Roo Study on Mom and Baby Well-Being
A Targeted Approach to Examine the Influence of Maternal Psychological Stress on Newborn Brain Outcomes
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
- be 21-45 years old
- be a female who is currently pregnant (8-22 weeks GA at screening)
- fluently speak English
- be available and physically able to attend group scheduled meetings
- have a single gestation, and
- have a history of an internalizing psychiatric disorder.
Exclusion criteria include:
- Major neurological or medical condition (e.g., diabetes, MS),
- IQ <80
- maternal use of psychotropic medications, insulin, or any other medications that might impact the central nervous system (at the time of enrollment)
- current diagnosis of substance use disorder, illicit drug use or nicotine use
- diagnosis of autism, developmental disorder involving intellectual disability or a psychotic disorder
- current major depressive episode, eating disorder or manic episode
- current active suicidality and/or homicidally, or interpersonal violence
- prior history of engaging in mindfulness-based psychotherapeutic interventions (e.g., MBCT, MBSR, DBT (mindfulness module))
- pregnancy-specific medical conditions or complications including placental abnormality or other conditions requiring bed rest
- known congenital, genetic, or neurologic disorder of the fetus (e.g., Down syndrome, fragile X)
- uncorrectable vision or hearing impairments (including color blindness)
Infants:
Inclusion for infants to participate in MRI scan include:
- being between 37 and 50 weeks gestational age (GA) equivalent at time of 1st scan*
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:
- congenital, genetic, or neurologic disorder (e.g., Down syndrome, fragile X)
- major neurologic disorder at birth (e.g., bacterial meningitis, epilepsy)
- birth < 30 weeks GA
- medical complications following birth requiring ongoing hospitalization.
- medical complications or health problems at or following birth, which could make an MRI scan unsafe or uncomfortable
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Mindfulness Based Cognitive Therapy
MBCT adapted for pregnancy includes 8 sequential, weekly 2-hour group sessions co-led by two master's level therapists.
Sessions include: 1) introducing new mindfulness skills through in-session practice, 2) reviewing mindfulness practices and troubleshooting barriers to practice, 3) reinforcing mindfulness skills through in-session practice and debriefing, 4) learning about how thoughts influence feelings and behaviors (not all sessions), 5) providing psychoeducational information to support skills, and 6) encouraging the establishment of social support.
The intervention is focused on skill development through active engagement in mindfulness practices and exercises to increase awareness of thoughts, feelings and behavior in session, and assignment and review of daily home practices.
|
See "Mindfulness Based Cognitive Therapy (MBCT) Arm" description
Other Names:
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No Intervention: Treatment as Usual
All participants will receive routine prenatal care from an identified medical provider, which they have initiated on their own.
They will be able to engage in any services recommended by their primary medical provider or that they voluntarily initiate.
For ethical reasons, they are not prohibited from engaging in any type of therapeutic, complementary, or medication treatment (after enrollment).
The TAU group will be offered a delayed treatment option, after the 6 month follow-up.
This will be a 2 hour mindfulness psychoeducation session, offered between 6 and 9 months postpartum.
Several core mindfulness concepts included in the full MBCT curriculum will be taught and participants will complete several brief mindfulness activities.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Psychological Stress
Time Frame: 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.
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Intake - 34 Weeks GA (T5)
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Maternal Depression
Time Frame: Intake - 34 Weeks GA (T5)
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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.
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Intake - 34 Weeks GA (T5)
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood assay for inflammatory marker IL6
Time Frame: 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.
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34 Weeks GA (T5)
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Maternal Cortisol
Time Frame: 34 Weeks GA (T5)
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The cortisol levels obtained from participant's hair samples to assess cumulative cortisol from pre- to post-intervention.
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34 Weeks GA (T5)
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Neonatal Resting State fMRI scan
Time Frame: Infant Scan (T6)
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MRI scans with neonates will occur during natural sleep.
Resting state functional connectivity will be the outcome of interest.
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Infant Scan (T6)
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Neonatal Structural MRI scan
Time Frame: Infant Scan (T6)
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MRI scans with neonates will occur during natural sleep.
Neonatal subcortical brain structure volume will be the outcome of interest.
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Infant Scan (T6)
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Maternal Pregnancy Specific Psychological Stress
Time Frame: Intake - 34 weeks (T5)
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The Prenatal Distress Questionnaire (PDQ) is a short measure designed to assess specific worries and concerns related to pregnancy.
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Intake - 34 weeks (T5)
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Alice Graham, PHD, Oregon Health and Science University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- R00MH111805 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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