Remote Mindfulness Training Following Early Life Adversity 2

NCT07085052 | Completed

• 1 other identifier: STUDY25020112
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Mindfulness; Early Life Adversity

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

Secondary Outcomes (8)

• Feasibility of Recruitment (Screened Eligible)

  assessed pre-enrollment

• Feasibility of Recruitment (Enrollment)

  assessed at enrollment

• Feasibility of Retention

  assessed across the entire study period, approximately 14 weeks

• Feasibility of Adherence: MBSR attendance

  assessed across the entire 10-week intervention period

• 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)

Other Outcomes (33)

• Early Life Adversity: Childhood Trauma

  pre-intervention baseline laboratory assessment

• Early Life Adversity: Emotional Neglect

  pre-intervention baseline laboratory assessment

• Early Life Adversity: Childhood SES Indexed Via Parental Education

  pre-intervention baseline laboratory assessment

Study Arms (1)

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.

Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Interventions

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.

Mindfulness-Based Stress Reduction (MBSR)

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Emily K Lindsay, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 25, 2025
• Study Start: July 15, 2025
• Primary Completion: December 16, 2025
• Study Completion: December 16, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)