Mindfulness App Training for Cardiovascular Health

NCT06152185 | Active Not Recruiting

• 2 other identifiers: STUDY22090002R34HL163245
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Mindfulness

Keywords

Mindfulness; Cardiovascular Disease; Stress

Outcome Measures

Primary Outcomes (14)

• Change in Task Strain from pre-intervention to post-intervention

  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 assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)

• Change in Task Strain from pre-intervention to 3-month follow-up

  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 assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)

• Change In Systolic Blood Pressure Response to Momentary Psychosocial Stress from pre-intervention to post-intervention

  Ambulatory systolic blood pressure response in relation to hourly measures of momentary strain (high task demand and low decision latitude)

  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)

• Change In Systolic Blood Pressure Response to Momentary Psychosocial Stress from pre-intervention to 3-month follow-up

  Ambulatory systolic blood pressure response in relation to hourly measures of momentary strain (high task demand and low decision latitude)

  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)

• Change in Social Conflict from pre-intervention to post-intervention

  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 assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)

• Change in Social Conflict from pre-intervention to 3-month follow-up

  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 assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)

• Change in Systolic Blood Pressure Response to Social Conflict from pre-intervention to post-intervention

  Ambulatory systolic blood pressure response in relation to hourly measures of social conflict

  Change in Systolic Blood Pressure Response to Social Conflict assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)

• Change in Systolic Blood Pressure Response to Social Conflict from pre-intervention to 3-month follow-up

  Ambulatory systolic blood pressure response in relation to hourly measures of social conflict

  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)

• Feasibility of recruitment

  Recruitment benchmark: \>7 participants will be enrolled each month on average

  Assessed at enrollment

• Feasibility of retention

  Retention benchmark: ≥73% retention from initial enrollment through follow-up

  Assessed across the entire 5-month study period

• Feasibility of adherence

  Adherence benchmark: average completion of ≥85% of intervention lessons and ≥75% of ambulatory assessments

  Assessed across the entire 5-month study period

• Acceptability: Treatment Expectancies

  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)

  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)

• Feasibility of safe implementation: Side Effects

  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

  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)

• Acceptability: Study Burden

  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

  Study Burden assessed at post-intervention and 3-month follow-up

Secondary Outcomes (27)

• 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)

Other Outcomes (27)

• Change in Momentary Perceived Stress

  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)

• Change in Momentary Distress Tolerance

  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)

• Change in Momentary Rumination

  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)

Study Arms (2)

Mindfulness Training

EXPERIMENTAL

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.

Behavioral: Mindfulness Training

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Usual Care

Interventions

Enhanced Usual Care BEHAVIORAL

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.

Enhanced Usual Care (EUC)

Mindfulness Training BEHAVIORAL

The mindfulness intervention includes 28 daily 20-minute audio lessons plus brief daily practice prompts. The first 14 lessons train techniques for developing foundational mindfulness skills through didactics and guided practice; the second 14 lessons review these techniques through guided practice. Based on the Unified Mindfulness system, lessons train 3 mindfulness skills: concentration, sensory clarity, and equanimity. Concentration, a state of stable attention, enables participants to monitor present-moment physical and emotional body experiences. Sensory clarity, the monitoring of momentary experiences, involves detecting subtle sensations and discriminating between different experiences. Equanimity, an attitude of acceptance toward momentary experiences, is trained through 3 strategies: (a) body relaxation, (b) mental welcoming, and (c) a gentle tone of voice. Practice prompts delivered 3 times daily encourage participants to practice brief moments of mindful awareness.

Mindfulness Training

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Thomas W Kamarck, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Emily K Lindsay, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to the Mindfulness intervention (n = 63) or Enhanced Usual Care (n = 42) using a 3:2 randomization sequence.

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: February 6, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Final research data from this study will be deposited into the ICPSR repository approximately 6 to 12 months after the acceptance of peer-reviewed reports of results bearing on the project's specific aims.
• Access Criteria: ICPSR will make the final research data from this project available to the broader social science research community. The ICPSR has policies and procedures in place that will provide data access to qualified researchers.

Locations

US (1)