Mindfulness App Training for Cardiovascular Health

Phase

N/A

Condition

Vascular Diseases

Treatment

Enhanced Usual Care

Mindfulness Training

Clinical Study ID

NCT06152185

STUDY22090002

R34HL163245

Ages > 45
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 visitsand activities during this period
High perceived stress (greater than or equal to 14 on the 10-item Perceived StressScale)
Diagnosed with hypertension by medical provider and, if medicated, blood pressurebelow 150/100, or if unmedicated, clinic blood pressure reading greater than orequal to 125/75 and less than 150/100
Moderate-to-high cardiovascular disease risk, as indicated by hypertension and atleast 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

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) inthe 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 CarePTSD screen for DSM-5)
Positive Bipolar Disorder screen (≥7 yes responses to item 1, yes to item 2, andmoderate 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 smartphonesoftware

Study Design

Enhanced Usual Care

February 06, 2024

April 30, 2026

Study 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.

Connect with a study center

University of Pittsburgh
Pittsburgh, Pennsylvania 15213
United States
Active - Recruiting

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