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ACTIVE NOT RECRUITING

NCT06152185

Mindfulness App Training for Cardiovascular Health

Sponsor: University of Pittsburgh

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2024-02-06

Completion Date

2026-06-30

Last Updated

2026-03-20

Healthy Volunteers

Conditions

Cardiovascular Diseases Mindfulness

Interventions

BEHAVIORAL

Mindfulness Training

The mindfulness intervention includes 28 daily 20-minute audio lessons plus brief daily practice prompts. The first 14 lessons train techniques for developing foundational mindfulness skills through didactics and guided practice; the second 14 lessons review these techniques through guided practice. Based on the Unified Mindfulness system, lessons train 3 mindfulness skills: concentration, sensory clarity, and equanimity. Concentration, a state of stable attention, enables participants to monitor present-moment physical and emotional body experiences. Sensory clarity, the monitoring of momentary experiences, involves detecting subtle sensations and discriminating between different experiences. Equanimity, an attitude of acceptance toward momentary experiences, is trained through 3 strategies: (a) body relaxation, (b) mental welcoming, and (c) a gentle tone of voice. Practice prompts delivered 3 times daily encourage participants to practice brief moments of mindful awareness.

BEHAVIORAL

Enhanced Usual Care

Participants in the EUC condition will have no study requirements during the 4-week intervention period, but they will receive a list of stress management resources upon randomization (websites, books, health tracking apps, and mental health services) with no additional intervention support.

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

Locations (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States