University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
NCT Number: NCT07085052
This pilot study aims to evaluate the effects of a 10-week online Mindfulness-Based Stress Reduction (MBSR) intervention on stress and inflammatory outcomes in a sample of emerging adults with a history of early life adversity. 15 participants (ages 18-29) with a history of childhood trauma will receive online, group-based MBSR sessions over 10 weeks. At pre- and post-intervention, participants will complete laboratory assessments, including self-report questionnaires and blood sample collection to assess markers of inflammation. Data assessing subjective and physiological stress in daily life will be collected for one week at pre- and post-intervention. This preliminary data will be used to test effects of online MBSR on health-relevant outcomes among young adults with a history of childhood trauma.
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Notify Me18 year–29 year
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15213, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10-week online MBSR program, involving 10 weekly 2.5-hour group sessions, a day-long online retreat, and approximately 45 minutes of home practice assignments six days per week.
Time frame: change in stress assessed in daily life for 1 week at two timepoints: pre-intervention ambulatory assessment and post-intervention ambulatory assessment (an average of 11 weeks)
State perceived stress assessed in daily life four times per day for one week at two time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the two time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment) will be averaged in MLM analyses. Stress will be assessed on a 1-7 Likert scale, with higher scores indicating higher perceived stress.
Time frame: change in stress assessed in daily life for 1 week at two timepoints: pre-intervention ambulatory assessment and post-intervention ambulatory assessment (an average of 11 weeks)
Daily perceived stress assessed in daily life each evening for one week at two time points via end-of day diary, totaling up to 7 assessments at each time point. All 7 assessments at each of the two time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment) will be averaged in MLM analyses. Stress will be assessed on a 1-7 Likert scale, with higher scores indicating higher perceived stress.
Time frame: change in stress assessed in daily life for 1 week at two timepoints: pre-intervention ambulatory assessment and post-intervention ambulatory assessment (an average of 11 weeks)
Stress events assessed on a binary scale (yes/no) in daily life four times per day for one week at two time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the two time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment) will be averaged in logistic MLM analyses. Outcomes will be reported as mean percentage of surveys at each time point that stress events were endorsed, with higher percentages indicating more stress events.
Time frame: change in stress assessed in daily life for 1 week at two timepoints: pre-intervention ambulatory assessment and post-intervention ambulatory assessment (an average of 11 weeks)
Daily stress events assessed in daily life each evening for one week at two time points via end-of day diary, totaling up to 7 assessments at each time point. All 7 assessments at each of the two time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment) will be averaged in logistic MLM analyses. Outcomes will be reported as mean percentage of days at each time point that stress events were endorsed, with higher percentages indicating more stress events.
Time frame: change in HR reactivity assessed in daily life for 1 week at two timepoints: pre-intervention ambulatory assessment and post-intervention ambulatory assessment (an average of 11 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 two time points, totaling up to 28 windows at each time point. All (up to) 28 assessments at each of the two time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment) will be averaged in MLM analyses. Higher scores indicate higher HR in beats per minute (relative to an individual's average daily HR) at high stress moments (relative to an individual's average perceived stress).
Time frame: assessed pre-enrollment
Recruitment benchmark: >10% of people screened will be eligible
Time frame: assessed at enrollment
Recruitment benchmark: >60% of those eligible will enroll
Time frame: assessed across the entire study period, approximately 14 weeks
Retention benchmark: >80% retention through intervention and >75% retention through post-intervention assessments
Time frame: assessed across the entire 10-week intervention period
Adherence benchmark: average completion of at least 7 of 11 MBSR sessions
Time frame: assessed for 1 week at two time points: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 11 weeks)
Adherence benchmark: average completion of >75% of ambulatory assessments
Time frame: assessed for 1 week at two time points: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 11 weeks)
Adherence benchmark: collecting Fitbit sensor data on >75% of days
Time frame: assessed across the entire study period, approximately 14 weeks
Safety benchmark: <10% of participants showing substantial (>2SD) increases in anxiety, trauma, or depressive symptoms (using PROMIS Anxiety and Depression scales and Posttraumatic Stress Disorder Checklist-Civilian scale described in other outcomes below) combined to create treatment-emergent symptom rate
Time frame: assessed in-person at post-intervention laboratory assessment (an average of 13 weeks)
Acceptability of interventions, with benchmark of >80% of participants giving positive ratings of treatment expectancies (>3 on 6-item Credibility/Expectancy Questionnaire)
Time frame: pre-intervention baseline laboratory assessment
Assessed via the Childhood Trauma Questionnaire (a 28-item scale with three 5-item abuse subscales - physical, sexual, and emotional abuse - ranging from 5-25, with higher scores indicating higher childhood trauma)
Time frame: pre-intervention baseline laboratory assessment
Early Life Adversity assessed via the Childhood Experiences of Care and Abuse Inventory (a 16-item scale separated into 8-item mother and father figure emotional neglect subscales ranging from 8-40, with higher scores indicating higher levels of emotional neglect)
Time frame: pre-intervention baseline laboratory assessment
Childhood SES indexed via parental educational attainment, ranging from less than high school education to doctoral degree (1 = No High School Diploma, 2 = GED, 3 = High School Diploma, 4 = Technical Training, 5 = Some College, no degree, 6 = Associate Degree, 7 = Bachelor's Degree, 8 = Master's Degree, 9 = MD, PhD, JD, or PharmD), with higher scores indicating higher educational attainment
Time frame: pre-intervention baseline laboratory assessment
Childhood SES assessed via National Comorbidity Survey: Adolescents item assessing government food assistance
Time frame: pre-intervention baseline laboratory assessment
Early Life Adversity assessed via Adverse Childhood Experiences Survey (using a 5-item domestic violence subscale, ranging from 0-10, with higher scores indicating higher levels of domestic violence)
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks)
Circulating IL-6 assessed via dried blood spot (DBS) [additional funding needed to assess]
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks)
Circulating IL-10 assessed via dried blood spot (DBS) [additional funding needed to assess]
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks)
Circulating TNF assessed via dried blood spot (DBS) [additional funding needed to assess]
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks)
Circulating uPAR assessed via dried blood spot (DBS) [additional funding needed to assess]
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks)
Circulating CRP assessed via dried blood spot (DBS) [additional funding needed to assess]
Time frame: change in affect assessed in daily life for 1 week at two timepoints: pre-intervention ambulatory assessment and post-intervention ambulatory assessment (an average of 11 weeks)
State positive affect assessed in daily life four times per day for one week at two time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the two time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment) will be averaged in MLM analyses. Positive affect will be assessed on a 1-7 Likert scale, with higher scores indicating higher positive affect.
Time frame: change in affect assessed in daily life for 1 week at two timepoints: pre-intervention ambulatory assessment and post-intervention ambulatory assessment (an average of 11 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 two time points via end-of day diary, totaling up to 7 scores at each time point. All 7 composite scores at each of the two time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment) will be averaged in MLM analyses. Higher scores reflect higher positive affect.
Time frame: change in affect assessed in daily life for 1 week at two timepoints: pre-intervention ambulatory assessment and post-intervention ambulatory assessment (an average of 11 weeks)
State negative affect assessed in daily life four times per day for one week at two time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the two time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment) will be averaged in MLM analyses. Negative affect will be assessed on a 1-7 Likert scale, with higher scores indicating higher negative affect.
Time frame: change in affect assessed in daily life for 1 week at two timepoints: pre-intervention ambulatory assessment and post-intervention ambulatory assessment (an average of 11 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 two time points via end-of day diary, totaling up to 7 scores at each time point. All 7 composite scores at each of the two time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment) will be averaged in MLM analyses. Higher scores reflect higher negative affect.
Time frame: change in interactions assessed in daily life for 1 week at two timepoints: pre-intervention ambulatory assessment and post-intervention ambulatory assessment (an average of 11 weeks)
Number of social interactions assessed in daily life four times per day for one week at two time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the two time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment) will be averaged in MLM analyses. Higher numbers indicate more social interactions.
Time frame: change in interactions assessed in daily life for 1 week at two timepoints: pre-intervention ambulatory assessment and post-intervention ambulatory assessment (an average of 11 weeks)
Number of social interactions assessed in daily life each evening for one week at two time points via end-of day diary, totaling up to 7 assessments at each time point. All 7 assessments at each of the two time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment) will be averaged in MLM analyses. Higher numbers indicate more social interactions.
Time frame: change in awareness assessed in daily life for 1 week at two timepoints: pre-intervention ambulatory assessment and post-intervention ambulatory assessment (an average of 11 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 two time points via end- of-day diary, totaling up to 7 scores at each time point. All 7 composite scores at each of the two time points (pre- intervention ambulatory assessment, post-intervention ambulatory assessment) will be averaged in MLM analyses. Higher composite scores reflect higher mindful awareness.
Time frame: change in acceptance assessed in daily life for 1 week at two timepoints: pre-intervention ambulatory assessment and post-intervention ambulatory assessment (an average of 11 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 two time points via end- of-day diary, totaling up to 7 scores at each time point. All 7 composite scores at each of the two time points (pre- intervention ambulatory assessment, post-intervention ambulatory assessment) will be averaged in MLM analyses. Higher composite scores reflect higher acceptance.
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 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
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 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
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 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
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 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)
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks)
Assessed in-person via Perceived Stress Scale (a 10-item scale ranging from 0-40, with higher scores indicating higher perceived stress)
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 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
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks)
Assessed in-person via Pittsburgh Sleep Quality Index (6-item short form, ranging from 0-12, with higher scores indicating worse sleep)
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 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
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 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
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 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
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 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)
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks)
Acceptance and Action Questionnaire-II (a 7-item scale ranging from 7-49, with higher scores indicating higher experiential avoidance)
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks)
Distress Tolerance Scale (a 15-item scale ranging from 1-5, with higher scores indicating higher distress tolerance)
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks)
Self-Compassion Scale (a 25-item scale ranging from 1-5, with higher scores indicating higher self-compassion)
Time frame: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks)
Multidimensional Assessment of Interoceptive Awareness Scale (a 32-item scale comprised of eight subscales [Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting] ranging from 0-5, with higher scores indicating greater interoceptive awareness)
University of Pittsburgh
Other
Remote Mindfulness Study 2
Acronym: ReMind 2
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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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