Evaluating the Effects of a Mindfulness Intervention on Health Outcomes in Individuals With Hypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Inability to read and/or understand English (MIM intervention, study consent and questionnaires in English).
Established mindfulness practice.
Chronic kidney disease
Renal artery stenosis
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness in Motion
BehavioralMindfulness 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Mindfulness in Motion plus Usual Care (Intervention Group)Experimental treatment 1 intervention
Group B: Usual Care (Control Group)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 study2
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 periodSecondary outcomes
1
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.2
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.3
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.Other outcomes
1
Mindfulness in Motion Attendance
Intervention Group percentage of attendance of the 8-weekly virtual sessions.
Time frame
At the end of the 12-month study period2
Mindfulness in Motion App Usage total time per 12-month study period
Intervention group Mindfulness in Motion app usage, total time over 12 months in minutes/hours per participant.
Time frame
At the end of the 12-month study period.3
Mindfulness in Motion mean app usage per day
Intervention group Mindfulness in Motion app usage, mean per day per participant in minutes.
Time frame
At the end of the 12-month study period.Sponsors and contacts
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Source ClinicalTrials.gov
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