Stress Scale-10

  At baseline, at 2-months, 6-months, and at the end of the 12-month study period.

• Connor-Davidson Resilience Scale-10

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

• PROMIS Sleep Disturbance Scale

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

Other Outcomes (3)

• Mindfulness in Motion Attendance

  At the end of the 12-month study period

• Mindfulness in Motion App Usage total time per 12-month study period

  At the end of the 12-month study period.

• Mindfulness in Motion mean app usage per day

  At the end of the 12-month study period.

Study Arms (2)

Mindfulness in Motion plus Usual Care (Intervention Group)

EXPERIMENTAL

Behavioral: Mindfulness in Motion

Usual Care (Control Group)

NO INTERVENTION

Interventions

Mindfulness in Motion BEHAVIORAL

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.

Mindfulness in Motion plus Usual Care (Intervention Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

Mindfulness; Motion

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Physical Phenomena

Central Study Contacts

Beth Steinberg, PhD, RN

CONTACT

614-406-7067; beth.steinberg@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director of Research

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 1, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06

Locations

US (1)