Mindfulness App Training for Cardiovascular Health

Browse trials for

• Cardiovascular Diseases 4,904

Keywords

• Mindfulness
• Cardiovascular Disease
• Stress

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's enrollment of 106 is close to the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Study arms

• 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.

  Behavioral: Mindfulness Training

• 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.

  Behavioral: Enhanced Usual Care

Interventions

• BehavioralMindfulness Training

  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.

• BehavioralEnhanced Usual Care

  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.

Primary outcomes

1. 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

   Time frame: Change in Task Strain assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)

2. 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

   Time frame: Change in Task Strain assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)

3. 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)

   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)

4. 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)

   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)

5. 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

   Time frame: Change in Social Conflict assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)

6. 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

   Time frame: Change in Social Conflict assessed for 3 days at pre-intervention and three-month follow-up (an average of 18 weeks)

7. 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

   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)

8. 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

   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)

9. Feasibility of recruitment

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

   Time frame: Assessed at enrollment

10. Feasibility of retention

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

    Time frame: Assessed across the entire 5-month study period

11. Feasibility of adherence

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

    Time frame: Assessed across the entire 5-month study period

12. 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)

    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)

13. 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

    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)

14. 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

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

Secondary outcomes

1. Change in Clinic Blood Pressure from pre-intervention to post-intervention

   Average of clinic blood pressure (systolic and diastolic) readings at two assessments for each time point (pre-intervention, post-intervention)

   Time frame: Change in clinic blood pressure assessed with 2 pre-intervention assessments and 2 post-intervention assessments (average of 6 weeks)

2. Change in Clinic Blood Pressure from pre-intervention to 3-month follow-up

   Average of clinic blood pressure (systolic and diastolic) readings at two assessments for each time point (pre-intervention, 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)

3. Change in Mean Ambulatory Blood Pressure from pre-intervention to post-intervention

   Average of hourly ambulatory systolic blood pressure and diastolic blood pressure readings

   Time frame: Change in Mean Ambulatory Blood Pressure assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)

4. Change in Mean Ambulatory Blood Pressure from pre-intervention to 3-month follow-up

   Average of hourly ambulatory systolic blood pressure and diastolic blood pressure readings

   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)

5. Change in Momentary Positive Affect from pre-intervention to post-intervention

   Average of state positive affect assessed hourly using 1-item scale, with scores ranging from 0-10 and higher scores indicating greater positive affect

   Time frame: Change in Mean Momentary Positive Affect assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)

6. Change in Momentary Positive Affect from pre-intervention to 3-month follow-up

   Average of state positive affect assessed hourly using 1-item scale, with scores ranging from 0-10 and higher scores indicating greater positive affect

   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)

7. Change in Momentary Negative Affect from pre-intervention to post-intervention

   Average of state negative affect assessed hourly using 1-item scale, with scores ranging from 0-10 and higher scores indicating greater negative affect

   Time frame: Change in Mean Momentary Negative Affect assessed for 3 days at pre-intervention and post-intervention (an average of 5 weeks)

8. Change in Momentary Negative Affect from pre-intervention to 3-month follow-up

   Average of state negative affect assessed hourly using 1-item scale, with scores ranging from 0-10 and higher scores indicating greater negative affect

   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)

9. Change in Negative Affect Reactivity to Task-Related Strain from pre-intervention to post-intervention

   Average negative affect response (measured with 1-item scale) in relation to hourly measures of momentary strain (high task demand and low decision latitude)

   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)

10. Change in Negative Affect Reactivity to Task-Related Strain from pre-intervention to 3-month follow-up

    Average negative affect response (measured with 1-item scale) in relation to hourly measures of momentary strain (high task demand and low decision latitude)

    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)

11. Change in Negative Affect Reactivity to Social Conflict from pre-intervention to post-intervention

    Average negative affect response (measured with 1-item scale) in relation to hourly measures of social conflict

    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)

12. Change in Negative Affect Reactivity to Social Conflict from pre-intervention to 3-month follow-up

    Average negative affect response (measured with 1-item scale) in relation to hourly measures of social conflict

    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)

13. Change in Blood Pressure Reactivity to Acute Stress from pre-intervention to post-intervention

    Assessed from blood pressure responses to an acute laboratory stress task

    Time frame: Change in Blood Pressure Reactivity to Acute Stress from pre-intervention to post-intervention (average of 7 weeks)

14. Change in Subjective Reactivity to Acute Stress from pre-intervention to post-intervention

    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

    Time frame: Change in Subjective Reactivity to Acute Stress from pre-intervention to post-intervention (average of 7 weeks)

15. Change in Trait Affect from pre-intervention to post-intervention

    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

    Time frame: Change in Trait Affect assessed at pre-intervention and post-intervention (average of 6 weeks)

16. Change in Trait Affect from pre-intervention to 3-month follow-up

    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

    Time frame: Change in Trait Affect assessed at pre-intervention and 3-month follow-up (average of 19 weeks)

17. Change in Positive and Negative Social Exchanges from pre-intervention to post-intervention

    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

    Time frame: Change in Social Exchanges from pre-intervention to post-intervention (average of 6 weeks)

18. Change in Positive and Negative Social Exchanges from pre-intervention to 3-month follow-up

    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

    Time frame: Change in Social Exchanges from pre-intervention to 3-month follow-up (average of 19 weeks)

19. Change in Perceived Stress from pre-intervention to post-intervention

    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

    Time frame: Change in Perceived Stress from pre-screening to post-intervention (average of 7 weeks)

20. Change in Perceived Stress from pre-intervention to 3-month follow-up

    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

    Time frame: Change in Perceived Stress from pre-screening to three-month follow up (average of 20 weeks)

21. Change in Anxiety Symptoms from pre-intervention to post-intervention

    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

    Time frame: Change in Anxiety Symptoms from pre-intervention to post-intervention (average of 6 weeks)

22. Change in Anxiety Symptoms from pre-intervention to 3-month follow-up

    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

    Time frame: Change in Anxiety Symptoms from pre-intervention to three-month follow up (average of 19 weeks)

23. Change in Job Strain from pre-intervention to post-intervention

    Assessed via the Job Content Questionnaire (Karasek et al., 1985), a 42-item self-report instrument for employed individuals 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)

    Time frame: Change in Job Strain from pre-intervention to post-intervention (average of 6 weeks)

24. Change in Job Strain from pre-intervention to 3-month follow-up

    Assessed via the Job Content Questionnaire (Karasek et al., 1985), a 42-item self-report instrument for employed individuals 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)

    Time frame: Change in Job Strain from pre-intervention to three-month follow up (average of 19 weeks)

25. Daily Perceived Stress during mindfulness intervention

    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

    Time frame: Collected daily throughout the 4-week intervention period for Mindfulness participants only

26. Change in Momentary Perceived Stress before and after mindfulness prompts

    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

    Time frame: Collected before and after mindfulness prompts throughout the 4-week intervention period for Mindfulness participants only

27. Mindfulness Prompt Helpfulness

    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

    Time frame: Collected daily throughout the 4-week intervention period for Mindfulness participants only

Other outcomes

1. Change in Momentary Perceived Stress

   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

   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)

2. Change in Momentary Distress Tolerance

   Average of state distress tolerance assessed hourly using 1-item scale with scores ranging from 0-10 and higher scores indicating greater distress intolerance

   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)

3. Change in Momentary Rumination

   Average of state rumination assessed hourly using 1-item scale with scores ranging from 0-10 and higher scores indicating greater 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)

4. Change in Daily Perceived Stress

   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

   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)

5. Change in Daily Positive Affect

   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

   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)

6. Change in Daily Negative Affect

   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

   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)

7. Change in Social Interactions

   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

   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)

8. Change in Social Interaction Characteristics

   Characteristics of most recent social interaction assessed hourly using 4-item scale

   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)

9. Change in Social Interaction Responsiveness

   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

   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)

10. Change in Daily Loneliness

    Loneliness assessed daily using 1-item via end-of-day diary, with scores ranging from 0-10 and higher scores indicating greater 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)

11. Change in Sleepiness

    Sleepiness assessed daily using 2-items via end-of-day diary, with average scores ranging from 0-10 and higher scores indicating greater 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)

12. Change in Daily Life Mindfulness

    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

    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)

13. Change in Daily Distress Tolerance

    Distress tolerance assessed via end-of-day diary using 1-item, with scores ranging from 0-10 and higher scores indicating greater 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)

14. Change in Stressful Events

    Stressful events assessed daily via end-of-day diary using 17-item scale

    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)

15. Change in Positive Events

    Positive events assessed daily via end-of-day diary using 7-item scale

    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)

16. Passive sensor stress models

    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

    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)

17. Change in Physical Activity

    Average physical activity assessed via Fitbit estimate of caloric expenditure

    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)

18. Change in Sleep Duration

    Average sleep duration assessed via Fitbit

    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)

19. Change in Daily Sleep Patterns

    Sleep patterns assessed each morning via 10-item questionnaire measuring sleep time and quality

    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)

20. Change in Self-Compassion

    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

    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)

21. Change in Trait Mindfulness

    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

    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)

22. Change in Experiential Avoidance

    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

    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)

23. Change in Health Behaviors

    Assessed using a 16-item measure that assesses general health behaviors (e.g., caffeine, smoking, alcohol, physical activity, sedentary behavior, diet)

    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)

24. Childhood Trauma

    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

    Time frame: Pre-intervention, to be used in exploratory moderator analyses

25. Everyday Discrimination

    Assessed via the Everyday Discrimination Scale, a 10-item measure of perceived discrimination, with higher scores indicating higher discrimination

    Time frame: Pre-intervention, to be used in exploratory moderator analyses

26. Continued Mindfulness Practice

    Mindfulness practice after the intervention period assessed using a 2-item measure of duration and quality (mindfulness condition only) during end-of-day diary

    Time frame: Mindfulness Practice assessed for 7 days at two timepoints: post-intervention and three-month follow up

27. Monthly Stress Management

    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

    Time frame: Stress Management practice assessed monthly at post-intervention, 1-month follow-up, 2-month follow-up, and 3-month follow-up

Study documents

• Informed consent form · Jun 16, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — We plan to document and archive the data sets collected as part of this project to be made available in the public domain and on-line. Following publication of the primary aims, specific analyses and reporting, consolidated data, along with data dictionaries and program-specific setup syntax files, will be made publicly available via an online portal (e.g., Inter-university Consortium for Political and Social Research \[ICPSR\] data repository).