CompletedNot Applicable

Mindfulness App Training for Cardiovascular Health

United States106 participantsStarted 2024-02-06

Plain-language summary

This study will investigate the feasibility and effects of a smartphone-based mindfulness training program vs. usual care in a sample of stressed midlife and older adults at risk for cardiovascular disease. 105 participants will be randomly assigned to complete a four-week mindfulness training intervention, which involves 28 audio-guided lessons and practice prompts delivered 3x daily, or to continue with their regular routines. Data will be collected at baseline, post-intervention, and three-month follow-up. The study will involve seven laboratory visits, which will include assessments and training on daily life monitoring and intervention procedures. Data assessing subjective and physiological stress reactivity in daily life will be collected for 3 days at pre-intervention, post-intervention, and 3-month follow-up. Passive sensor data will be continuously collected from participants' smartphones and wearable devices to develop models that predict daily life stress. Data will be used to evaluate feasibility of the intervention and assessments in a sample at risk for cardiovascular disease and to test effects of mindfulness training on subjective and physiological stress reactivity.

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 45 years or older * Fluent in English and proficient in reading English * Living in the Pittsburgh area for the next 5 months and available for study visits and activities during this period * High perceived stress (greater than or equal to 14 on the 10-item Perceived Stress Scale) * Diagnosed with hypertension by medical provider and, if medicated, blood pressure below 150/100, or if unmedicated, clinic blood pressure reading greater than or equal to 125/75 and less than 150/100 * Moderate-to-high cardiovascular disease risk, as indicated by hypertension and at least 1 of the following: * Diagnosed with diabetes by medical provider * Diagnosed with high cholesterol by medical provider * Current smoker by self-report (smoking or vaping every day or nearly every day) * Body Mass Index ≥30 * Android or iOS smartphone that meets study requirements * Participant otherwise able to meet study requirements Exclusion Criteria: * Clinical or symptomatic atherosclerotic disease, including ischemic heart disease, heart failure, angina, stroke, or atrial fibrillation * Two or more "night shift" episodes in the past month * Pregnancy * Typical alcohol consumption ≥15 drinks per week * Marijuana or hashish use \>9 of the past 30 days * Use of other controlled substances (e.g., cocaine, crack, heroin, meth, ecstasy) in the past 30 days * Current moderate-to-severe depressive symptoms (score ≥15 on PHQ-9) * Suicidal ideation (PHQ-9 item 9 score \>0) * Po…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Task Strain from pre-intervention to post-intervention

Timeframe: Change in Task Strain assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)

Change in Task Strain from pre-intervention to 3-month follow-up

Timeframe: Change in Task Strain assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)

Change In Systolic Blood Pressure Response to Momentary Psychosocial Stress from pre-intervention to post-intervention

Timeframe: Change in Systolic Blood Pressure Response to Momentary Psychosocial Stress assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)

Change In Systolic Blood Pressure Response to Momentary Psychosocial Stress from pre-intervention to 3-month follow-up

Timeframe: Change in Systolic Blood Pressure Response to Momentary Psychosocial Stress assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)

Change in Social Conflict from pre-intervention to post-intervention

Timeframe: Change in Social Conflict assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)

Trial details

NCT IDNCT06152185

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

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