← Back to all trials
Not Yet Recruiting
NCT07679984
Evaluating the Effects of a Mindfulness Intervention on Health Outcomes in Individuals With Hypertension
Conditions: Hypertension, Essential (Primary) Hypertension
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: Ohio State University
Location: The Ohio State University Wexner Medical Center Columbus Ohio
Summary
The purpose of this study is to evaluate the effectiveness of adding the Mindfulness in Motion (MIM) program to the 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, we 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, all participants will be asked to complete short questionnaires about stress, sleep, and resilience four times via a smartphone, tablet, or computer.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07679984). StuddyBuddy aggregates publicly available trial information.