Smartphone-based Mindfulness Training for Health Following Early Life Adversity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Feasibility of Adherence: Mobile Sensor Data
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Feasibility of Adherence: Mobile Sensor Data
时间窗: assessed across the entire 8-week study period
Numbers represent percentages of days on which wearable sensor (Fitbit) data and AWARE phone sensor data were collected in mindfulness and coping groups \[calculated as (average number of days that Fitbit/AWARE data were collected / 56 days among all participants in each group) \* 100\]. The original adherence benchmark was collecting mobile sensor data on \>75% of days; reported percentages that are greater than that benchmark represent feasibility of mobile sensor data collection adherence.
Feasibility of Recruitment (Screened Eligible)
时间窗: assessed pre-enrollment
Recruitment benchmark: \>10% of people screened will be eligible
Feasibility of Retention
时间窗: assessed across the entire 8-week study period
Retention benchmark: \>80% retention through intervention and \>75% retention through follow-up
Feasibility of Adherence: Intervention Lessons
时间窗: assessed across the entire 2-week intervention period
Numbers represent percentages of intervention lessons completed in mindfulness and coping groups \[calculated as (average number of lessons completed / 14 total lessons among all participants in each group) \* 100\]. The original adherence benchmark was an average completion of \>85% of intervention lessons; reported percentages that are greater than that benchmark represent feasibility of intervention adherence.
Feasibility of Safe Implementation: Incidence of Treatment-emergent Increases in Mental Health Symptoms
时间窗: 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
时间窗: assessed in-person at post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (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
时间窗: change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)
State perceived stress assessed in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Stress was assessed on a 1-7 Likert scale, with higher scores indicating higher perceived stress.
Change in Daily Life Subjective Stress: Daily Perceived Stress
时间窗: change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)
Daily perceived stress assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 assessments at each time point. All 7 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Stress was assessed on a 1-7 Likert scale, with higher scores indicating higher perceived stress.
Change in Daily Life Objective Stress: Stress Events in the Past 2.5 Hours
时间窗: change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)
Stress events assessed on a binary scale (yes/no) in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in logistic MLM analyses. Outcomes are reported as mean percentage of surveys at each time point that stress events were endorsed, with higher percentages indicating more stress events.
Change in Daily Life Objective Stress: Daily Stress Events
时间窗: change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)
Daily stress events assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 assessments at each time point. All 7 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in logistic MLM analyses. Outcomes are reported as mean percentage of days at each time point that stress events were endorsed, with higher percentages indicating more stress events.
Change in Daily Life Physiological Stress Reactivity
时间窗: change in HR reactivity assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)
Heart Rate (HR) measured continuously in daily life, with HR averaged in 30-minute windows around daily life stress reported via EMA up to four times per day for one week at three time points, totaling up to 28 windows at each time point. All (up to) 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher scores indicate higher HR in beats per minute (relative to an individual's average daily HR) at high stress moments (relative to an individual's average perceived stress).
Change in Circulating Inflammatory Markers
时间窗: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks)
Circulating IL-6 assessed via dried blood spot (DBS), reported as raw concentration in pg/mL assessed via ProteinSimple Simple Plex Human IL-6 (3rd gen) on Ella instrument
Feasibility of Recruitment (Enrollment)
时间窗: assessed pre-enrollment
Recruitment benchmark: \>60% of those eligible will enroll
Feasibility of Adherence: Intervention Practice Prompts
时间窗: assessed across the entire 2-week intervention period
Numbers represent percentages of intervention practice prompts completed in mindfulness and coping groups \[calculated as (average number of prompts completed / 42 total prompts among all participants in each group) \* 100\]. The original adherence benchmark was an average completion of \>60% of prompts; reported percentages that are greater than that benchmark represent feasibility of intervention practice prompt adherence.
Feasibility of Adherence: Ambulatory Assessments
时间窗: assessed for 1 week at three time points: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)
Numbers represent percentages of ambulatory assessment surveys completed in mindfulness and coping groups \[calculated as (average number of surveys completed / 105 total surveys among all participants in each group) \* 100\]. The original adherence benchmark was an average completion of \>75% of ambulatory assessments; reported percentages that are greater than that benchmark represent feasibility of ambulatory assessment adherence.
Feasibility of Recruitment (Screened Eligible)
时间窗: assessed pre-enrollment
Recruitment benchmark: \>10% of people screened will be eligible
Feasibility of Retention
时间窗: assessed across the entire 8-week study period
Retention benchmark: \>80% retention through intervention and \>75% retention through follow-up
Feasibility of Adherence: Intervention Lessons
时间窗: assessed across the entire 2-week intervention period
Numbers represent percentages of intervention lessons completed in mindfulness and coping groups \[calculated as (average number of lessons completed / 14 total lessons among all participants in each group) \* 100\]. The original adherence benchmark was an average completion of \>85% of intervention lessons; reported percentages that are greater than that benchmark represent feasibility of intervention adherence.
Feasibility of Safe Implementation: Incidence of Treatment-emergent Increases in Mental Health Symptoms
时间窗: 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
时间窗: assessed in-person at post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (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
时间窗: change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)
State perceived stress assessed in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Stress was assessed on a 1-7 Likert scale, with higher scores indicating higher perceived stress.
Change in Daily Life Subjective Stress: Daily Perceived Stress
时间窗: change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)
Daily perceived stress assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 assessments at each time point. All 7 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Stress was assessed on a 1-7 Likert scale, with higher scores indicating higher perceived stress.
Change in Daily Life Objective Stress: Stress Events in the Past 2.5 Hours
时间窗: change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)
Stress events assessed on a binary scale (yes/no) in daily life four times per day for one week at three time points via Ecological Momentary Assessment (EMA), totaling up to 28 assessments at each time point. All 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in logistic MLM analyses. Outcomes are reported as mean percentage of surveys at each time point that stress events were endorsed, with higher percentages indicating more stress events.
Change in Daily Life Objective Stress: Daily Stress Events
时间窗: change in stress assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)
Daily stress events assessed in daily life each evening for one week at three time points via end-of day diary, totaling up to 7 assessments at each time point. All 7 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in logistic MLM analyses. Outcomes are reported as mean percentage of days at each time point that stress events were endorsed, with higher percentages indicating more stress events.
Feasibility of Adherence: Mobile Sensor Data
时间窗: assessed across the entire 8-week study period
Numbers represent percentages of days on which wearable sensor (Fitbit) data and AWARE phone sensor data were collected in mindfulness and coping groups \[calculated as (average number of days that Fitbit/AWARE data were collected / 56 days among all participants in each group) \* 100\]. The original adherence benchmark was collecting mobile sensor data on \>75% of days; reported percentages that are greater than that benchmark represent feasibility of mobile sensor data collection adherence.
Change in Daily Life Physiological Stress Reactivity
时间窗: change in HR reactivity assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)
Heart Rate (HR) measured continuously in daily life, with HR averaged in 30-minute windows around daily life stress reported via EMA up to four times per day for one week at three time points, totaling up to 28 windows at each time point. All (up to) 28 assessments at each of the three time points (pre-intervention ambulatory assessment, post-intervention ambulatory assessment, and one-month follow-up ambulatory assessment) were averaged in MLM analyses. Higher scores indicate higher HR in beats per minute (relative to an individual's average daily HR) at high stress moments (relative to an individual's average perceived stress).
Change in Circulating Inflammatory Markers
时间窗: change from pre-intervention laboratory assessment to post-intervention laboratory assessment (an average of 4 weeks) and one-month follow-up laboratory assessment (an average of 8 weeks)
Circulating IL-6 assessed via dried blood spot (DBS), reported as raw concentration in pg/mL assessed via ProteinSimple Simple Plex Human IL-6 (3rd gen) on Ella instrument
Feasibility of Recruitment (Enrollment)
时间窗: assessed pre-enrollment
Recruitment benchmark: \>60% of those eligible will enroll
Feasibility of Adherence: Intervention Practice Prompts
时间窗: assessed across the entire 2-week intervention period
Numbers represent percentages of intervention practice prompts completed in mindfulness and coping groups \[calculated as (average number of prompts completed / 42 total prompts among all participants in each group) \* 100\]. The original adherence benchmark was an average completion of \>60% of prompts; reported percentages that are greater than that benchmark represent feasibility of intervention practice prompt adherence.
Feasibility of Adherence: Ambulatory Assessments
时间窗: assessed for 1 week at three time points: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks)
Numbers represent percentages of ambulatory assessment surveys completed in mindfulness and coping groups \[calculated as (average number of surveys completed / 105 total surveys among all participants in each group) \* 100\]. The original adherence benchmark was an average completion of \>75% of ambulatory assessments; reported percentages that are greater than that benchmark represent feasibility of ambulatory assessment adherence.
次要结局
- Change in Daily Life Positive Affect: State(change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks))
- Change in Daily Life Positive Affect: Daily(change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks))
- Change in Daily Life Negative Affect: State(change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks))
- Change in Daily Life Negative Affect: Daily(change in affect assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks))
- Change in Daily Life Social Interactions: Interactions in the Past 2.5 Hours(change in interactions assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks))
- Change in Daily Life Social Interactions: Daily(change in interactions assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks))
- Change in Daily Life Mindfulness: Awareness(change in awareness assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks))
- Change in Daily Life Mindfulness: Acceptance(change in acceptance assessed in daily life for 1 week at three timepoints: pre-intervention ambulatory assessment, post-intervention ambulatory assessment (an average of 3 weeks), and one-month follow-up ambulatory assessment (an average of 7 weeks))
研究者
Emily Lindsay
Research Assistant Professor
University of Pittsburgh