Status:
COMPLETED
Examine the Effects of Mindfulness in Woman With a History of Child Adversity
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Stress
Psychological Stress
Eligibility:
FEMALE
30-50 years
Phase:
NA
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 advers...
Detailed 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 primari...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
June 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05255380
Start Date
June 3 2022
End Date
April 19 2024
Last Update
May 4 2025
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94118