Roo Study on Mom and Baby Well-Being

Study Overview
=================
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.

Official Title
-----------------
A Targeted Approach to Examine the Influence of Maternal Psychological Stress on Newborn Brain Outcomes

Conditions
-----------------
Maternal Psychological Distress, Prenatal Stress, Infant Development, Functional Neuroimaging, Pregnancy Related

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Based Cognitive Therapy


Participation Criteria
=================
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: 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

Ages Eligible for Study
-----------------
Minimum Age: 3 Days
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Based Cognitive Therapy<br>MBCT adapted for pregnancy includes 8 sequential, weekly 2-hour group sessions co-led by two master's level therapists. Sessions include: 1) introducing new mindfulness skills through in-session practice, 2) reviewing mindfulness practices and troubleshooting barriers to practice, 3) reinforcing mindfulness skills through in-session practice and debriefing, 4) learning about how thoughts influence feelings and behaviors (not all sessions), 5) providing psychoeducational information to support skills, and 6) encouraging the establishment of social support. The intervention is focused on skill development through active engagement in mindfulness practices and exercises to increase awareness of thoughts, feelings and behavior in session, and assignment and review of daily home practices. | Behavioral: Mindfulness Based Cognitive Therapy<br>* See Mindfulness Based Cognitive Therapy (MBCT) Arm description<br>* Other names: Mindfulness Based Cognitive Therapy for Perinatal Depression;|
| No Intervention: Treatment as Usual<br>All participants will receive routine prenatal care from an identified medical provider, which they have initiated on their own. They will be able to engage in any services recommended by their primary medical provider or that they voluntarily initiate. For ethical reasons, they are not prohibited from engaging in any type of therapeutic, complementary, or medication treatment (after enrollment). The TAU group will be offered a delayed treatment option, after the 6 month follow-up. This will be a 2 hour mindfulness psychoeducation session, offered between 6 and 9 months postpartum. Several core mindfulness concepts included in the full MBCT curriculum will be taught and participants will complete several brief mindfulness activities. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Psychological Stress | Maternal psychological stress will be a composite of the Perceived Stress Scale (PSS), Beck Anxiety Inventory (BAI), and Pregnancy Distress Questionnaire (PDQ) The magnitude and trajectory of maternal psychological stress will be examined. | Intake - 34 Weeks GA (T5) | 
| Maternal Depression | Maternal depressive symptoms will be measured using the Center for Epidemiologic Studies Depression Scale - Revised (CESD-R). The magnitude and trajectory of maternal psychological stress will be examined. | Intake - 34 Weeks GA (T5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood assay for inflammatory marker IL6 | Levels of IL6 assayed from maternal blood samples. Difference in magnitude of inflammation between groups at T5 after adjusting for inflammation prior to the intervention. | 34 Weeks GA (T5) | 
| Maternal Cortisol | The cortisol levels obtained from participant's hair samples to assess cumulative cortisol from pre- to post-intervention. | 34 Weeks GA (T5) | 
| Neonatal Resting State fMRI scan | MRI scans with neonates will occur during natural sleep. Resting state functional connectivity will be the outcome of interest. | Infant Scan (T6) | 
| Neonatal Structural MRI scan | MRI scans with neonates will occur during natural sleep. Neonatal subcortical brain structure volume will be the outcome of interest. | Infant Scan (T6) | 
| Maternal Pregnancy Specific Psychological Stress | The Prenatal Distress Questionnaire (PDQ) is a short measure designed to assess specific worries and concerns related to pregnancy. | Intake - 34 weeks (T5) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MBCT, Infant MRI, Brain Development, Mindfulness