Mindfulness training using a smartphone app for heart health
Mindfulness App Training for Cardiovascular Health
This study is trying out a smartphone app that teaches mindfulness to see if it helps stressed adults at risk for heart problems feel better compared to just sticking with their usual routines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06152185 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility and effects of a smartphone-based mindfulness training program compared to usual care for stressed midlife and older adults at risk for cardiovascular disease. A total of 105 participants will be randomly assigned to either a four-week mindfulness intervention, which includes 28 audio-guided lessons and practice prompts, or to continue their regular routines. Data will be collected at baseline, post-intervention, and three months later, including subjective and physiological stress reactivity assessments. Participants will also use wearable devices to monitor their daily activity and stress levels throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45 and older who are fluent in English and have high perceived stress and moderate-to-high cardiovascular disease risk.
Not a fit: Patients without high perceived stress or those not at risk for cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce stress levels and improve cardiovascular health in at-risk individuals.
How similar studies have performed: Other studies have shown promising results with mindfulness interventions for stress reduction and cardiovascular health, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Thomas W Kamarck, PhD — University of Pittsburgh
- Study coordinator: Thomas W Kamarck, PhD
- Email: tkam@pitt.edu
- Phone: 412-624-2080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.