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

NCT04606199 | Completed Results

• 2 other identifiers: 19-27198K99AG062778
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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).

Conditions

Stress; Psychological Stress; Child Maltreatment; Depressive Symptoms; Signs and Symptoms; Psychological Distress; Psychological

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  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.

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

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

  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.

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

Secondary Outcomes (8)

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

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

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

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

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

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

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

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

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

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

Other Outcomes (3)

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

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

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

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

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

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

Study Arms (2)

Mindfulness-based intervention

EXPERIMENTAL

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

No intervention

NO INTERVENTION

Participants will continue their normal activities and not practice any form of mindfulness mediation at the time of app-notification.

Interventions

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

The intervention consist of mindfulness and compassion-based practices that are selected to maximize their effect on stress targets. Interventions include, for example, practices that focus on the breath/body (e.g., 3 minute breathing space; compassionate body scan; five senses mediation), on increasing participants' inner resources (e.g., imaging a safe person or safe place), on reducing negative affect (e.g., self-compassion and acceptance-based practices), or on increasing positive emotions (e.g., gratitude practice; metta practices).

Mindfulness-based intervention

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: Self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Francisco: lead
• Harvard University: collaborator
• National Institute on Aging (NIA): collaborator
• Penn State University: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Depression; Signs and Symptoms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Stefanie Mayer
• Organization: University of California San Francisco

Stefanie.mayer@ucsf.edu

7345450698

Study Officials

• Stefanie E Mayer, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 28, 2020
• Study Start: November 2, 2020
• Primary Completion: July 12, 2021
• Study Completion: July 12, 2021
• Last Updated: May 4, 2025
• Results First Posted: August 11, 2022

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)