Pilot Testing of an Ecological Momentary Mindfulness-based Intervention (EMMI) for People With Early Life Adversity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Change in Negative Affect, as Measured by Ecological Momentary Assessment (EMA)
Study Overview
Brief Summary
The aim of the Everyday Moments of Mindfulness (EMMI) study is to test whether brief mindfulness-based practices will improve daily psychological stress responses in women (age 30-60) who report a history of early life adversity. Following a baseline visit (remotely or in person), participants complete daily surveys and audio-guided mindfulness-based practices in everyday life via the study app. Specifically, participants receive app-notifications three times/day (morning, afternoon, evening) to complete daily surveys of current stressors and psychological states. At each notification, each participant is then randomly assigned to either receive a mindfulness-based intervention or not (max of 3 interventions/day). Thus, participants are randomized many times over the course of this 30-day study. At the end of the study, participants complete a follow-up visit (remotely or in person).
Detailed Description
The aim of the present study is to test whether brief app-based mindfulness and compassion practices will improve daily psychological stress responses in a sample of adult women (age 30-60) who report a history of early life adversity. The study will incorporate surveys and mindfulness-based intervention practices into everyday life using mobile technology (study app). Participants receive app-notifications three times/day (morning, afternoon, evening) to complete Ecological Momentary Assessments (EMAs) of current psychological stress states (pre-EMA; e.g., stress appraisals, affect, perseverative cognitions, self-criticism, social connection). At each notification, each participant is then randomized to either receive a mindfulness-based intervention (described in detail below) or no intervention. Thus, each participant is randomized many times over this 30-day study (Micro-Randomized Trial, MRT). Psychological stress states are again measured approximately 15 min post-randomization (post-EMA; e.g., stress appraisals, affect, perseverative cognitions, self-criticism, social connection) to assess a treatment effect by comparing psychological stress responses after a mindfulness-based intervention vs. no intervention. The MRT will continue for 30 days. All study participants will be asked to fill out questionnaires at baseline and post-intervention (after 30 days). Weekly measures of depressive symptoms are also obtained. A trained research assistant will monitor participant adherence and address potential difficulties.
Mindfulness-based intervention: The intervention consists of mindfulness and compassion-based practices. For example, practices focus on the breath/body (e.g., 3 minute breathing space; compassionate body scan; five senses mediation), on increasing participants' inner resources (e.g., imaging a safe person or safe place), on reducing negative affect (e.g., self-compassionate and acceptance-based practices), or on increasing positive emotions (e.g., gratitude practice; metta practices). All interventions are brief (≤5 minutes) and audio-guided.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Since the study uses a MRT design (each participant is randomized multiple times), the investigator and outcomes assessor do not know at what time points participants are assigned to an intervention or not over the course of this 30-day study.
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •female gender
- •age 30-60
- •reports at least two adverse childhood experiences on the 10-item Adverse Childhood Experiences (ACE) scale
- •reports at least mild depressive symptoms (Patient Health Questionnaire ≥ 5)
- •has access to a personal smartphone
Exclusion Criteria
- •Non-English speaker or unable to provide informed consent
- •Current regular mindfulness practice (exclude if >20 min/week)
- •Diagnosis of severe psychiatric disorders, including psychosis/schizophrenia, bipolar disorder, post-traumatic stress disorder (PTSD), alcohol/substance-use disorder, major depressive disorder (PHQ-9 ≥ 15), and self-harm or suicidal ideation (PHQ-9, item 9).
- •Unstable medication use and psychotherapy treatment (<3 months).
Arms & Interventions
Mindfulness-based intervention
Participants will be randomly assigned to an app-based intervention that includes brief (<5 min) audio-guided mindfulness and compassion-based practices.
Intervention: Mindfulness-based intervention, up to 5 minutes 0-3 times/day (Behavioral)
No intervention
Participants will continue their normal activities and not practice any form of mindfulness mediation at the time of app-notification.
Outcomes
Primary Outcomes
Change in Negative Affect, as Measured by Ecological Momentary Assessment (EMA)
Time Frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.
Negative affect was measured by computing a total mean score of "I feel sad, downhearted, unhappy" and "I feel angry, irritated, frustrated." The total mean score ranges from 1 to 7, with higher scores indicating greater negative affect. Negative affect was measured at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of negative affect immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in negative affect was calculated as post-EMA minus pre-EMA.
Change in Stressor Demands, as Measured by Ecological Momentary Assessment (EMA)
Time Frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.
Stressor demands were measured by computing a total mean score of "I feel stressed, anxious, overwhelmed" and "I feel strained, upset, overburdened." The total mean score ranges from 1 to 7, with higher scores indicating greater stressor demands. Stressor demands were assessed at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of stressor demands immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in stressor demands was calculated as post-EMA minus pre-EMA.
Secondary Outcomes
- Change in Negative Stressor Impact, as Measured by Ecological Momentary Assessment (EMA)(From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.)
- Change in Coping Resources, as Measured by Ecological Momentary Assessment (EMA)(From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.)
- Change in Contextualized Stressor Demands, as Measured by Ecological Momentary Assessment (EMA)(From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.)
- Change in Positive Affect, as Measured by Ecological Momentary Assessment (EMA)(From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.)
- Change in Self-criticism, as Measured by Ecological Momentary Assessment (EMA)(From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.)
- Change in Perseverative Cognitions, as Measured by Ecological Momentary Assessment (EMA)(From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.)
- Change in Social Connection, as Measured by Ecological Momentary Assessment (EMA)(From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.)
- Change in Contextualized Coping Resources, as Measured by Ecological Momentary Assessment (EMA)(From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.)