Examine the Effects of Mindfulness in Woman With a History of Child Adversity — EMMA  

Stress Clinical Trial

Official title: Pilot Randomized Controlled Trial Examining the Effects of Daily Mindfulness in Woman With a History of Child Adversity

Status Completed

Clinical Trial Summary

The aim of this pilot Randomized Controlled Trial (RCT) is to test whether brief mindfulness-based practices will improve well-being and health in women (age 30-50) with a history of early life adversity. Following a baseline visit (remotely via Zoom), participants are randomized (50% probability) to either a Mindful Activity group or a Mindful Awareness group. In the Mindful Activity group, participants will complete brief (approximately 5-10 min) audio-guided mindfulness practices twice a day (morning and evening) for 8 weeks using the study app. This is followed by a brief survey about their current thoughts and feelings. In the Mindful Awareness group, participants are asked to be mindful (pay attention) to their thoughts and feelings twice a day (morning and evening) for 8 weeks using the study app. After the 8-week intervention period, all participants complete a follow-up visit (remotely). Primary goals of the pilot RCT are to test acceptability, feasibility, and adherence.

Clinical Trial Description

The pilot Randomized Controlled Trial (RCT) randomly assigns midlife women (age 30-50) with a history of early life adversity to either a Mindful Activity group or a Mindful Awareness group to primarily test acceptability, feasibility, and adherence. Randomization will occur by chance at the end of the baseline visit.

Participants randomized to the Mindful Activity group will receive 8 weeks of ecological momentary assessment and intervention sessions via the study app. Mindfulness-based interventions consist 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 audio-guided and approximately 5-10 minutes. Participants complete two mindfulness interventions/day (one in the morning; one in the evening). After completing a mindfulness-based intervention, participants will complete ecological momentary assessments of their current psychological stress states (e.g., stress appraisals, affect, perseverative cognitions, self-criticism, social connection) via the study app.

Participants randomized to the Mindful Awareness group are instructed to be mindful (pay attention) to their current thoughts and feelings and complete ecological momentary assessments of their current psychological stress states (e.g., stress appraisals, affect, perseverative cognitions, self-criticism, social connection) twice/day (morning and evening) for 8 weeks via the study app.

A trained research assistant will monitor participant adherence and address potential difficulties. All participants will complete assessments at baseline (pre-intervention) and post-intervention (after the 8-week intervention). Weekly measures of depressive symptoms are also obtained. The investigators plan to consent about 100 participants with the goal of having 70 eligible participants enrolled in the study (about 35 in each group). ;

Related Conditions & MeSH terms

• Child Maltreatment
• Depression
• Depressive Symptoms
• Psychological Stress
• Signs and Symptoms
• Stress
• Stress, Psychological

• NCT number: NCT05255380
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Completed
• Phase: N/A
• Start date: June 3, 2022
• Completion date: April 19, 2024