ReMind: Remote Mindfulness Training Following Early Life Adversity
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: Mindfulness
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.
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| Active Comparator: 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. |
Behavioral: Coping
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.
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Outcome Measures
Primary Outcome Measures
- Feasibility of recruitment [assessed pre-enrollment]
Recruitment benchmark: >10% of people screened will be eligible and >60% of those eligible will enroll
- Feasibility of retention [assessed across the entire 8-week study period]
Retention benchmark: >80% retention through intervention and >75% retention through follow-up
- 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
- 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
- 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: 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: 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 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)
- 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 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
- 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)
Secondary Outcome Measures
- 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 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 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: 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 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")
Other Outcome Measures
- Passive sensor stress models [collected continuously for 8 weeks]
Passive sensor data from smartphones (location, activity, screen status, battery, weather, time zone, communication) and wearable devices (heart rate, activity, sleep) combined to develop machine learning models predicting state stress
- Change in state stress following intervention practice [change from pre- to post-practice across two-week intervention period]
State stress following intervention practice used to evaluate immediate benefit of practice delivered at high-stress moments
- Daily stress following intervention practice [daily stress across two-week intervention period]
End-of-day stress on days with intervention practice used to evaluate day-level benefit of practice delivered at high-stress moments
- Early Life Adversity: Childhood Trauma [pre-intervention]
Assessed via the Childhood Trauma Questionnaire (a 28-item scale with 5 subscales - physical, sexual, and emotional abuse, and physical and emotional neglect - with higher scores indicating higher childhood trauma)
- Early Life Adversity: Emotional neglect [pre-intervention]
Early Life Adversity assessed via the Childhood Experiences of Care and Abuse Inventory (16-item scale in reference to mother and father figures, focused on 8-item emotional neglect subscale, with higher scores indicating higher levels of emotional neglect)
- Early Life Adversity: Childhood SES indexed by parental education [pre-intervention]
Childhood SES assessed via parental figure educational attainment (ranging from less than high school education to doctoral degree)
- Early Life Adversity: Childhood SES indexed government assistance [pre-intervention]
Childhood SES assessed via National Comorbidity Survey: Adolescents item assessing government food assistance
- Early Life Adversity: Domestic Violence [pre-intervention]
Early Life Adversity assessed via Adverse Childhood Experiences Survey (5-item domestic violence subscale, with higher scores indicating higher levels of domestic violence)
- Change in Circulating Inflammatory Biomarkers: CRP [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Circulating CRP assessed via dried blood spot (DBS) [additional funding needed to assess]
- Change in Circulating Inflammatory Biomarkers: TNF [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Circulating TNF assessed via dried blood spot (DBS) [additional funding needed to assess]
- Change in Circulating Inflammatory Biomarkers: IL-8 [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Circulating IL-8 assessed via dried blood spot (DBS) [additional funding needed to assess]
- Change in Circulating Inflammatory Biomarkers: IL-10 [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Circulating IL-10 assessed via dried blood spot (DBS) [additional funding needed to assess]
- Change in Global Psychosocial Stress: Anxiety [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Assessed via PROMIS Anxiety (a 4-item scale, with higher scores indicating higher anxiety)
- Change in Global Psychosocial Stress: Depressive Symptoms [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Assessed via PROMIS Depression (a 4-item scale with higher scores indicating higher depressive symptoms)
- Change in Global Psychosocial Stress: Social Isolation [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Assessed via PROMIS Social Isolation (a 14-item scale, with higher scores indicating higher social isolation)
- Change in Global Psychosocial Stress: Perceived Stress [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Assessed via Perceived Stress Scale (a 10-item scale, with higher scores indicating higher perceived stress)
- Change in Global Psychosocial Stress: Trauma Symptoms [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Assessed via Posttraumatic Stress Disorder Checklist-Civilian (a 17-item scale, with higher scores indicating higher levels of trauma)
- Change in Global Psychosocial Stress: Depersonalization [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Assessed via Cambridge Depersonalization Scale (a 29-item scale assessing frequency and duration of depersonalization symptoms, with higher scores indicating greater depersonalization)
- Change in Sleep Quality [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Assessed via Pittsburgh Sleep Quality Index (6-item short form, with higher scores indicating worse sleep)
- Change in Global Psychosocial Resilience: Life Satisfaction [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Assessed via PROMIS Life Satisfaction (a 5-item scale, with higher scores indicating higher life satisfaction)
- Change in Global Psychosocial Resilience: Positive Affect [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Assessed via PROMIS Positive Affect (a 15-item scale, with higher scores indicating higher positive affect)
- Change in Global Psychosocial Resilience: Self-Efficacy [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Assessed via PROMIS Self-efficacy (a 4-item scale, with higher scores indicating higher life self-efficacy)
- Change in Global Mindfulness [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Five Facet Mindfulness Questionnaire-Short Form (a 24-item scale with observing, describing, acting with awareness, nonreactivity, and nonjudgment subscales, with higher scores indicating higher mindfulness)
- Change in Global Experiential Avoidance [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Acceptance and Action Questionnaire-II (a 7-item scale, with higher scores indicating higher experiential avoidance)
- Change in Global Distress Tolerance [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Distress Tolerance Scale (a 15-item scale, with higher scores indicating lower distress tolerance)
- Change in Global Self-Compassion [change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)]
Self-Compassion Scale (a 25-item scale, with higher scores indicating higher self-compassion)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ages 18-29 years
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English speaking
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History of moderate-to-severe physical, emotional, or sexual abuse in childhood
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Data-enabled Android or iOS smartphone
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Able to meet study requirements
Exclusion Criteria:
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Self-reported diagnosis of chronic physical disease (e.g., cancer, HIV, heart disease, diabetes, bleeding disorder)
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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
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Substance use disorder
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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
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Current antibiotic, antiviral, or antimicrobial treatment
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Shift workers
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Pregnancy
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Regular systematic mind-body practice (>2 times per week)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- University of Pittsburgh
- National Institutes of Health (NIH)
- National Center for Complementary and Integrative Health (NCCIH)
Investigators
- Principal Investigator: Emily K Lindsay, PhD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY21030189
- K01AT011232