Roo Study on Mom and Baby Well-Being
Condition: Maternal Psychological Distress; Prenatal Stress; Infant Development; Functional Neuroimaging; Pregnancy Related
Study type: Interventional

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.
    

Intervention name(s): Mindfulness Based Cognitive Therapy
Intervention type(s): Behavioral
Intervention description(s): See "Mindfulness Based Cognitive Therapy (MBCT) Arm" description
Other intervention name(s): Mindfulness Based Cognitive Therapy for Perinatal Depression
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Infant MRI; Brain Development; MBCT; Mindfulness