NCT06152185

Mindfulness App Training for Cardiovascular Health

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is aimed at assessing the feasibility and effects of a smartphone-based mindfulness training program vs. usual care. The objective is to determine the program's effectiveness in reducing stress levels and cardiovascular responses to stress in the daily lives of participants, with a specific focus on individuals at risk of cardiovascular disease. Participants will be aged 45 or above and have risk factors for cardiovascular disease. Participants will be randomly assigned to either receive a smartphone-based mindfulness training program or continue their regular daily routines. The study consists of seven laboratory visits that include assessments and training for completing at-home study activities and using monitoring devices. These devices will track activity levels, heart rate, and various stress indicators during the study at three separate weeklong periods. A mobile blood pressure device will take hourly blood pressure readings during three monitoring days at pre-intervention, post-intervention, and three-month follow-up. On these days, participants will complete brief surveys on their smartphones at each reading and at the beginning and end of each day about their mood, behaviors, and social interactions. Participants will also wear Fitbit activity monitors and a sensor application will be installed on participants' smartphones to continuously collect data on movement, heart rate, location, screen status, and other parameters. Together, this data will be used to gain insights into daily stress indicators. Participants assigned to the mindfulness training group will engage in daily 20-minute audio recordings and practice assignments at home over a one-month period. They will also be asked to answer questions about their daily stressors and the effectiveness of the training program, both at the beginning and end of each day. The study team will periodically contact them by phone to address any questions or concerns during this month. Participants assigned to the usual care control group will receive resources for stress management but will not participate in a structured intervention or be required to respond to specific questions over the one-month period. After the intervention period, all participants will complete a second week of daily life monitoring, and a third week of monitoring three months later. They will also complete a laboratory cardiovascular reactivity task at pre-intervention and post-intervention.

Conditions

• Cardiovascular Diseases
• Mindfulness

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-02-06
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2023-11-30
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States