Clinical Research Directory

Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women

Perinatal Mood and Anxiety Disorders (PMADs) encompass a range of mental health disorders that occur during pregnancy and up to one year postpartum. Approximately 13% of women experience PMADs. This rate doubles for those with adverse perinatal outcomes (APO) and triples in Black women. Recent research points to racism as one significant source of these health disparities. Cultural adaptations to improve communication with providers decrease rates of depression in minority patients as well as improve adherence to treatment, insight and alliance. Discrimination stress and worries about experiencing medical consequences are thought to increase systemic inflammation, a mechanism known to drive mental and physical symptoms. Inflammation has been implicated in both PMADs and APO, suggesting a shared underlying etiology. Evidence from our work suggests that inflammation contributes to the pathophysiology of PMADs. The proposed pilot randomized control trial will allow the investigators to build on promising preliminary results and identify whether our culturally relevant mobile Health (mHealth) intervention is effective in improving outcomes among Black pregnant women randomized to the intervention compared to a control group. The culturally relevant modules include building communication and self-advocacy skills and provide a support network. The primary objective of this research is to provide guidance for clinical care of Black women during the perinatal period, with the goal to improve mental health and physical health outcomes. A secondary goal is to examine novel inflammatory signatures that change as a function of the intervention to reduce PMADs in this population. As inflammation may be diagnostic of PMADs, identification of its role may shed light of potential intervention targets and provide critical knowledge to improve women's long-term health. PMAD symptoms will be assessed prospectively in 150 Black pregnant women, half of whom will be randomized to receive the culturally relevant mHealth intervention. The investigators hypothesize that women in the intervention group will have reduced rates of PMADs and APOs, an increase in adherence to mental health treatment and will report increased self-advocacy skills, increased communication with providers, and reduced levels of discrimination related stress. Participants will also have improved biological risk indicators including lower circulating C-reactive protein and a transcription profile of differentially expressed inflammatory genes, marked by a decreased activity of inflammatory transcription factors from blood spots. Given the high burden of both PMADs and APOs among Black mothers and the numerous consequences on maternal and child outcomes, it is imperative that investigators develop and implement effective interventions, and test the biological mechanisms that might drive these effects. This work is interdisciplinary, building on a network of community advocates to implement a novel mHealth intervention informed by real world experiences designed to enhance self-advocacy, reduce stress and prevent adverse outcomes

The Effect of Yoga Applied to Primiparous Pregnant Women on Postpartum Depression and Maternal Attachment

This randomized controlled trial aims to evaluate the effects of an 8-week prenatal yoga intervention on postpartum depression and maternal attachment among primiparous pregnant women.

Brexanolone Lifting Outcomes Of Moms

The purpose of this research study is to test the study drug, LPCN 1154A, as a possible treatment for postpartum depression (PPD). The trial aims to determine: * If LPCN 1154A reduces depressive symptoms in subjects with severe PPD * How well LPCN 1154A is tolerated and what side effects it may cause

Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study

This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 674 Medi-Cal eligible pregnant individuals in Fresno, California. The goal is to see whether group prenatal care with wrap around services versus individual prenatal care supplemented by services covered by the California Department of Public Health Comprehensive Perinatal Services Program (CPSP) results in less depression and anxiety, and more respectful, more person-centered maternity care and lower rates of preterm birth.

Enhancing Mental and Physical Health of Women Veterans

Women Veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 20 VA facilities from 4 regions.

Effect of Peripartum 40 Hz Audiovisual Stimulation on Postpartum Depression in Women Undergoing Elective Cesarean Section: A Randomized Clinical Trial

Postpartum depression (PPD) is a common mental health condition affecting 10%-30% of new mothers, with serious consequences for both mother and child. Effective prevention is limited by barriers to psychological or pharmacological treatments. This study evaluates whether short-term 40 Hz light and sound stimulation during and immediately after elective cesarean section can reduce PPD risk. The intervention group receives three 30-minute sessions of combined 40 Hz flashing light and pulsed sound (starting after baby delivery, then at 24 and 48 hours postpartum). The control group receives identical non-flickering light and white noise as placebo.The main outcome is the Edinburgh Postnatal Depression Scale score at 42 days postpartum. Secondary outcomes include depression rates, insomnia severity, and anxiety levels.Participants are women aged ≥18 years with single full-term pregnancy scheduled for elective cesarean section. Exclusion criteria include psychiatric disorders, epilepsy, or eye conditions affecting light sensitivity. If effective, this non-invasive, drug-free intervention could provide a safe and accessible PPD prevention strategy during routine cesarean delivery.

A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Year After The End of Their Pregnancy

In this study, researchers will learn more about how zuranolone affects the symptoms of postpartum depression, also known as PPD. Zuranolone is a drug that healthcare professionals can prescribe for adults with PPD. After giving birth, adults with PPD can suffer from symptoms such as tiredness, sadness, and a loss of interest in their daily activities. This study is known as an observational study, which means it collects health information about study participants after a healthcare professional has already prescribed treatment. Participants for this study will be found in the United States using a database from Consumer Value Store (CVS) Specialty Pharmacy. This will include anyone who was prescribed zuranolone between June 2025 and May 2026 and who filled the prescription within 1 year after the end of their pregnancy. The main goal of this study is to learn more about how zuranolone affects the participants' PPD symptoms. This will be measured using a questionnaire completed by participants called the Edinburgh Postnatal Depression Scale, also known as the EPDS. A higher score on the EPDS may indicate more severe PPD symptoms. The main question researchers want to answer in this study is: \- Do PPD symptoms change after treatment with zuranolone based on EPDS scores measured at Day 15? Researchers will also learn more about: * Changes in participants' EPDS scores from before treatment to Day 3, Day 45, and Day 90, which is 30 days after treatment ends. * How many participants breastfeed their babies while taking zuranolone * How many participants do not start new medicine after finishing their zuranolone treatment * How many participants take new medicines after finishing zuranolone * How many participants already tried other medicines for their depression symptoms before joining this study * How many participants take other medicines in general while taking zuranolone * Characteristics of participants' treatment use during the study This study will be done as follows: * People who fill their zuranolone prescription through CVS Specialty Pharmacy will be contacted by email or phone to ask them about their interest in participating in the study. * Those who agree to take part will answer written questions about their symptoms using the EPDS tool. They will also answer other survey questions about their background, environment, and general health information. Participants must take their first dose of zuranolone within 7 days of joining the study. * Participants will then be asked to answer questions using the EPDS tools, 3 days, 15 days, 45 days, and 90 days after taking the first dose of zuranolone.

Healing at Home 2.0 - Enhanced Chat Tool for Lowering Postpartum Depression

The purpose of the study is to determine if access to a text-message based holistic chatbot support program "Healing at Home 2.0" decreases depressive symptoms as measured by the Edinburgh Postnatal Depression Scale (EPDS) compared to usual postpartum care for patients of color.

Multimodal Biomarkers and Precision TMS for Postpartum Depression

The purpose of this study is to identify multimodal biological markers associated with postpartum depression (PPD) and to evaluate the effectiveness of precision brain stimulation treatment. PPD is a common mental health condition after childbirth that can affect maternal well-being and early child development. Current identification of PPD relies largely on clinical assessments and screening questionnaires, which may not fully capture underlying biological changes. This study uses brain activity, cardiac signals, blood-based biomarkers, interoceptive assessments, and clinical measures to characterize multimodal biological profiles associated with PPD and treatment response. The main questions it aims to answer are: * What multimodal biological differences exist between women with diagnosed PPD and healthy comparison groups, including postpartum and non-postpartum controls? * Which biological or psychological markers can predict whether a patient will respond well to repetitive transcranial magnetic stimulation (rTMS) treatment? * Can a clinical model be created to help doctors choose the best treatment based on these markers? The study focuses on characterizing multimodal biological differences in women with diagnosed PPD and examining clinical response profiles following rTMS treatment, rather than predicting the onset of PPD in the general population. Participants will: * Undergo electroencephalography (EEG) using a 128-channel cap to measure neural activity. * Have electrocardiography (ECG) recorded to analyze heart rate variability and autonomic function. * Provide blood samples to measure inflammatory cytokines, endocrine levels, and metabolic markers. * Complete Interoceptive Assessments (tasks to measure awareness of internal body signals) and clinical psychological surveys. * Complete follow-up assessments via online surveys and scheduled visits at 2 weeks, 1 month, and 3 months postpartum. Participants in the PPD group will: * Receive 4 weeks of high-precision, robot-guided rTMS treatment (20 sessions total). * Undergo pre-intervention multimodal assessments, including EEG, ECG, blood biomarkers, and interoceptive tasks, to identify potential predictors of clinical response to rTMS treatment.

Integrated Psychological Program for Management of Postnatal Depression and Persistent Postpartum Pain After Childbirth

The integrated psychological program (IPP) is based on evidence from the local population showing that the interventional components (mindfulness training, music listening, video counselling) are amenable to implementation in the outpatient care setting. Incorporating innovative digital mobile and electronic applications in the care of an increasingly technology-savvy population will be strategic. The proposal will transform the healthcare model for treating postnatal depression (PND) and persistent postpartum pain (PPP).

CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery)

Postnatal depression affects about 10-15% of women after childbirth. Approximately 3-5% of women experience a moderate-to-severe depression that requires medical attention. This study aims to investigate the implication of pain relief choice in reducing the postnatal depression of women who deliver their babies.

A Study to Assess the Efficacy, Safety, and Tolerability of Oral NORA520 in Adults With Severe Postpartum Depression

The purpose of this research study is to test the study drug, NORA520, as a possible treatment for severe postpartum depression (PPD). The trial aims to determine: * How well NORA520 is tolerated and what side effects it may cause * If NORA520 reduces depressive symptoms in subjects with severe PPD * The amount of NORA520 in the blood at various times after taking the study drug; this provides information that helps determine how often NORA520 should be taken * In a subset of subjects, the amount of NORA520 in breastmilk at various times after taking it to determine if and how much NORA520 can pass into breastmilk Participate in this study will be randomly assigned to one of 3 different groups. All subjects will take the study drug for 3 days.

IMAGINE: Pilot Trial of a Digital Group Intervention to Prevent Perinatal Depression

The goal of this clinical trial is to evaluate if a digital group intervention (named IMAGINE) can prevent depression in perinatal populations. The main questions it aims to answer are: Does IMAGINE engage cognitive behavioral therapy targets? Does IMAGINE lead to lower depression scores? Is IMAGINE acceptable, appropriate, usable and feasible? Participants will be randomized to either participate in an IMAGINE group for 12 weeks or receive standard of care. Participants will respond to questionnaires at enrollment and study visits at 12 and 24 weeks after enrollment.

MOther-Child Interaction Assessment TRAINING for Pediatricians

The originality of the MOCITRAINING study lies in the integration of infant and maternal care during the pediatric consultation and the assessment of the impact of this type of care in the short and medium term on The MOCITRAINING program could contribute to improving the quality of parent-child interactions.

Feasibility of M-health Version of "What Were We Thinking" Intervention to Promote Maternal Postpartum Mental Health

The purpose of this study is to assess the feasibility, acceptability and preliminary effectiveness of "What Were We Thinking" (WWWT) a psychoeducational intervention -delivered remotely via communication technologies- to prevent symptoms of postpartum depression and anxiety in new mothers; which has been shown to be effective in primary health settings. WWWT was developed in Australia and has been culturally adapted to be used in Chile. The m-health version of the Chilean adaptation of WWWT for the current study includes: Psychoeducational modules on issues relevant to mothers during the post-partum period; contact with the program facilitator through instant messaging services available on mobile phones and a virtual group meeting. This pilot study will use a mixed design. The quantitative component will consist of a before-after design with control group including 90 adult mothers of child aged 6-8 weeks who receive health care in a primary health centers in Santiago, Chile. Mothers will be randomized into the experimental (EG) or control groups (CG) in a rate of 1:1. Both EG and CG will receive usual treatment provided by primary health centers (TAU), and only de EG will receive the m-health adapted version of the WWWT. The qualitative component considers 12 users semi-structured interviews. The maximum variation sampling strategy will be used according to the completion of m-health version of WWWT. An open coding of Grounded Theory will be used to data analysis. The feasibility of m-health version of WWWT intervention will be evaluated in terms of eligibility rates, recruitment rates and reasons for study refusals, feasibility to deliver the three components of the intervention, data attrition and follow-up rates by treatment condition. Their acceptability considers participant completion of the intervention rates, and a qualitative assessment of the users' acceptability of and satisfaction. Secondary outcomes will include changes on maternal levels of depressive and anxiety symptoms, maternal self-efficacy and perceived social support. And differences in mother-infant quality of interaction between intervention and control groups.

Bed Rest With a Short Cervix on Preterm Birth

Maternal AR has long been used to prevent PTB. However, definitions of AR vary widely, ranging from complete bed rest to partial limitation of physical activity for one or more hours daily. The use of maternal AR to prevent preterm birth is largely based on observational evidence linking strenuous physical activity to an increased risk of preterm birth, and the assumption that reduced activity may decrease myometrial activity. However, the existing evidence on the clinical effects of AR remains limited and has not demonstrated a reduction in preterm birth or a delay in deliv-ery. In contrast, some studies suggest a potential increase in preterm birth following AR and instead significant adverse maternal and fetal effects. The overall aim of this study is to compare gestational age at birth in women with a short cervix who are prescribed AR compared with women with a short cervix who are not prescribed AR (NAR). The primary hypothesis is that NAR is non-inferior to AR in prolonging pregnancy in women with a short cervix. Secondary hypotheses are that, compared with AR, NAR is associated with higher level of physical activity, lower risk of maternal depression, and reduced risk of loss of maternal bone mineral density. Through the BEWISE study, we wish to implement a change in the Danish national clinical practice regarding AR from recommending AR in risk groups (current practice) to no longer recommending AR as part as routine care (new practice). We will evaluate this change in clinical practice by prospectively collecting data from women both before and after implementation of the new recommendation. The transition from AR to NAR will be implemented sequentially in each Danish region using a randomised stepped-wedge (SW) cluster design, with each region constituting a cluster. The order in which regions transition is determined by randomisation. Each region will adopt the new recommendation at 3-month intervals, resulting in full national transition from AR to NAR within 12 months Eligible participants are pregnant women in gestational age 20+0 to 33+6 and cervical length \< 25 mm in singleton pregnancies and \< 30 mm in multiple pregnancies. Participants must be above 18 years of age and be able to read and understand Danish or English. There are no exclusion criteria. The primary outcome is gestational age in days (continuous).

Enhanced Problem-solving Therapy and HIV Engagement Support to Improve Perinatal Mental Health & HIV Outcomes in Malawi

The main objective of the proposed study is to evaluate the effectiveness of the Enhanced Friendship Bench intervention to improve perinatal depression, HIV care engagement, and infant health outcomes among pregnant women with HIV and depression in Malawi.

Minimum Intervention to Maintain a Postpartum Depression Prevention Program in Clinics Serving Low-income Women

Postpartum depression (PPD) is common and can have lasting consequences for mother and child. ROSE is an intervention to prevent PPD, delivered during pregnancy in outpatient prenatal settings. ROSE has been found to significantly reduce cases of PPD in multiple randomized trials in community prenatal settings with racially and ethnically diverse low-income pregnant women. Requests for ROSE training and recent policy changes supporting payment for comprehensive perinatal services to underserved populations suggest a context ripe for embedding ROSE in prenatal clinics long-term. Given the need for return on investment studies about sustainment efforts, we propose a Sequential Multiple Assignment Randomized (SMART) Trial of the effectiveness and cost-effectiveness of a stepwise approach to sustainment of ROSE in 90 outpatient clinics providing prenatal care to pregnant women on public assistance in 6 U.S. states. In Year 1, all clinics will receive enhanced implementation as usual (EIAU; initial training + tools for sustainment). At the first time at which a clinic is determined to be at risk for failure to sustain (i.e., at 3, 6, 9, 12, 15 months), that clinic will be randomized to receive either: (1) no additional implementation support (i.e., EIAU only), or (2) low-intensity coaching and feedback (LICF). If clinics receiving LICF are still found to be at risk at subsequent assessments, they will be randomized to either (1) EIAU + LICF only, or (2) high-intensity coaching and feedback (HICF). Additional study follow-up interviews will occur at 18, 24, and 30 months, but no implementation intervention will occur after 18 months. Outcomes include: 1. Sustainment of core program elements at each time point and total length of time ROSE services were provided and were provided with at least moderate fidelity. 2. Health impact (PPD rates over time at each clinic) and reach. 3. ROI (costs, cost-offsets, and cost-effectiveness) of each sustainment step. Hypothesized mechanisms include sustainment of clinical and organizational capacity to deliver core elements, and engagement/ownership. The study will also examine predictors, tailoring variables, and implementation processes to determine which kinds of clinics need which level of sustainment support and when. To our knowledge, this study will be the first randomized trial evaluating the ROI of a stepped approach to sustainment, a critical unanswered question in implementation science.

Validation of the French Version of the Edinburgh Postnatal Depression Scale (EPDS) Postnatally in the Father

In recent years, fatherhood has changed considerably. Fathers are now more involved during the perinatal period, with their partner but also in caring for the child. Investigators now know that this period is also a source of major psychological upheaval, identity crisis, apprehension and anxiety for men. These upheavals can lead to depression that must be detected and treated as early as possible. This is an easy screening to perform using the EPDS (Edinburgh Postnatal Depression Scale). Currently, the EPDS is the most widely used self-questionnaire to assess the risk of depression in women during the perinatal period. Indeed, it is systematically recommended in many countries. It is starting to be used for the same purpose in the perinatal period in men, although the scale has not been validated in a representative sample of men in the pre- or post-natal period. The main objective is to validate the use of the EPDS scale as a screening tool for postnatal depression in a population of French fathers. They complete the PH-Q9, EPDS and socio-demographic questionnaires online at inclusion and 6 to 8 weeks after the birth of their child. Fathers included at the maternity ward also too Mini International Neuropsychiatric Interview (MINI) at inclusion.

From Prevention to Treatment: How Biological Rhythms Can Maintain Perinatal Mental Health

Depression and anxiety are significant public health issues during pregnancy and the postnatal period, particularly affecting those in developing countries. Disruptions in biological rhythms, sleep problems, and low exposure to daylight are associated with a higher risk of these mental health issues. The perinatal period poses unique challenges to the temporal program, with evidence indicating that sleep disturbances significantly increase the risk of postnatal depression. A Randomised Clinical Trial (RCT) is being conducted to assess the effectiveness of Blue Light Therapy (BlueLT) in treating depressive and anxiety symptoms during the postpartum. The RCT will also investigate the alignment of rest-activity and internal body time as mediating factors. This study will focus on various chronobiological factors, including rest-activity rhythms, light exposure levels, temperature rhythms, sleep duration and phase, social jetlag, and BodyTime (assessed through a single blood sample). The goal is to recruit 50 women with postpartum depression, with 25 in the BlueLT intervention group and 25 in the ControlLT placebo group, alongside 100 healthy controls. The BlueLT device uses a short-wavelength LED lamp mainly composed by a wavelength peak on blue spectrum, while the ControlLT device has a dim long-wavelength LED. A Healthy Control group will also be included to account for changes unrelated to depression diagnosis or placebo/treatment effects. Exclusion criteria involve a history of major depressive or anxiety disorder, current psychotic disorder, night shift work, active suicidal thoughts, unstable medical conditions interfering with data collection, and newborns with severe health conditions. The study aims to evaluate the impact of BlueLT on postpartum depression and understand the role of chronobiological factors in the health/disease process.

TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety

This trial will assess the safety, feasibility, acceptability, usability and agreement with validated scales of an automated mood monitoring App (TrueBlue), in adult, perinatal participants (recruited between 12 weeks of pregnancy and 12 weeks post-partum), recruited across multiple sites in Nottinghamshire, United Kingdom (UK). An initial within-study pilot phase will assess key aspects of the study including recruitment rate, usability issues and a detailed understanding of any device related adverse events; prior to full recruitment of a total 125 participants over a total 14-month period.

HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis

Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.

Implementation of a Psychoeducational Intervention in New Mothers

The goal of this clinical trial is to implement and examine the clinical effectiveness in a randomized study of the Catalan and Spanish versions of the culturally adapted "What Were We Thinking (WWWT)" psychoeducational intervention in primary care services, with the aim of preventing and reducing the prevalence of postpartum mental illness in new mothers. Additionally, the trial will assess the acceptability and accessibility of the intervention by families and professionals. Researchers will compare "Usual Care" (standard postnatal care provided by professionals from the Sexual and Reproductive Health Service) with "Intervention group" (usual care plus two psychoeducative intervention WWWT sessions) to see if the "WWWT intervention" is better than "Usual Care" at preventing postpartum depression and anxiety disorders in new mothers. Participants will: * Take baseline questionnaires at 2-4 weeks postpartum * Take usual care or usual care plus two psychoeducative intervention WWWT sessions within the first 6 weeks postpartum * Take the same questionnaires used in baseline plus a semi-structured interview to diagnose major mental disorder (all participants) at 3 and 6 months follow-up * Take a brief anonymous self-report survey (only those participants taking the WWWT intervention)

Diagnostic Accuracy of the Stepped Screening Protocol and Its Screening Tools in the Perinatal Period.

It is known that 1 in 5 women experience psychological difficulties during their pregnancy or in the first year after giving birth. Unfortunately, in 75% of cases, these problems go undetected, resulting in the woman, her partner and the baby not receiving the proper care. For this reason, the Flemish government wants to screen all women in the perinatal period for their mental well-being using short questionnaires with the aim of referring them to appropriate care. Before they can recommend this screening to all women in the perinatal period, it is necessary to investigate the effectiveness of these short questionnaires, as well as the proposed stepped screening protocol. The investigators want to use this study to determine whether the questionnaires and the stepped screening protocol are sufficiently sensitive to detect mental health problems during this period. This means that they want to check whether the (future) moms who screen positive actually have problems and whether the (future) moms who screen negative effectively do not have psychological problems. In case of positive findings, teh investigators want to recommend that screening for psychological well-being should best be part of standard care in the future. Participants will be asked to answer some questions regarding depressive and anxiety symptoms using existing screening instruments (Whooley, GAD-2, EPDS and GAD-7). On the basis of an online application one can be assigned to the group that will be invited for a telephone interview by a study employee of the UZ Gent (psychologist or psyciatrist) to conduct a semi-structured interview within 2 weeks after completing these questions. The interviewer will ask questions about current psychological well-being and, where applicable, psychological problems in the past. The interviewer will not be aware of the responses to the questionnaires, so as not to be prejudiced. Being contacted for an interview does not necessarily mean that those women scored higher on the questionnaires, as they may also belong to the control group. In addition, a number of demographic data are requested (such as age, marital status, level of education, occupational category, how many pregnancies, number of other (living) children, (expected) delivery date, current forms of treatment (medications, psychotherapeutic interventions) and psychiatric history).