Summary

Eligibility
for females ages 30-50 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Stefanie Mayer
Headshot of Stefanie Mayer
Stefanie Mayer

Description

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.

Official Title

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

Details

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).

Keywords

Stress Psychological Stress Child Maltreatment Depressive Symptoms Signs and Symptoms Mindfulness Adverse childhood experiences Depression Stress, Psychological Mindfulness and compassion-based practices; approximately 5-10 minutes two times/day Mindful awareness and reporting of current thoughts and feelings, 2 times/day

Eligibility

You can join if…

Open to females ages 30-50

  1. female sex and gender identity (to control for sex and gender differences in stress responses and health outcomes)
  2. age 30-50 (to examine intervention effects on health outcomes in midlife)
  3. ≥2 Adverse Childhood Experiences (to ensure exposure to early life adversity)
  4. mild depressive symptoms (to allow for outcome improvements: PHQ-9 ≥ 5)
  5. having a smartphone (to access app-based assessments/interventions)

You CAN'T join if...

  1. Non-English speaker or unable to provide informed consent
  2. Current regular mindfulness practice (exclude if >20 min/week)
  3. 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
  4. 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
  5. Free from medications known to affect the immune and endocrine systems with the exception of antidepressant medication and oral contraceptives
  6. Psychotherapy treatment permitted if stable (≥3 months)
  7. Current smoking and nicotine use
  8. Currently pregnant

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94118 United States

Lead Scientist at UCSF

  • Stefanie Mayer
    Stefanie Mayer is a clinical scientist at the UCSF Department of Psychiatry and Behavioral Sciences. She obtained her PhD in Clinical Psychology from the University of Michigan in 2017. Stefanie`s research focuses on the biopsychosocial pathways by which stress exposure – throughout the lifespan – can get “under the skin” and increase risk for adverse mental and physical health outcomes.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05255380
Study Type
Interventional
Participants
Expecting 70 study participants
Last Updated