Clinical Research Directory

Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression

The goal of this clinical trial is to learn whether repetitive transcranial magnetic stimulation (rTMS) can reduce depressive symptoms in women who are pregnant or up to 12 months after childbirth and have peripartum depression. rTMS is a non-invasive treatment in which a device placed on the scalp delivers gentle magnetic pulses to a brain area involved in mood regulation. It does not involve medication or anaesthesia. The main questions this study aims to answer are: * Does active rTMS reduce depressive symptoms more than sham rTMS? * What side effects occur during treatment, and how well is rTMS tolerated? * Are improvements in depressive symptoms still present one month after treatment? Researchers will compare active rTMS with sham rTMS, a treatment designed to feel and sound similar but not to provide effective brain stimulation. Neither participants nor the clinicians assessing depressive symptoms will know which treatment was assigned during the main study phase. Up to 60 women aged 18 years or older who are pregnant or up to 12 months after childbirth and have clinically relevant depressive symptoms may take part. Participants will: * Attend a screening and baseline visit, including questionnaires, EEG and ECG recordings, and collection of small hair and sputum samples to study stress-related hormone levels * Be assigned by chance to receive either active rTMS or sham rTMS * Attend 30 treatment sessions, scheduled flexibly over approximately 1.5 to 10 weeks to accommodate childcare, breastfeeding, fatigue, and medical appointments * Complete questionnaires about mood, wellbeing, quality of life, social support, and treatment expectations before and after treatment * Have safety and side effects checked before each treatment session * Complete a telephone follow-up assessment one month after treatment * Be asked to complete a short questionnaire about their child's development one year after treatment Each treatment visit lasts about 30 minutes, including preparation, treatment, and a short safety check. Infants may be brought to treatment visits when this can be done safely. rTMS is generally well tolerated. Possible temporary side effects include headache, scalp discomfort, facial muscle twitching during stimulation, dizziness, or tiredness. A seizure is a very rare but serious possible risk; therefore, people with epilepsy, certain implants, or other relevant risk factors cannot take part. Participation is voluntary. Participants can pause or stop participation at any time without affecting their usual care. Personal data will be coded and handled confidentially. Women assigned to sham treatment will be offered active rTMS after the blinded study phase, if they wish. The results may help clarify whether rTMS is an effective non-medication treatment option for peripartum depression.

A Web-based Intervention Program for Postpartum Depression

This study evaluates a Web-based intervention program to treat women with postpartum depression.

The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.

The primary objective of this research is to conduct a randomized clinical trial to examine the impact of nurse-coordinated, doula-delivered postpartum support (intervention arm) on postpartum health care utilization, health outcomes, and patient-reported experiences compared with standard postpartum care (control arm) among individuals with preterm births \<34 weeks' gestation requiring neonatal intensive care unit (NICU) admission.

Methyl Donor-Rich Diet in the Postpartum Period

This study aims to evaluate the effects of a methyl-donor-rich diet during the postpartum period on maternal depression, breastfeeding success, and infant weight. Postpartum women will first complete a three-day dietary record to assess their intake of selected nutrients involved in one-carbon metabolism, including folate, choline, betaine, methionine, vitamin B6, and vitamin B12. Women whose intake of at least one of these nutrients is below two-thirds of the applicable reference intake and who meet the other eligibility criteria will be eligible to participate. Eligible participants will be randomly assigned to one of two groups. The intervention group will receive an individualized methyl-donor-rich dietary program and nutrition education for two months. The control group will receive standard postpartum care and routine dietary advice. The study will compare the groups in terms of maternal depressive symptoms, breastfeeding success, and infant weight. Dietary intake will also be assessed.

AI-Enabled Wearable Monitoring for Detection of Postpartum Depression and Anxiety

The goal of this observational study is to examine whether passively collected wearable data can be used to predict onset and severity of postpartum depression and anxiety symptoms. The main questions it aims to answer are: 1. When do depression and anxiety symptoms emerge, worsen, and improve across the first 6 months postpartum? 2. Can machine learning/artificial intelligence models prospectively predict clinically significant depression symptoms using Apple Watch metrics? Women who have given birth within the past 2 months and who live in Hawai'i will be eligible for the study. Participants will wear an Apple Watch and answer weekly online survey questions until they reach 6 months postpartum. The study is designed to be fully remote to maximize accessibility across the Hawaiian Islands.

Virtual Reality-Assisted Intraoperative Sensory Modulation on Postpartum Depression and the Kynurenine Pathway

The research will be conducted as a prospective, observational, and comparative study with 98 pregnant volunteers aged 18-45 at Düzce University Faculty of Medicine. Participants will be divided into a VR group and a control group. Data will be collected using STAI-I, EPDS, NRS scales, and biochemical analyses (tryptophan, kynurenine, etc.). Upon completion, the project is expected to contribute to non-pharmacological approaches and new care protocols for reducing postpartum depression.

Postpartum Care in the NICU Multi-Site

Parents of infants admitted to the neonatal intensive care unit (NICU) face unique challenges in caring for their own health after giving birth. The demands of having a critically ill infant often make it difficult or impossible to attend postpartum care appointments, and research shows that NICU mothers are significantly more likely than other new mothers to develop postpartum depression and other health conditions, including hypertensive disorders of pregnancy. However, these conditions frequently go undetected and untreated because standard postpartum care systems are not designed to address the needs of NICU mothers, who often prioritize being present in the NICU over their own needs. The PeliCaN (Postpartum Care in the NICU) Multi-Site trial will test whether trained postpartum doulas supporting mothers directly in the NICU can help close postpartum care gaps. Study doulas will provide emotional support, help mothers monitor their blood pressure, screen for postpartum depression, assist with scheduling and attending postpartum care visits, and connect families to community resources while their infant is in the NICU and after discharge for up to 6 months. The study team will enroll approximately 756 mothers across 13 NICUs in the Metro-Philadelphia area. Participating NICUs will be randomly assigned to groups on a stepped-wedge schedule to begin offering the doula intervention. Mothers enrolled before their site begins the doula intervention will receive standard postpartum care and support; mothers enrolled after their site transitions to the intervention period will receive doula support. All participants will complete surveys at enrollment and at 6 months after birth and will have their medical records reviewed. The study's main goals are to determine whether having a doula in the NICU helps mothers to receive recommended comprehensive postpartum care within the first 12 weeks after birth and will assess whether doula support reduces symptoms of postpartum depression and increases maternal transition to primary adult care by 6 months postpartum. The study will also examine the experience of implementing doulas in the NICU across multiple hospital sites among intervention participants and NICU staff members.

Maternal Outcomes: Mood, Alcohol Use, and Depressive Symptoms

This study aims to learn about depression and alcohol use in postpartum mothers and whether an intervention based on contingency management and problem-solving therapy (CM-PST) can help reduce these symptoms. The main questions it seeks to answer are: 1. How do new mothers fare with depressive symptoms and alcohol use in the first 12 months after giving birth? 2. Will a CM-PST intervention reduce depressive symptoms and alcohol use frequency among new mothers? 3. Is a CM-PST intervention practical for new mothers? The researchers will recruit approximately 30 new mothers and randomly select half to attend a 6-week CM-PST intervention. They will compare those who received the intervention versus those who did not to see if there are any differences in their depressive symptoms and alcohol usage. Participants will: * Complete 4 remote intervention sessions over 6 weeks * Conduct at-home urine drug tests 2x per week during the 6-week intervention * Answer online surveys about their mental health and alcohol use

SAINT in Postpartum Depression (PPD)

This study is a large, multi-site clinical trial testing whether Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), a fast-acting form of repetitive transcranial magnetic stimulation (rTMS), can more effectively reduce symptoms of postpartum depression (PPD) compared to a sham treatment. It will enroll 192 women within 12 months postpartum who are experiencing depression, and will track their progress for up to 12 months. The trial's main goal is to see if SAINT leads to reduction in depression severity in women with postpartum depression.

Deconstructing Maternal Burdens: Doulas and the Community Unite for Health

This study is a randomized controlled trial comparing two models of doula support for pregnant individuals enrolled in Medicaid: an enhanced doula support model, in which support starts earlier in pregnancy, occurs more frequently, and continues through the first year after birth, versus the standard doula care currently covered by Medicaid in Florida. The study also builds the doula workforce needed to sustain this model of care, training doulas to become eligible to bill Medicaid for their services. The primary goal is to determine whether the enhanced doula model results in significantly lower rates of perinatal depressive and anxiety symptoms compared to standard doula support, while gathering data on real-world implementation. The study also evaluates the effectiveness of Medicaid-covered doula services more broadly, with findings intended to inform state-level policy on Medicaid reimbursement and the extension of doula services into the postpartum period.

Treatment of Anaemia After Caesarean With Intravenous Versus Oral Iron and Postpartum Depression

The objectif of the IRON-DEP Study is to assess the efficacy of intravenous (IV) versus oral iron treatment on the prevalence of postpartum depression (PPD) in women with moderate iron deficiency anemia after caesarean delivery.

A Mobile Application for Early Detection and Symptoms Trajectories of Postpartum Depression Using Ecological Momentary Assessment (EMA)

This pilot study will recruit 120 perinatal pregnant women and follow them up for 6 months. Both momentary and retrospective assessments of emotional well-being and psychosocial factors will be conducted on a mobile application. We aim to understand the symptom trajectories and provide evidence for effective individualized interventions.

Narrative Nursing for Cesarean Mothers' Anxiety and Breastfeeding Confidence

This study tests whether a nurse-led "4-step narrative nursing" program can reduce anxiety and improve breastfeeding confidence in mothers who are having a planned or non-emergency cesarean section. What is the problem? About 30-40% of Chinese cesarean mothers feel high anxiety after surgery, and 1 in 5 is at risk for postpartum depression. Low confidence in breastfeeding is also common. What will we do? We will randomly assign 160 mothers (1:1) to either: Usual care - standard education and ward care, or Usual care plus narrative nursing - four short (10-20 min) conversations with a trained nurse: Before surgery - help the mother talk about her fears. 24-48 h after surgery - encourage her to "name" pain or worries and separate them from herself. Before discharge - guide her to find positive moments and build a "strong-mom" story. Two weeks later by phone - strengthen the new story and review feeding success. What will we measure? Main result: anxiety score at 48 h (STAI scale). Other results: depression risk, breastfeeding confidence, pain, and feeding rates up to 3 months. Possible benefits: Lower anxiety, better mood, higher breastfeeding rates. No drugs or extra procedures are involved, only talking. Risks: Minimal; some mothers may feel emotional during conversations, but nurses can pause or refer to counselling if needed.

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

Informing Implementation of a Circadian-Focused Intervention for Postpartum Depression

The proposed study is an open-label trial of Re-Timer® wearable morning bright light therapy for postpartum depression. The study is focused on evaluating the feasibility, acceptability, and implementation context of morning Bright Light Treatment (mBLT) for postpartum depression.

Routine vs. Early Postpartum Depression Screening: A Pragmatic Clinical Trial

After having a baby, some women develop a condition called postpartum depression, or PPD, which can cause sadness, anxiety, and difficulty bonding with their newborn. Right now, most women aren't screened for PPD until about 6 to 8 weeks after giving birth, but this study wants to find out if checking earlier could help identify signs sooner. To test this, researchers will work with 428 women who deliver at an MGH hospital clinic and have no history of depression. Each woman will be randomly placed into one of two groups: one group will fill out a short depression questionnaire online at 2 to 3 weeks after delivery, while the other group will follow the usual process and complete the same questionnaire at their regular 6-week visit. The results will go to each woman's doctor, who will decide if any follow-up care is needed, just like they normally would. The study will follow each participant for 6 months after delivery to see whether earlier screening makes a difference.

Parents and Babies Pilot

The goal of this study will be piloting the Parents and Babies perinatal depression prevention intervention to examine its feasibility and acceptability and to obtain preliminary data on its efficacy. This includes exploring/understanding users' experiences navigating the interventions (e.g., from an implementation perspective) and preliminary evaluations of clinical outcomes, including mental health and minority stress. With data gathered from this pilot study, we will make final adaptations to the Parents and Babies manuals and plan to develop a randomized-control trial to evaluate efficacy of the intervention.

A Study of MI078 for Postpartum Depression

This is a multicenter, randomized, double-blind, placebo-controlled trial consisting of an experimental drug group and a placebo group, each enrolling 100 participants. The objective of this study is to assess the efficacy and safety of MI078 capsules for the treatment of postpartum depression.

Essential Coaching Postpartum: Evaluating a Parent-focused Postpartum Text Message Program in Nova Scotia

The transition to parenthood is often an exciting yet hard period for parents. In the first year after a new baby, many parents feel less confident, have more anxiety and depression, and feel more isolated and alone. During this time, many parents use their phones and the Internet to seek out information and support. Thus, the investigators are exploring the opportunity of using mHealth, or mobile health, to provide information directly to parents after the birth of their first baby. The investigators have developed a program for both birthing and non-birthing parents called the Essential Coaching Postpartum program. This program provides 332 parents with text messages sent for 6 weeks after birth to share information on newborn care and parent outcomes. This will be tailored based on whether they are the birthing parent (Essential Coaching for Every Mother) or non-birthing parent (Essential Coaching for Every Partner). The investigators will evaluate this program by comparing a group of parents who receive the messages to a group of parents do not receive any text messages. To determine the success of the Essential Coaching Postpartum program, the investigators will compare parents' confidence, anxiety, depression, and co-parenting between the two groups after six-weeks and six-months. The investigators believe that parents who get the text messages will have higher confidence and co-parenting outcomes and lower anxiety and depression. The investigator's goal with the Essential Coaching Postpartum program is to help make the first few weeks after a new baby less stressful by providing information and support directly to parents that they know they can trust.

Midwife-led Childbirth Review and Psychological Outcomes in New Parents

The aim of this clinical trial is to support psychological well-being and facilitate adjustment to parenthood among postpartum mothers and fathers through a midwife-led childbirth review (MLCR). MLCR is a structured 45-60-minute postpartum intervention focused on processing and integration of the individual's childbirth experience, involving active listening, emotional support, and provision of information. In this study, the investigators will employ the MLCR intervention developed by Gamble and Creedy (2009) for women with traumatic birth experiences, adapted for use in the general population of new parents, including both mothers and fathers/partners. This study will compare the effectiveness of three MLCR models - MLCR provided within the first postpartum week, MLCR provided at 6-8 weeks postpartum, and MLCR provided at both time points - with standard postpartum care and with each other.

NICU Utilization of Remote Voice Technology to Improve mateRnal Experience (NURTURE)

The study's objective is to conduct a Phase II randomized controlled trial examining the preliminary efficacy of the VoiceLove app compared to usual care on maternal postpartum depression in mothers with infants admitted to the Neonatal Intensive Care Unit (NICU). Primary aim: Assess the effects of VoiceLove on maternal postpartum depression, measured by the Edinburgh Postnatal Depression Scale (EPDS). The estimates from this study will be used for a future definitive Phase III trial. Secondary aim: Assess feasibility, acceptability, and patterns of communication and engagement among mothers, partners, and NICU clinicians during the NICU hospitalization, measured through app usage metrics, satisfaction surveys, and qualitative interviews. Additionally, we will evaluate effects of infant length of stay.

mHealth Intervention to Prevent Postpartum Depression and Anxiety in Chilean Women (WWWT)

The goal of this clinical trial is to evaluate the effectiveness of a digital psychoeducational intervention, "What Were We Thinking" (WWWT), to prevent the development of postpartum depression and anxiety symptoms in first-time mothers in Chile. The study includes adult women with a healthy, full-term infant younger than two months who are receiving care in primary health centers. The main questions it aims to answer are: * Does participation in the WWWT intervention reduce depressive and anxiety symptoms at 3 months after the end of the intervention compared to usual care? * Does participation in the intervention improve maternal self-efficacy, perceived social support, and coparenting relationship quality compared to usual care? Researchers will compare an experimental group receiving the full WWWT intervention with a control group receiving usual care to determine the effectiveness of the intervention. Participants will: * Complete self-report questionnaires assessing depressive symptoms, anxiety symptoms, maternal self-efficacy, perceived social support, and coparenting at baseline and at 3-month follow-up * Be randomly assigned to either the intervention group or the control group * Receive the WWWT intervention between 4 and 10 weeks postpartum (intervention group), including: * Fourteen psychoeducational video modules (3-5 minutes each) delivered via text messaging over 4-5 weeks * Individual contact with a trained facilitator through text messaging * One virtual group session with other mothers and a facilitator * Continue receiving usual care in primary health services (control group) and receive a shortened version of the intervention after the follow-up assessment

Qualitative Study on the Experiences of Mothers 6 to 12 Months After Their Participation in the Mother-baby Groups of the HUGS Study

The HUGS-QUALI study is a qualitative investigation that explores the experiences of mothers who participated in HUGS mother-baby therapy groups. Conducted 6 to 12 months after the intervention, the study aims to understand how this culturally adapted therapy influences the bond between mothers and their infants and affects their daily lives. By collecting detailed personal stories through in-depth interviews, the study seeks to understand if the adapted HUGS program effectively support French mothers in improving their interactions with their babies, when facing postpartum depression.

Maternal Expectations on Labor Analgesia and Risk of Postpartum Depression: An Observational Study

Postpartum Depression (PPD) is defined as the development of depression at any time during the first year after childbirth¹. Its prevalence ranges from 15% to 20%. It can manifest with symptoms such as depressed mood, loss of interest and energy, insomnia, anxiety, and may even lead to suicidal ideation. The consequences are numerous, both physical and psychological, with long-term repercussions on the mother-infant bond, family dysfunction, and the development of emotional and cognitive disorders in children. The etiology of PPD is multifactorial, but numerous recent studies have focused on the role of labor pain and its management with labor analgesia techniques. The aim of the present study is therefore to assess whether there is a difference in the incidence of PPD between parturients whose expectations regarding labor analgesia were met ('expectations met' group) versus those whose expectations were unmet.