Pregnancy Related Clinical Trial
Official title:
A Targeted Approach to Examine the Influence of Maternal Psychological Stress on Newborn Brain Outcomes
Verified date | September 2023 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health and Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University |
United States,
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
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) |
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