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Smartphone mindfulness app tested to lower heart disease risk

NCT ID NCT06152185

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study tests whether a smartphone-based mindfulness training program can reduce stress and improve cardiovascular health in stressed adults aged 45 and older who are at risk for heart disease. About 106 participants will either use the app for 28 days or continue their usual routine. Researchers will measure changes in stress, blood pressure, and daily life reactions over three months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mindfulness training app
What this could lead to
If it works, this could point toward a simple, low-cost way to lower stress and improve heart health in at-risk adults.
What could go wrong
This is a small, early feasibility study with only 106 participants. Results may not apply to everyone, and the app may not produce lasting changes in stress or blood pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

106 people

The number who actually took part.

Started

Feb 2024

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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) * Positive PTSD screen (traumatic event(s) endorsed and total score ≥3 on Primary Care PTSD screen for DSM-5) * Positive Bipolar Disorder screen (≥7 yes responses to item 1, yes to item 2, and moderate or serious on item 3 of Mood Disorder Questionnaire) * Positive screen for psychosis (≥1 on Two-Item Screen for Early Psychosis) * Regular systematic mind-body practice (e.g., yoga or meditation \>2 times/week) * Current participation in another clinical trial or in a study that uses smartphone software

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.