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

• ClinicalTrials.gov Identifier: NCT04606199
• Recruitment Status: Completed
• First Posted: October 28, 2020
• Last Update Posted: September 27, 2021
• Sponsor: University of California, San Francisco
• Collaborators: Harvard University; National Institute on Aging (NIA); Penn State University
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Stress; Psychological Stress; Child Maltreatment; Depressive Symptoms; Signs and Symptoms; Psychological Distress; Psychological	Behavioral: Mindfulness-based intervention, up to 5 minutes 0-3 times/day	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Since the study uses a MRT design (each participant is randomized multiple times), the investigator and outcomes assessor do not know at what time points participants are assigned to an intervention or not over the course of this 30-day study.
• Primary Purpose: Basic Science
• Official Title: Pilot Testing of an Ecological Momentary Mindfulness-based Intervention (EMMI) for People With Early Life Adversity
• Actual Study Start Date: November 2, 2020
• Actual Primary Completion Date: July 12, 2021
• Actual Study Completion Date: July 12, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Mindfulness-based intervention; Participants will be randomly assigned to an app-based intervention that includes brief (<5 min) audio-guided mindfulness and compassion-based practices.	Behavioral: Mindfulness-based intervention, up to 5 minutes 0-3 times/day; 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).
No Intervention: No intervention; Participants will continue their normal activities and not practice any form of mindfulness mediation at the time of app-notification.

Outcome Measures

Primary Outcome Measures :

1. Change in mean 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) ]
   Stressor demands (mean of "I feel stressed, anxious, overwhelmed" and "I feel strained, upset, overburdened") are 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 complete EMAs of stressor demands immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater stressor demands. Analyses will account for repeated measures within participants.
2. Change in mean negative affect, as measured by EMA [ Time Frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization) ]
   Negative affect (mean of "I feel sad, downhearted, unhappy" and" I feel angry, irritated, frustrated") is 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 complete EMAs of negative affect immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater negative affect. Analyses will account for repeated measures within participants.

Secondary Outcome Measures :

1. Change in mean coping resources, as measured by EMA [ Time Frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization) ]
   Coping resources (mean of "I feel in control, coping well, on top of things" and "I feel capable, competent, managing well") are 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 complete EMAs of coping resources immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater coping resources. Analyses will account for repeated measures within participants.
2. Change in mean positive affect, as measured by EMA [ Time Frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization) ]
   Positive affect (mean of "I feel joyful, glad, happy"; "I feel calm, peaceful, quiet"; "I feel grateful, appreciative, thankful") is 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 complete EMAs of positive affect immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater positive affect. Analyses will account for repeated measures within participants.
3. Change in mean perseverative cognitions, as measured by EMA [ Time Frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization) ]
   Perseverative cognitions (mean of "I feel worried, concerned, uneasy" and "I dwell, ruminate, brood on my personal problems and feelings") are 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 complete EMAs of perseverative cognitions immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater perseverative cognitions (greater rumination/worry). Analyses will account for repeated measures within participants.
4. Change in mean self-criticism, as measured by EMA [ Time Frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization) ]
   Self-criticism (mean of "I feel self-critical, self-blaming, self-loathing" and "I feel inadequate, not good enough, unworthy") is 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 complete EMAs of self-criticism immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater self-criticism. Analyses will account for repeated measures within participants.
5. Change in mean social connection, as measured by EMA [ Time Frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization) ]
   Social connection (mean of "I feel love, closeness, trust" and "I feel lonely, isolated, disconnected" [reverse coded]) is 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 complete EMAs of social connection immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater social connection. Analyses will account for repeated measures within participants.
6. Change in contextualized stressor demands, as measured by EMA [ Time Frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization) ]
   Participants are asked about current stressors ("Is there a stressful situation in your day right now?"). If a response other than "not at all" is endorsed on the 7-pt scale, contextualized stressor demands ("How demanding is it to deal with this situation well right now?") are 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 complete EMAs of contextualized stressor demands immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater stressor demands. Analyses will account for repeated measures within participants.
7. Change in contextualized coping resources, as measured by EMA [ Time Frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization) ]
   Participants are asked about current stressors ("Is there a stressful situation in your day right now?"). If a response other than "not at all" is endorsed on the 7-pt scale, contextualized coping resources ("Do you feel like you can handle this situation well right now?") are 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 complete EMAs of contextualized coping resources immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater coping resources. Analyses will account for repeated measures within participants.
8. Change in negative stressor impact, as measured by EMA [ Time Frame: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization) ]
   Participants are asked about current stressors ("Is there a stressful situation in your day right now?"). If a response other than "not at all" is endorsed on the 7-pt scale, negative stressor impact ["How much does this situation negatively impact you right now (e.g., interferes with your well-being or functioning)?"] is 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 complete EMAs of negative stressor impact immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater negative stressor impact. Analyses will account for repeated measures within participants.

Other Outcome Measures:

1. Change in depressive symptoms, as measured by the total score on the 9-item Patient Health Questionnaire (PHQ-9). [ Time Frame: Baseline to post-intervention, an anticipated average 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.
2. Change in perceived stress, as determined by the total score on the Perceived Stress Scale (PSS). [ Time Frame: Baseline to post-intervention, an anticipated average 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.
3. Change in anxiety, as determined by the total score on the 7-item General Anxiety Disorder (GAD-7) questionnaire. [ Time Frame: Baseline to post-intervention, an anticipated average 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.

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 60 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Self-representation of gender identity.
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

United States, California

University of California, San Francisco

San Francisco, California, United States, 94118

Sponsors and Collaborators

University of California, San Francisco

Harvard University

National Institute on Aging (NIA)

Penn State University

Investigators

• Principal Investigator: Stefanie E Mayer, PhD; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT04606199
• Other Study ID Numbers: 19-27198; K99AG062778 ( U.S. NIH Grant/Contract )
• First Posted: October 28, 2020
• Last Update Posted: September 27, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:

Mindfulness; Adverse childhood experiences; Stress appraisals; Affect; Daily psychological stress responses; Stress; Depressive symptoms

Additional relevant MeSH terms:

Depression; Stress, Psychological; Behavioral Symptoms