Summary

Eligibility
for females ages 30-60 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Stefanie E Mayer, PhD
Photo of Stefanie E Mayer
Stefanie E Mayer

Description

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).

Official Title

Pilot Testing of an Ecological Momentary Mindfulness-based Intervention (EMMI) for People With Early Life Adversity

Details

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. The goal is to recruit as many as 30 participants. 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.

Keywords

Stress Psychological Stress Child Maltreatment Depressive Symptoms Signs and Symptoms Psychological Distress Psychological Mindfulness Adverse childhood experiences Stress appraisals Affect Daily psychological stress responses Depression Stress, Psychological Mindfulness-based intervention, up to 5 minutes 0-3 times/day

Eligibility

You can join if…

Open to females ages 30-60

  • 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

You CAN'T join if...

  • 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).

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94118 United States

Lead Scientist at UCSF

  • Stefanie E Mayer, PhD
    Stefanie E. Mayer is a postdoctoral research scholar at the UCSF Department of Psychiatry. She obtained her PhD in Clinical Psychology from the University of Michigan in 2017. Stefanie`s research focuses on the biopsychosocial pathways by which stress exposure – throughout the lifespan – can get “under the skin” and increase risk for adverse mental and physical health outcomes.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT04606199
Study Type
Interventional
Last Updated