University of Pittsburgh
Thomas Kamarck
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.
Cardiovascular Diseases
Mindfulness
Mindfulness Training
Enhanced Usual Care
NA
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 105 participants |
| Masking : | SINGLE |
| Masking Description : | The research associates who interact with participants following randomization will be blind to condition. The study coordinator and investigators will not be blind to condition; they will be responsible for interacting with participants during the intervention but will not be involved in post-randomization data collection. |
| Primary Purpose : | BASIC_SCIENCE |
| Official Title : | Mindfulness App Training for Cardiovascular Health |
| Actual Study Start Date : | 2024-02-06 |
| Estimated Primary Completion Date : | 2026-04-30 |
| Estimated Study Completion Date : | 2026-04-30 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 45 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213