University of California, San Francisco
San Francisco, California, 94118, United States
NCT Number: NCT05255380
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.
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Notify Me30 year–50 year
Female
Interventional
Not applicable
San Francisco, California, 94118, United States
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The app-based (audio-guided) interventions 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).
Participants 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)
Time frame: Assessed at post-intervention, approximately 8 weeks from baseline
The Treatment Acceptability Questionnaire (TAQ) is a six-item scale assessing whether participants view their assigned intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable), with a possible score range from 6 to 42. Higher scores indicate better treatment acceptability and positive perceptions of the treatment. A total mean score of at least 24 will indicate sufficient acceptability of the intervention.
Time frame: Anticipated study period of 12 months
Feasibility outcomes will include: >70% of eligible participants (passed web-based and phone screener) will be consented, >70% of consented participants will pass further baseline screening procedures and will be randomized to treatment, >70% of participants who are randomized to treatment will be retained at follow-up. Reasons for ineligibility and drop out will also be assessed.
Time frame: Baseline to follow-up, an anticipated 8 weeks
Completion of at least 50% of assigned intervention group practices (Ecological Momentary Assessments for Mindful Awareness group; mindfulness practices for Mindful Activity group) is considered acceptable.
Time frame: Baseline to post-intervention, an anticipated 8 weeks
The 9-item Patient Health Questionnaire (PHQ-9) has a total score scale range of 0 to 27, with higher values indicating more depressive symptoms.
University of California, San Francisco
Other
Pilot Randomized Controlled Trial Examining the Effects of Daily Mindfulness in Woman With a History of Child Adversity
Acronym: EMMA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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