Examine the Effects of Meditation on Daily Psychological Stress Responses in Woman With a History of Child Adversity
Condition: Stress; Psychological Stress; Child Maltreatment; Depressive Symptoms; Signs and Symptoms; Psychological Distress; Psychological
MeSH terms: Depression; Stress, Psychological
Study type: Interventional

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).
    

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.
    

Intervention name(s): Mindfulness-based intervention, up to 5 minutes 0-3 times/day
Intervention type(s): Behavioral
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A Micro-Randomized Trial (MRT) is a design that randomly assigns an intervention at each notification time point (similar to a crossover design in that each participant is randomized to both conditions at different times, except in the MRT the crossover occurs at multiple times): Participants use the study app for 30 days and receive three notifications per day. At each notification time point, participants complete an Ecological Momentary Assessment (EMA) of their current psychological stress states (pre-EMA). Then, at each notification, each participant is randomized (50 percent probability) to either receive a mindfulness-based intervention or not. Thus, participants are randomized many times over the 30-day study. Approximately thirty minutes post-randomization, an EMA is obtained again to assess psychological stress states (post-EMA). A treatment effect is examined by comparing psychological stress responses after a mindfulness-based intervention compared to no intervention.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Mindfulness; Adverse childhood experiences; Stress appraisals; Affect; Daily psychological stress responses; Stress; Depressive symptoms