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

Not Applicable

Completed

• Conditions: Stress; Child Maltreatment; Signs and Symptoms; Psychological Stress; Depressive Symptoms; Psychological; Psychological Distress
• Interventions: Behavioral: Mindfulness-based intervention, up to 5 minutes 0-3 times/day

• Registration Number: NCT04606199
• Lead Sponsor: University of California, San Francisco

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-10-28
• Study Start: 2020-11-02
• Primary Completion: 2021-07-12
• Study Completion: 2021-07-12
• Results First Submitted: 2022-07-13
• Results First Submitted QC: 2022-07-13
• Results First Posted: 2022-08-11
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mindfulness-based intervention	Mindfulness-based intervention, up to 5 minutes 0-3 times/day	Participants will be randomly assigned to an app-based intervention that includes brief (\<5 min) audio-guided mindfulness and compassion-based practices.

Primary Outcome Measures

Name	Time	Method
Change in Negative Affect, as Measured by Ecological Momentary Assessment (EMA)	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.
Change in Stressor Demands, as Measured by Ecological Momentary Assessment (EMA)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Negative Stressor Impact, as Measured by Ecological Momentary Assessment (EMA)	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.
Change in Coping Resources, as Measured by Ecological Momentary Assessment (EMA)	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.
Change in Contextualized Stressor Demands, as Measured by Ecological Momentary Assessment (EMA)	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.
Change in Positive Affect, as Measured by Ecological Momentary Assessment (EMA)	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.
Change in Self-criticism, as Measured by Ecological Momentary Assessment (EMA)	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.
Change in Perseverative Cognitions, as Measured by Ecological Momentary Assessment (EMA)	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.
Change in Social Connection, as Measured by Ecological Momentary Assessment (EMA)	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.
Change in Contextualized Coping Resources, as Measured by Ecological Momentary Assessment (EMA)	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States