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

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Completed

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04606199
K99AG062778 (U.S. NIH Grant/Contract)
19-27198

Details and patient eligibility

About

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).

Full 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.

Enrollment

53 patients

Sex

Female

Ages

30 to 60 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

53 participants in 2 patient groups

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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