Trial Outcomes & Findings for Remote Mindfulness Training Following Early Life Adversity (NCT NCT05516108)
NCT ID: NCT05516108
Last Updated: 2025-08-08
Results Overview
Recruitment benchmark: \>10% of people screened will be eligible
COMPLETED
PHASE1
81 participants
assessed pre-enrollment
2025-08-08
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
39
|
|
Overall Study
COMPLETED
|
37
|
34
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Time Commitment
|
3
|
1
|
|
Overall Study
Reason Unknown
|
2
|
4
|
Baseline Characteristics
Remote Mindfulness Training Following Early Life Adversity
Baseline characteristics by cohort
| Measure |
Mindfulness
n=42 Participants
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.
|
Coping
n=39 Participants
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.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.02 Years
STANDARD_DEVIATION 3.11 • n=5 Participants
|
23.79 Years
STANDARD_DEVIATION 3.50 • n=7 Participants
|
23.91 Years
STANDARD_DEVIATION 3.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: assessed pre-enrollmentRecruitment benchmark: \>10% of people screened will be eligible
Outcome measures
| Measure |
Screening & Enrollment
n=891 Participants
All individuals who were pre-screened for eligibility before randomization.
|
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.
|
|---|---|---|
|
Feasibility of Recruitment (Screened Eligible)
Screened eligible at in-person screening
|
81 Participants
|
—
|
|
Feasibility of Recruitment (Screened Eligible)
Pre-screened eligible but screened ineligible at in-person screening
|
56 Participants
|
—
|
|
Feasibility of Recruitment (Screened Eligible)
Pre-screened eligible but did not attend in-person screening
|
112 Participants
|
—
|
|
Feasibility of Recruitment (Screened Eligible)
Pre-screened ineligible
|
642 Participants
|
—
|
PRIMARY outcome
Timeframe: assessed across the entire 8-week study periodRetention benchmark: \>80% retention through intervention and \>75% retention through follow-up
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Feasibility of Retention
Retained through follow-up assessments
|
37 Participants
|
34 Participants
|
|
Feasibility of Retention
Did not complete intervention
|
4 Participants
|
5 Participants
|
|
Feasibility of Retention
Completed intervention but did not complete follow-up assessments
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: assessed across the entire 2-week intervention periodPopulation: study completers
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.
Outcome measures
| Measure |
Screening & Enrollment
n=14 intervention lessons
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=14 intervention lessons
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.
|
|---|---|---|
|
Feasibility of Adherence: Intervention Lessons
|
94.57 percentage of lessons completed
|
94.71 percentage of lessons completed
|
PRIMARY outcome
Timeframe: assessed across the entire 8-week study periodPopulation: intervention completers
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
Outcome measures
| Measure |
Screening & Enrollment
n=38 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=34 Participants
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.
|
|---|---|---|
|
Feasibility of Safe Implementation: Incidence of Treatment-emergent Increases in Mental Health Symptoms
No substantial (>2SD) symptom increase
|
35 Participants
|
34 Participants
|
|
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
|
0 Participants
|
PRIMARY outcome
Timeframe: 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
Acceptability of interventions, with benchmark of \>80% of participants giving positive ratings of treatment expectancies (\>3 on 6-item Credibility/Expectancy Questionnaire)
Outcome measures
| Measure |
Screening & Enrollment
n=37 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=34 Participants
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.
|
|---|---|---|
|
Acceptability: Treatment Expectancies
Post-intervention
|
95 percentage of treatment completers
|
91 percentage of treatment completers
|
|
Acceptability: Treatment Expectancies
One-month follow-up
|
92 percentage of treatment completers
|
88 percentage of treatment completers
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Daily Life Subjective Stress: State Perceived Stress
Pre-intervention
|
2.48 units on a scale
Standard Error .13
|
2.5 units on a scale
Standard Error .13
|
|
Change in Daily Life Subjective Stress: State Perceived Stress
Post-intervention
|
2.56 units on a scale
Standard Error .13
|
2.37 units on a scale
Standard Error .13
|
|
Change in Daily Life Subjective Stress: State Perceived Stress
One-month follow-up
|
2.46 units on a scale
Standard Error .13
|
2.32 units on a scale
Standard Error .13
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Screening & Enrollment
n=41 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Daily Life Subjective Stress: Daily Perceived Stress
Pre-intervention
|
3.01 units on a scale
Standard Error .14
|
2.91 units on a scale
Standard Error .15
|
|
Change in Daily Life Subjective Stress: Daily Perceived Stress
Post-intervention
|
3.19 units on a scale
Standard Error .15
|
2.69 units on a scale
Standard Error .15
|
|
Change in Daily Life Subjective Stress: Daily Perceived Stress
One-month follow-up
|
2.90 units on a scale
Standard Error .15
|
2.63 units on a scale
Standard Error .15
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
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
|
18.5 percentage of surveys with stressors
Standard Error 2.09
|
|
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
|
12.33 percentage of surveys with stressors
Standard Error 1.72
|
|
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
|
10.78 percentage of surveys with stressors
Standard Error 1.6
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Screening & Enrollment
n=41 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Daily Life Objective Stress: Daily Stress Events
Pre-intervention
|
65.93 percentage of days with stressors
Standard Error 4.01
|
51.52 percentage of days with stressors
Standard Error 4.46
|
|
Change in Daily Life Objective Stress: Daily Stress Events
Post-intervention
|
57.54 percentage of days with stressors
Standard Error 4.46
|
47.75 percentage of days with stressors
Standard Error 4.69
|
|
Change in Daily Life Objective Stress: Daily Stress Events
One-month follow-up
|
48.18 percentage of days with stressors
Standard Error 4.61
|
46.08 percentage of days with stressors
Standard Error 4.70
|
PRIMARY outcome
Timeframe: 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
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).
Outcome measures
| Measure |
Screening & Enrollment
n=39 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=37 Participants
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.
|
|---|---|---|
|
Change in Daily Life Physiological Stress Reactivity
Pre-intervention
|
5.82 beats per minute
Standard Error .67
|
4.77 beats per minute
Standard Error .68
|
|
Change in Daily Life Physiological Stress Reactivity
Post-intervention
|
4.94 beats per minute
Standard Error .69
|
6.49 beats per minute
Standard Error .73
|
|
Change in Daily Life Physiological Stress Reactivity
One-month follow-up
|
6.6 beats per minute
Standard Error .73
|
5.80 beats per minute
Standard Error .78
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Circulating Inflammatory Markers
pre-intervention
|
.365 pg/mL
Standard Error .034
|
.266 pg/mL
Standard Error .035
|
|
Change in Circulating Inflammatory Markers
post-intervention
|
.343 pg/mL
Standard Error .036
|
.267 pg/mL
Standard Error .038
|
|
Change in Circulating Inflammatory Markers
one-month follow-up
|
.344 pg/mL
Standard Error .036
|
.279 pg/mL
Standard Error .037
|
PRIMARY outcome
Timeframe: assessed pre-enrollmentRecruitment benchmark: \>60% of those eligible will enroll
Outcome measures
| Measure |
Screening & Enrollment
n=81 Participants
All individuals who were pre-screened for eligibility before randomization.
|
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.
|
|---|---|---|
|
Feasibility of Recruitment (Enrollment)
|
81 Participants
|
—
|
PRIMARY outcome
Timeframe: assessed across the entire 2-week intervention periodPopulation: study completers
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.
Outcome measures
| Measure |
Screening & Enrollment
n=42 intervention practice prompts
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=42 intervention practice prompts
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.
|
|---|---|---|
|
Feasibility of Adherence: Intervention Practice Prompts
|
57.33 percentage of prompts completed
|
60.34 percentage of prompts completed
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Screening & Enrollment
n=105 ambulatory assessment surveys
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=105 ambulatory assessment surveys
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.
|
|---|---|---|
|
Feasibility of Adherence: Ambulatory Assessments
|
86.28 percentage of surveys completed
|
87.53 percentage of surveys completed
|
PRIMARY outcome
Timeframe: assessed across the entire 8-week study periodPopulation: study completers
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.
Outcome measures
| Measure |
Screening & Enrollment
n=56 days of mobile sensor data collection
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=56 days of mobile sensor data collection
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.
|
|---|---|---|
|
Feasibility of Adherence: Mobile Sensor Data
% of days AWARE data collected
|
94.35 percentage of days
|
91.61 percentage of days
|
|
Feasibility of Adherence: Mobile Sensor Data
% of days Fitbit data collected
|
86.95 percentage of days
|
86.40 percentage of days
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Daily Life Positive Affect: State
Pre-intervention
|
3.87 units on a scale
Standard Error .14
|
3.77 units on a scale
Standard Error .14
|
|
Change in Daily Life Positive Affect: State
Post-intervention
|
3.57 units on a scale
Standard Error .14
|
3.80 units on a scale
Standard Error .14
|
|
Change in Daily Life Positive Affect: State
One-month follow-up
|
3.74 units on a scale
Standard Error .14
|
3.75 units on a scale
Standard Error .14
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Screening & Enrollment
n=41 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Daily Life Positive Affect: Daily
Pre-intervention
|
3.30 units on a scale
Standard Error .14
|
3.34 units on a scale
Standard Error .14
|
|
Change in Daily Life Positive Affect: Daily
Post-intervention
|
2.94 units on a scale
Standard Error .14
|
3.32 units on a scale
Standard Error .15
|
|
Change in Daily Life Positive Affect: Daily
One-month follow-up
|
3.19 units on a scale
Standard Error .14
|
3.36 units on a scale
Standard Error .15
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Daily Life Negative Affect: State
Pre-intervention
|
2.19 units on a scale
Standard Error .11
|
2.06 units on a scale
Standard Error .12
|
|
Change in Daily Life Negative Affect: State
Post-intervention
|
2.34 units on a scale
Standard Error .11
|
1.96 units on a scale
Standard Error .12
|
|
Change in Daily Life Negative Affect: State
One-month follow-up
|
2.21 units on a scale
Standard Error .11
|
1.93 units on a scale
Standard Error .12
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Screening & Enrollment
n=41 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Daily Life Negative Affect: Daily
Pre-intervention
|
2.15 units on a scale
Standard Error .11
|
1.99 units on a scale
Standard Error .11
|
|
Change in Daily Life Negative Affect: Daily
Post-intervention
|
2.19 units on a scale
Standard Error .11
|
1.88 units on a scale
Standard Error .11
|
|
Change in Daily Life Negative Affect: Daily
One-month follow-up
|
2.13 units on a scale
Standard Error .11
|
1.82 units on a scale
Standard Error .11
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Daily Life Social Interactions: Interactions in the Past 2.5 Hours
Pre-intervention
|
2.79 number of interactions
Standard Error .26
|
2.96 number of interactions
Standard Error .27
|
|
Change in Daily Life Social Interactions: Interactions in the Past 2.5 Hours
Post-intervention
|
3.09 number of interactions
Standard Error .26
|
2.84 number of interactions
Standard Error .27
|
|
Change in Daily Life Social Interactions: Interactions in the Past 2.5 Hours
One-month follow-up
|
3.30 number of interactions
Standard Error .26
|
2.69 number of interactions
Standard Error .27
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Screening & Enrollment
n=41 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Daily Life Social Interactions: Daily
Post-intervention
|
13.60 number of interactions
Standard Error .79
|
11.18 number of interactions
Standard Error .82
|
|
Change in Daily Life Social Interactions: Daily
Pre-intervention
|
12.69 number of interactions
Standard Error .78
|
11.59 number of interactions
Standard Error .80
|
|
Change in Daily Life Social Interactions: Daily
One-month follow-up
|
14.61 number of interactions
Standard Error .80
|
11.25 number of interactions
Standard Error .82
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Screening & Enrollment
n=41 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Daily Life Mindfulness: Awareness
Pre-intervention
|
3.76 score on a scale
Standard Error .15
|
3.70 score on a scale
Standard Error .16
|
|
Change in Daily Life Mindfulness: Awareness
Post-intervention
|
3.98 score on a scale
Standard Error .16
|
4.10 score on a scale
Standard Error .16
|
|
Change in Daily Life Mindfulness: Awareness
One-month follow-up
|
4.03 score on a scale
Standard Error .16
|
4.10 score on a scale
Standard Error .16
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Screening & Enrollment
n=41 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Daily Life Mindfulness: Acceptance
Pre-intervention
|
4.25 score on a scale
Standard Error .14
|
4.35 score on a scale
Standard Error .14
|
|
Change in Daily Life Mindfulness: Acceptance
Post-intervention
|
4.33 score on a scale
Standard Error .14
|
4.74 score on a scale
Standard Error .15
|
|
Change in Daily Life Mindfulness: Acceptance
One-month follow-up
|
4.63 score on a scale
Standard Error .14
|
4.82 score on a scale
Standard Error .15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: collected continuously for 8 weeksPassive 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: change from pre- to post-practice across two-week intervention periodState stress following intervention practice used to evaluate immediate benefit of practice delivered at high-stress moments
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: daily stress across two-week intervention periodEnd-of-day stress on days with intervention practice used to evaluate day-level benefit of practice delivered at high-stress moments
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-interventionAssessed 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)
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Early Life Adversity: Childhood Trauma
Emotional abuse score
|
14.76 CTQ score
Standard Error 0.61
|
13.56 CTQ score
Standard Error 0.64
|
|
Early Life Adversity: Childhood Trauma
Physical abuse score
|
8.07 CTQ score
Standard Error 0.57
|
7.72 CTQ score
Standard Error 0.59
|
|
Early Life Adversity: Childhood Trauma
Sexual abuse score
|
6.88 CTQ score
Standard Error 0.60
|
7.10 CTQ score
Standard Error 0.62
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-interventionEarly 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)
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Early Life Adversity: Emotional Neglect
Mother figure neglect
|
13.67 CECA-Q score
Standard Error 1.04
|
10.51 CECA-Q score
Standard Error 1.08
|
|
Early Life Adversity: Emotional Neglect
Father figure neglect
|
18.12 CECA-Q score
Standard Error 1.20
|
17.15 CECA-Q score
Standard Error 1.25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-interventionChildhood 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
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Early Life Adversity: Childhood SES Indexed Via Parental Education
Maternal education
|
6.12 SES Score (Parental Education)
Standard Error 0.32
|
6.46 SES Score (Parental Education)
Standard Error 0.33
|
|
Early Life Adversity: Childhood SES Indexed Via Parental Education
Paternal education
|
5.95 SES Score (Parental Education)
Standard Error 0.35
|
5.95 SES Score (Parental Education)
Standard Error 0.37
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-interventionChildhood SES assessed via National Comorbidity Survey: Adolescents item assessing government food assistance
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Early Life Adversity: Childhood SES Indexed by Government Food Assistance
|
14 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: pre-interventionEarly 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)
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Early Life Adversity: Domestic Violence
ACES domestic violence
|
10 Participants
|
5 Participants
|
|
Early Life Adversity: Domestic Violence
ACES criminal behavior
|
1 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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) \[additional funding needed to assess\]
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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) \[additional funding needed to assess\]
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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) \[additional funding needed to assess\]
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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) \[additional funding needed to assess\]
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Global Psychosocial Stress: Anxiety
Mean Anxiety Score (Pre-Intervention)
|
61.37 t-score
Standard Error 1.13
|
60.29 t-score
Standard Error 1.17
|
|
Change in Global Psychosocial Stress: Anxiety
Mean Anxiety Score (Post-Intervention)
|
58.97 t-score
Standard Error 1.16
|
56.99 t-score
Standard Error 1.22
|
|
Change in Global Psychosocial Stress: Anxiety
Mean Anxiety Score (1 Month Follow Up)
|
58.56 t-score
Standard Error 1.17
|
56.94 t-score
Standard Error 1.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Global Psychosocial Stress: Depressive Symptoms
Mean Depressive Score (Pre-Intervention)
|
56.90 t-score
Standard Error 1.29
|
53.76 t-score
Standard Error 1.34
|
|
Change in Global Psychosocial Stress: Depressive Symptoms
Mean Depressive Score (Post-Intervention)
|
55.76 t-score
Standard Error 1.35
|
50.54 t-score
Standard Error 1.42
|
|
Change in Global Psychosocial Stress: Depressive Symptoms
Mean Depressive Score (1 Month Follow Up)
|
55.86 t-score
Standard Error 1.39
|
52.39 t-score
Standard Error 1.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Global Psychosocial Stress: Social Isolation
Mean Social Isolation Score (Pre-Intervention)
|
53.64 t-score
Standard Error 1.42
|
50.55 t-score
Standard Error 1.48
|
|
Change in Global Psychosocial Stress: Social Isolation
Mean Social Isolation Score (Post-Intervention)
|
51.52 t-score
Standard Error 1.45
|
49.64 t-score
Standard Error 1.52
|
|
Change in Global Psychosocial Stress: Social Isolation
Mean Social Isolation Score (1 Month Follow Up)
|
51.29 t-score
Standard Error 1.46
|
48.80 t-score
Standard Error 1.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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)
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Global Psychosocial Stress: Perceived Stress
Mean PSS Score (Pre-Intervention)
|
21.60 score on a scale
Standard Error 0.91
|
20.85 score on a scale
Standard Error 0.94
|
|
Change in Global Psychosocial Stress: Perceived Stress
Mean PSS Score (Post-Intervention)
|
20.42 score on a scale
Standard Error 0.96
|
16.92 score on a scale
Standard Error 1.01
|
|
Change in Global Psychosocial Stress: Perceived Stress
Mean PSS Score (1-Month Follow-Up)
|
18.21 score on a scale
Standard Error 0.99
|
16.81 score on a scale
Standard Error 1.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Global Psychosocial Stress: Trauma Symptoms
Mean PCL Score (Pre-Intervention)
|
40.19 score on a scale
Standard Error 1.89
|
40.21 score on a scale
Standard Error 1.97
|
|
Change in Global Psychosocial Stress: Trauma Symptoms
Mean PCL Score (Post-Intervention)
|
35.76 score on a scale
Standard Error 1.95
|
31.44 score on a scale
Standard Error 2.04
|
|
Change in Global Psychosocial Stress: Trauma Symptoms
Mean PCL Score (1 Month Follow Up)
|
34.63 score on a scale
Standard Error 1.96
|
32.18 score on a scale
Standard Error 2.04
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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)
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Global Psychosocial Stress: Depersonalization
Mean CDS Score (Pre-Intervention)
|
58.31 score on a scale
Standard Error 6.02
|
52.15 score on a scale
Standard Error 6.25
|
|
Change in Global Psychosocial Stress: Depersonalization
Mean CDS Score (Post-Intervention)
|
47.49 score on a scale
Standard Error 6.16
|
36.30 score on a scale
Standard Error 6.45
|
|
Change in Global Psychosocial Stress: Depersonalization
Mean CDS Score (1 Month Follow Up)
|
43.94 score on a scale
Standard Error 6.19
|
30.83 score on a scale
Standard Error 6.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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)
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Sleep Quality
Mean PSQI Score (Pre-Intervention)
|
4.14 score on a scale
Standard Error 0.37
|
4.28 score on a scale
Standard Error 0.38
|
|
Change in Sleep Quality
Mean PSQI Score (Post-Intervention)
|
4.13 score on a scale
Standard Error 0.33
|
3.20 score on a scale
Standard Error 0.35
|
|
Change in Sleep Quality
Mean PSQI Score (1 Month Follow Up)
|
3.81 score on a scale
Standard Error 0.34
|
3.85 score on a scale
Standard Error 0.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Global Psychosocial Resilience: Life Satisfaction
Mean Life Satisfaction Score (Pre-Intervention)
|
41.47 t-score
Standard Error 1.30
|
45.34 t-score
Standard Error 1.35
|
|
Change in Global Psychosocial Resilience: Life Satisfaction
Mean Life Satisfaction Score (Post-Intervention)
|
42.35 t-score
Standard Error 1.42
|
46.92 t-score
Standard Error 1.49
|
|
Change in Global Psychosocial Resilience: Life Satisfaction
Mean Life Satisfaction Score (1 Month Follow Up)
|
43.79 t-score
Standard Error 1.59
|
48.24 t-score
Standard Error 1.65
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Global Psychosocial Resilience: Positive Affect
Mean Positive Affect Score (Pre-Intervention)
|
41.09 t-score
Standard Error 1.17
|
44.16 t-score
Standard Error 1.22
|
|
Change in Global Psychosocial Resilience: Positive Affect
Mean Positive Affect Score (Post-Intervention)
|
41.96 t-score
Standard Error 1.24
|
45.15 t-score
Standard Error 1.30
|
|
Change in Global Psychosocial Resilience: Positive Affect
Mean Positive Affect Score (1 Month Follow Up)
|
42.53 t-score
Standard Error 1.28
|
44.16 t-score
Standard Error 1.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Global Psychosocial Resilience: Self-Efficacy
Mean Self-efficacy Score (Pre-Intervention)
|
44.60 t-score
Standard Error 1.47
|
45.32 t-score
Standard Error 1.53
|
|
Change in Global Psychosocial Resilience: Self-Efficacy
Mean Self-efficacy Score (Post-Intervention)
|
45.73 t-score
Standard Error 1.52
|
47.40 t-score
Standard Error 1.59
|
|
Change in Global Psychosocial Resilience: Self-Efficacy
Mean Self-efficacy Score (1 Month Follow Up)
|
48.22 t-score
Standard Error 1.53
|
47.55 t-score
Standard Error 1.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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)
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Global Mindfulness
Mean Global Mindfulness Score (Pre-Intervention)
|
3.10 score on a scale
Standard Error 0.07
|
3.15 score on a scale
Standard Error 0.08
|
|
Change in Global Mindfulness
Mean Global Mindfulness Score (Post-Intervention)
|
3.27 score on a scale
Standard Error 0.08
|
3.44 score on a scale
Standard Error 0.09
|
|
Change in Global Mindfulness
Mean Global Mindfulness Score (1 Month Follow Up)
|
3.39 score on a scale
Standard Error 0.09
|
3.49 score on a scale
Standard Error 0.10
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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)
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Global Experiential Avoidance
Mean AAQ-II Score (Pre-Intervention)
|
27.38 score on a scale
Standard Error 1.37
|
25.38 score on a scale
Standard Error 1.43
|
|
Change in Global Experiential Avoidance
Mean AAQ-II Score (Post-Intervention)
|
24.32 score on a scale
Standard Error 1.40
|
20.93 score on a scale
Standard Error 1.47
|
|
Change in Global Experiential Avoidance
Mean AAQ-II Score (1 Month Follow Up)
|
23.08 score on a scale
Standard Error 1.41
|
22.02 score on a scale
Standard Error 1.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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)
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Global Distress Tolerance
Mean DTS Score (Pre-Intervention)
|
3.16 score on a scale
Standard Error 0.13
|
3.30 score on a scale
Standard Error 0.14
|
|
Change in Global Distress Tolerance
Mean DTS Score (Post-Intervention)
|
3.50 score on a scale
Standard Error 0.14
|
3.61 score on a scale
Standard Error 0.14
|
|
Change in Global Distress Tolerance
Mean DTS Score (1 Month Follow Up)
|
3.49 score on a scale
Standard Error 0.14
|
3.67 score on a scale
Standard Error 0.15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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)
Outcome measures
| Measure |
Screening & Enrollment
n=42 Participants
All individuals who were pre-screened for eligibility before randomization.
|
Coping
n=39 Participants
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.
|
|---|---|---|
|
Change in Global Self-Compassion
Mean SCS Score (Pre-Intervention)
|
2.63 score on a scale
Standard Error 0.11
|
2.84 score on a scale
Standard Error 0.11
|
|
Change in Global Self-Compassion
Mean SCS Score (Post-Intervention)
|
2.97 score on a scale
Standard Error 0.12
|
3.20 score on a scale
Standard Error 0.12
|
|
Change in Global Self-Compassion
Mean SCS Score (1 Month Follow Up)
|
3.17 score on a scale
Standard Error 0.13
|
3.26 score on a scale
Standard Error 0.13
|
Adverse Events
Mindfulness
Coping
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place