Roo Study on Mom and Baby Well-Being

Not Applicable

Completed

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

• Registration Number: NCT03809598
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study First Submitted: 2019-01-09
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-18
• Study Start: 2019-03-01
• Primary Completion: 2022-05-24
• Study Completion: 2022-09-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maternal Psychological Stress	Intake - 34 Weeks GA (T5)	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.
Maternal Depression	Intake - 34 Weeks GA (T5)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States