Clinical trial NCT03809598: Roo Study on Mom and Baby Well-Being
Official title: A Targeted Approach to Examine the Influence of Maternal Psychological Stress on Newborn Brain Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Psychological Distress
Prenatal Stress
Infant Development
Functional Neuroimaging
Pregnancy Related
Keywords: Infant MRI
Brain Development
MBCT
Mindfulness
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 140
Sex: FEMALE
Minimum age (years): 3
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomized, control trial with an intervention arm, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnant women (Dimidjian, Goodman, et al., 2016), and treatment as usual (TAU) arm. The study will be blinded to staff (except for the study coordinator(s) and interventionists), but participant blinding is not possible due to the nature of the intervention. Participants will be randomized using a stratified block design after initial eligibility determination.
Primary purpose: PREVENTION

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 psychological stress during pregnancy (magnitude and trajectories of stress) and offspring brain systems integral to healthy and maladaptive emotion regulation. This study considers other potential influences on maternal stress and psychiatric symptomatology, and infant behavior and brain development. The study population is pregnant women aged 21-45, and their infants.

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 testing and a diagnostic interview, to further determine eligibility. After the assessment, they will be informed of their eligibility status and, if applicable, randomized to a Mindfulness Based Cognitive Therapy (MBCT) group involving an 8-session group-based intervention or to treatment as usual (TAU) during pregnancy followed by one mindfulness psychoeducation session postpartum. Eligible participants will then be invited in for a study visit during which they will give blood, urine, and saliva samples. Participants in the MBCT group will complete questionnaires prior to the 1st group session, after the 4th session, and after the 8th/final session. Participants in the TAU group will complete the same questionnaires at equivalent time points. All participants will come in for an in-person session at 34 weeks GA, during which they will complete questionnaires, a brief clinical interview and provide blood, urine, and saliva samples again. Participants will then come in with their infant for the infant MRI scan within one month of giving birth. Study staff will collect a hair and saliva sample from the infant at this time. Participants will have a remote visit at 6 weeks postpartum, during which time they will complete questionnaires and a clinical interview. At 6 months postpartum, participants will return for their final visit, during which they will complete questionnaires and a clinical interview. Mothers and infants will also provide a hair sample at this time. Some visits will be adapted as needed to accommodate institutional requirements with regard to restrictions due to COVID-19.

Eligibility criteria: 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:

1. be 21-45 years old
2. be a female who is currently pregnant (8-22 weeks GA at screening)
3. fluently speak English
4. be available and physically able to attend group scheduled meetings
5. have a single gestation, and
6. have a history of an internalizing psychiatric disorder.

Exclusion criteria include:

1. Major neurological or medical condition (e.g., diabetes, MS),
2. IQ \<80
3. maternal use of psychotropic medications, insulin, or any other medications that might impact the central nervous system (at the time of enrollment)
4. current diagnosis of substance use disorder, illicit drug use or nicotine use
5. diagnosis of autism, developmental disorder involving intellectual disability or a psychotic disorder
6. current major depressive episode, eating disorder or manic episode
7. current active suicidality and/or homicidally, or interpersonal violence
8. prior history of engaging in mindfulness-based psychotherapeutic interventions (e.g., MBCT, MBSR, DBT (mindfulness module))
9. pregnancy-specific medical conditions or complications including placental abnormality or other conditions requiring bed rest
10. known congenital, genetic, or neurologic disorder of the fetus (e.g., Down syndrome, fragile X)
11. uncorrectable vision or hearing impairments (including color blindness)

Infants:

Inclusion for infants to participate in MRI scan include:

1. being between 37 and 50 weeks gestational age (GA) equivalent at time of 1st scan\*
2. 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:

1. congenital, genetic, or neurologic disorder (e.g., Down syndrome, fragile X)
2. major neurologic disorder at birth (e.g., bacterial meningitis, epilepsy)
3. birth \< 30 weeks GA
4. medical complications following birth requiring ongoing hospitalization.
5. medical complications or health problems at or following birth, which could make an MRI scan unsafe or uncomfortable

Primary outcomes:
measure: Maternal Psychological Stress
timeFrame: Intake - 34 Weeks GA (T5)
measure: Maternal Depression
timeFrame: Intake - 34 Weeks GA (T5)
Secondary outcomes:
measure: Blood assay for inflammatory marker IL6
timeFrame: 34 Weeks GA (T5)
measure: Maternal Cortisol
timeFrame: 34 Weeks GA (T5)
measure: Neonatal Resting State fMRI scan
timeFrame: Infant Scan (T6)
measure: Neonatal Structural MRI scan
timeFrame: Infant Scan (T6)
measure: Maternal Pregnancy Specific Psychological Stress
timeFrame: Intake - 34 weeks (T5)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alice Graham, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dimidjian S, Goodman SH, Felder JN, Gallop R, Brown AP, Beck A. Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence. J Consult Clin Psychol. 2016 Feb;84(2):134-45. doi: 10.1037/ccp0000068. Epub 2015 Dec 14.