Remote Mindfulness Training Following Early Life Adversity

Study Overview
=================
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.

Official Title
-----------------
Smartphone-based Mindfulness Training for Health Following Early Life Adversity

Conditions
-----------------
Stress, Mindfulness, Early Life Adversity

Intervention / Treatment
-----------------
* Behavioral: Mindfulness
* Behavioral: Coping


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness<br>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. | Behavioral: Mindfulness<br>* The mindfulness intervention includes 14 daily 20-minute audio lessons plus brief daily practice prompts. Lessons train specific meditation techniques through didactic explanation and guided practice. Based on the Unified Mindfulness system, lessons train 3 mindfulness skills: concentration, sensory clarity, and equanimity. Concentration, a state of stable attention on the intended target, enables participants to monitor present-moment physical and emotional body experiences. Sensory clarity, the monitoring of momentary experiences, involves detecting subtle sensations and discriminating between different experiences. Equanimity, an attitude of acceptance toward momentary experiences, is trained through 3 strategies: (a) body relaxation, (b) mental welcoming, and (c) a gentle tone of voice. Practice prompts build on the skills trained in each lesson, encouraging participants to practice brief moments of mindful awareness, mindfulness while doing daily tasks, or formal meditation.<br>|
| Active Comparator: Coping<br>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. | Behavioral: Coping<br>* The coping intervention includes 14 daily 20-minute audio lessons plus brief daily practice prompts. Lessons train specific coping techniques through didactic explanation and guided practice. Lessons train coping skills (reflection, reappraisal, and problem solving) without encouraging focus on or acceptance of present experience (i.e., mindfulness skills). Participants are instructed to: (1) reflect and let their minds drift, (2) reframe or reappraise past and anticipated events, and (3) analyze and solve personal problems. Practice prompts build on the skills trained in each lesson, encouraging participants to take brief reflection breaks or to practice reappraisal or problem-solving skills.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruitment | Recruitment benchmark: >10% of people screened will be eligible and >60% of those eligible will enroll | assessed pre-enrollment | 
| Feasibility of retention | Retention benchmark: >80% retention through intervention and >75% retention through follow-up | assessed across the entire 8-week study period | 
| Feasibility of adherence | 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 | assessed across the entire 8-week study period | 
| 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 8-week study period | 
| 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 post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks) | 
| Change in Daily Life Subjective Stress: State Perceived Stress | State perceived stress assessed four times daily via Ecological Momentary Assessment (EMA) | 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) | 
| Change in Daily Life Subjective Stress: Daily Perceived Stress | Daily perceived stress assessed daily via end-of day diary | 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) | 
| Change in Daily Life Subjective Stress: Stress events in the past 2.5 hours | Stress events assessed four times daily via Ecological Momentary Assessment (EMA) | 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) | 
| Change in Daily Life Subjective Stress: Daily stress events | Daily stress events assessed daily via end-of day diary | 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) | 
| Change in Daily Life Physiological Stress Reactivity | Heart Rate (HR) measured continuously and analyzed in response to daily life stress assessed via EMA | 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) | 
| Change in Circulating Inflammatory Markers | Circulating IL-6 assessed via dried blood spot (DBS) | change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Daily Life Positive Affect: State | State positive affect assessed four times daily via Ecological Momentary Assessment (EMA) | 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) | 
| 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)) assessed daily via end-of day diary | 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) | 
| Change in Daily Life Negative Affect: State | State negative affect assessed four times daily via Ecological Momentary Assessment (EMA) | 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) | 
| 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)) assessed daily via end-of day diary | 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) | 
| Change in Daily Life Social Interactions: Interactions in the past 2.5 hours | Social interactions assessed four times daily via Ecological Momentary Assessment (EMA) | 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) | 
| Change in Daily Life Social Interactions: Daily | Social interactions assessed daily via end-of day diary | 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) | 
| Change in Daily Life Mindfulness: Awareness | 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 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) | 
| Change in Daily Life Mindfulness: Acceptance | 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) | 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) |