Clinical trial NCT05516108: Remote Mindfulness Training Following Early Life Adversity
Official title: Smartphone-based Mindfulness Training for Health Following Early Life Adversity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stress
Mindfulness
Early Life Adversity
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-08-25
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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)

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: assessed pre-enrollment
measure: Feasibility of retention
timeFrame: assessed across the entire 8-week study period
measure: Feasibility of adherence
timeFrame: assessed across the entire 8-week study period
measure: Feasibility of safe implementation: Incidence of treatment-emergent increases in mental health symptoms
timeFrame: assessed across the entire 8-week study period
measure: Acceptability: Treatment Expectancies
timeFrame: assessed post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Daily Life Subjective Stress: State Perceived Stress
timeFrame: 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)
measure: Change in Daily Life Subjective Stress: Daily Perceived Stress
timeFrame: 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)
measure: Change in Daily Life Subjective Stress: Stress events in the past 2.5 hours
timeFrame: 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)
measure: Change in Daily Life Subjective Stress: Daily stress events
timeFrame: 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)
measure: Change in Daily Life Physiological Stress Reactivity
timeFrame: 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)
measure: Change in Circulating Inflammatory Markers
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Secondary outcomes:
measure: Change in Daily Life Positive Affect: State
timeFrame: 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)
measure: Change in Daily Life Positive Affect: Daily
timeFrame: 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)
measure: Change in Daily Life Negative Affect: State
timeFrame: 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)
measure: Change in Daily Life Negative Affect: Daily
timeFrame: 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)
measure: Change in Daily Life Social Interactions: Interactions in the past 2.5 hours
timeFrame: 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)
measure: Change in Daily Life Social Interactions: Daily
timeFrame: 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)
measure: Change in Daily Life Mindfulness: Awareness
timeFrame: 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)
measure: Change in Daily Life Mindfulness: Acceptance
timeFrame: 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)
Other outcomes:
measure: Passive sensor stress models
timeFrame: collected continuously for 8 weeks
measure: Change in state stress following intervention practice
timeFrame: change from pre- to post-practice across two-week intervention period
measure: Daily stress following intervention practice
timeFrame: daily stress across two-week intervention period
measure: Early Life Adversity: Childhood Trauma
timeFrame: pre-intervention
measure: Early Life Adversity: Emotional neglect
timeFrame: pre-intervention
measure: Early Life Adversity: Childhood SES indexed by parental education
timeFrame: pre-intervention
measure: Early Life Adversity: Childhood SES indexed government assistance
timeFrame: pre-intervention
measure: Early Life Adversity: Domestic Violence
timeFrame: pre-intervention
measure: Change in Circulating Inflammatory Biomarkers: CRP
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Circulating Inflammatory Biomarkers: TNF
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Circulating Inflammatory Biomarkers: IL-8
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Circulating Inflammatory Biomarkers: IL-10
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Global Psychosocial Stress: Anxiety
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Global Psychosocial Stress: Depressive Symptoms
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Global Psychosocial Stress: Social Isolation
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Global Psychosocial Stress: Perceived Stress
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Global Psychosocial Stress: Trauma Symptoms
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Global Psychosocial Stress: Depersonalization
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Sleep Quality
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Global Psychosocial Resilience: Life Satisfaction
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Global Psychosocial Resilience: Positive Affect
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Global Psychosocial Resilience: Self-Efficacy
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Global Mindfulness
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Global Experiential Avoidance
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Global Distress Tolerance
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
measure: Change in Global Self-Compassion
timeFrame: change from pre-intervention to post-intervention (an average of 4 weeks) and one-month follow-up (an average of 8 weeks)
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Emily K Lindsay, PhD
role: PRINCIPAL_INVESTIGATOR
References: