Remote Mindfulness Training Following Early Life Adversity

Smartphone-based Mindfulness Training for Health Following Early Life Adversity

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05516108

Acronym

ReMind

Enrollment

Registered

2022-08-25

Start date

2022-09-01

Completion date

2024-05-22

Last updated

2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Life Adversity, Mindfulness, Stress

Brief summary

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.

Interventions

BEHAVIORALMindfulness

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.

BEHAVIORALCoping

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 29 Years

Healthy volunteers

Yes

Inclusion criteria

* Ages 18-29 years * English speaking * History of moderate-to-severe physical, emotional, or sexual abuse in childhood * Data-enabled Android or iOS smartphone * Able to meet study requirements

Exclusion criteria

* Self-reported diagnosis of chronic physical disease (e.g., cancer, HIV, heart disease, diabetes, bleeding disorder) * Self-reported diagnosis of chronic mental disorder (e.g., schizophrenia, personality disorder, or psychotic illness), major neurological disorder, or suicidal thoughts or wishes at baseline * Substance use disorder * Medication use that interferes with HPA-axis activity (e.g., corticosteroids), autonomic activity (e.g., antihypertensive medication), inflammatory activity (e.g., cholesterol medications), or blood clotting * Current antibiotic, antiviral, or antimicrobial treatment * Shift workers * Pregnancy * Regular systematic mind-body practice (\>2 times per week)

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of Adherence: Mobile Sensor Data	assessed across the entire 8-week study period	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.
Change in Daily Life Subjective Stress: State 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)	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 Daily Life Subjective Stress: Daily 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)	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 Daily Life Objective Stress: Stress Events in the Past 2.5 Hours	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)	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 Daily Life Objective Stress: Daily 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)	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 Daily Life Physiological Stress Reactivity	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)	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 Circulating Inflammatory Markers	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)	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
Feasibility of Adherence: Intervention Practice Prompts	assessed across the entire 2-week intervention period	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.
Feasibility of Adherence: Ambulatory Assessments	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)	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.
Feasibility of Recruitment (Enrollment)	assessed pre-enrollment	Recruitment benchmark: \>60% of those eligible will enroll
Feasibility of Recruitment (Screened Eligible)	assessed pre-enrollment	Recruitment benchmark: \>10% of people screened will be eligible
Feasibility of Retention	assessed across the entire 8-week study period	Retention benchmark: \>80% retention through intervention and \>75% retention through follow-up
Feasibility of Adherence: Intervention Lessons	assessed across the entire 2-week intervention period	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.
Feasibility of Safe Implementation: Incidence of Treatment-emergent Increases in Mental Health Symptoms	assessed across the entire 8-week study period	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
Acceptability: Treatment Expectancies	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)	Acceptability of interventions, with benchmark of \>80% of participants giving positive ratings of treatment expectancies (\>3 on 6-item Credibility/Expectancy Questionnaire)

Secondary

Measure	Time frame	Description
Change in Daily Life Positive Affect: Daily	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)	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 Daily Life Negative Affect: State	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)	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 Daily Life Negative Affect: Daily	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)	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 Daily Life Social Interactions: Interactions in the Past 2.5 Hours	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)	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 Daily Life Social Interactions: Daily	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)	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 Daily Life Mindfulness: 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)	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 Daily Life Mindfulness: 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)	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 Daily Life Positive Affect: State	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)	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.

Other

Measure	Time frame	Description
Change in Global 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)	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 in Global 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)	Self-Compassion Scale (a 25-item scale ranging from 1-5, with higher scores indicating higher self-compassion)
Change in Global 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)	Distress Tolerance Scale (a 15-item scale ranging from 1-5, with higher scores indicating higher distress tolerance)
Change in Global 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)	Acceptance and Action Questionnaire-II (a 7-item scale ranging from 7-49, with higher scores indicating higher experiential avoidance)
Passive Sensor Stress Models	collected continuously for 8 weeks	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
Change in State Stress Following Intervention Practice	change from pre- to post-practice across two-week intervention period	State stress following intervention practice used to evaluate immediate benefit of practice delivered at high-stress moments
Daily Stress Following Intervention Practice	daily stress across two-week intervention period	End-of-day stress on days with intervention practice used to evaluate day-level benefit of practice delivered at high-stress moments
Early Life Adversity: Childhood Trauma	pre-intervention	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)
Early Life Adversity: Emotional Neglect	pre-intervention	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)
Early Life Adversity: Childhood SES Indexed Via Parental Education	pre-intervention	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
Early Life Adversity: Childhood SES Indexed by Government Food Assistance	pre-intervention	Childhood SES assessed via National Comorbidity Survey: Adolescents item assessing government food assistance
Early Life Adversity: Domestic Violence	pre-intervention	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)
Change in Circulating Inflammatory Biomarkers: CRP	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)	Circulating CRP assessed via dried blood spot (DBS) \[additional funding needed to assess\]
Change in Circulating Inflammatory Biomarkers: TNF	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)	Circulating TNF assessed via dried blood spot (DBS) \[additional funding needed to assess\]
Change in Circulating Inflammatory Biomarkers: IL-8	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)	Circulating IL-8 assessed via dried blood spot (DBS) \[additional funding needed to assess\]
Change in Circulating Inflammatory Biomarkers: IL-10	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)	Circulating IL-10 assessed via dried blood spot (DBS) \[additional funding needed to assess\]
Change in Global Psychosocial Stress: 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)	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 in Global Psychosocial Stress: 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)	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 in Global Psychosocial Stress: 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)	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 in Global Psychosocial Stress: 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)	Assessed in-person via Perceived Stress Scale (a 10-item scale ranging from 0-40, with higher scores indicating higher perceived stress)
Change in Global Psychosocial Stress: Trauma 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)	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 in Global Psychosocial Stress: 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)	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 in Sleep Quality	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)	Assessed in-person via Pittsburgh Sleep Quality Index (6-item short form, ranging from 0-12, with higher scores indicating worse sleep)
Change in Global Psychosocial Resilience: 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)	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 in Global Psychosocial Resilience: 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)	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 in Global Psychosocial Resilience: 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)	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

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
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.	42
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.	39
Total	81

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Reason Unknown	2	4
Overall Study	Time Commitment	3	1

Baseline characteristics

Characteristic	Mindfulness	Total	Coping
Age, Continuous	24.02 Years STANDARD_DEVIATION 3.11	23.91 Years STANDARD_DEVIATION 3.29	23.79 Years STANDARD_DEVIATION 3.5
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	5 Participants	2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants	76 Participants	37 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	15 Participants	23 Participants	8 Participants
Race (NIH/OMB) Black or African American	6 Participants	14 Participants	8 Participants
Race (NIH/OMB) More than one race	2 Participants	4 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) White	18 Participants	39 Participants	21 Participants
Region of Enrollment United States	42 Participants	81 Participants	39 Participants
Sex: Female, Male Female	33 Participants	69 Participants	36 Participants
Sex: Female, Male Male	9 Participants	12 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 42	0 / 39
other Total, other adverse events	0 / 42	0 / 39
serious Total, serious adverse events	0 / 42	0 / 39

Outcome results

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)

Time frame: 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)

Population: study completers

Arm	Measure	Group	Value (NUMBER)
Screening & Enrollment	Acceptability: Treatment Expectancies	Post-intervention	95 percentage of treatment completers
Screening & Enrollment	Acceptability: Treatment Expectancies	One-month follow-up	92 percentage of treatment completers
Coping	Acceptability: Treatment Expectancies	Post-intervention	91 percentage of treatment completers
Coping	Acceptability: Treatment Expectancies	One-month follow-up	88 percentage of treatment completers

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

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Circulating Inflammatory Markers	pre-intervention	.365 pg/mL	Standard Error 0.034
Screening & Enrollment	Change in Circulating Inflammatory Markers	post-intervention	.343 pg/mL	Standard Error 0.036
Screening & Enrollment	Change in Circulating Inflammatory Markers	one-month follow-up	.344 pg/mL	Standard Error 0.036
Coping	Change in Circulating Inflammatory Markers	pre-intervention	.266 pg/mL	Standard Error 0.035
Coping	Change in Circulating Inflammatory Markers	post-intervention	.267 pg/mL	Standard Error 0.038
Coping	Change in Circulating Inflammatory Markers	one-month follow-up	.279 pg/mL	Standard Error 0.037

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.

Time frame: 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)

Population: all available data; n=1 participant provided no data at pre-intervention, post-intervention, or follow-up

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Daily Life Objective Stress: Daily Stress Events	Pre-intervention	65.93 percentage of days with stressors	Standard Error 4.01
Screening & Enrollment	Change in Daily Life Objective Stress: Daily Stress Events	Post-intervention	57.54 percentage of days with stressors	Standard Error 4.46
Screening & Enrollment	Change in Daily Life Objective Stress: Daily Stress Events	One-month follow-up	48.18 percentage of days with stressors	Standard Error 4.61
Coping	Change in Daily Life Objective Stress: Daily Stress Events	Pre-intervention	51.52 percentage of days with stressors	Standard Error 4.46
Coping	Change in Daily Life Objective Stress: Daily Stress Events	Post-intervention	47.75 percentage of days with stressors	Standard Error 4.69
Coping	Change in Daily Life Objective Stress: Daily Stress Events	One-month follow-up	46.08 percentage of days with stressors	Standard Error 4.7

Comparison: time (pre, post, follow-up) x condition (mindfulness, coping)p-value: 0.1Mixed Models Analysis

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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Daily Life Objective Stress: Stress Events in the Past 2.5 Hours	Pre-intervention	22.71 percentage of surveys with stressors	Standard Error 2.26
Screening & Enrollment	Change in Daily Life Objective Stress: Stress Events in the Past 2.5 Hours	Post-intervention	15.84 percentage of surveys with stressors	Standard Error 1.91
Screening & Enrollment	Change in Daily Life Objective Stress: Stress Events in the Past 2.5 Hours	One-month follow-up	15.31 percentage of surveys with stressors	Standard Error 1.89
Coping	Change in Daily Life Objective Stress: Stress Events in the Past 2.5 Hours	Pre-intervention	18.5 percentage of surveys with stressors	Standard Error 2.09
Coping	Change in Daily Life Objective Stress: Stress Events in the Past 2.5 Hours	Post-intervention	12.33 percentage of surveys with stressors	Standard Error 1.72
Coping	Change in Daily Life Objective Stress: Stress Events in the Past 2.5 Hours	One-month follow-up	10.78 percentage of surveys with stressors	Standard Error 1.6

Comparison: time (pre, post, follow-up) x condition (mindfulness, coping)p-value: 0.74Mixed Models Analysis

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).

Time frame: 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)

Population: all available data; n=5 participants provided no data at pre-intervention, post-intervention, or follow-up

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Daily Life Physiological Stress Reactivity	One-month follow-up	6.6 beats per minute	Standard Error 0.73
Screening & Enrollment	Change in Daily Life Physiological Stress Reactivity	Pre-intervention	5.82 beats per minute	Standard Error 0.67
Screening & Enrollment	Change in Daily Life Physiological Stress Reactivity	Post-intervention	4.94 beats per minute	Standard Error 0.69
Coping	Change in Daily Life Physiological Stress Reactivity	Pre-intervention	4.77 beats per minute	Standard Error 0.68
Coping	Change in Daily Life Physiological Stress Reactivity	Post-intervention	6.49 beats per minute	Standard Error 0.73
Coping	Change in Daily Life Physiological Stress Reactivity	One-month follow-up	5.80 beats per minute	Standard Error 0.78

Comparison: time (pre, post, follow-up) x condition (mindfulness, coping)p-value: 0.009Mixed Models Analysis

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.

Population: all available data; n=1 participant provided no data at pre-intervention, post-intervention, or follow-up

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Daily Life Subjective Stress: Daily Perceived Stress	Pre-intervention	3.01 units on a scale	Standard Error 0.14
Screening & Enrollment	Change in Daily Life Subjective Stress: Daily Perceived Stress	Post-intervention	3.19 units on a scale	Standard Error 0.15
Screening & Enrollment	Change in Daily Life Subjective Stress: Daily Perceived Stress	One-month follow-up	2.90 units on a scale	Standard Error 0.15
Coping	Change in Daily Life Subjective Stress: Daily Perceived Stress	Pre-intervention	2.91 units on a scale	Standard Error 0.15
Coping	Change in Daily Life Subjective Stress: Daily Perceived Stress	Post-intervention	2.69 units on a scale	Standard Error 0.15
Coping	Change in Daily Life Subjective Stress: Daily Perceived Stress	One-month follow-up	2.63 units on a scale	Standard Error 0.15

Comparison: time (pre, post, follow-up) x condition (mindfulness, coping)p-value: 0.02Mixed Models Analysis

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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Daily Life Subjective Stress: State Perceived Stress	Pre-intervention	2.48 units on a scale	Standard Error 0.13
Screening & Enrollment	Change in Daily Life Subjective Stress: State Perceived Stress	Post-intervention	2.56 units on a scale	Standard Error 0.13
Screening & Enrollment	Change in Daily Life Subjective Stress: State Perceived Stress	One-month follow-up	2.46 units on a scale	Standard Error 0.13
Coping	Change in Daily Life Subjective Stress: State Perceived Stress	Pre-intervention	2.5 units on a scale	Standard Error 0.13
Coping	Change in Daily Life Subjective Stress: State Perceived Stress	Post-intervention	2.37 units on a scale	Standard Error 0.13
Coping	Change in Daily Life Subjective Stress: State Perceived Stress	One-month follow-up	2.32 units on a scale	Standard Error 0.13

Comparison: time (pre, post, follow-up) x condition (mindfulness, coping)p-value: 0.004Mixed Models Analysis

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.

Time frame: 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)

Population: study completers

Arm	Measure	Value (NUMBER)
Screening & Enrollment	Feasibility of Adherence: Ambulatory Assessments	86.28 percentage of surveys completed
Coping	Feasibility of Adherence: Ambulatory Assessments	87.53 percentage of surveys completed

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.

Time frame: assessed across the entire 2-week intervention period

Population: study completers

Arm	Measure	Value (NUMBER)
Screening & Enrollment	Feasibility of Adherence: Intervention Lessons	94.57 percentage of lessons completed
Coping	Feasibility of Adherence: Intervention Lessons	94.71 percentage of lessons completed

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.

Time frame: assessed across the entire 2-week intervention period

Population: study completers

Arm	Measure	Value (NUMBER)
Screening & Enrollment	Feasibility of Adherence: Intervention Practice Prompts	57.33 percentage of prompts completed
Coping	Feasibility of Adherence: Intervention Practice Prompts	60.34 percentage of prompts completed

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.

Time frame: assessed across the entire 8-week study period

Population: study completers

Arm	Measure	Group	Value (NUMBER)
Screening & Enrollment	Feasibility of Adherence: Mobile Sensor Data	% of days Fitbit data collected	86.95 percentage of days
Screening & Enrollment	Feasibility of Adherence: Mobile Sensor Data	% of days AWARE data collected	94.35 percentage of days
Coping	Feasibility of Adherence: Mobile Sensor Data	% of days Fitbit data collected	86.40 percentage of days
Coping	Feasibility of Adherence: Mobile Sensor Data	% of days AWARE data collected	91.61 percentage of days

Primary

Feasibility of Recruitment (Enrollment)

Recruitment benchmark: \>60% of those eligible will enroll

Time frame: assessed pre-enrollment

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Screening & Enrollment	Feasibility of Recruitment (Enrollment)	81 Participants

Primary

Feasibility of Recruitment (Screened Eligible)

Recruitment benchmark: \>10% of people screened will be eligible

Time frame: assessed pre-enrollment

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Screening & Enrollment	Feasibility of Recruitment (Screened Eligible)	Screened eligible at in-person screening	81 Participants
Screening & Enrollment	Feasibility of Recruitment (Screened Eligible)	Pre-screened eligible but screened ineligible at in-person screening	56 Participants
Screening & Enrollment	Feasibility of Recruitment (Screened Eligible)	Pre-screened eligible but did not attend in-person screening	112 Participants
Screening & Enrollment	Feasibility of Recruitment (Screened Eligible)	Pre-screened ineligible	642 Participants

Primary

Feasibility of Retention

Retention benchmark: \>80% retention through intervention and \>75% retention through follow-up

Time frame: assessed across the entire 8-week study period

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Screening & Enrollment	Feasibility of Retention	Retained through follow-up assessments	37 Participants
Screening & Enrollment	Feasibility of Retention	Did not complete intervention	4 Participants
Screening & Enrollment	Feasibility of Retention	Completed intervention but did not complete follow-up assessments	1 Participants
Coping	Feasibility of Retention	Retained through follow-up assessments	34 Participants
Coping	Feasibility of Retention	Did not complete intervention	5 Participants
Coping	Feasibility of Retention	Completed intervention but did not complete follow-up assessments	0 Participants

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

Time frame: assessed across the entire 8-week study period

Population: intervention completers

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Screening & Enrollment	Feasibility of Safe Implementation: Incidence of Treatment-emergent Increases in Mental Health Symptoms	No substantial (>2SD) symptom increase	35 Participants
Screening & Enrollment	Feasibility of Safe Implementation: Incidence of Treatment-emergent Increases in Mental Health Symptoms	Substantial (>2SD) symptom increase at post-intervention or follow-up	3 Participants
Coping	Feasibility of Safe Implementation: Incidence of Treatment-emergent Increases in Mental Health Symptoms	No substantial (>2SD) symptom increase	34 Participants
Coping	Feasibility of Safe Implementation: Incidence of Treatment-emergent Increases in Mental Health Symptoms	Substantial (>2SD) symptom increase at post-intervention or follow-up	0 Participants

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.

Time frame: 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)

Population: all available data; n=1 participant provided no data at pre-intervention, post-intervention, or follow-up

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Daily Life Mindfulness: Acceptance	Pre-intervention	4.25 score on a scale	Standard Error 0.14
Screening & Enrollment	Change in Daily Life Mindfulness: Acceptance	Post-intervention	4.33 score on a scale	Standard Error 0.14
Screening & Enrollment	Change in Daily Life Mindfulness: Acceptance	One-month follow-up	4.63 score on a scale	Standard Error 0.14
Coping	Change in Daily Life Mindfulness: Acceptance	Pre-intervention	4.35 score on a scale	Standard Error 0.14
Coping	Change in Daily Life Mindfulness: Acceptance	Post-intervention	4.74 score on a scale	Standard Error 0.15
Coping	Change in Daily Life Mindfulness: Acceptance	One-month follow-up	4.82 score on a scale	Standard Error 0.15

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.

Time frame: 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)

Population: all available data; n=1 participant provided no data at pre-intervention, post-intervention, or follow-up

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Daily Life Mindfulness: Awareness	Pre-intervention	3.76 score on a scale	Standard Error 0.15
Screening & Enrollment	Change in Daily Life Mindfulness: Awareness	Post-intervention	3.98 score on a scale	Standard Error 0.16
Screening & Enrollment	Change in Daily Life Mindfulness: Awareness	One-month follow-up	4.03 score on a scale	Standard Error 0.16
Coping	Change in Daily Life Mindfulness: Awareness	Pre-intervention	3.70 score on a scale	Standard Error 0.16
Coping	Change in Daily Life Mindfulness: Awareness	Post-intervention	4.10 score on a scale	Standard Error 0.16
Coping	Change in Daily Life Mindfulness: Awareness	One-month follow-up	4.10 score on a scale	Standard Error 0.16

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.

Time frame: 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)

Population: all available data; n=1 participant provided no data at pre-intervention, post-intervention, or follow-up

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Daily Life Negative Affect: Daily	Pre-intervention	2.15 units on a scale	Standard Error 0.11
Screening & Enrollment	Change in Daily Life Negative Affect: Daily	Post-intervention	2.19 units on a scale	Standard Error 0.11
Screening & Enrollment	Change in Daily Life Negative Affect: Daily	One-month follow-up	2.13 units on a scale	Standard Error 0.11
Coping	Change in Daily Life Negative Affect: Daily	Pre-intervention	1.99 units on a scale	Standard Error 0.11
Coping	Change in Daily Life Negative Affect: Daily	Post-intervention	1.88 units on a scale	Standard Error 0.11
Coping	Change in Daily Life Negative Affect: Daily	One-month follow-up	1.82 units on a scale	Standard Error 0.11

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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Daily Life Negative Affect: State	Pre-intervention	2.19 units on a scale	Standard Error 0.11
Screening & Enrollment	Change in Daily Life Negative Affect: State	Post-intervention	2.34 units on a scale	Standard Error 0.11
Screening & Enrollment	Change in Daily Life Negative Affect: State	One-month follow-up	2.21 units on a scale	Standard Error 0.11
Coping	Change in Daily Life Negative Affect: State	Pre-intervention	2.06 units on a scale	Standard Error 0.12
Coping	Change in Daily Life Negative Affect: State	Post-intervention	1.96 units on a scale	Standard Error 0.12
Coping	Change in Daily Life Negative Affect: State	One-month follow-up	1.93 units on a scale	Standard Error 0.12

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.

Population: all available data; n=1 participant provided no data at pre-intervention, post-intervention, or follow-up

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Daily Life Positive Affect: Daily	Pre-intervention	3.30 units on a scale	Standard Error 0.14
Screening & Enrollment	Change in Daily Life Positive Affect: Daily	Post-intervention	2.94 units on a scale	Standard Error 0.14
Screening & Enrollment	Change in Daily Life Positive Affect: Daily	One-month follow-up	3.19 units on a scale	Standard Error 0.14
Coping	Change in Daily Life Positive Affect: Daily	Pre-intervention	3.34 units on a scale	Standard Error 0.14
Coping	Change in Daily Life Positive Affect: Daily	Post-intervention	3.32 units on a scale	Standard Error 0.15
Coping	Change in Daily Life Positive Affect: Daily	One-month follow-up	3.36 units on a scale	Standard Error 0.15

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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Daily Life Positive Affect: State	Pre-intervention	3.87 units on a scale	Standard Error 0.14
Screening & Enrollment	Change in Daily Life Positive Affect: State	Post-intervention	3.57 units on a scale	Standard Error 0.14
Screening & Enrollment	Change in Daily Life Positive Affect: State	One-month follow-up	3.74 units on a scale	Standard Error 0.14
Coping	Change in Daily Life Positive Affect: State	Pre-intervention	3.77 units on a scale	Standard Error 0.14
Coping	Change in Daily Life Positive Affect: State	Post-intervention	3.80 units on a scale	Standard Error 0.14
Coping	Change in Daily Life Positive Affect: State	One-month follow-up	3.75 units on a scale	Standard Error 0.14

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.

Time frame: 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)

Population: all available data; n=1 participant provided no data at pre-intervention, post-intervention, or follow-up

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Daily Life Social Interactions: Daily	Pre-intervention	12.69 number of interactions	Standard Error 0.78
Screening & Enrollment	Change in Daily Life Social Interactions: Daily	Post-intervention	13.60 number of interactions	Standard Error 0.79
Screening & Enrollment	Change in Daily Life Social Interactions: Daily	One-month follow-up	14.61 number of interactions	Standard Error 0.8
Coping	Change in Daily Life Social Interactions: Daily	Pre-intervention	11.59 number of interactions	Standard Error 0.8
Coping	Change in Daily Life Social Interactions: Daily	Post-intervention	11.18 number of interactions	Standard Error 0.82
Coping	Change in Daily Life Social Interactions: Daily	One-month follow-up	11.25 number of interactions	Standard Error 0.82

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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Daily Life Social Interactions: Interactions in the Past 2.5 Hours	Pre-intervention	2.79 number of interactions	Standard Error 0.26
Screening & Enrollment	Change in Daily Life Social Interactions: Interactions in the Past 2.5 Hours	Post-intervention	3.09 number of interactions	Standard Error 0.26
Screening & Enrollment	Change in Daily Life Social Interactions: Interactions in the Past 2.5 Hours	One-month follow-up	3.30 number of interactions	Standard Error 0.26
Coping	Change in Daily Life Social Interactions: Interactions in the Past 2.5 Hours	Pre-intervention	2.96 number of interactions	Standard Error 0.27
Coping	Change in Daily Life Social Interactions: Interactions in the Past 2.5 Hours	Post-intervention	2.84 number of interactions	Standard Error 0.27
Coping	Change in Daily Life Social Interactions: Interactions in the Past 2.5 Hours	One-month follow-up	2.69 number of interactions	Standard Error 0.27

Other Pre-specified

Change in Circulating Inflammatory Biomarkers: CRP

Circulating CRP assessed via dried blood spot (DBS) \[additional funding needed to assess\]

Time frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)

Other Pre-specified

Change in Circulating Inflammatory Biomarkers: IL-10

Circulating IL-10 assessed via dried blood spot (DBS) \[additional funding needed to assess\]

Time frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)

Other Pre-specified

Change in Circulating Inflammatory Biomarkers: IL-8

Circulating IL-8 assessed via dried blood spot (DBS) \[additional funding needed to assess\]

Time frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)

Other Pre-specified

Change in Circulating Inflammatory Biomarkers: TNF

Circulating TNF assessed via dried blood spot (DBS) \[additional funding needed to assess\]

Time frame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)

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)

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Global Distress Tolerance	Mean DTS Score (Pre-Intervention)	3.16 score on a scale	Standard Error 0.13
Screening & Enrollment	Change in Global Distress Tolerance	Mean DTS Score (Post-Intervention)	3.50 score on a scale	Standard Error 0.14
Screening & Enrollment	Change in Global Distress Tolerance	Mean DTS Score (1 Month Follow Up)	3.49 score on a scale	Standard Error 0.14
Coping	Change in Global Distress Tolerance	Mean DTS Score (Pre-Intervention)	3.30 score on a scale	Standard Error 0.14
Coping	Change in Global Distress Tolerance	Mean DTS Score (Post-Intervention)	3.61 score on a scale	Standard Error 0.14
Coping	Change in Global Distress Tolerance	Mean DTS Score (1 Month Follow Up)	3.67 score on a scale	Standard Error 0.15

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)

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Global Experiential Avoidance	Mean AAQ-II Score (Pre-Intervention)	27.38 score on a scale	Standard Error 1.37
Screening & Enrollment	Change in Global Experiential Avoidance	Mean AAQ-II Score (Post-Intervention)	24.32 score on a scale	Standard Error 1.4
Screening & Enrollment	Change in Global Experiential Avoidance	Mean AAQ-II Score (1 Month Follow Up)	23.08 score on a scale	Standard Error 1.41
Coping	Change in Global Experiential Avoidance	Mean AAQ-II Score (Pre-Intervention)	25.38 score on a scale	Standard Error 1.43
Coping	Change in Global Experiential Avoidance	Mean AAQ-II Score (Post-Intervention)	20.93 score on a scale	Standard Error 1.47
Coping	Change in Global Experiential Avoidance	Mean AAQ-II Score (1 Month Follow Up)	22.02 score on a scale	Standard Error 1.47

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)

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Global Mindfulness	Mean Global Mindfulness Score (Pre-Intervention)	3.10 score on a scale	Standard Error 0.07
Screening & Enrollment	Change in Global Mindfulness	Mean Global Mindfulness Score (Post-Intervention)	3.27 score on a scale	Standard Error 0.08
Screening & Enrollment	Change in Global Mindfulness	Mean Global Mindfulness Score (1 Month Follow Up)	3.39 score on a scale	Standard Error 0.09
Coping	Change in Global Mindfulness	Mean Global Mindfulness Score (Pre-Intervention)	3.15 score on a scale	Standard Error 0.08
Coping	Change in Global Mindfulness	Mean Global Mindfulness Score (Post-Intervention)	3.44 score on a scale	Standard Error 0.09
Coping	Change in Global Mindfulness	Mean Global Mindfulness Score (1 Month Follow Up)	3.49 score on a scale	Standard Error 0.1

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

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Global Psychosocial Resilience: Life Satisfaction	Mean Life Satisfaction Score (Pre-Intervention)	41.47 t-score	Standard Error 1.3
Screening & Enrollment	Change in Global Psychosocial Resilience: Life Satisfaction	Mean Life Satisfaction Score (Post-Intervention)	42.35 t-score	Standard Error 1.42
Screening & Enrollment	Change in Global Psychosocial Resilience: Life Satisfaction	Mean Life Satisfaction Score (1 Month Follow Up)	43.79 t-score	Standard Error 1.59
Coping	Change in Global Psychosocial Resilience: Life Satisfaction	Mean Life Satisfaction Score (Pre-Intervention)	45.34 t-score	Standard Error 1.35
Coping	Change in Global Psychosocial Resilience: Life Satisfaction	Mean Life Satisfaction Score (Post-Intervention)	46.92 t-score	Standard Error 1.49
Coping	Change in Global Psychosocial Resilience: Life Satisfaction	Mean Life Satisfaction Score (1 Month Follow Up)	48.24 t-score	Standard Error 1.65

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

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Global Psychosocial Resilience: Positive Affect	Mean Positive Affect Score (Pre-Intervention)	41.09 t-score	Standard Error 1.17
Screening & Enrollment	Change in Global Psychosocial Resilience: Positive Affect	Mean Positive Affect Score (Post-Intervention)	41.96 t-score	Standard Error 1.24
Screening & Enrollment	Change in Global Psychosocial Resilience: Positive Affect	Mean Positive Affect Score (1 Month Follow Up)	42.53 t-score	Standard Error 1.28
Coping	Change in Global Psychosocial Resilience: Positive Affect	Mean Positive Affect Score (Pre-Intervention)	44.16 t-score	Standard Error 1.22
Coping	Change in Global Psychosocial Resilience: Positive Affect	Mean Positive Affect Score (Post-Intervention)	45.15 t-score	Standard Error 1.3
Coping	Change in Global Psychosocial Resilience: Positive Affect	Mean Positive Affect Score (1 Month Follow Up)	44.16 t-score	Standard Error 1.34

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

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Global Psychosocial Resilience: Self-Efficacy	Mean Self-efficacy Score (Pre-Intervention)	44.60 t-score	Standard Error 1.47
Screening & Enrollment	Change in Global Psychosocial Resilience: Self-Efficacy	Mean Self-efficacy Score (Post-Intervention)	45.73 t-score	Standard Error 1.52
Screening & Enrollment	Change in Global Psychosocial Resilience: Self-Efficacy	Mean Self-efficacy Score (1 Month Follow Up)	48.22 t-score	Standard Error 1.53
Coping	Change in Global Psychosocial Resilience: Self-Efficacy	Mean Self-efficacy Score (Pre-Intervention)	45.32 t-score	Standard Error 1.53
Coping	Change in Global Psychosocial Resilience: Self-Efficacy	Mean Self-efficacy Score (Post-Intervention)	47.40 t-score	Standard Error 1.59
Coping	Change in Global Psychosocial Resilience: Self-Efficacy	Mean Self-efficacy Score (1 Month Follow Up)	47.55 t-score	Standard Error 1.59

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

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Global Psychosocial Stress: Anxiety	Mean Anxiety Score (Pre-Intervention)	61.37 t-score	Standard Error 1.13
Screening & Enrollment	Change in Global Psychosocial Stress: Anxiety	Mean Anxiety Score (Post-Intervention)	58.97 t-score	Standard Error 1.16
Screening & Enrollment	Change in Global Psychosocial Stress: Anxiety	Mean Anxiety Score (1 Month Follow Up)	58.56 t-score	Standard Error 1.17
Coping	Change in Global Psychosocial Stress: Anxiety	Mean Anxiety Score (Pre-Intervention)	60.29 t-score	Standard Error 1.17
Coping	Change in Global Psychosocial Stress: Anxiety	Mean Anxiety Score (Post-Intervention)	56.99 t-score	Standard Error 1.22
Coping	Change in Global Psychosocial Stress: Anxiety	Mean Anxiety Score (1 Month Follow Up)	56.94 t-score	Standard Error 1.22

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)

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Global Psychosocial Stress: Depersonalization	Mean CDS Score (Pre-Intervention)	58.31 score on a scale	Standard Error 6.02
Screening & Enrollment	Change in Global Psychosocial Stress: Depersonalization	Mean CDS Score (Post-Intervention)	47.49 score on a scale	Standard Error 6.16
Screening & Enrollment	Change in Global Psychosocial Stress: Depersonalization	Mean CDS Score (1 Month Follow Up)	43.94 score on a scale	Standard Error 6.19
Coping	Change in Global Psychosocial Stress: Depersonalization	Mean CDS Score (Pre-Intervention)	52.15 score on a scale	Standard Error 6.25
Coping	Change in Global Psychosocial Stress: Depersonalization	Mean CDS Score (Post-Intervention)	36.30 score on a scale	Standard Error 6.45
Coping	Change in Global Psychosocial Stress: Depersonalization	Mean CDS Score (1 Month Follow Up)	30.83 score on a scale	Standard Error 6.45

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

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Global Psychosocial Stress: Depressive Symptoms	Mean Depressive Score (Pre-Intervention)	56.90 t-score	Standard Error 1.29
Screening & Enrollment	Change in Global Psychosocial Stress: Depressive Symptoms	Mean Depressive Score (Post-Intervention)	55.76 t-score	Standard Error 1.35
Screening & Enrollment	Change in Global Psychosocial Stress: Depressive Symptoms	Mean Depressive Score (1 Month Follow Up)	55.86 t-score	Standard Error 1.39
Coping	Change in Global Psychosocial Stress: Depressive Symptoms	Mean Depressive Score (Pre-Intervention)	53.76 t-score	Standard Error 1.34
Coping	Change in Global Psychosocial Stress: Depressive Symptoms	Mean Depressive Score (Post-Intervention)	50.54 t-score	Standard Error 1.42
Coping	Change in Global Psychosocial Stress: Depressive Symptoms	Mean Depressive Score (1 Month Follow Up)	52.39 t-score	Standard Error 1.45

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)

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Global Psychosocial Stress: Perceived Stress	Mean PSS Score (Pre-Intervention)	21.60 score on a scale	Standard Error 0.91
Screening & Enrollment	Change in Global Psychosocial Stress: Perceived Stress	Mean PSS Score (Post-Intervention)	20.42 score on a scale	Standard Error 0.96
Screening & Enrollment	Change in Global Psychosocial Stress: Perceived Stress	Mean PSS Score (1-Month Follow-Up)	18.21 score on a scale	Standard Error 0.99
Coping	Change in Global Psychosocial Stress: Perceived Stress	Mean PSS Score (Pre-Intervention)	20.85 score on a scale	Standard Error 0.94
Coping	Change in Global Psychosocial Stress: Perceived Stress	Mean PSS Score (Post-Intervention)	16.92 score on a scale	Standard Error 1.01
Coping	Change in Global Psychosocial Stress: Perceived Stress	Mean PSS Score (1-Month Follow-Up)	16.81 score on a scale	Standard Error 1.04

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

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Global Psychosocial Stress: Social Isolation	Mean Social Isolation Score (Pre-Intervention)	53.64 t-score	Standard Error 1.42
Screening & Enrollment	Change in Global Psychosocial Stress: Social Isolation	Mean Social Isolation Score (Post-Intervention)	51.52 t-score	Standard Error 1.45
Screening & Enrollment	Change in Global Psychosocial Stress: Social Isolation	Mean Social Isolation Score (1 Month Follow Up)	51.29 t-score	Standard Error 1.46
Coping	Change in Global Psychosocial Stress: Social Isolation	Mean Social Isolation Score (Pre-Intervention)	50.55 t-score	Standard Error 1.48
Coping	Change in Global Psychosocial Stress: Social Isolation	Mean Social Isolation Score (Post-Intervention)	49.64 t-score	Standard Error 1.52
Coping	Change in Global Psychosocial Stress: Social Isolation	Mean Social Isolation Score (1 Month Follow Up)	48.80 t-score	Standard Error 1.52

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

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Global Psychosocial Stress: Trauma Symptoms	Mean PCL Score (Pre-Intervention)	40.19 score on a scale	Standard Error 1.89
Screening & Enrollment	Change in Global Psychosocial Stress: Trauma Symptoms	Mean PCL Score (Post-Intervention)	35.76 score on a scale	Standard Error 1.95
Screening & Enrollment	Change in Global Psychosocial Stress: Trauma Symptoms	Mean PCL Score (1 Month Follow Up)	34.63 score on a scale	Standard Error 1.96
Coping	Change in Global Psychosocial Stress: Trauma Symptoms	Mean PCL Score (Pre-Intervention)	40.21 score on a scale	Standard Error 1.97
Coping	Change in Global Psychosocial Stress: Trauma Symptoms	Mean PCL Score (Post-Intervention)	31.44 score on a scale	Standard Error 2.04
Coping	Change in Global Psychosocial Stress: Trauma Symptoms	Mean PCL Score (1 Month Follow Up)	32.18 score on a scale	Standard Error 2.04

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)

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Global Self-Compassion	Mean SCS Score (Pre-Intervention)	2.63 score on a scale	Standard Error 0.11
Screening & Enrollment	Change in Global Self-Compassion	Mean SCS Score (Post-Intervention)	2.97 score on a scale	Standard Error 0.12
Screening & Enrollment	Change in Global Self-Compassion	Mean SCS Score (1 Month Follow Up)	3.17 score on a scale	Standard Error 0.13
Coping	Change in Global Self-Compassion	Mean SCS Score (Pre-Intervention)	2.84 score on a scale	Standard Error 0.11
Coping	Change in Global Self-Compassion	Mean SCS Score (Post-Intervention)	3.20 score on a scale	Standard Error 0.12
Coping	Change in Global Self-Compassion	Mean SCS Score (1 Month Follow Up)	3.26 score on a scale	Standard Error 0.13

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)

Time frame: 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)

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Change in Sleep Quality	Mean PSQI Score (Pre-Intervention)	4.14 score on a scale	Standard Error 0.37
Screening & Enrollment	Change in Sleep Quality	Mean PSQI Score (Post-Intervention)	4.13 score on a scale	Standard Error 0.33
Screening & Enrollment	Change in Sleep Quality	Mean PSQI Score (1 Month Follow Up)	3.81 score on a scale	Standard Error 0.34
Coping	Change in Sleep Quality	Mean PSQI Score (Pre-Intervention)	4.28 score on a scale	Standard Error 0.38
Coping	Change in Sleep Quality	Mean PSQI Score (Post-Intervention)	3.20 score on a scale	Standard Error 0.35
Coping	Change in Sleep Quality	Mean PSQI Score (1 Month Follow Up)	3.85 score on a scale	Standard Error 0.35

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

Time frame: change from pre- to post-practice across two-week intervention period

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

Time frame: daily stress across two-week intervention period

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

Time frame: pre-intervention

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Screening & Enrollment	Early Life Adversity: Childhood SES Indexed by Government Food Assistance	14 Participants
Coping	Early Life Adversity: Childhood SES Indexed by Government Food Assistance	11 Participants

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

Time frame: pre-intervention

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Early Life Adversity: Childhood SES Indexed Via Parental Education	Maternal education	6.12 SES Score (Parental Education)	Standard Error 0.32
Screening & Enrollment	Early Life Adversity: Childhood SES Indexed Via Parental Education	Paternal education	5.95 SES Score (Parental Education)	Standard Error 0.35
Coping	Early Life Adversity: Childhood SES Indexed Via Parental Education	Maternal education	6.46 SES Score (Parental Education)	Standard Error 0.33
Coping	Early Life Adversity: Childhood SES Indexed Via Parental Education	Paternal education	5.95 SES Score (Parental Education)	Standard Error 0.37

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)

Time frame: pre-intervention

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Early Life Adversity: Childhood Trauma	Emotional abuse score	14.76 CTQ score	Standard Error 0.61
Screening & Enrollment	Early Life Adversity: Childhood Trauma	Physical abuse score	8.07 CTQ score	Standard Error 0.57
Screening & Enrollment	Early Life Adversity: Childhood Trauma	Sexual abuse score	6.88 CTQ score	Standard Error 0.6
Coping	Early Life Adversity: Childhood Trauma	Emotional abuse score	13.56 CTQ score	Standard Error 0.64
Coping	Early Life Adversity: Childhood Trauma	Physical abuse score	7.72 CTQ score	Standard Error 0.59
Coping	Early Life Adversity: Childhood Trauma	Sexual abuse score	7.10 CTQ score	Standard Error 0.62

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)

Time frame: pre-intervention

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Screening & Enrollment	Early Life Adversity: Domestic Violence	ACES criminal behavior	1 Participants
Screening & Enrollment	Early Life Adversity: Domestic Violence	ACES domestic violence	10 Participants
Coping	Early Life Adversity: Domestic Violence	ACES criminal behavior	4 Participants
Coping	Early Life Adversity: Domestic Violence	ACES domestic violence	5 Participants

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)

Time frame: pre-intervention

Arm	Measure	Group	Value (MEAN)	Dispersion
Screening & Enrollment	Early Life Adversity: Emotional Neglect	Mother figure neglect	13.67 CECA-Q score	Standard Error 1.04
Screening & Enrollment	Early Life Adversity: Emotional Neglect	Father figure neglect	18.12 CECA-Q score	Standard Error 1.2
Coping	Early Life Adversity: Emotional Neglect	Mother figure neglect	10.51 CECA-Q score	Standard Error 1.08
Coping	Early Life Adversity: Emotional Neglect	Father figure neglect	17.15 CECA-Q score	Standard Error 1.25

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

Time frame: collected continuously for 8 weeks

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Remote Mindfulness Training Following Early Life Adversity

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Recruitment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Acceptability: Treatment Expectancies

Change in Circulating Inflammatory Markers

Change in Daily Life Objective Stress: Daily Stress Events

Change in Daily Life Objective Stress: Stress Events in the Past 2.5 Hours

Change in Daily Life Physiological Stress Reactivity

Change in Daily Life Subjective Stress: Daily Perceived Stress

Change in Daily Life Subjective Stress: State Perceived Stress

Feasibility of Adherence: Ambulatory Assessments

Feasibility of Adherence: Intervention Lessons

Feasibility of Adherence: Intervention Practice Prompts

Feasibility of Adherence: Mobile Sensor Data

Feasibility of Recruitment (Enrollment)

Feasibility of Recruitment (Screened Eligible)

Feasibility of Retention

Feasibility of Safe Implementation: Incidence of Treatment-emergent Increases in Mental Health Symptoms

Change in Daily Life Mindfulness: Acceptance

Change in Daily Life Mindfulness: Awareness

Change in Daily Life Negative Affect: Daily

Change in Daily Life Negative Affect: State

Change in Daily Life Positive Affect: Daily

Change in Daily Life Positive Affect: State

Change in Daily Life Social Interactions: Daily

Change in Daily Life Social Interactions: Interactions in the Past 2.5 Hours

Change in Circulating Inflammatory Biomarkers: CRP

Change in Circulating Inflammatory Biomarkers: IL-10

Change in Circulating Inflammatory Biomarkers: IL-8

Change in Circulating Inflammatory Biomarkers: TNF

Change in Global Distress Tolerance

Change in Global Experiential Avoidance

Change in Global Mindfulness

Change in Global Psychosocial Resilience: Life Satisfaction

Change in Global Psychosocial Resilience: Positive Affect

Change in Global Psychosocial Resilience: Self-Efficacy

Change in Global Psychosocial Stress: Anxiety

Change in Global Psychosocial Stress: Depersonalization

Change in Global Psychosocial Stress: Depressive Symptoms

Change in Global Psychosocial Stress: Perceived Stress

Change in Global Psychosocial Stress: Social Isolation

Change in Global Psychosocial Stress: Trauma Symptoms

Change in Global Self-Compassion

Change in Sleep Quality

Change in State Stress Following Intervention Practice

Daily Stress Following Intervention Practice

Early Life Adversity: Childhood SES Indexed by Government Food Assistance

Early Life Adversity: Childhood SES Indexed Via Parental Education

Early Life Adversity: Childhood Trauma

Early Life Adversity: Domestic Violence

Early Life Adversity: Emotional Neglect

Passive Sensor Stress Models