Clinical trial NCT06152185: Mindfulness App Training for Cardiovascular Health
Official title: Mindfulness App Training for Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Mindfulness
Keywords: Mindfulness
Cardiovascular Disease
Stress
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-11-30
Enrollment: 105
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to the Mindfulness intervention (n = 63) or Enhanced Usual Care (n = 42) using a 3:2 randomization sequence.
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Task Strain from pre-intervention to post-intervention
timeFrame: Change in Task Strain assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
measure: Change in Task Strain from pre-intervention to 3-month follow-up
timeFrame: Change in Task Strain assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
measure: Change In Systolic Blood Pressure Response to Momentary Psychosocial Stress from pre-intervention to post-intervention
timeFrame: Change in Systolic Blood Pressure Response to Momentary Psychosocial Stress assessed for 3 days at three timepoints: pre-intervention and post-intervention (an average of 5 weeks)
measure: Change In Systolic Blood Pressure Response to Momentary Psychosocial Stress from pre-intervention to 3-month follow-up
timeFrame: Change in Systolic Blood Pressure Response to Momentary Psychosocial Stress assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
measure: Change in Social Conflict from pre-intervention to post-intervention
timeFrame: Change in Social Conflict assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
measure: Change in Social Conflict from pre-intervention to 3-month follow-up
timeFrame: Change in Social Conflict assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
measure: Change in Systolic Blood Pressure Response to Social Conflict from pre-intervention to post-intervention
timeFrame: Change in Systolic Blood Pressure Response to Social Conflict assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
measure: Change in Systolic Blood Pressure Response to Social Conflict from pre-intervention to 3-month follow-up
timeFrame: Change in Systolic Blood Pressure Response to Social Conflict assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
measure: Feasibility of recruitment
timeFrame: Assessed at enrollment
measure: Feasibility of retention
timeFrame: Assessed across the entire 5-month study period
measure: Feasibility of adherence
timeFrame: Assessed across the entire 5-month study period
measure: Acceptability: Treatment Expectancies
timeFrame: Treatment Expectancies assessed among participants randomized to the mindfulness condition at pre-intervention, post-intervention (average of 5 weeks), and 3-month follow-up (average of 19 weeks)
measure: Feasibility of safe implementation: Side Effects
timeFrame: Adverse effects assessed among participants randomized to the mindfulness condition at pre-intervention, post-intervention (average of 6 weeks), and 3-month follow-up (average of 20 weeks)
measure: Acceptability: Study Burden
timeFrame: Study Burden assessed at post-intervention and 3-month follow-up
Secondary outcomes:
measure: Change in Clinic Blood Pressure from pre-intervention to post-intervention
timeFrame: Change in clinic blood pressure assessed with 2 pre-intervention assessments and 2 post-intervention assessments (average of 6 weeks)
measure: Change in Clinic Blood Pressure from pre-intervention to 3-month follow-up
timeFrame: Change in clinic blood pressure assessed with 2 pre-intervention assessments and 2 3-month follow-up assessments (average of 19 weeks)
measure: Change in Mean Ambulatory Blood Pressure from pre-intervention to post-intervention
timeFrame: Change in Mean Ambulatory Blood Pressure assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
measure: Change in Mean Ambulatory Blood Pressure from pre-intervention to 3-month follow-up
timeFrame: Change in Mean Ambulatory Blood Pressure assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
measure: Change in Momentary Positive Affect from pre-intervention to post-intervention
timeFrame: Change in Mean Momentary Positive Affect assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
measure: Change in Momentary Positive Affect from pre-intervention to 3-month follow-up
timeFrame: Change in Mean Momentary Positive Affect assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
measure: Change in Momentary Negative Affect from pre-intervention to post-intervention
timeFrame: Change in Mean Momentary Negative Affect assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
measure: Change in Momentary Negative Affect from pre-intervention to 3-month follow-up
timeFrame: Change in Mean Momentary Negative Affect assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
measure: Change in Negative Affect Reactivity to Task-Related Strain from pre-intervention to post-intervention
timeFrame: Change in Negative Affect Reactivity to Task Strain assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
measure: Change in Negative Affect Reactivity to Task-Related Strain from pre-intervention to 3-month follow-up
timeFrame: Change in Negative Affect Reactivity to Task Strain assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
measure: Change in Negative Affect Reactivity to Social Conflict from pre-intervention to post-intervention
timeFrame: Change in Negative Affect Reactivity to Social Conflict assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
measure: Change in Negative Affect Reactivity to Social Conflict from pre-intervention to 3-month follow-up
timeFrame: Change in Negative Affect Reactivity to Social Conflict assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
measure: Change in Blood Pressure Reactivity to Acute Stress from pre-intervention to post-intervention
timeFrame: Change in Blood Pressure Reactivity to Acute Stress from pre-intervention to post-intervention (average of 7 weeks)
measure: Change in Subjective Reactivity to Acute Stress from pre-intervention to post-intervention
timeFrame: Change in Subjective Reactivity to Acute Stress from pre-intervention to post-intervention (average of 7 weeks)
measure: Change in Trait Affect from pre-intervention to post-intervention
timeFrame: Change in Trait Affect assessed at pre-intervention and post-intervention (average of 6 weeks)
measure: Change in Trait Affect from pre-intervention to 3-month follow-up
timeFrame: Change in Trait Affect assessed at pre-intervention and 3-month follow-up (average of 19 weeks)
measure: Change in Positive and Negative Social Exchanges from pre-intervention to post-intervention
timeFrame: Change in Social Exchanges from pre-intervention to post-intervention (average of 6 weeks)
measure: Change in Positive and Negative Social Exchanges from pre-intervention to 3-month follow-up
timeFrame: Change in Social Exchanges from pre-intervention to 3-month follow-up (average of 19 weeks)
measure: Change in Perceived Stress from pre-intervention to post-intervention
timeFrame: Change in Perceived Stress from pre-screening to post-intervention (average of 7 weeks)
measure: Change in Perceived Stress from pre-intervention to 3-month follow-up
timeFrame: Change in Perceived Stress from pre-screening to three-month follow up (average of 20 weeks)
measure: Change in Anxiety Symptoms from pre-intervention to post-intervention
timeFrame: Change in Anxiety Symptoms from pre-intervention to post-intervention (average of 6 weeks)
measure: Change in Anxiety Symptoms from pre-intervention to 3-month follow-up
timeFrame: Change in Anxiety Symptoms from pre-intervention to three-month follow up (average of 19 weeks)
measure: Job Strain at pre-intervention
timeFrame: Job Strain assessed at pre-intervention for employed individuals
measure: Job Strain at post-intervention
timeFrame: Job Strain assessed at post intervention (average of 6 weeks) for employed individuals
measure: Job Strain at 3-month follow-up
timeFrame: Job Strain assessed at 3-month follow-up (an average 19 weeks) for employed individuals
measure: Daily Perceived Stress during mindfulness intervention
timeFrame: Collected daily throughout the 4-week intervention period for Mindfulness participants only
measure: Change in Momentary Perceived Stress before and after mindfulness prompts
timeFrame: Collected before and after mindfulness prompts throughout the 4-week intervention period for Mindfulness participants only
measure: Mindfulness Prompt Helpfulness
timeFrame: Collected daily throughout the 4-week intervention period for Mindfulness participants only
Other outcomes:
measure: Change in Momentary Perceived Stress
timeFrame: Change in Momentary Perceived Stress is assessed for 3 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Momentary Distress Tolerance
timeFrame: Change in Distress Tolerance assessed for 3 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Momentary Rumination
timeFrame: Change in Momentary Rumination is assessed for 3 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Daily Perceived Stress
timeFrame: Change in Daily Perceived Stress assessed for 7 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Daily Positive Affect
timeFrame: Change in Mean Daily Positive Affect assessed for 7 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Daily Negative Affect
timeFrame: Change in Mean Daily Negative Affect assessed for 7 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Social Interactions
timeFrame: Change in frequency of Social Interactions assessed for 3 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Social Interaction Characteristics
timeFrame: Change in Social Interaction Characteristics assessed for 3 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Social Interaction Responsiveness
timeFrame: Change in Social Interaction Responsiveness assessed for 3 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Daily Loneliness
timeFrame: Change in Loneliness assessed for 7 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Sleepiness
timeFrame: Change in Sleepiness assessed for 7 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Daily Life Mindfulness
timeFrame: Change in Daily Life Mindfulness assessed for 7 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Daily Distress Tolerance
timeFrame: Change in Daily Distress Tolerance assessed for 7 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Stressful Events
timeFrame: Change in Stressful Events assessed for 7 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Positive Events
timeFrame: Change in Positive Events assessed for 7 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Passive sensor stress models
timeFrame: Sensor data collected continuously for 7 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Physical Activity
timeFrame: Change in Physical Activity assessed for 7 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Sleep Duration
timeFrame: Change in Sleep Duration assessed for 7 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Daily Sleep Patterns
timeFrame: Change in Sleep Patterns assessed for 3 days at three timepoints: pre-intervention, post-intervention (an average of 5 weeks), and three-month follow-up (an average of 18 weeks)
measure: Change in Self-Compassion
timeFrame: Change in Self-Compassion from pre-intervention to post-intervention (average of 6 weeks) and three-month follow up (average of 19 weeks)
measure: Change in Trait Mindfulness
timeFrame: Change in Trait Mindfulness from pre-intervention to post-intervention (average of 6 weeks) and three-month follow up (average of 19 weeks)
measure: Change in Experiential Avoidance
timeFrame: Change in Experiential Avoidance from pre-intervention to post-intervention (average of 6 weeks) and three-month follow up (average of 19 weeks)
measure: Change in Health Behaviors
timeFrame: Change in Health Behaviors from pre-intervention to post-intervention (average of 6 weeks) and three-month follow up (average of 19 weeks)
measure: Childhood Trauma
timeFrame: Pre-intervention, to be used in exploratory moderator analyses
measure: Everyday Discrimination
timeFrame: Pre-intervention, to be used in exploratory moderator analyses
measure: Continued Mindfulness Practice
timeFrame: Mindfulness Practice assessed for 7 days at two timepoints: post-intervention and three-month follow up
measure: Monthly Stress Management
timeFrame: Stress Management practice assessed monthly at post-intervention, 1-month follow-up, 2-month follow-up, and 3-month follow-up
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Thomas W Kamarck, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Emily K Lindsay, PhD
role: PRINCIPAL_INVESTIGATOR
References: