Examine the Effects of Meditation on Daily Psychological Stress Responses in Woman With a History of Child Adversity
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- Child Maltreatment
- Depressive Symptoms
- Psychological
- Psychological Distress
- Psychological Stress
- Signs and Symptoms
- Stress
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention 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 fifteen 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
Participation Requirements
- Age
- Between 30 years and 60 years
- Gender
- Only males
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 interve...
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. The goal is to recruit as many as 70 participants. 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.
Tracking Information
- NCT #
- NCT04606199
- Collaborators
- Harvard University
- National Institute on Aging (NIA)
- Penn State University
- Investigators
- Principal Investigator: Stefanie E Mayer, PhD University of California, San Francisco
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