N/A N=53 Randomized Double-blind Basic Science

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 · Signs and Symptoms

Bottom Line

View on ClinicalTrials.gov: NCT04606199 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2022

Primary outcome: Primary: Change in Stressor Demands, as Measured by Ecological Momentary Assessment (EMA) — -.0950; .0009 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mindfulness-based intervention, up to 5 minutes 0-3 times/day (Behavioral)
Age: Adult · 30+ yrs
Sex: Female
Sponsor: University of California, San Francisco
Primary completion: Jul 2021

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	—

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).

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).

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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.