Mindfulness App Training for Cardiovascular Health
Overview
- Phase
- Not Applicable
- Intervention
- Mindfulness Training
- Conditions
- Cardiovascular Diseases
- Sponsor
- University of Pittsburgh
- Enrollment
- 106
- Locations
- 2
- Primary Endpoint
- Change in Systolic Blood Pressure Response to Social Conflict from pre-intervention to post-intervention
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
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.
Investigators
Thomas Kamarck
Professor
University of Pittsburgh
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
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)
Arms & Interventions
Mindfulness Training
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.
Intervention: Mindfulness Training
Enhanced Usual Care (EUC)
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.
Intervention: Enhanced Usual Care
Outcomes
Primary Outcomes
Change in Systolic Blood Pressure Response to Social Conflict from pre-intervention to post-intervention
Time Frame: Change in Systolic Blood Pressure Response to Social Conflict assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
Ambulatory systolic blood pressure response in relation to hourly measures of social conflict
Change in Systolic Blood Pressure Response to Social Conflict from pre-intervention to 3-month follow-up
Time Frame: 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)
Ambulatory systolic blood pressure response in relation to hourly measures of social conflict
Change in Task Strain from pre-intervention to post-intervention
Time Frame: Change in Task Strain assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
Task strain assessed as the proportion of hourly observations during each ambulatory monitoring period that are assigned ratings above the sample median on a 3-item Task Demand scale and below the sample median on a 2-item Decision Latitude scale, with higher scores indicating higher task strain
Change in Task Strain from pre-intervention to 3-month follow-up
Time Frame: Change in Task Strain assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
Task strain assessed as the proportion of hourly observations during each ambulatory monitoring period that are assigned ratings above the sample median on a 3-item Task Demand scale and below the sample median on a 2-item Decision Latitude scale, with higher scores indicating higher task strain
Change In Systolic Blood Pressure Response to Momentary Psychosocial Stress from pre-intervention to post-intervention
Time Frame: Change in Systolic Blood Pressure Response to Momentary Psychosocial Stress assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
Ambulatory systolic blood pressure response in relation to hourly measures of momentary strain (high task demand and low decision latitude)
Feasibility of recruitment
Time Frame: Assessed at enrollment
Recruitment benchmark: \>7 participants will be enrolled each month on average
Change In Systolic Blood Pressure Response to Momentary Psychosocial Stress from pre-intervention to 3-month follow-up
Time Frame: 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)
Ambulatory systolic blood pressure response in relation to hourly measures of momentary strain (high task demand and low decision latitude)
Change in Social Conflict from pre-intervention to post-intervention
Time Frame: Change in Social Conflict assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
Social conflict assessed hourly using a 3-item scale, with average scores ranging from 0-10 and higher scores indicating greater social conflict, and a 1-item exploratory measure, with scores ranging from 0-10 and higher scores indicating greater social conflict
Change in Social Conflict from pre-intervention to 3-month follow-up
Time Frame: Change in Social Conflict assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
Social conflict assessed hourly using a 3-item scale, with average scores ranging from 0-10 and higher scores indicating greater social conflict, and a 1-item exploratory measure, with scores ranging from 0-10 and higher scores indicating greater social conflict
Acceptability: Treatment Expectancies
Time Frame: 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)
Acceptability of mindfulness intervention with benchmark of ≥75% of participants giving positive ratings of treatment expectancies (\>3 on a 6-item Credibility/Expectancy Questionnaire, with higher scores indicating greater positive treatment expectancy)
Feasibility of safe implementation: Side Effects
Time Frame: 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)
Feasibility of safe implementation, with a benchmark of \<10% of mindfulness participants endorsing occasional or moderately distressing side effects, assessed via the Adverse Effects Survey, a 15-item self-report survey on the frequency of unwanted side effects that may be associated with the experience of meditation
Feasibility of retention
Time Frame: Assessed across the entire 5-month study period
Retention benchmark: ≥73% retention from initial enrollment through follow-up
Feasibility of adherence
Time Frame: Assessed across the entire 5-month study period
Adherence benchmark: average completion of ≥85% of intervention lessons and ≥75% of ambulatory assessments
Acceptability: Study Burden
Time Frame: Study Burden assessed at post-intervention and 3-month follow-up
Study burden benchmark of ≥80% of participants giving ratings of 2.5 (less than burdensome) or below on average on a 5-item measure of study load
Secondary Outcomes
- Change in Clinic Blood Pressure from pre-intervention to post-intervention(Change in clinic blood pressure assessed with 2 pre-intervention assessments and 2 post-intervention assessments (average of 6 weeks))
- Change in Clinic Blood Pressure from pre-intervention to 3-month follow-up(Change in clinic blood pressure assessed with 2 pre-intervention assessments and 2 3-month follow-up assessments (average of 19 weeks))
- Change in Mean Ambulatory Blood Pressure from pre-intervention to post-intervention(Change in Mean Ambulatory Blood Pressure assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks))
- Change in Mean Ambulatory Blood Pressure from pre-intervention to 3-month follow-up(Change in Mean Ambulatory Blood Pressure assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks))
- Change in Momentary Positive Affect from pre-intervention to post-intervention(Change in Mean Momentary Positive Affect assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks))
- Change in Momentary Positive Affect from pre-intervention to 3-month follow-up(Change in Mean Momentary Positive Affect assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks))
- Change in Momentary Negative Affect from pre-intervention to post-intervention(Change in Mean Momentary Negative Affect assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks))
- Change in Momentary Negative Affect from pre-intervention to 3-month follow-up(Change in Mean Momentary Negative Affect assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks))
- Change in Negative Affect Reactivity to Task-Related Strain from pre-intervention to post-intervention(Change in Negative Affect Reactivity to Task Strain assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks))
- Change in Negative Affect Reactivity to Task-Related Strain from pre-intervention to 3-month follow-up(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))
- Change in Negative Affect Reactivity to Social Conflict from pre-intervention to post-intervention(Change in Negative Affect Reactivity to Social Conflict assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks))
- Change in Negative Affect Reactivity to Social Conflict from pre-intervention to 3-month follow-up(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))
- Change in Blood Pressure Reactivity to Acute Stress from pre-intervention to post-intervention(Change in Blood Pressure Reactivity to Acute Stress from pre-intervention to post-intervention (average of 7 weeks))
- Change in Subjective Reactivity to Acute Stress from pre-intervention to post-intervention(Change in Subjective Reactivity to Acute Stress from pre-intervention to post-intervention (average of 7 weeks))
- Change in Trait Affect from pre-intervention to post-intervention(Change in Trait Affect assessed at pre-intervention and post-intervention (average of 6 weeks))
- Change in Trait Affect from pre-intervention to 3-month follow-up(Change in Trait Affect assessed at pre-intervention and 3-month follow-up (average of 19 weeks))
- Change in Positive and Negative Social Exchanges from pre-intervention to post-intervention(Change in Social Exchanges from pre-intervention to post-intervention (average of 6 weeks))
- Change in Positive and Negative Social Exchanges from pre-intervention to 3-month follow-up(Change in Social Exchanges from pre-intervention to 3-month follow-up (average of 19 weeks))
- Change in Perceived Stress from pre-intervention to post-intervention(Change in Perceived Stress from pre-screening to post-intervention (average of 7 weeks))
- Change in Perceived Stress from pre-intervention to 3-month follow-up(Change in Perceived Stress from pre-screening to three-month follow up (average of 20 weeks))
- Change in Anxiety Symptoms from pre-intervention to post-intervention(Change in Anxiety Symptoms from pre-intervention to post-intervention (average of 6 weeks))
- Change in Anxiety Symptoms from pre-intervention to 3-month follow-up(Change in Anxiety Symptoms from pre-intervention to three-month follow up (average of 19 weeks))
- Change in Job Strain from pre-intervention to post-intervention(Change in Job Strain from pre-intervention to post-intervention (average of 6 weeks))
- Change in Job Strain from pre-intervention to 3-month follow-up(Change in Job Strain from pre-intervention to three-month follow up (average of 19 weeks))
- Daily Perceived Stress during mindfulness intervention(Collected daily throughout the 4-week intervention period for Mindfulness participants only)
- Change in Momentary Perceived Stress before and after mindfulness prompts(Collected before and after mindfulness prompts throughout the 4-week intervention period for Mindfulness participants only)
- Mindfulness Prompt Helpfulness(Collected daily throughout the 4-week intervention period for Mindfulness participants only)