Roo Study on Mom and Baby Well-Being

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.

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 (8-18 weeks GA at screening)

3. fluently speak English

4. primiparous

5. be available and physically able to attend group scheduled meetings

6. have a single gestation

7. experience heightened psychological stress based on scoring above average for women of
childbearing age on the Perceived Stress Scale and score ≥ 4 on the 10 item Distress
Thermometer, and

8. have a history of a mood or anxiety disorder.

Exclusion criteria include:

1. Major neurological or medical condition (e.g., diabetes, MS),

2. IQ <80

3. maternal use of psychotropic medications, corticosteroids, 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 neurodevelopmental disorder or 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

Therapists:

Inclusion criteria for therapist include:

1. be a licensed psychologist, psychiatrist or clinical social worker or

2. a clinical psychology graduate students or psychiatry trainee (resident or fellow),
who will be supervised by the PI or other licensed psychologist, psychiatrist or
clinical social worker with expertise in MBCT-PD. Two therapists will participate/lead
each group.

Exclusion criteria include:

(1) If the therapists meet inclusion criteria, there is no other exclusion criteria.