Remote Mindfulness Training Following Early Life Adversity 2

Not Applicable

Recruiting

• Conditions: Stress; Mindfulness; Early Life Adversity

• Registration Number: NCT07085052
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-03
• Study Start: 2025-07-15
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-25
• Last Update Posted: 2025-07-25
• Primary Completion: 2025-12-23
• Study Completion: 2025-12-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Ages 18-29 years
• English speaking
• History of adverse childhood experiences (specifically, moderate-to-severe physical, emotional, or sexual abuse in childhood: scoring >9, >12, or >7 on respective Childhood Trauma Questionnaire subscales)
• 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
• 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
• Substance use disorder
• Regular systematic mind-body practice (>2 times per week)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Daily Life Subjective Stress: State 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)	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 Daily Life Subjective Stress: Daily 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)	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 Daily Life Objective Stress: Stress Events in the Past 2.5 Hours	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.
Change in Daily Life Objective Stress: Daily 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)	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 Daily Life Physiological Stress Reactivity	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).

Secondary Outcome Measures

Name	Time	Method
Feasibility of Recruitment (Screened Eligible)	assessed pre-enrollment	Recruitment benchmark: \>10% of people screened will be eligible
Feasibility of Recruitment (Enrollment)	assessed at enrollment	Recruitment benchmark: \>60% of those eligible will enroll
Feasibility of Retention	assessed across the entire study period, approximately 14 weeks	Retention benchmark: \>80% retention through intervention and \>75% retention through post-intervention assessments
Feasibility of Adherence: MBSR attendance	assessed across the entire 10-week intervention period	Adherence benchmark: average completion of at least 7 of 11 MBSR sessions
Feasibility of Adherence: Ambulatory Assessments	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
Feasibility of Adherence: Mobile Sensor Data	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
Feasibility of Safe Implementation: Incidence of Treatment-emergent Increases in Mental Health Symptoms	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
Acceptability: Treatment Expectancies	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)

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States