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Completed

NCT Number: NCT04606199

Examine the Effects of Meditation on Daily Psychological Stress Responses in Woman With a History of Child Adversity

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).

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Key information

Conditions

Stress Behavior Behavioral Symptoms Child Maltreatment Depression Depressive Symptoms Pathological Conditions, Signs and Symptoms Psychological Psychological Distress Psychological Stress Signs and Symptoms Stress, Psychological

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mindfulness-based intervention, up to 5 minutes 0-3 times/day

Behavioral

The intervention consist of mindfulness and compassion-based practices that are selected to maximize their effect on stress targets. Interventions include, for example, practices that 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-compassion and acceptance-based practices), or on increasing positive emotions (e.g., gratitude practice; metta practices).

Primary outcomes

  1. Change in Stressor Demands, as Measured by Ecological Momentary Assessment (EMA)

    Time frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.

    Stressor demands were measured by computing a total mean score of "I feel stressed, anxious, overwhelmed" and "I feel strained, upset, overburdened." The total mean score ranges from 1 to 7, with higher scores indicating greater stressor demands. Stressor demands were assessed at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of stressor demands immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in stressor demands was calculated as post-EMA minus pre-EMA.

  2. Change in Negative Affect, as Measured by Ecological Momentary Assessment (EMA)

    Time frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.

    Negative affect was measured by computing a total mean score of "I feel sad, downhearted, unhappy" and "I feel angry, irritated, frustrated." The total mean score ranges from 1 to 7, with higher scores indicating greater negative affect. Negative affect was measured at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of negative affect immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in negative affect was calculated as post-EMA minus pre-EMA.

Secondary outcomes

  1. Change in Coping Resources, as Measured by Ecological Momentary Assessment (EMA)

    Time frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.

    Coping resources were measured by computing a total mean score of "I feel in control, coping well, on top of things" and "I feel capable, competent, managing well." The total mean score ranges from 1 to 7, with higher scores indicating greater coping resources. Coping resources were measured at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of coping resources immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in coping resources was calculated as post-EMA minus pre-EMA.

  2. Change in Positive Affect, as Measured by Ecological Momentary Assessment (EMA)

    Time frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.

    Positive affect was measured by computing a total mean score of "I feel joyful, glad, happy", "I feel calm, peaceful, quiet" and "I feel grateful, appreciative, thankful." The total mean score ranges from 1 to 7, with higher scores indicating greater positive affect. Positive affect was assessed at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of positive affect immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Changes in positive affect was calculated as post-EMA minus pre-EMA.

  3. Change in Perseverative Cognitions, as Measured by Ecological Momentary Assessment (EMA)

    Time frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.

    Perseverative cognitions were measured by computing a total mean score of "I feel worried, concerned, uneasy" and "I dwell, ruminate, brood on my personal problems and feelings." The total mean score ranges from 1 to 7, with higher scores indicating greater perseverative cognitions (greater rumination/worry). Perseverative cognitions were assessed at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of perseverative cognitions immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in perseverative cognitions was calculated as post-EMA minus pre-EMA.

  4. Change in Self-criticism, as Measured by Ecological Momentary Assessment (EMA)

    Time frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.

    Self-criticism were measured by computing a total mean score of "I feel self-critical, self-blaming, self-loathing" and "I feel inadequate, not good enough, unworthy." The total mean score ranges from 1 to 7, with higher scores indicating greater self-criticism. Self-criticism was assessed at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of self-criticism immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in self-criticism was calculated as post-EMA minus pre-EMA.

  5. Change in Social Connection, as Measured by Ecological Momentary Assessment (EMA)

    Time frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.

    Social connection was measured by computing a total mean score of "I feel love, closeness, trust" and "I feel lonely, isolated, disconnected" [reverse coded]). The total mean score ranges from 1 to 7, with higher scores indicating greater social connection. Social connection was assessed at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of social connection immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in social connection was calculated as post-EMA minus pre-EMA.

  6. Change in Contextualized Stressor Demands, as Measured by Ecological Momentary Assessment (EMA)

    Time frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.

    Participants were asked about current stressors ("Is there a stressful situation in your day right now?") using a 7-point scale (1 = "not at all"; 7 = "extremely"). If a response other than "not at all" was endorsed, contextualized stressor demands ("How demanding is it to deal with this situation well right now?") was measured on a 7-point scale (1 = "not at all"; 7 = "extremely") at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of contextualized stressor demands immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in contextualized stressor demands was calculated as post-EMA minus pre-EMA.

  7. Change in Contextualized Coping Resources, as Measured by Ecological Momentary Assessment (EMA)

    Time frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.

    Participants were asked about current stressors ("Is there a stressful situation in your day right now?") using a 7-point scale (1 = "not at all"; 7 = "extremely"). If a response other than "not at all" was endorsed, contextualized coping resources ("Do you feel like you can handle this situation well right now?") were measured on a 7-point scale (1 = "not at all"; 7 = "extremely") at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of contextualized coping resources immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in contextualized coping resources was calculated as post-EMA minus pre-EMA.

  8. Change in Negative Stressor Impact, as Measured by Ecological Momentary Assessment (EMA)

    Time frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.

    Participants were asked about current stressors ("Is there a stressful situation in your day right now?") using a 7-point scale (1 = "not at all"; 7 = "extremely"). If a response other than "not at all" was endorsed, negative stressor impact ["How much does this situation negatively impact you right now (e.g., interferes with your well-being or functioning)?"] was measured on a 7-point scale (1 = "not at all"; 7 = "extremely") at notification time points 3 times/day over a 30-day period. At each notification time point, participants completed EMAs of negative stressor impact immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Change in negative stressor impact was calculated as post-EMA minus pre-EMA.

Other outcomes

  1. Change in Depressive Symptoms, as Measured by the 9-item Patient Health Questionnaire (PHQ-9).

    Time frame: Baseline to post-intervention, over a period of 30 days.

    The 9-item Patient Health Questionnaire (PHQ-9) has a total score scale range of 0 to 27, with higher values indicating more depressive symptoms. Change in depressive symptoms was calculated as post-intervention minus baseline values.

  2. Change in Perceived Stress, as Measured by the 10-item Perceived Stress Scale (PSS)

    Time frame: Baseline to post-intervention, over a period of 30 days.

    The 10-item Perceived Stress Scale (PSS) has a total score scale range of 0 to 40, with higher values indicating higher perceived stress. Change in perceived stress was calculated as post-intervention minus baseline values.

  3. Change in Anxiety, as Measured by the 7-item General Anxiety Disorder (GAD-7) Questionnaire

    Time frame: Baseline to post-intervention, over a period of 30 days.

    The 7-item General Anxiety Disorder (GAD-7) questionnaire assesses symptoms of anxiety in the past 2 weeks. The total score scale ranges from 0 to 21, with higher values indicating higher anxiety. Change in anxiety was calculated as post-intervention minus baseline values.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Harvard University
  • National Institute on Aging (NIA)
  • Penn State University

Registry information

Official study title

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

Acronym: EMMI

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2020
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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