Roo Study on Mom and Baby Well-Being

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03809598
• Other study ID #: R00MH111805
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 1, 2022
• Est. primary completion date: May 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 3 Days to 45 Years

Eligibility

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 (8-22 weeks GA at screening)

3. fluently speak English

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

5. have a single gestation, and

6. have a history of an internalizing psychiatric disorder.

Exclusion criteria include:

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

2. IQ <80

3. maternal use of psychotropic medications, 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 autism, developmental disorder involving intellectual disability or a 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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Mindfulness Based Cognitive Therapy
See "Mindfulness Based Cognitive Therapy (MBCT) Arm" description

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dimidjian S, Goodman SH, Felder JN, Gallop R, Brown AP, Beck A. Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence. J Consult Clin Psychol. 2016 Feb;84(2):134-45. doi: 10.1037/ccp0000068. Epub 2015 Dec 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	Maternal Cortisol	The cortisol levels obtained from participant's hair samples to assess cumulative cortisol from pre- to post-intervention.	34 Weeks GA (T5)
Secondary	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)
Secondary	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)
Secondary	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)