Mindfulness App Training for Cardiovascular Health (MATCH)

University of Pittsburgh

Status: Enrolling

Conditions: Mindfulness; Cardiovascular Diseases

Treatments: Behavioral: Mindfulness Training; Behavioral: Enhanced Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06152185

R34HL163245 (U.S. NIH Grant/Contract)

STUDY22090002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 2 patient groups

Mindfulness Training

Experimental group

Description:

Mindfulness intervention involving 28 audio-guided lessons plus daily brief practice prompts. Lessons train meditation techniques for 3 mindfulness skills: concentration, sensory clarity, and equanimity. Practice prompts delivered 3x daily build on the skills trained in each lesson.

Treatment:

Behavioral: Mindfulness Training

Enhanced Usual Care (EUC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced Usual Care