Trial Outcomes & Findings for Examine the Effects of Meditation on Daily Psychological Stress Responses in Woman With a History of Child Adversity (NCT NCT04606199)

NCT ID: NCT04606199

Last Updated: 2025-05-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: From pre-EMA (immediately prior to intervention randomization) to post-EMA, approximately 15 minutes post-randomization, over a period of 30 days.
• Results posted on: 2025-05-04

Participant Flow

Participant milestones

Measure	Mindfulness-based Micro-intervention 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 Study STARTED	53
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

Mindfulness-based Micro-intervention 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 Study Withdrawal by Subject

2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Mindfulness-based Micro-intervention n=53 Participants 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.
Age, Continuous	40.85 years STANDARD_DEVIATION 8.46 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	53 Participants n=5 Participants
9-item Patient Health Questionnaire (PHQ-9)	8.62 units on a scale STANDARD_DEVIATION 2.33 • n=5 Participants
7-item General Anxiety Disorder (GAD-7)	9.75 units on a scale STANDARD_DEVIATION 4.99 • n=5 Participants
10-item Perceived Stress Scale (PSS)	23.47 units on a scale STANDARD_DEVIATION 5.84 • n=5 Participants

PRIMARY outcome

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

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

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.

Outcome measures

Measure	Mindfulness-based Intervention n=1547 Decision points 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).	No Intervention n=1653 Decision points Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Change in Stressor Demands, as Measured by Ecological Momentary Assessment (EMA)	-.0950 score on a scale Standard Deviation .84983	.0009 score on a scale Standard Deviation .74960

PRIMARY outcome

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

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

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.

Outcome measures

Measure	Mindfulness-based Intervention n=1542 Decision points 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).	No Intervention n=1650 Decision points Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Change in Negative Affect, as Measured by Ecological Momentary Assessment (EMA)	-.0610 score on a scale Standard Deviation .83630	.0018 score on a scale Standard Deviation .72844

SECONDARY outcome

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

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

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.

Outcome measures

Measure	Mindfulness-based Intervention n=1543 Decision points 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).	No Intervention n=1651 Decision points Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Change in Coping Resources, as Measured by Ecological Momentary Assessment (EMA)	.1134 score on a scale Standard Deviation .90167	.0112 score on a scale Standard Deviation .76279

SECONDARY outcome

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

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

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.

Outcome measures

Measure	Mindfulness-based Intervention n=1542 Decision points 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).	No Intervention n=1648 Decision points Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Change in Positive Affect, as Measured by Ecological Momentary Assessment (EMA)	.1288 score on a scale Standard Deviation .82500	.0038 score on a scale Standard Deviation .66488

SECONDARY outcome

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

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

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.

Outcome measures

Measure	Mindfulness-based Intervention n=1540 Decision points 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).	No Intervention n=1648 Decision points Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Change in Perseverative Cognitions, as Measured by Ecological Momentary Assessment (EMA)	-.1088 score on a scale Standard Deviation .78940	-.0322 score on a scale Standard Deviation .69380

SECONDARY outcome

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

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

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.

Outcome measures

Measure	Mindfulness-based Intervention n=1540 Decision points 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).	No Intervention n=1647 Decision points Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Change in Self-criticism, as Measured by Ecological Momentary Assessment (EMA)	-.0932 score on a scale Standard Deviation .74596	-.0188 score on a scale Standard Deviation .64742

SECONDARY outcome

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

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

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.

Outcome measures

Measure	Mindfulness-based Intervention n=1540 Decision points 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).	No Intervention n=1647 Decision points Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Change in Social Connection, as Measured by Ecological Momentary Assessment (EMA)	.0880 score on a scale Standard Deviation .77520	-.0134 score on a scale Standard Deviation .69068

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Mindfulness-based Intervention n=823 Decision points 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).	No Intervention n=870 Decision points Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Change in Contextualized Stressor Demands, as Measured by Ecological Momentary Assessment (EMA)	-.0984 score on a scale Standard Deviation 1.15313	-.0161 score on a scale Standard Deviation 1.08752

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Mindfulness-based Intervention n=823 Decision points 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).	No Intervention n=870 Decision points Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Change in Contextualized Coping Resources, as Measured by Ecological Momentary Assessment (EMA)	.0668 score on a scale Standard Deviation 1.01529	-.0172 score on a scale Standard Deviation .85195

SECONDARY outcome

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

Population: 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.

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.

Outcome measures

Measure	Mindfulness-based Intervention n=823 Decision points 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).	No Intervention n=870 Decision points Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Change in Negative Stressor Impact, as Measured by Ecological Momentary Assessment (EMA)	-.1021 score on a scale Standard Deviation 1.13098	-.0736 score on a scale Standard Deviation 1.02853

OTHER_PRE_SPECIFIED outcome

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

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

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.

Outcome measures

Measure	Mindfulness-based Intervention n=51 Participants 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).	No Intervention Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Change in Depressive Symptoms, as Measured by the 9-item Patient Health Questionnaire (PHQ-9).	-2.61 score on a scale Standard Deviation 4.78	—

OTHER_PRE_SPECIFIED outcome

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

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

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.

Outcome measures

Measure	Mindfulness-based Intervention n=51 Participants 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).	No Intervention Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Change in Perceived Stress, as Measured by the 10-item Perceived Stress Scale (PSS)	-3.76 score on a scale Standard Deviation 5.55	—

OTHER_PRE_SPECIFIED outcome

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

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

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.

Outcome measures

Measure	Mindfulness-based Intervention n=51 Participants 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).	No Intervention Participants continued their normal activities and did not practice any form of mindfulness mediation at the time of app-notification.
Change in Anxiety, as Measured by the 7-item General Anxiety Disorder (GAD-7) Questionnaire	-2.14 score on a scale Standard Deviation 4.59	—

Adverse Events

Mindfulness-based Micro-intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Stefanie Mayer

University of California San Francisco

Phone: 7345450698

Email: Stefanie.mayer@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place