Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
2 other identifiers
interventional
200
1 country
1
Brief Summary
The goal of this study is to investigate inflammation as the biological mechanism by which mindfulness based cognitive therapy for perinatal depression (MBCT-PD) administered during pregnancy improves women's emotional well-being and whole person health index during pregnancy and the early postpartum period. Secondarily the investigative team will determine if MBCT-PD administered during pregnancy improves the physical health and emotional well-being of the developing child.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2026
CompletedFirst Posted
Study publicly available on registry
October 23, 2026
CompletedStudy Start
First participant enrolled
November 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2030
Study Completion
Last participant's last visit for all outcomes
August 1, 2030
October 23, 2026
October 1, 2026
3.8 years
October 5, 2026
October 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Maternal Inflammation
A comprehensive panel of pro- and anti-inflammatory factors, acute-phase proteins, and adhesion molecules will be measured in maternal blood using a combination of enzyme-linked immunosorbent assay (ELISA) and multiplex protein assays.
Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.
Infant Emotional and Regulatory Responses During the Still Face Paradigm
The Still Face Paradigm is a standardized laboratory procedure that assesses infant emotion regulation in response to a brief disruption of caregiver-infant interaction. It consists of three consecutive episodes: a play episode in which the caregiver play peak a boo with the infant for 2 minutes, a still-face episode in which the caregiver maintains a neutral, unresponsive expression for 2 minutes, and a reunion episode in which normal interaction resumes for 2 minutes. Sessions are video recorded and coded by trained, reliable coders who are blinded to group assignment. Infant behavior will be coded from facial expressions, body movements, vocalizations, gaze, and self-regulation behaviors, yielding proportion of time in negative affect, and self-regulation in each episode. Change in infant behavior across episodes indexes reactivity to the still face and recovery after reunion. Higher negative affect scores indicate greater distress.
6 months of age
Infant Emotional Reactivity During the Gentle Arm Restraint Task
The gentle arm restraint task is a standardized laboratory procedure that elicits mild frustration and anger in infants. The infant is seated while an experimenter gently holds the infant's arms down at the infant's sides for up to 30 seconds or until the infant shows sustained intense distress, followed by a brief recovery period. Sessions are video recorded and coded by trained, reliable coders who are blinded to group assignment. Infant anger and distress will be coded from facial, vocal, and bodily expressions, yielding proportion of time in negative affect and self-regulatory behaviors. Higher scores indicate greater negative affect or greater self-regulation.
6 months of age
Infant Respiratory Sinus Arrhythmia (RSA)
Respiratory sinus arrhythmia (RSA) is a non-invasive index of parasympathetic (vagal) influence on the heart, reflected in the high-frequency variation in heart rate that is synchronized with breathing. Infant RSA will be derived from electrocardiogram (ECG) recordings collected during a resting baseline and standardized laboratory tasks still-face paradigm and gentle arm restraint. Inter-beat intervals will be extracted from the ECG, and high-frequency heart rate variability in an infant-appropriate band will be calculated in standardized software and expressed as the natural log of ms\^2. Higher baseline RSA indicates greater parasympathetic regulation of the heart. RSA reactivity (change from baseline to task) will index the child's autonomic regulation in response to challenge.
6 months of age
Infant Behavior Questionnaire-Revised (IBQ-R)
The IBQ-R is a caregiver-report questionnaire that assesses infant temperament. The mother rates how often her infant showed specific behaviors in concrete, everyday situations during the previous week (or two weeks, for less frequent situations) on a 7-point scale from 1 (never) to 7 (always), with a "does not apply" option. Items are grouped into 14 scales: Activity Level, Distress to Limitations, Fear, Duration of Orienting, Smiling and Laughter, High-Intensity Pleasure, Low-Intensity Pleasure, Soothability, Falling Reactivity/Rate of Recovery from Distress, Cuddliness, Perceptual Sensitivity, Sadness, Approach, and Vocal Reactivity. These scales load onto three broad dimensions: Surgency/Positive Affectivity, Negative Emotionality, and Orienting/Regulatory Capacity. Scale scores are the mean of the item responses, excluding "does not apply" items, and range from 1 to 7. Higher scores indicate greater expression of the characteristic measured by that scale.
6 months of age
Secondary Outcomes (31)
Center for Epidemiologic Studies Depression Scale (CES-D)
Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.
Edinburgh Postnatal Depression Scale (EPDS)
Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.
State-Trait Anxiety Inventory (STAI)
Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.
Beck Anxiety Inventory
Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.
Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2)
Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.
- +26 more secondary outcomes
Study Arms (2)
Mindfulness-based cognitive therapy for perinatal depression
EXPERIMENTALIndividuals will be randomized to Mindfulness-based cognitive therapy for perinatal depression (MBCT-PD).
Pregnancy Health Group
ACTIVE COMPARATORParticipants will be randomized to the active control group and will complete 8 sequential weekly, 2-hour sessions focused on pregnancy related health, nutrition, sleep and infant care (Pregnancy Health Group).
Interventions
MBCT-PD has been tailored for pregnant women. Individuals randomized to MBCT-PD will complete 8 sequential, weekly, 2-hour sessions conducted by doctoral (e.g., psychologist) or master's level (e.g., LMFT) or equivalent therapists with specialized training in MBCT-PD. Up to 10 pregnant women will be enrolled in each group, with at least 3 pregnant women needed to constitute a group. MBCT-PD sessions will include learning about key mindfulness concepts and engagement in guided mindfulness practice, learning about cognitive therapy and practicing using cognitive therapy skills, building social support networks, receiving feedback from group leaders to normalize challenges and encourage participation, and reviewing assigned at-home practices and barriers to practice. The intervention is manualized and has been implemented at multiple sites including our own. Schedule. Prior research indicates efficacy of MBCT for pregnant women initiated during the second trimester.
Participants in the active control group will complete 8 sequential weekly, 2-hour sessions focused on pregnancy related health, nutrition, sleep and infant care (Pregnancy Health Group)
Eligibility Criteria
You may qualify if:
- Pregnant women aged 18-50 in good health.
- Individuals who do not expect to move over the next year.
You may not qualify if:
- Pregnancies deemed high risk due to multiple pregnancies, medical conditions such as type 1 or 2 diabetes, mellitus, cancer, hypertension, kidney disease, and epilepsy, the presence of infections (HIV, hepatitis C), history of three or more miscarriages, or if the fetus has been diagnosed with a genetic condition such as Down syndrome.
- Smoking (\>5 cigarettes during pregnancy),
- Drinking alcohol (\>10 drinks during pregnancy)
- Marijuana use (legal in Oregon),
- Reported illicit drug use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health and Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elinor L Sullivan, PhD
Oregon Health and Science University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 5, 2026
First Posted
October 23, 2026
Study Start (Estimated)
November 1, 2026
Primary Completion (Estimated)
August 1, 2030
Study Completion (Estimated)
August 1, 2030
Last Updated
October 23, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
- Time Frame
- All submitted data (both descriptive/raw data analyzed data) will be made available for access by members of the research community according to the provisions defined in the NCCIH Data Sharing Policy and agreement. Descriptive/raw research data will be made available for access to other researchers as soon as possible and no later than the of as associated publication, or the end of the award/support period, whichever comes first. Descriptive data on banked biospecimens will be shared along with protein measurements. Analyzed research data will be submitted to OSF when a publication is accepted and made accessible as soon as possible, and no later than the time of an associated publication, or the end of the award/support period, whichever comes first. Data will remain available in alignment with NIH policies.
- Access Criteria
- De-identified individual participant data will be made available to qualified researchers for scientifically appropriate research purposes, consistent with participant informed consent and applicable institutional and NIH policies. Researchers requesting access may be required to submit a research proposal and obtain approval through the designated data repository or institutional review process. Data access may be subject to a data use agreement to ensure participant confidentiality and appropriate use of the data.
The proposed research will include data from approximately 200 parents and children. De-identified data including demographics, measures of maternal emotional well-being and mental health during pregnancy, measures of maternal whole person health, child emotional well-being, behavior, physical health and physiologic measures collected during the study visits will be shared. Measures of inflammation in maternal blood and cortisol in maternal hair will also be shared. Assessments of caregiving behaviors at the in-person study visit and measures of parental mental health and emotional well-being in the postnatal period will also be shared. This data will be stored on an appropriate data repository. We will submit de-identified, individual-level data to this data archive. The final dataset will be stripped of identifiers prior to release for sharing. Data sharing will align with NCCIH's and NIH's data sharing policies.