Clinical trial NCT04606199: Examine the Effects of Meditation on Daily Psychological Stress Responses in Woman With a History of Child Adversity
Official title: Pilot Testing of an Ecological Momentary Mindfulness-based Intervention (EMMI) for People With Early Life Adversity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Psychological Stress
Child Maltreatment
Depressive Symptoms
Signs and Symptoms
Psychological Distress
Psychological
Keywords: Mindfulness
Adverse childhood experiences
Stress appraisals
Affect
Daily psychological stress responses
Stress
Depressive symptoms
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Harvard University
name: National Institute on Aging (NIA)
name: Penn State University
First posted: 2020-10-28
Enrollment: 53
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A Micro-Randomized Trial (MRT) is a design that randomly assigns an intervention at each notification time point (similar to a crossover design in that each participant is randomized to both conditions at different times, except in the MRT the crossover occurs at multiple times): Participants use the study app for 30 days and receive three notifications per day. At each notification time point, participants complete an Ecological Momentary Assessment (EMA) of their current psychological stress states (pre-EMA). Then, at each notification, each participant is randomized (50 percent probability) to either receive a mindfulness-based intervention or not. Thus, participants are randomized many times over the 30-day study. Approximately thirty minutes post-randomization, an EMA is obtained again to assess psychological stress states (post-EMA). A treatment effect is examined by comparing psychological stress responses after a mindfulness-based intervention compared to no intervention.
Primary purpose: BASIC_SCIENCE

Brief 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).

Detailed description: 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.

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.

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).

Primary outcomes:
measure: 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.
measure: 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.
Secondary outcomes:
measure: Change in Coping Resources, 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.
measure: Change in Positive 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.
measure: Change in Perseverative Cognitions, 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.
measure: Change in Self-criticism, 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.
measure: Change in Social Connection, 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.
measure: Change in Contextualized 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.
measure: Change in Contextualized Coping Resources, 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.
measure: Change in Negative Stressor Impact, 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.
Other outcomes:
measure: Change in Depressive Symptoms, as Measured by the 9-item Patient Health Questionnaire (PHQ-9).
timeFrame: Baseline to post-intervention, over a period of 30 days.
measure: Change in Perceived Stress, as Measured by the 10-item Perceived Stress Scale (PSS)
timeFrame: Baseline to post-intervention, over a period of 30 days.
measure: Change in Anxiety, as Measured by the 7-item General Anxiety Disorder (GAD-7) Questionnaire
timeFrame: Baseline to post-intervention, over a period of 30 days.
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Stefanie E Mayer, PhD
role: PRINCIPAL_INVESTIGATOR
References: