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Mindfulness Practices for Stress Due to Child Adversity (Fully Remote Trial) (EMMA Trial)

Verified Trial
N/A
Recruiting
Led By Stefanie E Mayer, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
female sex and gender identity (to control for sex and gender differences in stress responses and health outcomes)
age 30-50 (to examine intervention effects on health outcomes in midlife)
Must not have
Major psychiatric condition, including psychosis/schizophrenia, bipolar disorder, post-traumatic stress disorder, eating disorders, alcohol/substance use, major depression (PHQ-9 ≥ 15), and self-harm or suicidal ideation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up anticipated study period of 12 months
Awards & highlights

EMMA Trial Summary

This trial is testing whether brief mindfulness-based practices can help improve wellbeing and health for women who have faced early life adversity. There are two groups in the trial, one that will do mindful activities and one that will do mindful awareness, both for 8 weeks. The trial is measuring feasibility and acceptability.

Who is the study for?
This trial is for women aged 30-50 with a history of childhood adversity and mild depressive symptoms, who own a smartphone. They must have experienced at least two adverse childhood events but cannot be on certain medications or have major medical/psychiatric conditions, nor can they be pregnant or current smokers.Check my eligibility
What is being tested?
The study tests if brief mindfulness practices improve well-being in midlife women with past adversity. Participants are randomly assigned to either Mindful Activity (guided exercises) or Mindful Awareness (self-monitoring thoughts/feelings), using an app twice daily for 8 weeks.See study design
What are the potential side effects?
Mindfulness practices are generally considered safe but may sometimes bring up uncomfortable emotions or memories, especially in individuals with a history of trauma. It's important to report any distressing feelings during the study.

EMMA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I identify as female.
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I am between 30 and 50 years old.
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You have experienced at least two negative events during your childhood.
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I have mild depression symptoms.
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You need to have a smartphone to use an app for assessments and interventions.
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I identify as female.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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You have a serious mental health condition like schizophrenia, bipolar disorder, or severe depression.

EMMA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~anticipated study period of 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and anticipated study period of 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of the intervention will be measured with an adapted version of the Treatment Acceptability Questionnaire (TAQ).
Adherence, as measured by the percentage of assigned and completed intervention group practices.
Feasibility, as indicated by numbers of participants screened (completed web-based screener and phone screener), eligible based on web-based screener and phone screener, consented, randomized to treatment, and retained at follow-up.
Secondary outcome measures
Change in depressive symptoms, as measured by the total score on the 9-item Patient Health Questionnaire (PHQ-9).

EMMA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mindful Activity groupExperimental Treatment1 Intervention
Participants complete mindfulness and compassion-based practices via the study app.
Group II: Mindful Awareness groupPlacebo Group1 Intervention
Participants monitor and report their thoughts and feelings via the study app.

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,674 Previous Clinical Trials
28,020,835 Total Patients Enrolled
35 Trials studying Depression
28,263 Patients Enrolled for Depression
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,485 Total Patients Enrolled
71 Trials studying Depression
28,758 Patients Enrolled for Depression
Stefanie E Mayer, PhDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
53 Total Patients Enrolled
1 Trials studying Depression
53 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial currently have capacity to enroll individuals?

"According to clinicaltrials.gov, this medical experiment is still seeking volunteers; it was initially posted on June 3rd 2022 and its most recent update was November 17th of the same year."

Answered by AI

How can I become involved in this experimental research?

"This study desires 70 participants aged 30-50 who experience stress and psychological distress. Furthermore, these patients should identify as female, have endured at least two Adverse Childhood Experiences, display mild depressive symptoms (PHQ-9 ≥ 5), and possess a smartphone in order to leverage app-based interventions."

Answered by AI

Does this study offer participation for individuals younger than 65 years old?

"According to the eligibility requirements, this trial has a minimum age of 30 years old and will not accept any participants older than 50."

Answered by AI

What is the aggregate amount of individuals subscribing to this trial?

"Correct. Information from clinicaltrials.gov demonstrates that the current recruitment for this medical trial is still underway - it was initially posted on June 3rd 2022 and recently updated on November 17th of the same year. 70 participants need to be gathered at a single site in order to complete enrollment."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
California
How old are they?
18 - 65
What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I joined this trial to help the company help people like me. My son has multiple significant chronic medical conditions and it is very stressful.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. University of California, San Francisco: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
Examine the Effects of Mindfulness in Woman With a History of Child Adversity
2022. "Examine the Effects of Mindfulness in Woman With a History of Child Adversity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05255380.
~6 spots leftby Jul 2024
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