Remote Mindfulness Training Following Early Life Adversity
- Conditions
- StressMindfulnessEarly Life Adversity
- Interventions
- Behavioral: MindfulnessBehavioral: Coping
- Registration Number
- NCT05516108
- Lead Sponsor
- University of Pittsburgh
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindfulness Mindfulness Mindfulness intervention involving 14 foundational audio-guided lessons plus daily brief practice prompts. Lessons train meditation techniques for 3 mindfulness skills: concentration, sensory clarity, and equanimity. Practice prompts delivered 3x daily build on the skills trained in each lesson. Coping Coping Coping intervention involving 14 foundational audio-guided lessons plus daily brief practice prompts. Lessons train techniques for 3 coping skills: reflection, reappraisal, and problem solving. Practice prompts delivered 3x daily build on the skills trained in each lesson.
- Primary Outcome Measures
Name Time Method Feasibility of safe implementation: Incidence of treatment-emergent increases in mental health symptoms assessed across the entire 8-week study period 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
Feasibility of recruitment assessed pre-enrollment Recruitment benchmark: \>10% of people screened will be eligible and \>60% of those eligible will enroll
Change in Daily Life Physiological Stress Reactivity change in HR reactivity assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks) Heart Rate (HR) measured continuously and analyzed in response to daily life stress assessed via EMA
Feasibility of retention assessed across the entire 8-week study period Retention benchmark: \>80% retention through intervention and \>75% retention through follow-up
Acceptability: Treatment Expectancies assessed post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks) Acceptability of interventions, with benchmark of \>80% of participants giving positive ratings of treatment expectancies (\>3 on 6-item Credibility/Expectancy Questionnaire)
Change in Daily Life Subjective Stress: Daily stress events change in stress assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks) Daily stress events assessed daily via end-of day diary
Change in Daily Life Subjective Stress: Daily Perceived Stress change in stress assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks) Daily perceived stress assessed daily via end-of day diary
Change in Circulating Inflammatory Markers change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks) Circulating IL-6 assessed via dried blood spot (DBS)
Feasibility of adherence assessed across the entire 8-week study period Adherence benchmark: average completion of \>85% of intervention lessons, \>60% of practice prompts, \>75% of ambulatory assessments, and mobile sensor data on \>75% of days
Change in Daily Life Subjective Stress: State Perceived Stress change in stress assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks) State perceived stress assessed four times daily via Ecological Momentary Assessment (EMA)
Change in Daily Life Subjective Stress: Stress events in the past 2.5 hours change in stress assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks) Stress events assessed four times daily via Ecological Momentary Assessment (EMA)
- Secondary Outcome Measures
Name Time Method Change in Daily Life Positive Affect: Daily change in affect assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 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)) assessed daily via end-of day diary
Change in Daily Life Negative Affect: State change in affect assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks) State negative affect assessed four times daily via Ecological Momentary Assessment (EMA)
Change in Daily Life Social Interactions: Interactions in the past 2.5 hours change in interactions assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks) Social interactions assessed four times daily via Ecological Momentary Assessment (EMA)
Change in Daily Life Positive Affect: State change in affect assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks) State positive affect assessed four times daily via Ecological Momentary Assessment (EMA)
Change in Daily Life Negative Affect: Daily change in affect assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 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)) assessed daily via end-of day diary
Change in Daily Life Social Interactions: Daily change in interactions assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks) Social interactions assessed daily via end-of day diary
Change in Daily Life Mindfulness: Awareness change in mindfulness assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks) Mindful awareness assessed via end-of-day diary using 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")
Change in Daily Life Mindfulness: Acceptance change in mindfulness assessed for 1 week at three timepoints: pre-intervention, post-intervention (an average of 3 weeks), and one-month follow-up (an average of 7 weeks) Mindful acceptance assessed via end-of-day diary using 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")
Trial Locations
- Locations (1)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States