BUMPP: A Study to Better Understand Mood During the Perinatal Period

Study Overview
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Brief Summary
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The overall goal of the BUMPP study is to improve our understanding of a range of moods, feelings, and thoughts that women can experience during pregnancy and soon after they give birth. This study will examine how these moods, feelings, and thoughts are related to changes in hormonal and immune health that women experience during and after pregnancy, and to mother-baby relationships and infant development in the early postpartum months.

Official Title
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BUMPP: A Study to Better Understand Mood During the Perinatal Period

Conditions
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Pregnancy, Postpartum, Mental Health Issue

Intervention / Treatment
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* Other: Observation Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older 35 weeks pregnant or less carrying only one baby (not twins or triplets) first time giving birth can speak/read/write in English Exclusion Criteria: major medical health condition like a heart, kidney, or liver disease or HIV currently taking corticosteroids, progesterone, or immunosuppressive medications that might impact the samples we are taking in this research study have regularly used alcohol, tobacco, or recreational drugs (such as marijuana or prescription drugs for non-medical reasons) during pregnancy (regularly means more than a few times total, such as on a monthly, weekly, or daily basis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation Group<br>Researchers will collect data on maternal mental health symptoms, as well as health and psychosocial factors, via short interviews (sessions 1 and 4) and via self-report questionnaires completed through REDCap at each session. Participating women will also provide one small hair sample (session 4) for measurement of the stress hormone cortisol and several finger stick blood spot samples (sessions 1,2, and 4) for measurement of immune markers. | Other: Observation Group<br>* No intervention; this is an observational study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-report questionnaire measure of depressive symptoms (Edinburgh Postnatal Depression Scale) | Assessed at each of 4 sessions | 35 weeks of pregnancy through 2 months postpartum | 
| Self-report questionnaire measure of anxiety symptoms (Generalized Anxiety Disorder-7) | Assessed at each of 4 sessions | 35 weeks of pregnancy through 2 months postpartum | 
| Self-report questionnaire measure of manic symptoms (Highs Scale) | Assessed at each of 4 sessions | 35 weeks of pregnancy through 2 months postpartum | 
| Self-report questionnaire measure of symptoms of psychosis (subscales of Symptom Checklist-90) | Assessed at each of 4 sessions | 35 weeks of pregnancy through 2 months postpartum | 
| Mother-infant behavior during 5 min play episode coded using Global Rating Scales | Assessed at in-person laboratory session (session 4) | 2 months postpartum | 
| Bayley Scales of Infant Development, 4th edition, to assess infant cognitive development | Assessed at in-person laboratory session (session 4) | 2 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monthly cortisol levels determined from hair sample | 1 sample at session 4 | 35 weeks of pregnancy through 2 months postpartum | 
| Cytokine levels determined from finger prick blood spot | 3 samples (sessions 1, 2, and 4) | 35 weeks of pregnancy through 2 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Postpartum, Mental Health