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

NCT05255380 | Completed

• 2 other identifiers: IRB# 21-35255R00AG062778
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Mindfulness; Adverse childhood experiences; Stress; Depressive symptoms

Outcome Measures

Primary Outcomes (3)

• Acceptability of the intervention will be measured with an adapted version of the Treatment Acceptability Questionnaire (TAQ).

  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.

  Assessed at post-intervention, approximately 8 weeks from baseline

• Feasibility, as indicated by numbers of participants screened (completed web-based screener and phone screener), eligible based on web-based screener and phone screener, consented, randomized to treatment, and retained at follow-up.

  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.

  Anticipated study period of 12 months

• Adherence, as measured by the percentage of assigned and completed intervention group practices.

  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.

  Baseline to follow-up, an anticipated 8 weeks

Secondary Outcomes (1)

• Change in depressive symptoms, as measured by the total score on the 9-item Patient Health Questionnaire (PHQ-9).

  Baseline to post-intervention, an anticipated 8 weeks

Study Arms (2)

Mindful Activity group

EXPERIMENTAL

Participants complete mindfulness and compassion-based practices via the study app.

Behavioral: Mindfulness and compassion-based practices; approximately 5-10 minutes two times/day

Mindful Awareness group

SHAM COMPARATOR

Participants monitor and report their thoughts and feelings via the study app.

Behavioral: Mindful awareness and reporting of current thoughts and feelings, 2 times/day

Interventions

Mindfulness and compassion-based practices; approximately 5-10 minutes two times/day BEHAVIORAL

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).

Mindful Activity group

Mindful awareness and reporting of current thoughts and feelings, 2 times/day BEHAVIORAL

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)

Mindful Awareness group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: Self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female sex and gender identity (to control for sex and gender differences in stress responses and health outcomes)
• age 30-50 (to examine intervention effects on health outcomes in midlife)
• ≥2 Adverse Childhood Experiences (to ensure exposure to early life adversity)
• mild depressive symptoms (to allow for outcome improvements: PHQ-9 ≥ 5)
• having a smartphone (to access app-based assessments/interventions)

You may not qualify if:

• Non-English speaker or unable to provide informed consent
• Current regular mindfulness practice (exclude if \>20 min/week)
• Major psychiatric condition, including psychosis/schizophrenia, bipolar disorder, post-traumatic stress disorder, eating disorders, alcohol/substance use, major depression (PHQ-9 ≥ 15), and self-harm or suicidal ideation
• Major medical conditions, including no history of coronary heart disease, diabetes, severe asthma or lung disease, autoimmune disorders, infectious disease, epilepsy, brain injury, endocrine disorders, diagnosis of cancer or chemotherapy or radiation in the past 10 years
• Free from medications known to affect the immune and endocrine systems with the exception of antidepressant medication and oral contraceptives
• Psychotherapy treatment permitted if stable (≥3 months)
• Current smoking and nicotine use
• Currently pregnant

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Depression; Signs and Symptoms

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Stefanie E Mayer, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to either a Mindful Activity group or a Mindful Awareness group. Randomization will occur by chance (50%) at the end of the baseline visit.

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 24, 2022
• Study Start: June 3, 2022
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)