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

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT04606199
• Collaborator: Harvard University (Other), National Institute on Aging (NIA) (NIH), Penn State University (Other)
• Enrollment: 53
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.3
• Patients Per Site Per Month: 6.4

Study Details

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	N/A

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
• 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.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: Nov 2, 2020
• Actual Primary Completion Date: Jul 12, 2021
• Actual Study Completion Date: Jul 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 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]

   Stressor demands (mean of "I feel stressed, anxious, overwhelmed" and "I feel strained, upset, overburdened") 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 stressor demands immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater stressor demands. Change in stressor demands was calculated as post-EMA minus pre-EMA.

2. 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]

   Negative affect (mean of "I feel sad, downhearted, unhappy" and" I feel angry, irritated, frustrated") 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 affect immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater negative affect. Change in negative affect was calculated as post-EMA minus pre-EMA.

Secondary Outcome Measures

1. 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]

   Coping resources (mean of "I feel in control, coping well, on top of things" and "I feel capable, competent, managing well") 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 coping resources immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater coping resources. Change in coping resources was calculated as post-EMA minus pre-EMA.

2. 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]

   Positive affect (mean of "I feel joyful, glad, happy"; "I feel calm, peaceful, quiet"; "I feel grateful, appreciative, thankful") 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 positive affect immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater positive affect. Change in positive affect was calculated as post-EMA minus pre-EMA.

3. 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]

   Perseverative cognitions (mean of "I feel worried, concerned, uneasy" and "I dwell, ruminate, brood on my personal problems and feelings") 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 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). Change in perseverative cognitions was calculated as post-EMA minus pre-EMA.

4. 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]

   Self-criticism (mean of "I feel self-critical, self-blaming, self-loathing" and "I feel inadequate, not good enough, unworthy") 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 self-criticism immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater self-criticism. Change in self-criticism was calculated as post-EMA minus pre-EMA.

5. 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]

   Social connection (mean of "I feel love, closeness, trust" and "I feel lonely, isolated, disconnected" [reverse coded]) 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 social connection immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater social connection. 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) [From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization]

   Participants were asked about current stressors ("Is there a stressful situation in your day right now?"). If a response other than "not at all" was endorsed on the 7-pt scale, contextualized stressor demands ("How demanding is it to deal with 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 stressor demands immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater stressor demands. 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) [From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization)]

   Participants were asked about current stressors ("Is there a stressful situation in your day right now?"). If a response other than "not at all" was endorsed on the 7-pt scale, 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). Higher scores indicate greater coping resources. 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) [From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization]

   Participants were asked about current stressors ("Is there a stressful situation in your day right now?"). If a response other than "not at all" was 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)?"] 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). Higher scores indicate greater negative stressor impact. Change in negative stressor impact was calculated as post-EMA minus pre-EMA.

Other Outcome Measures

1. Change in Depressive Symptoms, as Measured by the 9-item Patient Health Questionnaire (PHQ-9). [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. 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) [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. 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 [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. Change in anxiety was calculated as post-intervention minus baseline values.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 4, 2021

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT04606199
• Other Study ID Numbers: 19-27198; K99AG062778
• First Posted: Oct 28, 2020
• Last Update Posted: Aug 11, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

Participant Flow

Arm/Group Title	Mindfulness-based Micro-intervention
Arm/Group Description	Overview: The study used a micro-randomized trial design in which participants received app-notifications three times/day (morning, afternoon, evening). At each notification time-point, participants had a 50% chance of receiving either a mindfulness-based intervention or no intervention (described below). Thus, each participant was randomized many times over this 30-day study. Mindfulness-based intervention: Participants randomly assigned to an app-based mindfulness intervention were instructed to do a brief (<5 min) audio-guided mindfulness practice. The intervention was randomly selected out of 12 practices that consisted of mindfulness and compassion-based practices (e.g., 3 minute breathing space; compassionate body scan; five senses meditation, imagining a safe person or safe place, self-compassion and acceptance-based practices; gratitude practice; metta practices). No intervention: Participants randomly assigned to "no intervention" just continued their normal activities; they did not practice any form of mindfulness mediation at the time of app-notification.
Period Title: Overall Study
STARTED	53
COMPLETED	51
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Mindfulness-based Micro-intervention
Arm/Group Description	Overview: The study used a micro-randomized trial design in which participants received app-notifications three times/day (morning, afternoon, evening). At each notification time-point, participants had a 50% chance of receiving either a mindfulness-based intervention or no intervention (described below). Thus, each participant was randomized many times over this 30-day study. Mindfulness-based intervention: Participants randomly assigned to an app-based mindfulness intervention were instructed to do a brief (<5 min) audio-guided mindfulness practice. The intervention was randomly selected out of 12 practices that consisted of mindfulness and compassion-based practices (e.g., 3 minute breathing space; compassionate body scan; five senses meditation, imagining a safe person or safe place, self-compassion and acceptance-based practices; gratitude practice; metta practices). No intervention: Participants randomly assigned to "no intervention" just continued their normal activities; they did not practice any form of mindfulness mediation at the time of app-notification.
Overall Participants	53
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.85 (8.46)
Sex: Female, Male (Count of Participants)
Female	53 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 3.8%
Not Hispanic or Latino	51 96.2%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	13 24.5%
Native Hawaiian or Other Pacific Islander	2 3.8%
Black or African American	9 17%
White	24 45.3%
More than one race	4 7.5%
Unknown or Not Reported	1 1.9%
Region of Enrollment (Count of Participants)
United States	53 100%
9-item Patient Health Questionnaire (PHQ-9) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	8.62 (2.33)
7-item General Anxiety Disorder (GAD-7) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	9.75 (4.99)
10-item Perceived Stress Scale (PSS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	23.47 (5.84)

Outcome Measures

1. Primary Outcome

Title	Change in Stressor Demands, as Measured by Ecological Momentary Assessment (EMA)
Description	Stressor demands (mean of "I feel stressed, anxious, overwhelmed" and "I feel strained, upset, overburdened") 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 stressor demands immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater stressor demands. Change in stressor demands was calculated as post-EMA minus pre-EMA.
Time Frame	From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization

Outcome Measure Data

Analysis Population Description

All 53 participants were included in the analysis. There was a total of 90 possible decision points per participant. Unimputed data are reported here.

Arm/Group Title	Mindfulness-based Intervention	No Intervention
Arm/Group Description	Participants were randomly assigned to an app-based intervention that included brief (<5 min) audio-guided mindfulness and compassion-based practices. Mindfulness-based intervention, up to 5 minutes 0-3 times/day: The intervention consisted of mindfulness and compassion-based practices that were selected to maximize their effect on stress targets. Interventions included, for example, practices that focused 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).	Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Measure Participants	53	53
Measure Decision points	1547	1653
Mean (Standard Deviation) [score on a scale]	-.0950 (.84983)	.0009 (.74960)

2. Primary Outcome

Title	Change in Negative Affect, as Measured by Ecological Momentary Assessment (EMA)
Description	Negative affect (mean of "I feel sad, downhearted, unhappy" and" I feel angry, irritated, frustrated") 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 affect immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater negative affect. Change in negative affect was calculated as post-EMA minus pre-EMA.
Time Frame	From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization

Outcome Measure Data

Analysis Population Description

All 53 participants were included in the analysis. There was a total of 90 possible decision points per participant. Unimputed data are reported here.

Arm/Group Title	Mindfulness-based Intervention	No Intervention
Arm/Group Description	Participants were randomly assigned to an app-based intervention that included brief (<5 min) audio-guided mindfulness and compassion-based practices. Mindfulness-based intervention, up to 5 minutes 0-3 times/day: The intervention consisted of mindfulness and compassion-based practices that were selected to maximize their effect on stress targets. Interventions included, for example, practices that focused 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).	Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Measure Participants	53	53
Measure Decision points	1542	1650
Mean (Standard Deviation) [score on a scale]	-.0610 (.83630)	.0018 (.72844)

3. Secondary Outcome

Title	Change in Coping Resources, as Measured by Ecological Momentary Assessment (EMA)
Description	Coping resources (mean of "I feel in control, coping well, on top of things" and "I feel capable, competent, managing well") 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 coping resources immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater coping resources. Change in coping resources was calculated as post-EMA minus pre-EMA.
Time Frame	From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization

Outcome Measure Data

Analysis Population Description

All 53 participants were included in the analysis. There was a total of 90 possible decision points per participant. Unimputed data are reported here.

Arm/Group Title	Mindfulness-based Intervention	No Intervention
Arm/Group Description	Participants were randomly assigned to an app-based intervention that included brief (<5 min) audio-guided mindfulness and compassion-based practices. Mindfulness-based intervention, up to 5 minutes 0-3 times/day: The intervention consisted of mindfulness and compassion-based practices that were selected to maximize their effect on stress targets. Interventions included, for example, practices that focused 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).	Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Measure Participants	53	53
Measure Decision points	1543	1651
Mean (Standard Deviation) [score on a scale]	.1134 (.90167)	.0112 (.76279)

4. Secondary Outcome

Title	Change in Positive Affect, as Measured by Ecological Momentary Assessment (EMA)
Description	Positive affect (mean of "I feel joyful, glad, happy"; "I feel calm, peaceful, quiet"; "I feel grateful, appreciative, thankful") 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 positive affect immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater positive affect. Change in positive affect was calculated as post-EMA minus pre-EMA.
Time Frame	From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization

Outcome Measure Data

Analysis Population Description

All 53 participants were included in the analysis. There was a total of 90 possible decision points per participant. Unimputed data are reported here.

Arm/Group Title	Mindfulness-based Intervention	No Intervention
Arm/Group Description	Participants were randomly assigned to an app-based intervention that included brief (<5 min) audio-guided mindfulness and compassion-based practices. Mindfulness-based intervention, up to 5 minutes 0-3 times/day: The intervention consisted of mindfulness and compassion-based practices that were selected to maximize their effect on stress targets. Interventions included, for example, practices that focused 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).	Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Measure Participants	53	53
Measure Decision points	1542	1648
Mean (Standard Deviation) [score on a scale]	.1288 (.82500)	.0038 (.66488)

5. Secondary Outcome

Title	Change in Perseverative Cognitions, as Measured by Ecological Momentary Assessment (EMA)
Description	Perseverative cognitions (mean of "I feel worried, concerned, uneasy" and "I dwell, ruminate, brood on my personal problems and feelings") 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 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). Change in perseverative cognitions was calculated as post-EMA minus pre-EMA.
Time Frame	From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization

Outcome Measure Data

Analysis Population Description

All 53 participants were included in the analysis. There was a total of 90 possible decision points per participant. Unimputed data are reported here.

Arm/Group Title	Mindfulness-based Intervention	No Intervention
Arm/Group Description	Participants were randomly assigned to an app-based intervention that included brief (<5 min) audio-guided mindfulness and compassion-based practices. Mindfulness-based intervention, up to 5 minutes 0-3 times/day: The intervention consisted of mindfulness and compassion-based practices that were selected to maximize their effect on stress targets. Interventions included, for example, practices that focused 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).	Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Measure Participants	53	53
Measure Decision points	1540	1648
Mean (Standard Deviation) [score on a scale]	-.1088 (.78940)	-.0322 (.69380)

6. Secondary Outcome

Title	Change in Self-criticism, as Measured by Ecological Momentary Assessment (EMA)
Description	Self-criticism (mean of "I feel self-critical, self-blaming, self-loathing" and "I feel inadequate, not good enough, unworthy") 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 self-criticism immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater self-criticism. Change in self-criticism was calculated as post-EMA minus pre-EMA.
Time Frame	From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization

Outcome Measure Data

Analysis Population Description

All 53 participants were included in the analysis. There was a total of 90 possible decision points per participant. Unimputed data are reported here.

Arm/Group Title	Mindfulness-based Intervention	No Intervention
Arm/Group Description	Participants were randomly assigned to an app-based intervention that included brief (<5 min) audio-guided mindfulness and compassion-based practices. Mindfulness-based intervention, up to 5 minutes 0-3 times/day: The intervention consisted of mindfulness and compassion-based practices that were selected to maximize their effect on stress targets. Interventions included, for example, practices that focused 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).	Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Measure Participants	53	53
Measure Decision points	1540	1647
Mean (Standard Deviation) [score on a scale]	-.0932 (.74596)	-.0188 (.64742)

7. Secondary Outcome

Title	Change in Social Connection, as Measured by Ecological Momentary Assessment (EMA)
Description	Social connection (mean of "I feel love, closeness, trust" and "I feel lonely, isolated, disconnected" [reverse coded]) 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 social connection immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater social connection. Change in social connection was calculated as post-EMA minus pre-EMA.
Time Frame	From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization

Outcome Measure Data

Analysis Population Description

All 53 participants were included in the analysis. There was a total of 90 possible decision points per participant. Unimputed data are reported here.

Arm/Group Title	Mindfulness-based Intervention	No Intervention
Arm/Group Description	Participants were randomly assigned to an app-based intervention that included brief (<5 min) audio-guided mindfulness and compassion-based practices. Mindfulness-based intervention, up to 5 minutes 0-3 times/day: The intervention consisted of mindfulness and compassion-based practices that were selected to maximize their effect on stress targets. Interventions included, for example, practices that focused 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).	Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Measure Participants	53	53
Measure Decision points	1540	1647
Mean (Standard Deviation) [score on a scale]	.0880 (.77520)	-.0134 (.69068)

8. Secondary Outcome

Title	Change in Contextualized Stressor Demands, as Measured by Ecological Momentary Assessment (EMA)
Description	Participants were asked about current stressors ("Is there a stressful situation in your day right now?"). If a response other than "not at all" was endorsed on the 7-pt scale, contextualized stressor demands ("How demanding is it to deal with 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 stressor demands immediately prior to intervention randomization (pre-EMA) and approximately 15 minutes post randomization (post-EMA). Higher scores indicate greater stressor demands. Change in contextualized stressor demands was calculated as post-EMA minus pre-EMA.
Time Frame	From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization

Outcome Measure Data

Analysis Population Description

All 53 participants were included in the analysis. There was a total of 90 possible decision points per participant at which they were asked about current stressors ("Is there a stressful situation in your day right now?"). If a response other than "not at all" was endorsed, contextualized stressor demands were assessed. Unimputed data are reported here.

Arm/Group Title	Mindfulness-based Intervention	No Intervention
Arm/Group Description	Participants were randomly assigned to an app-based intervention that included brief (<5 min) audio-guided mindfulness and compassion-based practices. Mindfulness-based intervention, up to 5 minutes 0-3 times/day: The intervention consisted of mindfulness and compassion-based practices that were selected to maximize their effect on stress targets. Interventions included, for example, practices that focused 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).	Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Measure Participants	53	53
Measure Decision points	823	870
Mean (Standard Deviation) [score on a scale]	-.0984 (1.15313)	-.0161 (1.08752)

9. Secondary Outcome

Title	Change in Contextualized Coping Resources, as Measured by Ecological Momentary Assessment (EMA)
Description	Participants were asked about current stressors ("Is there a stressful situation in your day right now?"). If a response other than "not at all" was endorsed on the 7-pt scale, 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). Higher scores indicate greater coping resources. Change in contextualized coping resources was calculated as post-EMA minus pre-EMA.
Time Frame	From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization)

Outcome Measure Data

Analysis Population Description

All 53 participants were included in the analysis. There was a total of 90 possible decision points per participant at which they were asked about current stressors ("Is there a stressful situation in your day right now?"). If a response other than "not at all" was endorsed, contextualized coping resources were assessed. Unimputed data are reported here.

Arm/Group Title	Mindfulness-based Intervention	No Intervention
Arm/Group Description	Participants were randomly assigned to an app-based intervention that included brief (<5 min) audio-guided mindfulness and compassion-based practices. Mindfulness-based intervention, up to 5 minutes 0-3 times/day: The intervention consisted of mindfulness and compassion-based practices that were selected to maximize their effect on stress targets. Interventions included, for example, practices that focused 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).	Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Measure Participants	53	53
Measure Decision points	823	870
Mean (Standard Deviation) [score on a scale]	.0668 (1.01529)	-.0172 (.85195)

10. Secondary Outcome

Title	Change in Negative Stressor Impact, as Measured by Ecological Momentary Assessment (EMA)
Description	Participants were asked about current stressors ("Is there a stressful situation in your day right now?"). If a response other than "not at all" was 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)?"] 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). Higher scores indicate greater negative stressor impact. Change in negative stressor impact was calculated as post-EMA minus pre-EMA.
Time Frame	From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization

Outcome Measure Data

Analysis Population Description

All 53 participants were included in the analysis. There was a total of 90 possible decision points per participant at which they were asked about current stressors ("Is there a stressful situation in your day right now?"). If a response other than "not at all" was endorsed, negative stressor impact were assessed. Unimputed data are reported here.

Arm/Group Title	Mindfulness-based Intervention	No Intervention
Arm/Group Description	Participants were randomly assigned to an app-based intervention that included brief (<5 min) audio-guided mindfulness and compassion-based practices. Mindfulness-based intervention, up to 5 minutes 0-3 times/day: The intervention consisted of mindfulness and compassion-based practices that were selected to maximize their effect on stress targets. Interventions included, for example, practices that focused 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).	Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Measure Participants	53	53
Measure Decision points	823	870
Mean (Standard Deviation) [score on a scale]	-.1021 (1.13098)	-.0736 (1.02853)

11. Other Pre-specified Outcome

Title	Change in Depressive Symptoms, as Measured by the 9-item Patient Health Questionnaire (PHQ-9).
Description	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.
Time Frame	Baseline to post-intervention, an anticipated average of 30 days

Outcome Measure Data

Analysis Population Description

Participants who completed both pre and post measures were included (n = 51).

Arm/Group Title	Mindfulness-based Micro-intervention
Arm/Group Description	Overview: The study used a micro-randomized trial design in which participants received app-notifications three times/day (morning, afternoon, evening). At each notification time-point, participants had a 50% chance of receiving either a mindfulness-based intervention or no intervention (described below). Thus, each participant was randomized many times over this 30-day study. Mindfulness-based intervention: Participants randomly assigned to an app-based mindfulness intervention were instructed to do a brief (<5 min) audio-guided mindfulness practice. The intervention was randomly selected out of 12 practices that consisted of mindfulness and compassion-based practices (e.g., 3 minute breathing space; compassionate body scan; five senses meditation, imagining a safe person or safe place, self-compassion and acceptance-based practices; gratitude practice; metta practices). No intervention: Participants randomly assigned to "no intervention" just continued their normal activities; they did not practice any form of mindfulness mediation at the time of app-notification.
Measure Participants	51
Mean (Standard Deviation) [score on a scale]	-2.61 (4.78)

12. Other Pre-specified Outcome

Title	Change in Perceived Stress, as Measured by the 10-item Perceived Stress Scale (PSS)
Description	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.
Time Frame	Baseline to post-intervention, an anticipated average of 30 days

Outcome Measure Data

Analysis Population Description

Participants who completed both pre and post measures were included (n = 51).

Arm/Group Title	Mindfulness-based Micro-intervention
Arm/Group Description	Overview: The study used a micro-randomized trial design in which participants received app-notifications three times/day (morning, afternoon, evening). At each notification time-point, participants had a 50% chance of receiving either a mindfulness-based intervention or no intervention (described below). Thus, each participant was randomized many times over this 30-day study. Mindfulness-based intervention: Participants randomly assigned to an app-based mindfulness intervention were instructed to do a brief (<5 min) audio-guided mindfulness practice. The intervention was randomly selected out of 12 practices that consisted of mindfulness and compassion-based practices (e.g., 3 minute breathing space; compassionate body scan; five senses meditation, imagining a safe person or safe place, self-compassion and acceptance-based practices; gratitude practice; metta practices). No intervention: Participants randomly assigned to "no intervention" just continued their normal activities; they did not practice any form of mindfulness mediation at the time of app-notification.
Measure Participants	51
Mean (Standard Deviation) [score on a scale]	-3.76 (5.55)

13. Other Pre-specified Outcome

Title	Change in Anxiety, as Measured by the 7-item General Anxiety Disorder (GAD-7) Questionnaire
Description	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.
Time Frame	Baseline to post-intervention, an anticipated average of 30 days

Outcome Measure Data

Analysis Population Description

Participants who completed both pre and post measures were included (n = 51).

Arm/Group Title	Mindfulness-based Micro-intervention
Arm/Group Description	Overview: The study used a micro-randomized trial design in which participants received app-notifications three times/day (morning, afternoon, evening). At each notification time-point, participants had a 50% chance of receiving either a mindfulness-based intervention or no intervention (described below). Thus, each participant was randomized many times over this 30-day study. Mindfulness-based intervention: Participants randomly assigned to an app-based mindfulness intervention were instructed to do a brief (<5 min) audio-guided mindfulness practice. The intervention was randomly selected out of 12 practices that consisted of mindfulness and compassion-based practices (e.g., 3 minute breathing space; compassionate body scan; five senses meditation, imagining a safe person or safe place, self-compassion and acceptance-based practices; gratitude practice; metta practices). No intervention: Participants randomly assigned to "no intervention" just continued their normal activities; they did not practice any form of mindfulness mediation at the time of app-notification.
Measure Participants	51
Mean (Standard Deviation) [score on a scale]	-2.14 (4.59)

Adverse Events

Time Frame	Baseline to post-intervention, an anticipated average of 30 days.
Arm/Group Title	Mindfulness-based Micro-intervention
Arm/Group Description	Overview: The study used a micro-randomized trial design in which participants received app-notifications three times/day (morning, afternoon, evening). At each notification time-point, participants had a 50% chance of receiving either a mindfulness-based intervention or no intervention (described below). Thus, each participant was randomized many times over this 30-day study. Mindfulness-based intervention: Participants randomly assigned to an app-based mindfulness intervention were instructed to do a brief (<5 min) audio-guided mindfulness practice. The intervention was randomly selected out of 12 practices that consisted of mindfulness and compassion-based practices (e.g., 3 minute breathing space; compassionate body scan; five senses meditation, imagining a safe person or safe place, self-compassion and acceptance-based practices; gratitude practice; metta practices). No intervention: Participants randomly assigned to "no intervention" just continued their normal activities; they did not practice any form of mindfulness mediation at the time of app-notification.
All Cause Mortality
	Mindfulness-based Micro-intervention
	Affected / at Risk (%)	# Events
Total	0/53 (0%)
Serious Adverse Events
	Mindfulness-based Micro-intervention
	Affected / at Risk (%)	# Events
Total	0/53 (0%)
Other (Not Including Serious) Adverse Events
	Mindfulness-based Micro-intervention
	Affected / at Risk (%)	# Events
Total	0/53 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.