- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06152185
Mindfulness App Training for Cardiovascular Health (MATCH)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thomas W Kamarck, PhD
- Phone Number: 412-624-2080
- Email: tkam@pitt.edu
Study Contact Backup
- Name: Emily K Lindsay, PhD
- Phone Number: 412-648-4515
- Email: emily.lindsay@pitt.edu
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- University of Pittsburgh
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Principal Investigator:
- Emily K Lindsay, PhD
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Contact:
- Thomas W Kamarck, PhD
- Phone Number: 412-624-2080
- Email: tkam@pitt.edu
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Principal Investigator:
- Thomas W Kamarck, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 (above 15 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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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.
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Active Comparator: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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
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Change in Task Strain assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
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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)
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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
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Change in Task Strain assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
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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 three timepoints: pre-intervention and post-intervention (an average of 5 weeks)
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Ambulatory systolic blood pressure response in relation to hourly measures of momentary strain (high task demand and low decision latitude)
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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)
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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)
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Ambulatory systolic blood pressure response in relation to hourly measures of momentary strain (high task demand and low decision latitude)
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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)
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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)
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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
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Change in Social Conflict assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
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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)
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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
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Change in Social Conflict assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
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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)
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Ambulatory systolic blood pressure response in relation to hourly measures of social conflict
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Change in Systolic Blood Pressure Response to Social Conflict assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
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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)
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Ambulatory systolic blood pressure response in relation to hourly measures of social conflict
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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)
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Feasibility of recruitment
Time Frame: Assessed at enrollment
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Recruitment benchmark: >7 participants will be enrolled each month on average
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Assessed at enrollment
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Feasibility of retention
Time Frame: Assessed across the entire 5-month study period
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Retention benchmark: ≥73% retention from initial enrollment through follow-up
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Assessed across the entire 5-month study period
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Feasibility of adherence
Time Frame: Assessed across the entire 5-month study period
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Adherence benchmark: average completion of ≥85% of intervention lessons and ≥75% of ambulatory assessments
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Assessed across the entire 5-month study period
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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)
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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)
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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)
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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)
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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
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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)
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Acceptability: Study Burden
Time Frame: Study Burden assessed at post-intervention and 3-month follow-up
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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
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Study Burden assessed at post-intervention and 3-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Clinic Blood Pressure from pre-intervention to post-intervention
Time Frame: Change in clinic blood pressure assessed with 2 pre-intervention assessments and 2 post-intervention assessments (average of 6 weeks)
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Average of clinic blood pressure (systolic and diastolic) readings at two assessments for each time point (pre-intervention, post-intervention)
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Change in clinic blood pressure assessed with 2 pre-intervention assessments and 2 post-intervention assessments (average of 6 weeks)
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Change in Clinic Blood Pressure from pre-intervention to 3-month follow-up
Time Frame: Change in clinic blood pressure assessed with 2 pre-intervention assessments and 2 3-month follow-up assessments (average of 19 weeks)
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Average of clinic blood pressure (systolic and diastolic) readings at two assessments for each time point (pre-intervention, 3-month follow-up)
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Change in clinic blood pressure assessed with 2 pre-intervention assessments and 2 3-month follow-up assessments (average of 19 weeks)
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Change in Mean Ambulatory Blood Pressure from pre-intervention to post-intervention
Time Frame: Change in Mean Ambulatory Blood Pressure assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
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Average of hourly ambulatory systolic blood pressure and diastolic blood pressure readings
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Change in Mean Ambulatory Blood Pressure assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
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Change in Mean Ambulatory Blood Pressure from pre-intervention to 3-month follow-up
Time Frame: Change in Mean Ambulatory Blood Pressure assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
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Average of hourly ambulatory systolic blood pressure and diastolic blood pressure readings
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Change in Mean Ambulatory Blood Pressure assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
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Change in Momentary Positive Affect from pre-intervention to post-intervention
Time Frame: Change in Mean Momentary Positive Affect assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
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Average of state positive affect assessed hourly using 1-item scale, with scores ranging from 0-10 and higher scores indicating greater positive affect
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Change in Mean Momentary Positive Affect assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
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Change in Momentary Positive Affect from pre-intervention to 3-month follow-up
Time Frame: Change in Mean Momentary Positive Affect assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
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Average of state positive affect assessed hourly using 1-item scale, with scores ranging from 0-10 and higher scores indicating greater positive affect
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Change in Mean Momentary Positive Affect assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
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Change in Momentary Negative Affect from pre-intervention to post-intervention
Time Frame: Change in Mean Momentary Negative Affect assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
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Average of state negative affect assessed hourly using 1-item scale, with scores ranging from 0-10 and higher scores indicating greater negative affect
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Change in Mean Momentary Negative Affect assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
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Change in Momentary Negative Affect from pre-intervention to 3-month follow-up
Time Frame: Change in Mean Momentary Negative Affect assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
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Average of state negative affect assessed hourly using 1-item scale, with scores ranging from 0-10 and higher scores indicating greater negative affect
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Change in Mean Momentary Negative Affect assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)
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Change in Negative Affect Reactivity to Task-Related Strain from pre-intervention to post-intervention
Time Frame: Change in Negative Affect Reactivity to Task Strain assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
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Average negative affect response (measured with 1-item scale) in relation to hourly measures of momentary strain (high task demand and low decision latitude)
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Change in Negative Affect Reactivity to Task Strain assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
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Change in Negative Affect Reactivity to Task-Related Strain from pre-intervention to 3-month follow-up
Time Frame: 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)
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Average negative affect response (measured with 1-item scale) in relation to hourly measures of momentary strain (high task demand and low decision latitude)
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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)
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Change in Negative Affect Reactivity to Social Conflict from pre-intervention to post-intervention
Time Frame: Change in Negative Affect Reactivity to Social Conflict assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
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Average negative affect response (measured with 1-item scale) in relation to hourly measures of social conflict
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Change in Negative Affect Reactivity to Social Conflict assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)
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Change in Negative Affect Reactivity to Social Conflict from pre-intervention to 3-month follow-up
Time Frame: 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)
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Average negative affect response (measured with 1-item scale) in relation to hourly measures of social conflict
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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)
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Change in Blood Pressure Reactivity to Acute Stress from pre-intervention to post-intervention
Time Frame: Change in Blood Pressure Reactivity to Acute Stress from pre-intervention to post-intervention (average of 7 weeks)
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Assessed from blood pressure responses to an acute laboratory stress task
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Change in Blood Pressure Reactivity to Acute Stress from pre-intervention to post-intervention (average of 7 weeks)
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Change in Subjective Reactivity to Acute Stress from pre-intervention to post-intervention
Time Frame: Change in Subjective Reactivity to Acute Stress from pre-intervention to post-intervention (average of 7 weeks)
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Assessed via a 3-item measure of perceived stress to an acute laboratory stress task, with average score ranging from 0-100 and higher scores indicating greater stress
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Change in Subjective Reactivity to Acute Stress from pre-intervention to post-intervention (average of 7 weeks)
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Change in Trait Affect from pre-intervention to post-intervention
Time Frame: Change in Trait Affect assessed at pre-intervention and post-intervention (average of 6 weeks)
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Assessed via the Trait Affect Scale (Cohen et al., 2003), a 25-item self-report questionnaire yielding three 3-item positive affect scales, three 3-item negative affect scales, one 4-item fatigue scale, and one 3-item fear scale, with average scores ranging from 0-4 and higher scores indicating greater positive affect, negative affect, fatigue, or fear
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Change in Trait Affect assessed at pre-intervention and post-intervention (average of 6 weeks)
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Change in Trait Affect from pre-intervention to 3-month follow-up
Time Frame: Change in Trait Affect assessed at pre-intervention and 3-month follow-up (average of 19 weeks)
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Assessed via the Trait Affect Scale (Cohen et al., 2003), a 25-item self-report questionnaire yielding three 3-item positive affect scales, three 3-item negative affect scales, one 4-item fatigue scale, and one 3-item fear scale, with average scores ranging from 0-4 and higher scores indicating greater positive affect, negative affect, fatigue, or fear
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Change in Trait Affect assessed at pre-intervention and 3-month follow-up (average of 19 weeks)
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Change in Positive and Negative Social Exchanges from pre-intervention to post-intervention
Time Frame: Change in Social Exchanges from pre-intervention to post-intervention (average of 6 weeks)
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Assessed via that Positive and Negative Social Exchanges (PANSE), a 24-item measure that measures quality of interpersonal interactions, with two overall sum scores: Positive Social Exchanges, ranging from 0-48, with higher scores indicating more positive social exchanges, and Negative Social Exchanges, ranging from 0-48, with higher scores indicating more negative social exchanges; within each domain are 4 3-item subscales: informational support, instrumental support, companionship, emotional support, unwanted advice or intrusion, failure to provide help, unsympathetic or insensitive behavior, and rejection or neglect
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Change in Social Exchanges from pre-intervention to post-intervention (average of 6 weeks)
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Change in Positive and Negative Social Exchanges from pre-intervention to 3-month follow-up
Time Frame: Change in Social Exchanges from pre-intervention to 3-month follow-up (average of 19 weeks)
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Assessed via that Positive and Negative Social Exchanges (PANSE), a 24-item measure that measures quality of interpersonal interactions, with two overall sum scores: Positive Social Exchanges, ranging from 0-48, with higher scores indicating more positive social exchanges, and Negative Social Exchanges, ranging from 0-48, with higher scores indicating more negative social exchanges; within each domain are 4 3-item subscales: informational support, instrumental support, companionship, emotional support, unwanted advice or intrusion, failure to provide help, unsympathetic or insensitive behavior, and rejection or neglect
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Change in Social Exchanges from pre-intervention to 3-month follow-up (average of 19 weeks)
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Change in Perceived Stress from pre-intervention to post-intervention
Time Frame: Change in Perceived Stress from pre-screening to post-intervention (average of 7 weeks)
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Assessed via the Perceived Stress Scale (PSS), a 10-item questionnaire that measures perceived stress over the past month, with total scores ranging from 0-40 and higher scores indicating greater perceived stress
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Change in Perceived Stress from pre-screening to post-intervention (average of 7 weeks)
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Change in Perceived Stress from pre-intervention to 3-month follow-up
Time Frame: Change in Perceived Stress from pre-screening to three-month follow up (average of 20 weeks)
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Assessed via the Perceived Stress Scale (PSS), a 10-item questionnaire that measures perceived stress over the past month, with total scores ranging from 0-40 and higher scores indicating greater perceived stress
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Change in Perceived Stress from pre-screening to three-month follow up (average of 20 weeks)
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Change in Anxiety Symptoms from pre-intervention to post-intervention
Time Frame: Change in Anxiety Symptoms from pre-intervention to post-intervention (average of 6 weeks)
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Assessed via the Generalized Anxiety Disorder-7 (GAD-7), a 7-item measure of anxiety symptoms, with total score ranging from 0-21 and higher scores indicating greater anxiety severity
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Change in Anxiety Symptoms from pre-intervention to post-intervention (average of 6 weeks)
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Change in Anxiety Symptoms from pre-intervention to 3-month follow-up
Time Frame: Change in Anxiety Symptoms from pre-intervention to three-month follow up (average of 19 weeks)
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Assessed via the Generalized Anxiety Disorder-7 (GAD-7), a 7-item measure of anxiety symptoms, with total score ranging from 0-21 and higher scores indicating greater anxiety severity
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Change in Anxiety Symptoms from pre-intervention to three-month follow up (average of 19 weeks)
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Job Strain at pre-intervention
Time Frame: Job Strain assessed at pre-intervention for employed individuals
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Assessed via the Job Content Questionnaire (Karasek et al., 1985), a 42-item self-report instrument that measures (1) Work Demands (from 5 items measuring work load and intensity, with higher average scores indicating greater work demands) and (2) Decision Latitude (from a weighted sum of two subscales: Skill Discretion (6 items, with higher scores indicating greater creative challenge on the job) and Decision Authority (3 items, with higher scores indicating greater authority over day-to-day tasks)
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Job Strain assessed at pre-intervention for employed individuals
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Job Strain at post-intervention
Time Frame: Job Strain assessed at post intervention (average of 6 weeks) for employed individuals
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Assessed via the Job Content Questionnaire (Karasek et al., 1985), a 42-item self-report instrument that measures (1) Work Demands (from 5 items measuring work load and intensity, with higher average scores indicating greater work demands) and (2) Decision Latitude (from a weighted sum of two subscales: Skill Discretion (6 items, with higher scores indicating greater creative challenge on the job) and Decision Authority (3 items, with higher scores indicating greater authority over day-to-day tasks)
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Job Strain assessed at post intervention (average of 6 weeks) for employed individuals
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Job Strain at 3-month follow-up
Time Frame: Job Strain assessed at 3-month follow-up (an average 19 weeks) for employed individuals
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Assessed via the Job Content Questionnaire (Karasek et al., 1985), a 42-item self-report instrument that measures (1) Work Demands (from 5 items measuring work load and intensity, with higher average scores indicating greater work demands) and (2) Decision Latitude (from a weighted sum of two subscales: Skill Discretion (6 items, with higher scores indicating greater creative challenge on the job) and Decision Authority (3 items, with higher scores indicating greater authority over day-to-day tasks)
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Job Strain assessed at 3-month follow-up (an average 19 weeks) for employed individuals
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Daily Perceived Stress during mindfulness intervention
Time Frame: Collected daily throughout the 4-week intervention period for Mindfulness participants only
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Daily perceived stress (2-items from the Perceived Stress Scale) assessed daily via end-of-day diary during the mindfulness intervention period in the mindfulness condition only, with scores ranging from 0-10 and higher average scores indicating higher perceived stress, used to evaluate random vs. pre-selected prompt timing
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Collected daily throughout the 4-week intervention period for Mindfulness participants only
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Change in Momentary Perceived Stress before and after mindfulness prompts
Time Frame: Collected before and after mindfulness prompts throughout the 4-week intervention period for Mindfulness participants only
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Momentary perceived stress assessed via 1-item scale before and after each mindfulness prompt (delivered three times daily during the mindfulness intervention period in the mindfulness condition only), with scores ranging from 0-10 and higher average scores indicating higher perceived stress and greater change scores indicating greater reduction in perceived stress following mindfulness prompts
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Collected before and after mindfulness prompts throughout the 4-week intervention period for Mindfulness participants only
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Mindfulness Prompt Helpfulness
Time Frame: Collected daily throughout the 4-week intervention period for Mindfulness participants only
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Helpfulness of daily mindfulness practice prompts assessed with 1-item in the mindfulness condition only, ranging from 0-10 with higher scores indicating greater helpfulness, used to evaluate random vs. pre-selected prompt timing
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Collected daily throughout the 4-week intervention period for Mindfulness participants only
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Momentary Perceived Stress
Time Frame: 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)
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Average of state perceived stress assessed hourly using 2-items adapted from the Perceived Stress Scale, with scores ranging from 0-10 and higher scores indicating greater stress, and 1-item on current ongoing stress, with scores ranging from 0-10 and higher scores indicating greater stress
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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)
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Change in Momentary Distress Tolerance
Time Frame: 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)
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Average of state distress tolerance assessed hourly using 1-item scale with scores ranging from 0-10 and higher scores indicating greater distress intolerance
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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)
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Change in Momentary Rumination
Time Frame: 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)
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Average of state rumination assessed hourly using 1-item scale with scores ranging from 0-10 and higher scores indicating greater rumination
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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)
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Change in Daily Perceived Stress
Time Frame: 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)
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Daily perceived stress (2-items from the Perceived Stress Scale) assessed daily via end-of-day diary, with average scores ranging from 0-10 and higher scores indicating greater stress
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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)
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Change in Daily Positive Affect
Time Frame: 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)
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Daily positive affect (composite of 3 positive affect items (calm, energetic, happy)) assessed daily via end-of-day diary, with average scores ranging from 0-10 and higher scores indicating greater positive affect
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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)
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Change in Daily Negative Affect
Time Frame: 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)
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Daily negative affect (composite of 3 negative affect items (angry, depressed, tense)) assessed daily via end-of-day diary, with average scores ranging from 0-10 and higher scores indicating greater negative affect
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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)
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Change in Social Interactions
Time Frame: 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)
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Frequency of social interactions assessed hourly using 1-item assessing current involvement in social interactions, 1-item assessing timing of most recent social interaction, and 1-item assessing number of social interactions
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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)
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Change in Social Interaction Characteristics
Time Frame: 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)
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Characteristics of most recent social interaction assessed hourly using 4-item scale
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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)
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Change in Social Interaction Responsiveness
Time Frame: 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)
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Responsiveness of most recent social interaction assessed hourly using 2-item scale, with average scores ranging from 0-10 and higher scores indicating greater social interaction responsiveness
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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)
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Change in Daily Loneliness
Time Frame: 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)
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Loneliness assessed daily using 1-item via end-of-day diary, with scores ranging from 0-10 and higher scores indicating greater loneliness
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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)
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Change in Sleepiness
Time Frame: 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)
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Sleepiness assessed daily using 2-items via end-of-day diary, with average scores ranging from 0-10 and higher scores indicating greater sleepiness
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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)
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Change in Daily Life Mindfulness
Time Frame: 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)
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Mindful awareness assessed via end-of-day diary using 3-item scale, with average scores ranging from 0-10 and higher scores indicating greater mindfulness
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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)
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Change in Daily Distress Tolerance
Time Frame: 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)
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Distress tolerance assessed via end-of-day diary using 1-item, with scores ranging from 0-10 and higher scores indicating greater distress tolerance
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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)
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Change in Stressful Events
Time Frame: 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)
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Stressful events assessed daily via end-of-day diary using 17-item scale
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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)
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Change in Positive Events
Time Frame: 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)
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Positive events assessed daily via end-of-day diary using 7-item scale
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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)
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Passive sensor stress models
Time Frame: 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)
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Passive sensor data from smartphones (location, activity, screen status, battery, weather, time zone, communication) and wearable devices (heart rate, activity, sleep) combined to develop machine learning models predicting state stress
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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)
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Change in Physical Activity
Time Frame: 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)
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Average physical activity assessed via Fitbit estimate of caloric expenditure
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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)
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Change in Sleep Duration
Time Frame: 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)
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Average sleep duration assessed via Fitbit
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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)
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Change in Daily Sleep Patterns
Time Frame: 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)
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Sleep patterns assessed each morning via 10-item questionnaire measuring sleep time and quality
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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)
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Change in Self-Compassion
Time Frame: Change in Self-Compassion from pre-intervention to post-intervention (average of 6 weeks) and three-month follow up (average of 19 weeks)
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Assessed via the Self-Compassion Scale Short Form, a 12-item scale, with average scores ranging from 1-5 and higher scores indicating greater self-compassion
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Change in Self-Compassion from pre-intervention to post-intervention (average of 6 weeks) and three-month follow up (average of 19 weeks)
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Change in Trait Mindfulness
Time Frame: Change in Trait Mindfulness from pre-intervention to post-intervention (average of 6 weeks) and three-month follow up (average of 19 weeks)
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Assessed via the Five Facet Mindfulness Questionnaire-Short Form, a 15-item scale with observing, describing, acting with awareness, nonreactivity, and nonjudgment subscales, with higher scores indicating higher mindfulness
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Change in Trait Mindfulness from pre-intervention to post-intervention (average of 6 weeks) and three-month follow up (average of 19 weeks)
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Change in Experiential Avoidance
Time Frame: Change in Experiential Avoidance from pre-intervention to post-intervention (average of 6 weeks) and three-month follow up (average of 19 weeks)
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Assessed via the Acceptance and Action Questionnaire (AAQ-2), a 7-item scale assessing psychological inflexibility and experiential avoidance, with higher scores indicating higher avoidance
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Change in Experiential Avoidance from pre-intervention to post-intervention (average of 6 weeks) and three-month follow up (average of 19 weeks)
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Change in Health Behaviors
Time Frame: Change in Health Behaviors from pre-intervention to post-intervention (average of 6 weeks) and three-month follow up (average of 19 weeks)
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Assessed using a 16-item measure that assesses general health behaviors (e.g., caffeine, smoking, alcohol, physical activity, sedentary behavior, diet)
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Change in Health Behaviors from pre-intervention to post-intervention (average of 6 weeks) and three-month follow up (average of 19 weeks)
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Childhood Trauma
Time Frame: Pre-intervention, to be used in exploratory moderator analyses
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Assessed via the Childhood Trauma Questionnaire, a 28-item scale with 5 subscales (physical, sexual, and emotional abuse, and physical and emotional neglect), with higher scores indicating greater trauma
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Pre-intervention, to be used in exploratory moderator analyses
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Everyday Discrimination
Time Frame: Pre-intervention, to be used in exploratory moderator analyses
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Assessed via the Everyday Discrimination Scale, a 10-item measure of perceived discrimination, with higher scores indicating higher discrimination
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Pre-intervention, to be used in exploratory moderator analyses
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Continued Mindfulness Practice
Time Frame: Mindfulness Practice assessed for 7 days at two timepoints: post-intervention and three-month follow up
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Mindfulness practice after the intervention period assessed using a 2-item measure of duration and quality (mindfulness condition only) during end-of-day diary
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Mindfulness Practice assessed for 7 days at two timepoints: post-intervention and three-month follow up
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Monthly Stress Management
Time Frame: Stress Management practice assessed monthly at post-intervention, 1-month follow-up, 2-month follow-up, and 3-month follow-up
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Stress management practice in the past month assessed via 5-item survey that asks participants to report on the type, frequency, and quality of practice, plus 2 items assessing psychological treatment and formal stress management during the study period at 3-month follow-up only
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Stress Management practice assessed monthly at post-intervention, 1-month follow-up, 2-month follow-up, and 3-month follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily K Lindsay, PhD, University of Pittsburgh
- Principal Investigator: Thomas W Kamarck, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY22090002
- R34HL163245 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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