Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR) | Experimental | MBSR is a standardized curriculum-based group program. In this study, MBSR will be adapted to include 10 (rather than the standard 8) weekly 2.5-hour group sessions delivered online, plus a day-long online retreat and 30-45 minutes of home practice assignments six days per week. MBSR includes guided mindfulness meditations intended to foster awareness of present-moment experiences and an open, accepting, and nonjudgmental perspective. Guidance and group discussions also encourage nonjudgmental awareness in everyday life, including when experiencing stress or other challenging emotions. Group discussions involve exploration of habitual reactions to stress and the cultivation of skills such as pausing before responding. Foundationally, the course centers on self-care and group support, including support for the challenge of integrating meditation practice into daily life. Home practice recordings will guide participants through body awareness, mindful movement, and seated meditation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Daily Life Subjective Stress: State Perceived Stress | 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. | 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) |
| Change in Daily Life Subjective Stress: Daily Perceived Stress | 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. | 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) |
| Change in Daily Life Objective Stress: Stress Events in the Past 2.5 Hours | Stress events assessed on a binary scale (yes/no) in daily life four times per day for one week at 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Recruitment (Screened Eligible) | Recruitment benchmark: >10% of people screened will be eligible | assessed pre-enrollment |
| Feasibility of Recruitment (Enrollment) | Recruitment benchmark: >60% of those eligible will enroll |
| Measure | Description | Time Frame |
|---|---|---|
| Early Life Adversity: Childhood Trauma | Assessed via the Childhood Trauma Questionnaire (a 28-item scale with three 5-item abuse subscales - physical, sexual, and emotional abuse - ranging from 5-25, with higher scores indicating higher childhood trauma) | pre-intervention baseline laboratory assessment |
| Early Life Adversity: Emotional Neglect |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emily K Lindsay, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
There are no plans to share IPD from this small pilot study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 23, 2025 | Jul 2, 2025 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Change in Daily Life Objective Stress: Daily Stress Events | 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. | 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) |
| Change in Daily Life Physiological Stress Reactivity | Heart Rate (HR) measured continuously in daily life, with HR averaged in 30-minute windows around daily life stress reported via EMA up to four times per day for one week at 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). | 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) |
| assessed at enrollment |
| Feasibility of Retention | Retention benchmark: >80% retention through intervention and >75% retention through post-intervention assessments | assessed across the entire study period, approximately 14 weeks |
| Feasibility of Adherence: MBSR attendance | Adherence benchmark: average completion of at least 7 of 11 MBSR sessions | assessed across the entire 10-week intervention period |
| Feasibility of Adherence: Ambulatory Assessments | Adherence benchmark: average completion of >75% of ambulatory assessments | assessed for 1 week at two time points: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 11 weeks) |
| Feasibility of Adherence: Mobile Sensor Data | Adherence benchmark: collecting Fitbit sensor data on >75% of days | assessed for 1 week at two time points: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 11 weeks) |
| Feasibility of Safe Implementation: Incidence of Treatment-emergent Increases in Mental Health Symptoms | Safety benchmark: <10% of participants showing substantial (>2SD) increases in anxiety, trauma, or depressive symptoms (using PROMIS Anxiety and Depression scales and Posttraumatic Stress Disorder Checklist-Civilian scale described in other outcomes below) combined to create treatment-emergent symptom rate | assessed across the entire study period, approximately 14 weeks |
| Acceptability: Treatment Expectancies | Acceptability of interventions, with benchmark of >80% of participants giving positive ratings of treatment expectancies (>3 on 6-item Credibility/Expectancy Questionnaire) | assessed in-person at post-intervention laboratory assessment (an average of 13 weeks) |
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) |
| pre-intervention baseline laboratory assessment |
| Early Life Adversity: Childhood SES Indexed Via Parental Education | Childhood SES indexed via parental educational attainment, ranging from less than high school education to doctoral degree (1 = No High School Diploma, 2 = GED, 3 = High School Diploma, 4 = Technical Training, 5 = Some College, no degree, 6 = Associate Degree, 7 = Bachelor's Degree, 8 = Master's Degree, 9 = MD, PhD, JD, or PharmD), with higher scores indicating higher educational attainment | pre-intervention baseline laboratory assessment |
| Early Life Adversity: Childhood SES Indexed by Government Food Assistance | Childhood SES assessed via National Comorbidity Survey: Adolescents item assessing government food assistance | pre-intervention baseline laboratory assessment |
| Early Life Adversity: Domestic Violence | Early Life Adversity assessed via Adverse Childhood Experiences Survey (using a 5-item domestic violence subscale, ranging from 0-10, with higher scores indicating higher levels of domestic violence) | pre-intervention baseline laboratory assessment |
| Change in Circulating Inflammatory Markers (IL-6) | Circulating IL-6 assessed via dried blood spot (DBS) [additional funding needed to assess] | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Circulating Inflammatory Markers (IL-10) | Circulating IL-10 assessed via dried blood spot (DBS) [additional funding needed to assess] | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Circulating Inflammatory Markers (TNF) | Circulating TNF assessed via dried blood spot (DBS) [additional funding needed to assess] | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Circulating Inflammatory Markers (uPAR) | Circulating uPAR assessed via dried blood spot (DBS) [additional funding needed to assess] | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Circulating Inflammatory Markers (CRP) | Circulating CRP assessed via dried blood spot (DBS) [additional funding needed to assess] | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Daily Life Positive Affect: State | 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. | 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) |
| Change in Daily Life Positive Affect: Daily | Daily positive affect (composite of 9 positive affect items across 3 subscales: happiness (happy, pleased, and cheerful), calm (calm, at-ease, and relaxed), and vigor (lively, full-of-pep, and energetic), each assessed on a 1-7 Likert scale) assessed in daily life each evening for one week at 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. | 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) |
| Change in Daily Life Negative Affect: State | 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. | 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) |
| Change in Daily Life Negative Affect: Daily | Daily negative affect (composite of 9 negative affect items across 3 subscales: anxiety (on edge, nervous, and tense), depression (sad, depressed, and unhappy), and hostility (hostile, resentful, and angry), each assessed on a 1-7 Likert scale) assessed in daily life each evening for one week at 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. | 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) |
| Change in Daily Life Social Interactions: Interactions in the Past 2.5 Hours | Number of social interactions assessed in daily life four times per day for one week at 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. | 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) |
| Change in Daily Life Social Interactions: Daily | 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. | 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) |
| Change in Daily Life Mindfulness: Awareness | Mindful awareness (composite 3-item scale: "Today, I paid attention to what I was doing in the present moment" / "Today, I noticed body sensations come and go" / "Today, I noticed pleasant and unpleasant thoughts and emotions", each item assessed on a 1-7 Likert scale) assessed in daily life each evening for one week at 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. | 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) |
| Change in Daily Life Mindfulness: Acceptance | Mindful acceptance (composite 2-item scale: "Today, I was able to step back and be aware of distressing thoughts, emotions, and sensations, without being taken over by them" / "Today, I did not want to feel the way I was feeling", each item assessed on a 1-7 Likert scale) assessed in daily life each evening for one week at 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. | 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) |
| Change in Global Psychosocial Stress: Anxiety | Assessed in-person via PROMIS Anxiety, a 4-item scale with raw scores ranging from 4-20 and converted to t-scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t- scores indicating higher anxiety | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Global Psychosocial Stress: Depressive Symptoms | Assessed in-person via PROMIS Depression, a 4-item scale with raw scores ranging from 4-20 and converted to t- scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher depressive symptoms | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Global Psychosocial Stress: Trauma Symptoms | Assessed in-person via Post-Traumatic Stress Disorder Checklist for Civilians (PCL-C), a 17-item scale ranging from 17-85, with higher scores indicating higher levels of trauma, and scores of 30 or greater indicating at least moderately severe PTSD symptoms | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Global Psychosocial Stress: Depersonalization | Assessed in-person via Cambridge Depersonalization Scale (a 29-item scale ranging from 0-116, assessing frequency and duration of depersonalization symptoms, with higher scores indicating greater depersonalization) | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Global Psychosocial Stress: Perceived Stress | Assessed in-person via Perceived Stress Scale (a 10-item scale ranging from 0-40, with higher scores indicating higher perceived stress) | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Global Psychosocial Stress: Social Isolation | Assessed in-person via PROMIS Social Isolation, a 14-item scale with raw scores ranging from 14 to 70 and converted to t-scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher social isolation | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Sleep Quality | Assessed in-person via Pittsburgh Sleep Quality Index (6-item short form, ranging from 0-12, with higher scores indicating worse sleep) | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Global Psychosocial Resilience: Life Satisfaction | Assessed in-person via PROMIS Life Satisfaction, a 5-item scale with raw scores ranging from 5-35 and converted to t- scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher life satisfaction | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Global Psychosocial Resilience: Positive Affect | Assessed in-person via PROMIS Positive Affect, a 15-item scale with raw scores ranging from 15-75 and converted to t-scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher positive affect | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Global Psychosocial Resilience: Self-Efficacy | Assessed in-person via PROMIS Self-Efficacy, a 4-item scale with raw scores ranging from 4-20 and converted to t- scores, with t-scores of 50 (standard deviation = 10) representing the average for the US general population and higher t-scores indicating higher self-efficacy | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Global Mindfulness | Five Facet Mindfulness Questionnaire-Short Form (a 24-item scale including five subscales - observing, describing, acting with awareness, nonreactivity, and nonjudgment, with average scores ranging from 1-5 and higher scores indicating higher mindfulness) | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Global Experiential Avoidance | Acceptance and Action Questionnaire-II (a 7-item scale ranging from 7-49, with higher scores indicating higher experiential avoidance) | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Global Distress Tolerance | Distress Tolerance Scale (a 15-item scale ranging from 1-5, with higher scores indicating higher distress tolerance) | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Global Self-Compassion | Self-Compassion Scale (a 25-item scale ranging from 1-5, with higher scores indicating higher self-compassion) | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| Change in Global Interoceptive Awareness | 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) | change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 13 weeks) |
| D004191 |
| Behavioral Disciplines and Activities |