Status:
COMPLETED
Roo Study on Mom and Baby Well-Being
Lead Sponsor:
Oregon Health and Science University
Conditions:
Maternal Psychological Distress
Prenatal Stress
Eligibility:
FEMALE
3-45 years
Phase:
NA
Brief Summary
This study employs a randomized controlled trial of an established intervention, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnancy, to examine effects on various aspects of maternal psy...
Detailed Description
The study will involve an online screen of potentially eligible pregnant women. If women are eligible after the online screen, they will be invited in for an in-person assessment, including cognitive ...
Eligibility Criteria
Inclusion
- Pregnant Women/ Mothers:
- Inclusion and exclusion criteria for pregnant women/ mothers will be determined by a combination of the initial screen and intake assessment.
- Inclusion criteria include:
- be 21-45 years old
- be a female who is currently pregnant (8-22 weeks GA at screening)
- fluently speak English
- be available and physically able to attend group scheduled meetings
- have a single gestation, and
- have a history of an internalizing psychiatric disorder.
- Exclusion criteria include:
- Major neurological or medical condition (e.g., diabetes, MS),
- IQ \<80
- maternal use of psychotropic medications, insulin, or any other medications that might impact the central nervous system (at the time of enrollment)
- current diagnosis of substance use disorder, illicit drug use or nicotine use
- diagnosis of autism, developmental disorder involving intellectual disability or a psychotic disorder
- current major depressive episode, eating disorder or manic episode
- current active suicidality and/or homicidally, or interpersonal violence
- prior history of engaging in mindfulness-based psychotherapeutic interventions (e.g., MBCT, MBSR, DBT (mindfulness module))
- pregnancy-specific medical conditions or complications including placental abnormality or other conditions requiring bed rest
- known congenital, genetic, or neurologic disorder of the fetus (e.g., Down syndrome, fragile X)
- uncorrectable vision or hearing impairments (including color blindness)
- Infants:
- Inclusion for infants to participate in MRI scan include:
- being between 37 and 50 weeks gestational age (GA) equivalent at time of 1st scan\*
- not meeting any of the exclusion criteria below.
- We are using GA equivalent rather than postnatal age because infants born pre-term will not be scanned prior to term equivalent (37 weeks GA). Therefore, infants who are born preterm may be older in terms of postnatal age, but will be similar to infants born at term with regard to time since conception. The time since conception is more pertinent to our measures of brain development versus postnatal age.
- Exclusion criteria for infants (specifically exclusionary for MRI scan) include:
- congenital, genetic, or neurologic disorder (e.g., Down syndrome, fragile X)
- major neurologic disorder at birth (e.g., bacterial meningitis, epilepsy)
- birth \< 30 weeks GA
- medical complications following birth requiring ongoing hospitalization.
- medical complications or health problems at or following birth, which could make an MRI scan unsafe or uncomfortable
Exclusion
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03809598
Start Date
March 1 2019
End Date
September 1 2022
Last Update
September 29 2023
Active Locations (1)
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1
Oregon Health and Science University
Portland, Oregon, United States, 97239