Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
NCT07892326, Not applicable, Not yet recruiting, Oregon Health and Science University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health | ClinicalTrials.gov |
| NCT number | NCT07892326 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 200 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Oregon Health and Science University | ClinicalTrials.gov |
| Conditions | Inflammation, Depression Disorder, Mindfulness, Emotional Well-being, Physical Health, Mental Health | ClinicalTrials.gov |
| Interventions | Mindfulness-based cognitive therapy for perinatal depression, Pregnancy Health Group | ClinicalTrials.gov |
| First posted | 2026-10-23 | ClinicalTrials.gov |
| Last updated | 2026-10-23 | ClinicalTrials.gov |
Registered outcomes 36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Maternal Inflammation | Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit. | 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. | ClinicalTrials.gov |
| Primary | Infant Emotional and Regulatory Responses During the Still Face Paradigm | 6 months of age | 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. | ClinicalTrials.gov |
| Primary | Infant Emotional Reactivity During the Gentle Arm Restraint Task | 6 months of age | 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. | ClinicalTrials.gov |
| Primary | Infant Respiratory Sinus Arrhythmia (RSA) | 6 months of age | 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. | ClinicalTrials.gov |
| Primary | Infant Behavior Questionnaire-Revised (IBQ-R) | 6 months of age | 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. | ClinicalTrials.gov |
| Secondary | 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. | The CES-D is a 20-item self-report questionnaire that measures the frequency of depressive symptoms experienced during the past week. Items assess depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Participants rate each item on a 4-point scale from 0 (rarely or none of the time) to 3 (most or all of the time). Four positively worded items are reverse scored. Total scores range from 0 to 60, with higher scores indicating greater depressive symptom severity. A score of 16 or higher is commonly used to indicate a risk of clinically significant depression. | ClinicalTrials.gov |
| Secondary | Edinburgh Postnatal Depression Scale (EPDS) | Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit. | The EPDS is a 10-item self-report questionnaire that screens for perinatal depressive symptoms experienced during the past 7 days. Items assess the ability to laugh and enjoy things, anticipation of enjoyment, self-blame, anxiety or worry, fear or panic, feeling overwhelmed, sleep difficulty due to unhappiness, sadness, crying, and thoughts of self-harm. Participants choose one of four response options for each item, scored from 0 to 3, with some items reverse scored. Total scores range from 0 to 30, with higher scores indicating greater depressive symptom severity. A score of 10 or higher is commonly used to identify possible depression, and 13 or higher to identify probable depression. The EPDS is validated for use during pregnancy and the postpartum period. | ClinicalTrials.gov |
| Secondary | State-Trait Anxiety Inventory (STAI) | Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit. | The STAI is a 40-item self-report questionnaire that measures anxiety in adults using two 20-item subscales. The State Anxiety subscale assesses how the participant feels "right now, at this moment" (for example, tense, calm, worried), rated on a 4-point scale from 1 (not at all) to 4 (very much so). The Trait Anxiety subscale assesses how the participant "generally feels," reflecting a stable tendency toward anxiety, rated on a 4-point scale from 1 (almost never) to 4 (almost always). Anxiety-absent items (for example, "I feel calm") are reverse scored. Each subscale score ranges from 20 to 80, with higher scores indicating greater anxiety. State and trait anxiety will be analyzed as separate outcomes. | ClinicalTrials.gov |
| Secondary | Beck Anxiety Inventory | Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit. | The BAI is a 21-item self-report questionnaire that measures the severity of anxiety symptoms experienced during the past month, including today. Items describe common symptoms of anxiety, such as numbness or tingling, feeling hot, fear of the worst happening, heart pounding or racing, feeling unsteady, and fear of losing control. Participants rate how much each symptom has bothered them on a 4-point scale from 0 (not at all) to 3 (severely, it bothered me a lot). Total scores range from 0 to 63, with higher scores indicating greater anxiety severity. Scores are commonly interpreted as minimal (0-7), mild (8-15), moderate (16-25), or severe (26-63) anxiety. | ClinicalTrials.gov |
| Secondary | 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. | The PRAQ-R2 is a 10-item self-report questionnaire that measures anxiety specific to pregnancy and childbirth. Items cover three domains: fear of giving birth, worries about bearing a physically or mentally handicapped child, and concerns about one's appearance. Participants rate each item on a 5-point scale from 1 (absolutely not relevant) to 5 (very relevant). Scores are summed for a total score ranging from 10 to 50, with higher scores indicating greater pregnancy-related anxiety. Subscale scores may also be calculated. | ClinicalTrials.gov |
| Secondary | Perceived Stress Scale | Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit. | The PSS is a 10-item self-report questionnaire that measures the degree to which a person appraises situations in the past month as stressful. Items ask how often the participant felt unable to control important things in life, nervous and stressed, confident about handling personal problems, that things were going her way, or that difficulties were piling up too high to overcome. Participants rate each item on a 5-point scale from 0 (never) to 4 (very often). Four positively worded items are reverse scored. Total scores range from 0 to 40, with higher scores indicating greater perceived stress. | ClinicalTrials.gov |
| Secondary | Pregnancy Experience Scale (PES) | Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit. | The PES is a self-report questionnaire that assesses the emotional experience of pregnancy by measuring both its positive and negative aspects. Participants rate the current intensity of specific pregnancy-related experiences, including uplifts (for example, feeling the baby move or looking forward to the baby's arrival) and hassles (for example, physical discomfort or concerns about the birth). Items are rated on a 4-point scale from 0 (not at all) to 3 (a great deal). Scores are calculated for the intensity of uplifts, the intensity of hassles, and the ratio of uplifts to hassles, with a higher uplifts-to-hassles ratio indicating a more positive pregnancy experience. | ClinicalTrials.gov |
| Secondary | Prenatal Distress Questionnaire (PDQ) | Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit. | The PDQ is a 12-item self-report questionnaire that measures pregnancy-specific distress. Participants rate how much they have been bothered, upset, or worried by common pregnancy concerns, including the baby's health, labor and delivery, weight gain, changes in body shape, physical symptoms, emotional ups and downs, and relationships. Items are rated on a 5-point scale from 1 (not at all) to 5 (extremely). Item scores are summed to create a total score ranging from 0 to 48, with higher scores indicating greater pregnancy-specific distress. | ClinicalTrials.gov |
| Secondary | Stressful Life Events Scale | Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit. | The Stressful Life Events Scale is a self-report checklist with 20 items that measures exposure to major stressful life events. Participants indicate whether each event has occurred within your lifetime (at the baseline visit) and over the past year (for the 6 month visit), such as job loss, financial difficulty, serious illness or injury, death of a close person, relationship conflict or separation, legal problems, and housing instability. For events that occurred, participants may also rate how stressful or upsetting the event was. Scores are calculated as the total number of events endorsed and the summed impact score based on stress ratings of how much the event effected you, 0=no endorsement of event, 1=a little and 2=a lot . Higher scores indicate greater exposure to stressful life events. | ClinicalTrials.gov |
| Secondary | Emotion Regulation Questionnaire (ERQ) | Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit. | The ERQ is a 10-item self-report questionnaire that measures two strategies for regulating emotions: cognitive reappraisal (6 items), which involves changing how a situation is thought about to alter its emotional impact, and expressive suppression (4 items), which involves inhibiting outward signs of emotion. Participants rate their agreement with each statement on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree). Scores are calculated as the mean of the items in each subscale, so each ranges from 1 to 7. Higher reappraisal scores indicate more frequent use of reappraisal, and higher suppression scores indicate more frequent use of suppression. | ClinicalTrials.gov |
| Secondary | Brief COPE Inventory | Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit. | The Brief COPE is a 28-item self-report questionnaire that measures ways of coping with stress. Items are grouped into 14 two-item scales: self-distraction, active coping, denial, substance use, use of emotional support, use of instrumental support, behavioral disengagement, venting, positive reframing, planning, humor, acceptance, religion, and self-blame. Participants rate how much they have been using each coping strategy on a 4-point scale from 1 (I haven't been doing this at all) to 4 (I've been doing this a lot). Scale scores are the sum of the two items and range from 2 to 8. Higher scores indicate greater use of that coping strategy. Scales may also be grouped into broader adaptive and maladaptive coping dimensions. | ClinicalTrials.gov |
| Secondary | Subjective Social Status (MacArthur Scale of Subjective Social Status, SES Ladder) | Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit. | The MacArthur Scale of Subjective Social Status is a single-item self-report measure of perceived social standing. Participants are shown a picture of a ladder with 10 rungs and are asked to place themselves on the rung that best represents where they stand relative to others. Two versions are used: a society ladder, where the top represents the people who are best off (most money, most education, and most respected jobs) and the bottom represents those who are worst off, and a community ladder, where the top represents the people with the highest standing in their community. Scores range from 1 to 10, with higher scores indicating higher perceived social standing. | ClinicalTrials.gov |
| Secondary | Five Facet Mindfulness Questionnaire (FFMQ) | Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit. | The FFMQ is a 39-item self-report questionnaire that measures dispositional mindfulness in daily life. Items assess five facets: observing (8 items; noticing sensations, thoughts, and emotions), describing (8 items; labeling experiences with words), acting with awareness (8 items; attending to the present moment rather than acting on autopilot), nonjudging of inner experience (8 items), and nonreactivity to inner experience (7 items). Participants rate how true each statement is for them on a 5-point scale from 1 (never or very rarely true) to 5 (very often or always true). Negatively worded items are reverse scored. Facet scores are the sum of the items, and the total score ranges from 39 to 195, with higher scores indicating greater mindfulness. | ClinicalTrials.gov |
| Secondary | Maternal Whole Person Health Index | Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit. | The WPHI is a 9-item self-report measure of overall health developed by the National Center for Complementary and Integrative Health (NCCIH) and the National Center for Health Statistics (CDC/NCHS). Participants rate nine domains of health: general health, quality of life, social and family connections, diet, physical activity, ability to manage stress, sleep, ability to find meaning and purpose in daily life, and ability to manage their health. Each item is rated on a 5-point scale from 1 (poor) to 5 (excellent). The total score is the sum of the nine item scores and ranges from 9 to 45, with higher scores indicating better self-assessed overall health. | ClinicalTrials.gov |
| Secondary | Kaiser Physical Activity Survey (KPAS) | Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit. | The Kaiser Physical Activity Survey is a self-report questionnaire that assesses habitual physical activity across four domains, called indices: household and caregiving activities, occupational activities, active living habits (for example, walking and television viewing), and sports and exercise. Participants answer questions about the frequency or amount of activity in each domain over \[recall period\]. Most items are rated on a 5-point scale, and sports and exercise are scored from the type, intensity, and duration of reported activities. Each index score ranges from 1 to 5, with higher scores indicating greater physical activity. Index scores may be analyzed separately or summed into a total activity score. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
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Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
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Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R61AT013988 | Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal-Child Emotional Well-being and Whole Person Health | Sullivan, Elinor L.; Graham, Alice M; Tilden, Ellen Lane | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH | 2026 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)