Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health

Browse trials for

• Inflammation 3,512
• Psychological Well-Being 1,045
• Depression 8,240
• Stress, Psychological 806

Keywords

• emotional well-being
• mindfulness
• pregnancy
• infant behavior
• mental health
• perinatal
• depression
• psychological stress

Inflammation

3,512 studies on the registry are indexed under Inflammation; 640 are open to participants now.

This study's planned enrollment of 200 is above the median of 50 across 2,491 interventional studies indexed under Inflammation.

Lead sponsor

Oregon Health and Science University is the lead sponsor of 694 studies on the registry; 133 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 39 (76%) have results posted.

Study arms

• Experimental
  Mindfulness-based cognitive therapy for perinatal depression

  Individuals will be randomized to Mindfulness-based cognitive therapy for perinatal depression (MBCT-PD).

  Behavioral: Mindfulness-based cognitive therapy for perinatal depression

• Active comparator
  Pregnancy Health Group

  Participants 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).

  Behavioral: Pregnancy Health Group

Interventions

• BehavioralMindfulness-based cognitive therapy for perinatal depression

  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.

  Also known as: MBCT-PD

• BehavioralPregnancy Health Group

  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)

Primary outcomes

1. 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.

   Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

2. 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.

   Time frame: 6 months of age

3. 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.

   Time frame: 6 months of age

4. 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.

   Time frame: 6 months of age

5. 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.

   Time frame: 6 months of age

Secondary outcomes

1. Center for Epidemiologic Studies Depression Scale (CES-D)

   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.

   Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

2. Edinburgh Postnatal Depression Scale (EPDS)

   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.

   Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

3. State-Trait Anxiety Inventory (STAI)

   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.

   Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

4. Beck Anxiety Inventory

   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.

   Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

5. Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2)

   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.

   Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

6. Perceived Stress Scale

   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.

   Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

7. Pregnancy Experience Scale (PES)

   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.

   Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

8. Prenatal Distress Questionnaire (PDQ)

   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.

   Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

9. Stressful Life Events Scale

   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.

   Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

10. Emotion Regulation Questionnaire (ERQ)

    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.

    Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

11. Brief COPE Inventory

    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.

    Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

12. Subjective Social Status (MacArthur Scale of Subjective Social Status, SES Ladder)

    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.

    Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

13. Five Facet Mindfulness Questionnaire (FFMQ)

    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.

    Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

14. Maternal Whole Person Health Index

    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.

    Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

15. Kaiser Physical Activity Survey (KPAS)

    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.

    Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

16. Pittsburgh Sleep Quality Index (PSQI)

    The PSQI is a self-report questionnaire that assesses sleep quality and sleep disturbances over the previous month. It contains 19 self-rated items grouped into seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored from 0 to 3, and the seven components are summed to give a global score ranging from 0 to 21. Higher scores indicate worse sleep quality. A global score greater than 5 is commonly used to identify poor sleepers. Results will be reported as the mean global PSQI score and, if applicable, the proportion of participants with a global score above 5.

    Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

17. O'Leary-Porter Scales

    The O'Leary-Porter Scale is a parent-report questionnaire assessing how often the child in the study witnesses conflict between the parent and the parent's live-in partner or co-parent. Items refer to the past year. The 10-item version covers arguments in front of the child about money, discipline, and family roles; complaints about personal habits; general arguments; physical hostility; and verbal hostility. One item asks about displays of affection and is reverse-scored. Each item is rated Never, Rarely, Occasionally, Often, or Very Often, coded 1 to 5. Item scores are summed to give a total score ranging from 10 to 50. Higher scores indicate greater child exposure to overt interparental conflict. Participants without a live-in partner or co-parent do not complete the scale. Results will be reported as the sum total score at each time point.

    Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

18. Revised Conflict Tactics Scales, Short Form (CTS2S)

    The CTS2S is a 20-item self-report questionnaire assessing how couples handle disagreements over the past year. Each of 10 behaviors is rated twice, once for the respondent and once for the partner. Items form five subscales: negotiation, psychological aggression, physical assault, injury, and sexual coercion. Frequency is rated from 1 (once in the past year) to 6 (more than 20 times). Options 7 (not in the past year, but happened before) and 8 (never happened) both indicate no occurrence in the past year. Responses are converted to approximate past-year counts (1, 2, 4, 8, 15, 25), and counts are summed within each subscale for a chronicity score, with 0 for no occurrence. Higher scores indicate more frequent use of that tactic. Negotiation is a positive tactic, so higher scores there reflect more constructive conflict resolution. Results will be reported as mean subscale scores and/or the proportion reporting any occurrence in each subscale.

    Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

19. Norbeck Social Support Scale (NSSQ)

    The NSSQ is a self-report questionnaire that assesses a person's social support network and the functions of that support. Participants list up to 24 significant people, such as family, friends, work or school associates, and health care providers. For each person they rate six functional items from 0 (not at all) to 4 (a great deal): feeling liked or loved, respected or admired, ability to confide, agreement with or support of actions or thoughts, help with immediate needs, and help during a prolonged illness. Two network items rate how long the person has been known (1 to 5) and how often contact occurs (1 to 5). Additional items ask about relationships lost in the past year and how much support was lost (0 to 4). Scores include total functional support, which is the sum of the six functional ratings across all listed persons, total network size, and, if reported, duration, contact frequency, and loss. Higher functional and network scores indicate greater perceived social support.

    Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

20. Maternal 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. Maternal RSA will be derived from electrocardiogram (ECG) recordings collected during a resting baseline, and the Stroop Color and Word Test (SCWT). Inter-beat intervals will be extracted from the ECG, and high-frequency heart rate variability in a 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 mother's autonomic regulation in response to challenge.

    Time frame: Measured at the baseline visit, a post-intervention visit at approximately 37 weeks gestation, and 6 month visit.

21. Ages & Stages Questionnaire

    The Ages and Stages Questionnaires, Third Edition (ASQ-3), is a standardized, parent-report developmental screening measure used to assess early childhood development across five domains: communication, gross motor, fine motor, problem-solving, and personal-social skills. Age-specific questionnaires are completed by caregivers, with six items per developmental domain. Each item is scored as 0 (not yet), 5 (sometimes), or 10 (yes), yielding domain scores ranging from 0 to 60. Higher scores indicate more advanced developmental skills.

    Time frame: Measured at the 6 month visit

22. Brief Infant Sleep Questionnaire - Revised

    The BISQ-R is a parent-report questionnaire with 33 items that assesses infant sleep and sleep-related parenting behaviors and cognitions in infants and toddlers. The caregiver reports on the infant's sleep over the past 2 weeks, including nighttime and daytime sleep duration, number and length of night wakings, time to fall asleep, bedtime, sleep location, and the way the infant falls asleep.

    Time frame: Measured at the 6 month visit

23. Child Blood Pressure

    Child blood pressure will be measured during a neutral resting state using an electronic blood pressure monitor. Systolic and diastolic blood pressure will be recorded in millimeters of mercury (mmHg). Blood pressure values will be reported as raw values and standardized for child age, sex, and height (percentiles or z-scores). Higher values indicate higher blood pressure.

    Time frame: Measured at the 6 month visit

24. Child Weight (kg)

    Weight will be measured in kilograms using a digital infant scale. Higher values indicate greater body weight.

    Time frame: Measured at the 6 month visit

25. Child Recumbent Length (cm)

    Recumbent length will be measured in centimeters using a length board. Higher values indicate greater linear growth.

    Time frame: Measured at the 6 month visit

26. Child Body Mass Index (BMI) z-score

    BMI will be calculated from measured weight (kg) and recumbent length (m) as kg/m\^2 and converted to a z-score for child age and sex using WHO child growth standards. The reported value is the BMI z-score. Higher values indicate greater weight relative to length.

    Time frame: Measured at the 6 month visit

27. Child Abdominal Circumference (cm)

    Abdominal circumference will be measured in centimeters. Higher values indicate greater abdominal size.

    Time frame: Measured at the 6 month visit

28. Child Hip Circumference (cm)

    Hip circumference will be measured in centimeters. Higher values indicate greater hip size.

    Time frame: Measured at the 6 month visit

29. Child Waist Circumference (cm)

    Waist circumference will be measured in centimeters using a measuring tape. Higher values indicate greater waist size.

    Time frame: Measured at the 6 month visit

30. Child Head Circumference (cm)

    Head circumference will be measured in centimeters using a measuring tape. Higher values indicate larger head size.

    Time frame: Measured at the 6 month visit

31. Child Skinfold Thickness (mm)

    Skinfold thickness will be measured in millimeters using a caliper at the triceps. It will be measured on the back of the right upper arm, midway between the acromion (the bony point of the shoulder) and the olecranon (the point of the elbow). Higher values indicate greater subcutaneous fat.

    Time frame: Measured at the 6 month visit

Individual participant data

Plan to share: Yes — 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.

Supporting information: 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.