N/A
Completed N=53
Examine the Effects of Meditation on Daily Psychological Stress Responses in Woman With a History of Child Adversity
Stress · Psychological Stress · Child Maltreatment · Depressive Symptoms
Source: ClinicalTrials.gov NCT04606199 ↗
Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: Change in Stressor Demands, as Measured by Ecological Momentary Assessment (EMA) — -.0950; .0009 score on a scale
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Stressor Demands, as Measured by Ecological Momentary Assessment (EMA) |
-.0950; .0009 | — |
| PRIMARY Change in Negative Affect, as Measured by Ecological Momentary Assessment (EMA) |
-.0610; .0018 | — |
| SECONDARY Change in Coping Resources, as Measured by Ecological Momentary Assessment (EMA) |
.1134; .0112 | — |
| SECONDARY Change in Positive Affect, as Measured by Ecological Momentary Assessment (EMA) |
.1288; .0038 | — |
| SECONDARY Change in Perseverative Cognitions, as Measured by Ecological Momentary Assessment (EMA) |
-.1088; -.0322 | — |
| SECONDARY Change in Self-criticism, as Measured by Ecological Momentary Assessment (EMA) |
-.0932; -.0188 | — |
| SECONDARY Change in Social Connection, as Measured by Ecological Momentary Assessment (EMA) |
.0880; -.0134 | — |
| SECONDARY Change in Contextualized Stressor Demands, as Measured by Ecological Momentary Assessment (EMA) |
-.0984; -.0161 | — |
| SECONDARY Change in Contextualized Coping Resources, as Measured by Ecological Momentary Assessment (EMA) |
.0668; -.0172 | — |
| SECONDARY Change in Negative Stressor Impact, as Measured by Ecological Momentary Assessment (EMA) |
-.1021; -.0736 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04606199). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.