Examine the Effects of Meditation on Daily Psychological Stress Responses in Woman With a History… (NCT04606199) | Clinical Trial Compass
CompletedNot Applicable
Examine the Effects of Meditation on Daily Psychological Stress Responses in Woman With a History of Child Adversity
United States53 participantsStarted 2020-11-02
Plain-language 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).
Who can participate
Age range
30 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Stressor Demands, as Measured by Ecological Momentary Assessment (EMA)
Timeframe: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.
2
Change in Negative Affect, as Measured by Ecological Momentary Assessment (EMA)
Timeframe: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.