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Completed

NCT Number: NCT05516108

Remote Mindfulness Training Following Early Life Adversity

This study will test the feasibility of delivering smartphone-based mindfulness and coping interventions to a sample of emerging/young adults with a history of early life adversity (ELA). 80 participants with a history of ELA will be randomly assigned to complete a two-week mindfulness training intervention or matched coping control intervention, both involving 14 foundational audio-guided lessons and practice prompts randomly delivered 3x daily. At baseline, post-intervention, and one-month follow-up lab assessments, participants will complete questionnaires and provide blood samples for assessment of markers of inflammation. Data assessing subjective and physiological stress in daily life will be collected during the intervention and for one week before, immediately after, and one month after the intervention. Passive sensor data will be continuously collected from participants' smartphones and wearable devices to develop exploratory models that estimate and predict daily life stress. Data will be used to evaluate feasibility and acceptability of interventions and assessments in an ELA sample, test effects of mindfulness training on daily life stress and markers of inflammation in an ELA sample, and develop exploratory machine learning models of stress from passive sensor data.

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Key information

Conditions

Stress Early Life Adversity Mindfulness

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Mindfulness

Behavioral

The mindfulness intervention includes 14 daily 20-minute audio lessons plus brief daily practice prompts. Lessons train specific meditation techniques through didactic explanation and guided practice. Based on the Unified Mindfulness system, lessons train 3 mindfulness skills: concentration, sensory clarity, and equanimity. Concentration, a state of stable attention on the intended target, enables participants to monitor present-moment physical and emotional body experiences. Sensory clarity, the monitoring of momentary experiences, involves detecting subtle sensations and discriminating between different experiences. Equanimity, an attitude of acceptance toward momentary experiences, is trained through 3 strategies: (a) body relaxation, (b) mental welcoming, and (c) a gentle tone of voice. Practice prompts build on the skills trained in each lesson, encouraging participants to practice brief moments of mindful awareness, mindfulness while doing daily tasks, or formal meditation.

Coping

Behavioral

The coping intervention includes 14 daily 20-minute audio lessons plus brief daily practice prompts. Lessons train specific coping techniques through didactic explanation and guided practice. Lessons train coping skills (reflection, reappraisal, and problem solving) without encouraging focus on or acceptance of present experience (i.e., mindfulness skills). Participants are instructed to: (1) reflect and let their minds drift, (2) reframe or reappraise past and anticipated events, and (3) analyze and solve personal problems. Practice prompts build on the skills trained in each lesson, encouraging participants to take brief reflection breaks or to practice reappraisal or problem-solving skills.

Primary outcomes

  1. Feasibility of Recruitment (Screened Eligible)

    Time frame: assessed pre-enrollment

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

  2. Feasibility of Retention

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

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

  3. Feasibility of Adherence: Intervention Lessons

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

    Numbers represent percentages of intervention lessons completed in mindfulness and coping groups [calculated as (average number of lessons completed / 14 total lessons among all participants in each group) * 100]. The original adherence benchmark was an average completion of >85% of intervention lessons; reported percentages that are greater than that benchmark represent feasibility of intervention adherence.

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

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

    Safety benchmark: <10% of participants showing substantial (>2SD) increases in anxiety, trauma, or depressive symptoms (using PROMIS Anxiety and Depression scales and Posttraumatic Stress Disorder Checklist-Civilian scale described in other outcomes below) combined to create treatment-emergent symptom rate

  5. Acceptability: Treatment Expectancies

    Time frame: assessed in-person at post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks)

    Acceptability of interventions, with benchmark of >80% of participants giving positive ratings of treatment expectancies (>3 on 6-item Credibility/Expectancy Questionnaire)

  6. Change in Daily Life Subjective Stress: State Perceived Stress

    Time frame: change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

    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.

  7. Change in Daily Life Subjective Stress: Daily Perceived Stress

    Time frame: change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

    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.

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

    Time frame: change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

    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.

  9. Change in Daily Life Objective Stress: Daily Stress Events

    Time frame: change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

    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.

  10. Change in Daily Life Physiological Stress Reactivity

    Time frame: change in HR reactivity assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

    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).

  11. Change in Circulating Inflammatory Markers

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

    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

  12. Feasibility of Recruitment (Enrollment)

    Time frame: assessed pre-enrollment

    Recruitment benchmark: >60% of those eligible will enroll

  13. Feasibility of Adherence: Intervention Practice Prompts

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

    Numbers represent percentages of intervention practice prompts completed in mindfulness and coping groups [calculated as (average number of prompts completed / 42 total prompts among all participants in each group) * 100]. The original adherence benchmark was an average completion of >60% of prompts; reported percentages that are greater than that benchmark represent feasibility of intervention practice prompt adherence.

  14. Feasibility of Adherence: Ambulatory Assessments

    Time frame: assessed for 1 week at three time points: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

    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.

  15. Feasibility of Adherence: Mobile Sensor Data

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

    Numbers represent percentages of days on which wearable sensor (Fitbit) data and AWARE phone sensor data were collected in mindfulness and coping groups [calculated as (average number of days that Fitbit/AWARE data were collected / 56 days among all participants in each group) * 100]. The original adherence benchmark was collecting mobile sensor data on >75% of days; reported percentages that are greater than that benchmark represent feasibility of mobile sensor data collection adherence.

Secondary outcomes

  1. Change in Daily Life Positive Affect: State

    Time frame: change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

    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.

  2. Change in Daily Life Positive Affect: Daily

    Time frame: change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

    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.

  3. Change in Daily Life Negative Affect: State

    Time frame: change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

    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.

  4. Change in Daily Life Negative Affect: Daily

    Time frame: change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

    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.

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

    Time frame: change in interactions assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

    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.

  6. Change in Daily Life Social Interactions: Daily

    Time frame: change in interactions assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

    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.

  7. Change in Daily Life Mindfulness: Awareness

    Time frame: change in awareness assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

    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.

  8. Change in Daily Life Mindfulness: Acceptance

    Time frame: change in acceptance assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)

    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.

Other outcomes

  1. Passive Sensor Stress Models

    Time frame: collected continuously for 8 weeks

    Passive sensor data from smartphones (location, activity, screen status, battery, weather, time zone, communication) and wearable devices (heart rate, activity, sleep) combined to develop machine learning models predicting state stress

  2. Change in State Stress Following Intervention Practice

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

    State stress following intervention practice used to evaluate immediate benefit of practice delivered at high-stress moments

  3. Daily Stress Following Intervention Practice

    Time frame: daily stress across two-week intervention period

    End-of-day stress on days with intervention practice used to evaluate day-level benefit of practice delivered at high-stress moments

  4. Early Life Adversity: Childhood Trauma

    Time frame: pre-intervention

    Assessed via the Childhood Trauma Questionnaire (a 28-item scale with three 5-item abuse subscales - physical, sexual, and emotional abuse - ranging from 5-25, with higher scores indicating higher childhood trauma)

  5. Early Life Adversity: Emotional Neglect

    Time frame: pre-intervention

    Early Life Adversity assessed via the Childhood Experiences of Care and Abuse Inventory (a 16-item scale referencing mother and father figures, with an 8-item emotional neglect subscale ranging from 8-40, where higher scores indicate higher levels of emotional neglect)

  6. Early Life Adversity: Childhood SES Indexed Via Parental Education

    Time frame: pre-intervention

    Childhood SES indexed via parental educational attainment, ranging from less than high school education to doctoral degree (1 = No High School Diploma, 2 = GED, 3 = High School Diploma, 4 = Technical Training, 5 = Some College, no degree, 6 = Associate Degree, 7 = Bachelor's Degree, 8 = Master's Degree, 9 = MD, PhD, JD, or PharmD), with higher scores indicating higher educational attainment

  7. Early Life Adversity: Childhood SES Indexed by Government Food Assistance

    Time frame: pre-intervention

    Childhood SES assessed via National Comorbidity Survey: Adolescents item assessing government food assistance

  8. Early Life Adversity: Domestic Violence

    Time frame: pre-intervention

    Early Life Adversity assessed via Adverse Childhood Experiences Survey (using a 5-item domestic violence subscale, ranging from 0-10, with higher scores indicating higher levels of domestic violence)

  9. Change in Circulating Inflammatory Biomarkers: CRP

    Time frame: 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]

  10. Change in Circulating Inflammatory Biomarkers: TNF

    Time frame: 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]

  11. Change in Circulating Inflammatory Biomarkers: IL-8

    Time frame: 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]

  12. Change in Circulating Inflammatory Biomarkers: IL-10

    Time frame: 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]

  13. Change in Global Psychosocial Stress: Anxiety

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

    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

  14. Change in Global Psychosocial Stress: Depressive Symptoms

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

    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

  15. Change in Global Psychosocial Stress: Social Isolation

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

    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

  16. Change in Global Psychosocial Stress: Perceived Stress

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

    Assessed in-person via Perceived Stress Scale (a 10-item scale ranging from 0-40, with higher scores indicating higher perceived stress)

  17. Change in Global Psychosocial Stress: Trauma Symptoms

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

    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

  18. Change in Global Psychosocial Stress: Depersonalization

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

    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)

  19. Change in Sleep Quality

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

    Assessed in-person via Pittsburgh Sleep Quality Index (6-item short form, ranging from 0-12, with higher scores indicating worse sleep)

  20. Change in Global Psychosocial Resilience: Life Satisfaction

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

    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

  21. Change in Global Psychosocial Resilience: Positive Affect

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

    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

  22. Change in Global Psychosocial Resilience: Self-Efficacy

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

    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

  23. Change in Global Mindfulness

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

    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)

  24. Change in Global Experiential Avoidance

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

    Acceptance and Action Questionnaire-II (a 7-item scale ranging from 7-49, with higher scores indicating higher experiential avoidance)

  25. Change in Global Distress Tolerance

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

    Distress Tolerance Scale (a 15-item scale ranging from 1-5, with higher scores indicating higher distress tolerance)

  26. Change in Global Self-Compassion

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

    Self-Compassion Scale (a 25-item scale ranging from 1-5, with higher scores indicating higher self-compassion)

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Official study title

Smartphone-based Mindfulness Training for Health Following Early Life Adversity

Acronym: ReMind

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 25, 2022
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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