Remote Mindfulness Training Following Early Life Adversity

Stress Clinical Trial

— ReMind  

Official title:

Smartphone-based Mindfulness Training for Health Following Early Life Adversity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05516108
• Other study ID #: STUDY21030189
• Secondary ID: K01AT011232
• Status: Recruiting
• Phase: Phase 1
• Start date: September 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: University of Pittsburgh
• Contact: Emily K Lindsay, PhD
• Phone: 724-361-3157
• Email: emily.lindsay[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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)

Related Conditions & MeSH terms

• Early Life Adversity
• Mindfulness
• Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Passive sensor stress models	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	collected continuously for 8 weeks
Other	Change in state stress following intervention practice	State stress following intervention practice used to evaluate immediate benefit of practice delivered at high-stress moments	change from pre- to post-practice across two-week intervention period
Other	Daily stress following intervention practice	End-of-day stress on days with intervention practice used to evaluate day-level benefit of practice delivered at high-stress moments	daily stress across two-week intervention period
Other	Early Life Adversity: Childhood Trauma	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)	pre-intervention
Other	Early Life Adversity: Emotional neglect	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)	pre-intervention
Other	Early Life Adversity: Childhood SES indexed by parental education	Childhood SES assessed via parental figure educational attainment (ranging from less than high school education to doctoral degree)	pre-intervention
Other	Early Life Adversity: Childhood SES indexed government assistance	Childhood SES assessed via National Comorbidity Survey: Adolescents item assessing government food assistance	pre-intervention
Other	Early Life Adversity: Domestic Violence	Early Life Adversity assessed via Adverse Childhood Experiences Survey (5-item domestic violence subscale, with higher scores indicating higher levels of domestic violence)	pre-intervention
Other	Change in Circulating Inflammatory Biomarkers: CRP	Circulating CRP assessed via dried blood spot (DBS) [additional funding needed to assess]	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Circulating Inflammatory Biomarkers: TNF	Circulating TNF assessed via dried blood spot (DBS) [additional funding needed to assess]	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Circulating Inflammatory Biomarkers: IL-8	Circulating IL-8 assessed via dried blood spot (DBS) [additional funding needed to assess]	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Circulating Inflammatory Biomarkers: IL-10	Circulating IL-10 assessed via dried blood spot (DBS) [additional funding needed to assess]	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Global Psychosocial Stress: Anxiety	Assessed via PROMIS Anxiety (a 4-item scale, with higher scores indicating higher anxiety)	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Global Psychosocial Stress: Depressive Symptoms	Assessed via PROMIS Depression (a 4-item scale with higher scores indicating higher depressive symptoms)	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Global Psychosocial Stress: Social Isolation	Assessed via PROMIS Social Isolation (a 14-item scale, with higher scores indicating higher social isolation)	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Global Psychosocial Stress: Perceived Stress	Assessed via Perceived Stress Scale (a 10-item scale, with higher scores indicating higher perceived stress)	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Global Psychosocial Stress: Trauma Symptoms	Assessed via Posttraumatic Stress Disorder Checklist-Civilian (a 17-item scale, with higher scores indicating higher levels of trauma)	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Global Psychosocial Stress: Depersonalization	Assessed via Cambridge Depersonalization Scale (a 29-item scale assessing frequency and duration of depersonalization symptoms, with higher scores indicating greater depersonalization)	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Sleep Quality	Assessed via Pittsburgh Sleep Quality Index (6-item short form, with higher scores indicating worse sleep)	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Global Psychosocial Resilience: Life Satisfaction	Assessed via PROMIS Life Satisfaction (a 5-item scale, with higher scores indicating higher life satisfaction)	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Global Psychosocial Resilience: Positive Affect	Assessed via PROMIS Positive Affect (a 15-item scale, with higher scores indicating higher positive affect)	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Global Psychosocial Resilience: Self-Efficacy	Assessed via PROMIS Self-efficacy (a 4-item scale, with higher scores indicating higher life self-efficacy)	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Global Mindfulness	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 from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Global Experiential Avoidance	Acceptance and Action Questionnaire-II (a 7-item scale, with higher scores indicating higher experiential avoidance)	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Global Distress Tolerance	Distress Tolerance Scale (a 15-item scale, with higher scores indicating lower distress tolerance)	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Other	Change in Global Self-Compassion	Self-Compassion Scale (a 25-item scale, with higher scores indicating higher self-compassion)	change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Primary	Feasibility of recruitment	Recruitment benchmark: >10% of people screened will be eligible and >60% of those eligible will enroll	assessed pre-enrollment
Primary	Feasibility of retention	Retention benchmark: >80% retention through intervention and >75% retention through follow-up	assessed across the entire 8-week study period
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)