Stress Clinical Trial
— ReMindOfficial title:
Smartphone-based Mindfulness Training for Health Following Early Life Adversity
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH) |
United States,
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) |
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