Phase 1
N=81
Remote Mindfulness Training Following Early Life Adversity
Stress · Mindfulness · Early Life Adversity
Bottom Line
View on ClinicalTrials.gov: NCT05516108 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Feasibility of Recruitment (Screened Eligible) — 81; 56; 112; 642 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Mindfulness (Behavioral); Coping (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Recruitment (Screened Eligible) |
81; 56; 112; 642 | — |
| PRIMARY Feasibility of Retention |
37; 34; 4; 5; 1; 0 | — |
| PRIMARY Feasibility of Adherence: Intervention Lessons |
94.57; 94.71 | — |
| PRIMARY Feasibility of Safe Implementation: Incidence of Treatment-emergent Increases in Mental Health Symptoms |
35; 34; 3; 0 | — |
| PRIMARY Acceptability: Treatment Expectancies |
95; 91; 92; 88 | — |
| PRIMARY Change in Daily Life Subjective Stress: State Perceived Stress |
2.48; 2.5; 2.56; 2.37; 2.46; 2.32 | .004 sig |
| PRIMARY Change in Daily Life Subjective Stress: Daily Perceived Stress |
3.01; 2.91; 3.19; 2.69; 2.90; 2.63 | .020 sig |
| PRIMARY Change in Daily Life Objective Stress: Stress Events in the Past 2.5 Hours |
22.71; 18.5; 15.84; 12.33; 15.31; 10.78 | .74 |
| PRIMARY Change in Daily Life Objective Stress: Daily Stress Events |
65.93; 51.52; 57.54; 47.75; 48.18; 46.08 | .10 |
| PRIMARY Change in Daily Life Physiological Stress Reactivity |
5.82; 4.77; 4.94; 6.49; 6.6; 5.80 | .009 sig |
| PRIMARY Change in Circulating Inflammatory Markers |
.365; .266; .343; .267; .344; .279 | — |
| PRIMARY Feasibility of Recruitment (Enrollment) |
81 | — |
| PRIMARY Feasibility of Adherence: Intervention Practice Prompts |
57.33; 60.34 | — |
| PRIMARY Feasibility of Adherence: Ambulatory Assessments |
86.28; 87.53 | — |
| PRIMARY Feasibility of Adherence: Mobile Sensor Data |
86.95; 86.40; 94.35; 91.61 | — |
| SECONDARY Change in Daily Life Positive Affect: State |
3.87; 3.77; 3.57; 3.80; 3.74; 3.75 | — |
| SECONDARY Change in Daily Life Positive Affect: Daily |
3.30; 3.34; 2.94; 3.32; 3.19; 3.36 | — |
| SECONDARY Change in Daily Life Negative Affect: State |
2.19; 2.06; 2.34; 1.96; 2.21; 1.93 | — |
| SECONDARY Change in Daily Life Negative Affect: Daily |
2.15; 1.99; 2.19; 1.88; 2.13; 1.82 | — |
| SECONDARY Change in Daily Life Social Interactions: Interactions in the Past 2.5 Hours |
2.79; 2.96; 3.09; 2.84; 3.30; 2.69 | — |
| SECONDARY Change in Daily Life Social Interactions: Daily |
12.69; 11.59; 13.60; 11.18; 14.61; 11.25 | — |
| SECONDARY Change in Daily Life Mindfulness: Awareness |
3.76; 3.70; 3.98; 4.10; 4.03; 4.10 | — |
| SECONDARY Change in Daily Life Mindfulness: Acceptance |
4.25; 4.35; 4.33; 4.74; 4.63; 4.82 | — |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05516108). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.