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| ID | Type | Description | Link |
|---|---|---|---|
| K01AT011232 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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This study will test the feasibility of delivering smartphone-based mindfulness and coping interventions to a sample of emerging/young adults with a history of early life adversity (ELA). 80 participants with a history of ELA will be randomly assigned to complete a two-week mindfulness training intervention or matched coping control intervention, both involving 14 foundational audio-guided lessons and practice prompts randomly delivered 3x daily. At baseline, post-intervention, and one-month follow-up lab assessments, participants will complete questionnaires and provide blood samples for assessment of markers of inflammation. Data assessing subjective and physiological stress in daily life will be collected during the intervention and for one week before, immediately after, and one month after the intervention. Passive sensor data will be continuously collected from participants' smartphones and wearable devices to develop exploratory models that estimate and predict daily life stress. Data will be used to evaluate feasibility and acceptability of interventions and assessments in an ELA sample, test effects of mindfulness training on daily life stress and markers of inflammation in an ELA sample, and develop exploratory machine learning models of stress from passive sensor data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness | Experimental | Mindfulness intervention involving 14 foundational 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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| Coping | Active Comparator | Coping intervention involving 14 foundational audio-guided lessons plus daily brief practice prompts. Lessons train techniques for 3 coping skills: reflection, reappraisal, and problem solving. Practice prompts delivered 3x daily build on the skills trained in each lesson. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness | Behavioral | The mindfulness intervention includes 14 daily 20-minute audio lessons plus brief daily practice prompts. Lessons train specific meditation techniques through didactic explanation and guided practice. Based on the Unified Mindfulness system, lessons train 3 mindfulness skills: concentration, sensory clarity, and equanimity. Concentration, a state of stable attention on the intended target, 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 build on the skills trained in each lesson, encouraging participants to practice brief moments of mindful awareness, mindfulness while doing daily tasks, or formal meditation. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment (Screened Eligible) | Recruitment benchmark: >10% of people screened will be eligible | assessed pre-enrollment |
| Feasibility of Retention | Retention benchmark: >80% retention through intervention and >75% retention through follow-up | assessed across the entire 8-week study period |
| Feasibility of Adherence: Intervention Lessons | Numbers represent percentages of intervention lessons completed in mindfulness and coping groups [calculated as (average number of lessons completed / 14 total lessons among all participants in each group) * 100]. The original adherence benchmark was an average completion of >85% of intervention lessons; reported percentages that are greater than that benchmark represent feasibility of intervention adherence. | assessed across the entire 2-week intervention period |
| Feasibility of Safe Implementation: Incidence of Treatment-emergent Increases in Mental Health Symptoms | Safety benchmark: <10% of participants showing substantial (>2SD) increases in anxiety, trauma, or depressive symptoms (using PROMIS Anxiety and Depression scales and Posttraumatic Stress Disorder Checklist-Civilian scale described in other outcomes below) combined to create treatment-emergent symptom rate | assessed across the entire 8-week study period |
| Acceptability: Treatment Expectancies | Acceptability of interventions, with benchmark of >80% of participants giving positive ratings of treatment expectancies (>3 on 6-item Credibility/Expectancy Questionnaire) | assessed in-person at post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Daily Life Positive Affect: State | State positive affect assessed in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Positive affect was assessed on a 1-7 Likert scale, with higher scores indicating higher positive affect. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | collected continuously for 8 weeks |
| Change in State Stress Following Intervention Practice |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily K Lindsay, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
All data sharing will follow NIH and Pitt IRB guidelines. To gain access to IPD that underlie results in a publication, anyone not part of the original research will submit a Data Analysis Request Form, which requires a description of hypotheses, specific data requested, and investigator information. The investigator must complete the Pitt Certification Program in Research Practice Fundamentals or a comparable program. Upon approval, a de-identified dataset and codebook will be provided. Investigators outside Pitt must also complete a Data Use and Confidentiality Agreement. This signed letter of agreement states that the investigator (1) will cite the original study dataset and funding source in all presentations and publications, and (2) will not share these data and study materials with others. Participants will be made aware of the potential for sharing of de-identified data with outside investigators on informed consent documents.
Upon request, data collected for this study will also be made available to other investigators following publication of primary findings.
Data Analysis Request Form; completion of the University of Pittsburgh Certification Program in Research Practice Fundamentals or a comparable training program at their own institution; Data Use and Confidentiality Agreement for investigators outside University of Pittsburgh
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Participants were recruited into this study between August 2022 and March 2024. The study was advertised through "Pitt+Me," a registry of over 300,000 individuals in the Pittsburgh area interested in participating in research.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness | Mindfulness intervention involving 14 foundational 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. Mindfulness: The mindfulness intervention includes 14 daily 20-minute audio lessons plus brief daily practice prompts. Lessons train specific meditation techniques through didactic explanation and guided practice. Based on the Unified Mindfulness system, lessons train 3 mindfulness skills: concentration, sensory clarity, and equanimity. Concentration, a state of stable attention on the intended target, 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 build on the skills trained in each lesson, encouraging participants to practice brief moments of mindful awareness, mindfulness while doing daily tasks, or formal meditation. |
| FG001 | Coping | Coping intervention involving 14 foundational audio-guided lessons plus daily brief practice prompts. Lessons train techniques for 3 coping skills: reflection, reappraisal, and problem solving. Practice prompts delivered 3x daily build on the skills trained in each lesson. Coping: The coping intervention includes 14 daily 20-minute audio lessons plus brief daily practice prompts. Lessons train specific coping techniques through didactic explanation and guided practice. Lessons train coping skills (reflection, reappraisal, and problem solving) without encouraging focus on or acceptance of present experience (i.e., mindfulness skills). Participants are instructed to: (1) reflect and let their minds drift, (2) reframe or reappraise past and anticipated events, and (3) analyze and solve personal problems. Practice prompts build on the skills trained in each lesson, encouraging participants to take brief reflection breaks or to practice reappraisal or problem-solving skills. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness | Mindfulness intervention involving 14 foundational 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. Mindfulness: The mindfulness intervention includes 14 daily 20-minute audio lessons plus brief daily practice prompts. Lessons train specific meditation techniques through didactic explanation and guided practice. Based on the Unified Mindfulness system, lessons train 3 mindfulness skills: concentration, sensory clarity, and equanimity. Concentration, a state of stable attention on the intended target, 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 build on the skills trained in each lesson, encouraging participants to practice brief moments of mindful awareness, mindfulness while doing daily tasks, or formal meditation. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of Recruitment (Screened Eligible) | Recruitment benchmark: >10% of people screened will be eligible | Posted | Count of Participants | Participants | assessed pre-enrollment |
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8 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness | Mindfulness intervention involving 14 foundational 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. Mindfulness: The mindfulness intervention includes 14 daily 20-minute audio lessons plus brief daily practice prompts. Lessons train specific meditation techniques through didactic explanation and guided practice. Based on the Unified Mindfulness system, lessons train 3 mindfulness skills: concentration, sensory clarity, and equanimity. Concentration, a state of stable attention on the intended target, 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 build on the skills trained in each lesson, encouraging participants to practice brief moments of mindful awareness, mindfulness while doing daily tasks, or formal meditation. |
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Seven participants who met initial abbreviated CTQ inclusion thresholds on the online prescreening, but not full CTQ inclusion thresholds at the pre-intervention study visit, were enrolled before a coding error was discovered that flagged participants with scores one point below the CTQ threshold as eligible.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily K Lindsay, PhD | University of Pittsburgh | 412-601-0585 | emily.lindsay@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2022 | May 6, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 27, 2022 | Jun 10, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D000097813 | Coping Skills |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Coping | Behavioral | The coping intervention includes 14 daily 20-minute audio lessons plus brief daily practice prompts. Lessons train specific coping techniques through didactic explanation and guided practice. Lessons train coping skills (reflection, reappraisal, and problem solving) without encouraging focus on or acceptance of present experience (i.e., mindfulness skills). Participants are instructed to: (1) reflect and let their minds drift, (2) reframe or reappraise past and anticipated events, and (3) analyze and solve personal problems. Practice prompts build on the skills trained in each lesson, encouraging participants to take brief reflection breaks or to practice reappraisal or problem-solving skills. |
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| Change in Daily Life Subjective Stress: State Perceived Stress | State perceived stress assessed in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Stress was assessed on a 1-7 Likert scale, with higher scores indicating higher perceived stress. | change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
| Change in Daily Life Subjective Stress: Daily Perceived Stress | Daily perceived stress assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 assessments at each time point. All 7 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Stress was assessed on a 1-7 Likert scale, with higher scores indicating higher perceived stress. | change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
| Change in Daily Life Objective Stress: Stress Events in the Past 2.5 Hours | Stress events assessed on a binary scale (yes/no) in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in logistic MLM analyses. Outcomes are reported as mean percentage of surveys at each time point that stress events were endorsed, with higher percentages indicating more stress events. | change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
| Change in Daily Life Objective Stress: Daily Stress Events | Daily stress events assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 assessments at each time point. All 7 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in logistic MLM analyses. Outcomes are reported as mean percentage of days at each time point that stress events were endorsed, with higher percentages indicating more stress events. | change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
| Change in Daily Life Physiological Stress Reactivity | Heart Rate (HR) measured continuously in daily life, with HR averaged in 30-minute windows around daily life stress reported via EMA up to four times per day for one week at three time points, totaling up to 28 windows at each time point. All (up to) 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher scores indicate higher HR in beats per minute (relative to an individual's average daily HR) at high stress moments (relative to an individual's average perceived stress). | change in HR reactivity assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
| Change in Circulating Inflammatory Markers | Circulating IL-6 assessed via dried blood spot (DBS), reported as raw concentration in pg/mL assessed via ProteinSimple Simple Plex Human IL-6 (3rd gen) on Ella instrument | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| Feasibility of Recruitment (Enrollment) | Recruitment benchmark: >60% of those eligible will enroll | assessed pre-enrollment |
| Feasibility of Adherence: Intervention Practice Prompts | Numbers represent percentages of intervention practice prompts completed in mindfulness and coping groups [calculated as (average number of prompts completed / 42 total prompts among all participants in each group) * 100]. The original adherence benchmark was an average completion of >60% of prompts; reported percentages that are greater than that benchmark represent feasibility of intervention practice prompt adherence. | assessed across the entire 2-week intervention period |
| Feasibility of Adherence: Ambulatory Assessments | Numbers represent percentages of ambulatory assessment surveys completed in mindfulness and coping groups [calculated as (average number of surveys completed / 105 total surveys among all participants in each group) * 100]. The original adherence benchmark was an average completion of >75% of ambulatory assessments; reported percentages that are greater than that benchmark represent feasibility of ambulatory assessment adherence. | assessed for 1 week at three time points: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
| Feasibility of Adherence: Mobile Sensor Data | Numbers represent percentages of days on which wearable sensor (Fitbit) data and AWARE phone sensor data were collected in mindfulness and coping groups [calculated as (average number of days that Fitbit/AWARE data were collected / 56 days among all participants in each group) * 100]. The original adherence benchmark was collecting mobile sensor data on >75% of days; reported percentages that are greater than that benchmark represent feasibility of mobile sensor data collection adherence. | assessed across the entire 8-week study period |
| change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
| Change in Daily Life Positive Affect: Daily | Daily positive affect (composite of 9 positive affect items across 3 subscales: happiness (happy, pleased, and cheerful), calm (calm, at-ease, and relaxed), and vigor (lively, full-of-pep, and energetic), each assessed on a 1-7 Likert scale) assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 scores at each time point. All 7 composite scores at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher scores reflect higher positive affect. | change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
| Change in Daily Life Negative Affect: State | State negative affect assessed in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Negative affect was assessed on a 1-7 Likert scale, with higher scores indicating higher negative affect. | change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
| Change in Daily Life Negative Affect: Daily | Daily negative affect (composite of 9 negative affect items across 3 subscales: anxiety (on edge, nervous, and tense), depression (sad, depressed, and unhappy), and hostility (hostile, resentful, and angry), each assessed on a 1-7 Likert scale) assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 scores at each time point. All 7 composite scores at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher scores reflect higher negative affect. | change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
| Change in Daily Life Social Interactions: Interactions in the Past 2.5 Hours | Number of social interactions assessed in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher numbers indicate more social interactions. | change in interactions assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
| Change in Daily Life Social Interactions: Daily | Number of social interactions assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 assessments at each time point. All 7 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher numbers indicate more social interactions. | change in interactions assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
| Change in Daily Life Mindfulness: Awareness | Mindful awareness (composite 3-item scale: "Today, I paid attention to what I was doing in the present moment" / "Today, I noticed body sensations come and go" / "Today, I noticed pleasant and unpleasant thoughts and emotions", each item assessed on a 1-7 Likert scale) assessed in daily life each evening for one week at three time points via end-of-day diary, totaling up to 7 scores at each time point. All 7 composite scores at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher composite scores reflect higher mindful awareness. | change in awareness assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
| Change in Daily Life Mindfulness: Acceptance | Mindful acceptance (composite 2-item scale: "Today, I was able to step back and be aware of distressing thoughts, emotions, and sensations, without being taken over by them" / "Today, I did not want to feel the way I was feeling", each item assessed on a 1-7 Likert scale) assessed in daily life each evening for one week at three time points via end-of-day diary, totaling up to 7 scores at each time point. All 7 composite scores at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher composite scores reflect higher acceptance. | change in acceptance assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
State stress following intervention practice used to evaluate immediate benefit of practice delivered at high-stress moments |
| change from pre- to post-practice across two-week intervention period |
| Daily Stress Following Intervention Practice | End-of-day stress on days with intervention practice used to evaluate day-level benefit of practice delivered at high-stress moments | daily stress across two-week intervention period |
| Early Life Adversity: Childhood Trauma | Assessed via the Childhood Trauma Questionnaire (a 28-item scale with three 5-item abuse subscales - physical, sexual, and emotional abuse - ranging from 5-25, with higher scores indicating higher childhood trauma) | pre-intervention |
| Early Life Adversity: Emotional Neglect | Early Life Adversity assessed via the Childhood Experiences of Care and Abuse Inventory (a 16-item scale referencing mother and father figures, with an 8-item emotional neglect subscale ranging from 8-40, where higher scores indicate higher levels of emotional neglect) | pre-intervention |
| Early Life Adversity: Childhood SES Indexed Via Parental Education | Childhood SES indexed via parental educational attainment, ranging from less than high school education to doctoral degree (1 = No High School Diploma, 2 = GED, 3 = High School Diploma, 4 = Technical Training, 5 = Some College, no degree, 6 = Associate Degree, 7 = Bachelor's Degree, 8 = Master's Degree, 9 = MD, PhD, JD, or PharmD), with higher scores indicating higher educational attainment | pre-intervention |
| Early Life Adversity: Childhood SES Indexed by Government Food Assistance | Childhood SES assessed via National Comorbidity Survey: Adolescents item assessing government food assistance | pre-intervention |
| Early Life Adversity: Domestic Violence | Early Life Adversity assessed via Adverse Childhood Experiences Survey (using a 5-item domestic violence subscale, ranging from 0-10, with higher scores indicating higher levels of domestic violence) | pre-intervention |
| Change in Circulating Inflammatory Biomarkers: CRP | Circulating CRP assessed via dried blood spot (DBS) [additional funding needed to assess] | change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks) |
| Change in Circulating Inflammatory Biomarkers: TNF | Circulating TNF assessed via dried blood spot (DBS) [additional funding needed to assess] | change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks) |
| Change in Circulating Inflammatory Biomarkers: IL-8 | Circulating IL-8 assessed via dried blood spot (DBS) [additional funding needed to assess] | change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks) |
| Change in Circulating Inflammatory Biomarkers: IL-10 | Circulating IL-10 assessed via dried blood spot (DBS) [additional funding needed to assess] | change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks) |
| Change in Global Psychosocial Stress: Anxiety | Assessed in-person via PROMIS Anxiety, a 4-item scale with raw scores ranging from 4-20 and converted to t-scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher anxiety | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| Change in Global Psychosocial Stress: Depressive Symptoms | Assessed in-person via PROMIS Depression, a 4-item scale with raw scores ranging from 4-20 and converted to t-scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher depressive symptoms | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| Change in Global Psychosocial Stress: Social Isolation | Assessed in-person via PROMIS Social Isolation, a 14-item scale with raw scores ranging from 14 to 70 and converted to t-scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher social isolation | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| Change in Global Psychosocial Stress: Perceived Stress | Assessed in-person via Perceived Stress Scale (a 10-item scale ranging from 0-40, with higher scores indicating higher perceived stress) | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| Change in Global Psychosocial Stress: Trauma Symptoms | Assessed in-person via Post-Traumatic Stress Disorder Checklist for Civilians (PCL-C), a 17-item scale ranging from 17-85, with higher scores indicating higher levels of trauma, and scores of 30 or greater indicating at least moderately severe PTSD symptoms | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| Change in Global Psychosocial Stress: Depersonalization | Assessed in-person via Cambridge Depersonalization Scale (a 29-item scale ranging from 0-116, assessing frequency and duration of depersonalization symptoms, with higher scores indicating greater depersonalization) | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| Change in Sleep Quality | Assessed in-person via Pittsburgh Sleep Quality Index (6-item short form, ranging from 0-12, with higher scores indicating worse sleep) | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| Change in Global Psychosocial Resilience: Life Satisfaction | Assessed in-person via PROMIS Life Satisfaction, a 5-item scale with raw scores ranging from 5-35 and converted to t-scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher life satisfaction | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| Change in Global Psychosocial Resilience: Positive Affect | Assessed in-person via PROMIS Positive Affect, a 15-item scale with raw scores ranging from 15-75 and converted to t-scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher positive affect | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| Change in Global Psychosocial Resilience: Self-Efficacy | Assessed in-person via PROMIS Self-Efficacy, a 4-item scale with raw scores ranging from 4-20 and converted to t-scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher self-efficacy | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| Change in Global Mindfulness | Five Facet Mindfulness Questionnaire-Short Form (a 24-item scale including five subscales - observing, describing, acting with awareness, nonreactivity, and nonjudgment, with average scores ranging from 1-5 and higher scores indicating higher mindfulness) | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| Change in Global Experiential Avoidance | Acceptance and Action Questionnaire-II (a 7-item scale ranging from 7-49, with higher scores indicating higher experiential avoidance) | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| Change in Global Distress Tolerance | Distress Tolerance Scale (a 15-item scale ranging from 1-5, with higher scores indicating higher distress tolerance) | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| Change in Global Self-Compassion | Self-Compassion Scale (a 25-item scale ranging from 1-5, with higher scores indicating higher self-compassion) | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
| BG001 | Coping | Coping intervention involving 14 foundational audio-guided lessons plus daily brief practice prompts. Lessons train techniques for 3 coping skills: reflection, reappraisal, and problem solving. Practice prompts delivered 3x daily build on the skills trained in each lesson. Coping: The coping intervention includes 14 daily 20-minute audio lessons plus brief daily practice prompts. Lessons train specific coping techniques through didactic explanation and guided practice. Lessons train coping skills (reflection, reappraisal, and problem solving) without encouraging focus on or acceptance of present experience (i.e., mindfulness skills). Participants are instructed to: (1) reflect and let their minds drift, (2) reframe or reappraise past and anticipated events, and (3) analyze and solve personal problems. Practice prompts build on the skills trained in each lesson, encouraging participants to take brief reflection breaks or to practice reappraisal or problem-solving skills. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Number | Participants |
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| Primary | Feasibility of Retention | Retention benchmark: >80% retention through intervention and >75% retention through follow-up | Posted | Count of Participants | Participants | assessed across the entire 8-week study period |
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| Primary | Feasibility of Adherence: Intervention Lessons | Numbers represent percentages of intervention lessons completed in mindfulness and coping groups [calculated as (average number of lessons completed / 14 total lessons among all participants in each group) * 100]. The original adherence benchmark was an average completion of >85% of intervention lessons; reported percentages that are greater than that benchmark represent feasibility of intervention adherence. | study completers | Posted | Number | percentage of lessons completed | assessed across the entire 2-week intervention period | intervention lessons | intervention lessons |
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| Primary | Feasibility of Safe Implementation: Incidence of Treatment-emergent Increases in Mental Health Symptoms | Safety benchmark: <10% of participants showing substantial (>2SD) increases in anxiety, trauma, or depressive symptoms (using PROMIS Anxiety and Depression scales and Posttraumatic Stress Disorder Checklist-Civilian scale described in other outcomes below) combined to create treatment-emergent symptom rate | intervention completers | Posted | Count of Participants | Participants | assessed across the entire 8-week study period |
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| Primary | Acceptability: Treatment Expectancies | Acceptability of interventions, with benchmark of >80% of participants giving positive ratings of treatment expectancies (>3 on 6-item Credibility/Expectancy Questionnaire) | study completers | Posted | Number | percentage of treatment completers | assessed in-person at post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| Primary | Change in Daily Life Subjective Stress: State Perceived Stress | State perceived stress assessed in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Stress was assessed on a 1-7 Likert scale, with higher scores indicating higher perceived stress. | Posted | Mean | Standard Error | units on a scale | change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
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| Primary | Change in Daily Life Subjective Stress: Daily Perceived Stress | Daily perceived stress assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 assessments at each time point. All 7 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Stress was assessed on a 1-7 Likert scale, with higher scores indicating higher perceived stress. | all available data; n=1 participant provided no data at pre-intervention, post-intervention, or follow-up | Posted | Mean | Standard Error | units on a scale | change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
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| Primary | Change in Daily Life Objective Stress: Stress Events in the Past 2.5 Hours | Stress events assessed on a binary scale (yes/no) in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in logistic MLM analyses. Outcomes are reported as mean percentage of surveys at each time point that stress events were endorsed, with higher percentages indicating more stress events. | Posted | Mean | Standard Error | percentage of surveys with stressors | change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
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| Primary | Change in Daily Life Objective Stress: Daily Stress Events | Daily stress events assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 assessments at each time point. All 7 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in logistic MLM analyses. Outcomes are reported as mean percentage of days at each time point that stress events were endorsed, with higher percentages indicating more stress events. | all available data; n=1 participant provided no data at pre-intervention, post-intervention, or follow-up | Posted | Mean | Standard Error | percentage of days with stressors | change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
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| Primary | Change in Daily Life Physiological Stress Reactivity | Heart Rate (HR) measured continuously in daily life, with HR averaged in 30-minute windows around daily life stress reported via EMA up to four times per day for one week at three time points, totaling up to 28 windows at each time point. All (up to) 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher scores indicate higher HR in beats per minute (relative to an individual's average daily HR) at high stress moments (relative to an individual's average perceived stress). | all available data; n=5 participants provided no data at pre-intervention, post-intervention, or follow-up | Posted | Mean | Standard Error | beats per minute | change in HR reactivity assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
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| Primary | Change in Circulating Inflammatory Markers | Circulating IL-6 assessed via dried blood spot (DBS), reported as raw concentration in pg/mL assessed via ProteinSimple Simple Plex Human IL-6 (3rd gen) on Ella instrument | Posted | Mean | Standard Error | pg/mL | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| Primary | Feasibility of Recruitment (Enrollment) | Recruitment benchmark: >60% of those eligible will enroll | Posted | Count of Participants | Participants | assessed pre-enrollment |
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| Primary | Feasibility of Adherence: Intervention Practice Prompts | Numbers represent percentages of intervention practice prompts completed in mindfulness and coping groups [calculated as (average number of prompts completed / 42 total prompts among all participants in each group) * 100]. The original adherence benchmark was an average completion of >60% of prompts; reported percentages that are greater than that benchmark represent feasibility of intervention practice prompt adherence. | study completers | Posted | Number | percentage of prompts completed | assessed across the entire 2-week intervention period | intervention practice prompts | intervention practice prompts |
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| Primary | Feasibility of Adherence: Ambulatory Assessments | Numbers represent percentages of ambulatory assessment surveys completed in mindfulness and coping groups [calculated as (average number of surveys completed / 105 total surveys among all participants in each group) * 100]. The original adherence benchmark was an average completion of >75% of ambulatory assessments; reported percentages that are greater than that benchmark represent feasibility of ambulatory assessment adherence. | study completers | Posted | Number | percentage of surveys completed | assessed for 1 week at three time points: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) | ambulatory assessment surveys | ambulatory assessment surveys |
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| Primary | Feasibility of Adherence: Mobile Sensor Data | Numbers represent percentages of days on which wearable sensor (Fitbit) data and AWARE phone sensor data were collected in mindfulness and coping groups [calculated as (average number of days that Fitbit/AWARE data were collected / 56 days among all participants in each group) * 100]. The original adherence benchmark was collecting mobile sensor data on >75% of days; reported percentages that are greater than that benchmark represent feasibility of mobile sensor data collection adherence. | study completers | Posted | Number | percentage of days | assessed across the entire 8-week study period | days of mobile sensor data collection | days of mobile sensor data collection |
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| Secondary | Change in Daily Life Positive Affect: State | State positive affect assessed in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Positive affect was assessed on a 1-7 Likert scale, with higher scores indicating higher positive affect. | Posted | Mean | Standard Error | units on a scale | change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
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| Secondary | Change in Daily Life Positive Affect: Daily | Daily positive affect (composite of 9 positive affect items across 3 subscales: happiness (happy, pleased, and cheerful), calm (calm, at-ease, and relaxed), and vigor (lively, full-of-pep, and energetic), each assessed on a 1-7 Likert scale) assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 scores at each time point. All 7 composite scores at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher scores reflect higher positive affect. | all available data; n=1 participant provided no data at pre-intervention, post-intervention, or follow-up | Posted | Mean | Standard Error | units on a scale | change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
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| Secondary | Change in Daily Life Negative Affect: State | State negative affect assessed in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Negative affect was assessed on a 1-7 Likert scale, with higher scores indicating higher negative affect. | Posted | Mean | Standard Error | units on a scale | change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
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| Secondary | Change in Daily Life Negative Affect: Daily | Daily negative affect (composite of 9 negative affect items across 3 subscales: anxiety (on edge, nervous, and tense), depression (sad, depressed, and unhappy), and hostility (hostile, resentful, and angry), each assessed on a 1-7 Likert scale) assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 scores at each time point. All 7 composite scores at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher scores reflect higher negative affect. | all available data; n=1 participant provided no data at pre-intervention, post-intervention, or follow-up | Posted | Mean | Standard Error | units on a scale | change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
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| Secondary | Change in Daily Life Social Interactions: Interactions in the Past 2.5 Hours | Number of social interactions assessed in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher numbers indicate more social interactions. | Posted | Mean | Standard Error | number of interactions | change in interactions assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
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| Secondary | Change in Daily Life Social Interactions: Daily | Number of social interactions assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 assessments at each time point. All 7 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher numbers indicate more social interactions. | all available data; n=1 participant provided no data at pre-intervention, post-intervention, or follow-up | Posted | Mean | Standard Error | number of interactions | change in interactions assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
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| Secondary | Change in Daily Life Mindfulness: Awareness | Mindful awareness (composite 3-item scale: "Today, I paid attention to what I was doing in the present moment" / "Today, I noticed body sensations come and go" / "Today, I noticed pleasant and unpleasant thoughts and emotions", each item assessed on a 1-7 Likert scale) assessed in daily life each evening for one week at three time points via end-of-day diary, totaling up to 7 scores at each time point. All 7 composite scores at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher composite scores reflect higher mindful awareness. | all available data; n=1 participant provided no data at pre-intervention, post-intervention, or follow-up | Posted | Mean | Standard Error | score on a scale | change in awareness assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
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| Secondary | Change in Daily Life Mindfulness: Acceptance | Mindful acceptance (composite 2-item scale: "Today, I was able to step back and be aware of distressing thoughts, emotions, and sensations, without being taken over by them" / "Today, I did not want to feel the way I was feeling", each item assessed on a 1-7 Likert scale) assessed in daily life each evening for one week at three time points via end-of-day diary, totaling up to 7 scores at each time point. All 7 composite scores at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher composite scores reflect higher acceptance. | all available data; n=1 participant provided no data at pre-intervention, post-intervention, or follow-up | Posted | Mean | Standard Error | score on a scale | change in acceptance assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks) |
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| Other Pre-specified | 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 | Not Posted | collected continuously for 8 weeks | Participants |
| Other Pre-specified | Change in State Stress Following Intervention Practice | State stress following intervention practice used to evaluate immediate benefit of practice delivered at high-stress moments | Not Posted | change from pre- to post-practice across two-week intervention period | Participants |
| Other Pre-specified | Daily Stress Following Intervention Practice | End-of-day stress on days with intervention practice used to evaluate day-level benefit of practice delivered at high-stress moments | Not Posted | daily stress across two-week intervention period | Participants |
| Other Pre-specified | Early Life Adversity: Childhood Trauma | Assessed via the Childhood Trauma Questionnaire (a 28-item scale with three 5-item abuse subscales - physical, sexual, and emotional abuse - ranging from 5-25, with higher scores indicating higher childhood trauma) | Posted | Mean | Standard Error | CTQ score | pre-intervention |
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| Other Pre-specified | Early Life Adversity: Emotional Neglect | Early Life Adversity assessed via the Childhood Experiences of Care and Abuse Inventory (a 16-item scale referencing mother and father figures, with an 8-item emotional neglect subscale ranging from 8-40, where higher scores indicate higher levels of emotional neglect) | Posted | Mean | Standard Error | CECA-Q score | pre-intervention |
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| Other Pre-specified | Early Life Adversity: Childhood SES Indexed Via Parental Education | Childhood SES indexed via parental educational attainment, ranging from less than high school education to doctoral degree (1 = No High School Diploma, 2 = GED, 3 = High School Diploma, 4 = Technical Training, 5 = Some College, no degree, 6 = Associate Degree, 7 = Bachelor's Degree, 8 = Master's Degree, 9 = MD, PhD, JD, or PharmD), with higher scores indicating higher educational attainment | Posted | Mean | Standard Error | SES Score (Parental Education) | pre-intervention |
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| Other Pre-specified | Early Life Adversity: Childhood SES Indexed by Government Food Assistance | Childhood SES assessed via National Comorbidity Survey: Adolescents item assessing government food assistance | Posted | Count of Participants | Participants | pre-intervention |
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| Other Pre-specified | Early Life Adversity: Domestic Violence | Early Life Adversity assessed via Adverse Childhood Experiences Survey (using a 5-item domestic violence subscale, ranging from 0-10, with higher scores indicating higher levels of domestic violence) | Posted | Count of Participants | Participants | pre-intervention |
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| Other Pre-specified | Change in Circulating Inflammatory Biomarkers: CRP | Circulating CRP assessed via dried blood spot (DBS) [additional funding needed to assess] | Not Posted | change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks) | Participants |
| Other Pre-specified | Change in Circulating Inflammatory Biomarkers: TNF | Circulating TNF assessed via dried blood spot (DBS) [additional funding needed to assess] | Not Posted | change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks) | Participants |
| Other Pre-specified | Change in Circulating Inflammatory Biomarkers: IL-8 | Circulating IL-8 assessed via dried blood spot (DBS) [additional funding needed to assess] | Not Posted | change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks) | Participants |
| Other Pre-specified | Change in Circulating Inflammatory Biomarkers: IL-10 | Circulating IL-10 assessed via dried blood spot (DBS) [additional funding needed to assess] | Not Posted | change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks) | Participants |
| Other Pre-specified | Change in Global Psychosocial Stress: Anxiety | Assessed in-person via PROMIS Anxiety, a 4-item scale with raw scores ranging from 4-20 and converted to t-scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher anxiety | Posted | Mean | Standard Error | t-score | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| Other Pre-specified | Change in Global Psychosocial Stress: Depressive Symptoms | Assessed in-person via PROMIS Depression, a 4-item scale with raw scores ranging from 4-20 and converted to t-scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher depressive symptoms | Posted | Mean | Standard Error | t-score | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| Other Pre-specified | Change in Global Psychosocial Stress: Social Isolation | Assessed in-person via PROMIS Social Isolation, a 14-item scale with raw scores ranging from 14 to 70 and converted to t-scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher social isolation | Posted | Mean | Standard Error | t-score | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| Other Pre-specified | Change in Global Psychosocial Stress: Perceived Stress | Assessed in-person via Perceived Stress Scale (a 10-item scale ranging from 0-40, with higher scores indicating higher perceived stress) | Posted | Mean | Standard Error | score on a scale | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| Other Pre-specified | Change in Global Psychosocial Stress: Trauma Symptoms | Assessed in-person via Post-Traumatic Stress Disorder Checklist for Civilians (PCL-C), a 17-item scale ranging from 17-85, with higher scores indicating higher levels of trauma, and scores of 30 or greater indicating at least moderately severe PTSD symptoms | Posted | Mean | Standard Error | score on a scale | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| Other Pre-specified | Change in Global Psychosocial Stress: Depersonalization | Assessed in-person via Cambridge Depersonalization Scale (a 29-item scale ranging from 0-116, assessing frequency and duration of depersonalization symptoms, with higher scores indicating greater depersonalization) | Posted | Mean | Standard Error | score on a scale | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| Other Pre-specified | Change in Sleep Quality | Assessed in-person via Pittsburgh Sleep Quality Index (6-item short form, ranging from 0-12, with higher scores indicating worse sleep) | Posted | Mean | Standard Error | score on a scale | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| Other Pre-specified | Change in Global Psychosocial Resilience: Life Satisfaction | Assessed in-person via PROMIS Life Satisfaction, a 5-item scale with raw scores ranging from 5-35 and converted to t-scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher life satisfaction | Posted | Mean | Standard Error | t-score | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| Other Pre-specified | Change in Global Psychosocial Resilience: Positive Affect | Assessed in-person via PROMIS Positive Affect, a 15-item scale with raw scores ranging from 15-75 and converted to t-scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher positive affect | Posted | Mean | Standard Error | t-score | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| Other Pre-specified | Change in Global Psychosocial Resilience: Self-Efficacy | Assessed in-person via PROMIS Self-Efficacy, a 4-item scale with raw scores ranging from 4-20 and converted to t-scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher self-efficacy | Posted | Mean | Standard Error | t-score | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| Other Pre-specified | Change in Global Mindfulness | Five Facet Mindfulness Questionnaire-Short Form (a 24-item scale including five subscales - observing, describing, acting with awareness, nonreactivity, and nonjudgment, with average scores ranging from 1-5 and higher scores indicating higher mindfulness) | Posted | Mean | Standard Error | score on a scale | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| Other Pre-specified | Change in Global Experiential Avoidance | Acceptance and Action Questionnaire-II (a 7-item scale ranging from 7-49, with higher scores indicating higher experiential avoidance) | Posted | Mean | Standard Error | score on a scale | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| Other Pre-specified | Change in Global Distress Tolerance | Distress Tolerance Scale (a 15-item scale ranging from 1-5, with higher scores indicating higher distress tolerance) | Posted | Mean | Standard Error | score on a scale | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| Other Pre-specified | Change in Global Self-Compassion | Self-Compassion Scale (a 25-item scale ranging from 1-5, with higher scores indicating higher self-compassion) | Posted | Mean | Standard Error | score on a scale | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks) |
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| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | Coping | Coping intervention involving 14 foundational audio-guided lessons plus daily brief practice prompts. Lessons train techniques for 3 coping skills: reflection, reappraisal, and problem solving. Practice prompts delivered 3x daily build on the skills trained in each lesson. Coping: The coping intervention includes 14 daily 20-minute audio lessons plus brief daily practice prompts. Lessons train specific coping techniques through didactic explanation and guided practice. Lessons train coping skills (reflection, reappraisal, and problem solving) without encouraging focus on or acceptance of present experience (i.e., mindfulness skills). Participants are instructed to: (1) reflect and let their minds drift, (2) reframe or reappraise past and anticipated events, and (3) analyze and solve personal problems. Practice prompts build on the skills trained in each lesson, encouraging participants to take brief reflection breaks or to practice reappraisal or problem-solving skills. | 0 | 39 | 0 | 39 | 0 | 39 |
Not provided
Not provided
| Completed intervention but did not complete follow-up assessments |
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| One-month follow-up |
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| One-month follow-up |
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| One-month follow-up |
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| One-month follow-up |
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| One-month follow-up |
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| one-month follow-up |
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| One-month follow-up |
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| One-month follow-up |
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| One-month follow-up |
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| One-month follow-up |
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| One-month follow-up |
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| One-month follow-up |
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| One-month follow-up |
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| One-month follow-up |
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| Sexual abuse score |
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| Mean Anxiety Score (1 Month Follow Up) |
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| Mean Depressive Score (1 Month Follow Up) |
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| Mean Social Isolation Score (1 Month Follow Up) |
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| Mean PSS Score (1-Month Follow-Up) |
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| Mean PCL Score (1 Month Follow Up) |
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| Mean CDS Score (1 Month Follow Up) |
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| Mean PSQI Score (1 Month Follow Up) |
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| Mean Life Satisfaction Score (1 Month Follow Up) |
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| Mean Positive Affect Score (1 Month Follow Up) |
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| Mean Self-efficacy Score (1 Month Follow Up) |
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| Mean Global Mindfulness Score (1 Month Follow Up) |
|
| Mean AAQ-II Score (1 Month Follow Up) |
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| Mean DTS Score (1 Month Follow Up) |
|
| Mean SCS Score (1 Month Follow Up) |
|