NCT03809598

Roo Study on Mom and Baby Well-Being

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 3 Days – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Maternal Psychological Distress
• Prenatal Stress
• Infant Development
• Functional Neuroimaging
• Pregnancy Related

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness Based Cognitive Therapy	See "Mindfulness Based Cognitive Therapy (MBCT) Arm" description

Timeline

• Start date: 2019-03-01
• Primary completion: 2022-05-24
• Completion: 2022-09-01
• First posted: 2019-01-18
• Last updated: 2023-09-29

Locations

1 site across 1 country: United States