Functional Neuroimaging, Infant Development, Maternal Psychological Distress, Pregnancy Related, Prenatal Stress
Conditions
Keywords
Infant MRI, Brain Development, MBCT, Mindfulness
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.
Interventions
BEHAVIORALMindfulness Based Cognitive Therapy
See Mindfulness Based Cognitive Therapy (MBCT) Arm description
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Given the use of a psychotherapeutic intervention involving participation in group sessions, participants and interventionists cannot be blinded to group assignment. The study is designed to minimize the extent to which study staff, aside from interventionists and the primary Study Coordinator(s), are aware of group assignment. The Study Coordinator(s) needs to know group assignment because they will inform participants of their group assignment and will communicate with participants regarding group attendance. The Study Coordinator(s) will be the main point of contact for participants throughout the study to reduce risk of participants revealing their group assignment to other study staff. Participants will be informed that only the Study Coordinator(s) and interventionists, if applicable, are aware of their group assignment. Therefore, in order to ensure the integrity of the research study, they should refrain from discussing their group assignment with other staff members.
Intervention model description
The study is a randomized, control trial with an intervention arm, Mindfulness Based Cognitive Therapy (MBCT) adapted for pregnant women (Dimidjian, Goodman, et al., 2016), and treatment as usual (TAU) arm. The study will be blinded to staff (except for the study coordinator(s) and interventionists), but participant blinding is not possible due to the nature of the intervention. Participants will be randomized using a stratified block design after initial eligibility determination.
Eligibility
Sex/Gender
FEMALE
Age
3 Days to 45 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Cortisol | 34 Weeks GA (T5) | The cortisol levels obtained from participant's hair samples to assess cumulative cortisol from pre- to post-intervention. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed