Postpartum Depression

36

Review clinical trials related to Postpartum Depression. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression

The goal of this clinical trial is to learn if extended admission to the Kangaroo Mother Care (KMC) ward helps to prevent postpartum depression in mothers of low birthweight infants in a low-resource setting whose newborns were admitted to the neonatal intensive care unit (NICU) more than standard of care KMC. The main questions it aims to answer are: * Does longer KMC decrease the incidence of postpartum depression in mothers of low birthweight infants in a low-resource setting? * Does longer KMC improve neurodevelopmental outcomes of low birthweight infants at 6, 12, and 18 months in a low-resource setting? * What are the barriers to practicing KMC in low birthweight infants following hospital discharge in a low-resource setting? * What is the prevalence of paternal depression in a low resource setting? * Is it cost effective to admit preterm mother-infant dyads to the KMC ward following NICU discharge? Researchers will compare (extended admission to the KMC ward) to (standard of care KMC) to see if extended KMC decreases PPD in mothers of preterm infants in low-resource settings. Participants (infants) will: * At time of discharge from the NICU, when clinically stable, spend either \< 2 days in the KMC ward with their mothers or spend longer in the KMC ward until discharge. * Return to clinic at routine follow-up visits (at 2 weeks and at 6-8 weeks) where mothers will be screened for postpartum depression and fathers will be screened for depression. * Return to clinic for neurodevelopmental screening at 6, 12, and 18 months where mothers will be screened for postpartum depression and perceived social support and fathers will be screened for depression.

Participants needed: 1,908
Trial details
Age: 1-89Biological sex: AllType: InterventionalSponsor: University of Alabama at BirminghamUpdated: Jun 22, 2026Locations: 1
Eligibility criteria

AIM #3 [+6]

AIM #1-2 and #5 [+7]

Status: Not yet recruiting

Whole-Body Hyperthermia for Mood and Anxiety Disorders

This study aims to examine the scientific mechanisms of whole-body hyperthermia (WBH), a novel, rapidly acting, single session antidepressant and anxiolytic therapy. It also aims to determine its feasibility and acceptability in women with postpartum depression (PPD). The study will enroll four cohorts of participants: healthy postpartum controls; postpartum women with PPD; healthy adult controls; and adults with major depressive disorder or anxiety disorders in a longitudinal protocol.

Participants needed: 240
Trial details
Age: 18-50Biological sex: AllType: InterventionalSponsor: Weill Medical College of Cornell UniversityUpdated: Jun 23, 2026Locations: 1
Eligibility criteria

Group 2 [+6]

For logistics, we will exclude individuals with BMI >30 and waist size > 35, who... [+11]

Status: Not yet recruiting

Intranasal Esketamine-dexmedetomidine Combination and Postpartum Depression

Esketamine has rapid-onset antidepressant effects and may reduce postpartum depression in parturients with prenatal depressive symptoms. However, its adverse neuropsychiatric symptoms limits clinical application. Dexmedetomidine can alleviate these adverse symptoms and has independent antidepressant effect. This randomized, double-blind, placebo-controlled trial is designed to evaluate whether intranasal esketamine combined with dexmedetomidine can reduce the prevalence of postpartum depression in women with prenatal depressive symptoms.

Participants needed: 164
Trial details
Phase: Phase 4Age: 18+Biological sex: FemaleType: InterventionalSponsor: Peking University First HospitalUpdated: Jun 15, 2026Locations: 1
Eligibility criteria

Pregnant women aged ≥18 years who are preparing for childbirth; [+1]

History of schizophrenia or existence of communication barriers; [+5]

Status: Not yet recruiting

A Descriptive Study of the Correlation Between Postpartum Depression and Body Image Dissatisfaction, Self-objectification, and Social Media Appearance Comparison

The goal of this observational study is to assess the prevalence of postpartum depression and analyze its relationship with body image dissatisfaction, self-objectification, and social media appearance comparison in postpartum women seeking care at the Obstetrics Department. The main questions it aims to answer are: What is the current status of postpartum depression, body image dissatisfaction, and self-objectification in this population? How do body image dissatisfaction, self-objectification, and appearance-related social media comparison correlate with postpartum depression? Participants will answer online survey questions about their psychological status and social media usage.

Participants needed: 385
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Sun Yat-sen UniversityUpdated: May 22, 2026
Eligibility criteria

Aged ≥ 18 years; [+3]

A confirmed pre-pregnancy diagnosis of psychiatric disorders or intellectual dis... [+4]

Status: Recruiting

The ROSE Scale-up Study: Informing a Decision About ROSE as Universal PPD Prevention

The Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program is an evidence-based intervention that prevents half of cases of postpartum depression and was one of two interventions recommended by the US Preventive Services Task Force in 2019. All effectiveness trials of ROSE and of the other recommended PPD prevention intervention included only low-income women a single risk factor that doubles incidence of PPD. Thus, the existing evidence base for PPD prevention consists primarily of women at increased risk for PPD. Based on data from the PIs' current implementation study of ROSE, many healthcare and community agencies in this implementation trial (78%) find it is more feasible for them to provide or offer ROSE to every woman as part of their standard workflow, than it is to create a screening and referral process for at risk women. In addition to being more feasible for agencies, universal prevention may also be advantageous because the cost of a screening false negative (resulting in a preventable case of PPD; $32,000) far exceeds the cost of ROSE delivery ($50-$300/woman). Effectiveness of ROSE among low-income women at risk for PPD is known (ROSE prevents \~50% of PPD cases). To inform a recommendation about using ROSE as universal vs. selective or indicated prevention, we need to determine the effectiveness of ROSE among general populations of women, including women screening negative for PPD risk. Thus, this project will assess ROSE effectiveness across PPD risk levels and across prevention approaches in a sample of 2,320 women from a large regional health system (based in Detroit, MI). Each proposed aim gathers a piece of information missing that is needed to guide decision-making about ROSE as universal prevention. We will assess ROSE as universal, selective, and indicated prevention in terms of: (1) ROSE effectiveness relative to a control for each prevention approach in preventing PPD and improving functioning; (2) cost outcome, (3) equity and (4) scalability of each prevention approach; and (5) mechanisms of ROSE effects across PPD risk levels. We will integrate results to advise about ROSE as universal prevention. This definitive PPD prevention trial will show how best to get an evidence-based program to those who need it in settings where they receive perinatal care by addressing a pragmatic and novel question (should ROSE be universal prevention?) and by examining equity and cost-outcome of universal vs. other prevention approaches.

Participants needed: 2,320
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Michigan State UniversityUpdated: May 18, 2026Locations: 1
Eligibility criteria

Is aged 18 or older [+5]

Has a current major depressive episode [+1]

Status: Recruiting

The Mom and Infant Outcomes (MOMI) Study

The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering scalable integrated clinical and supportive care that is effective for all. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk for all by increasing patient engagement with evidence-based cilnical and supportive care, thus improving biopsychosocial profiles that drive clinical risk. To test this hypothesis, the investigators will conduct a hybrid type 1 randomized controlled trial (RCT) of MOMI PODS versus enhanced usual care (EUC, which we will term MOMI CARE) among a total sample of up to 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants during late pregnancy and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites.

Participants needed: 384
Trial details
Biological sex: FemaleType: InterventionalSponsor: Ohio State UniversityUpdated: May 14, 2026Locations: 1
Eligibility criteria

Not listed

Status: Not yet recruiting

Midwife-Led Digital Follow-Up After Cesarean Section

This randomized controlled trial aims to evaluate the effect of a midwife-led digital follow-up program on postpartum depression, perceived social support, and breastfeeding self-efficacy in women who will undergo cesarean section. Participants will be randomly assigned to either an intervention group that will receive structured face-to-face education followed by a 4-week digital follow-up program, or a control group that will receive routine postpartum care. Data will be collected at baseline (postpartum day 1), at 1 week, and at 4 weeks postpartum using validated measurement tools. The study will provide evidence on the effectiveness of continuous, midwife-led digital support in improving maternal psychological well-being and breastfeeding outcomes in the early postpartum period.

Participants needed: 104
Trial details
Age: 18-45Biological sex: FemaleType: InterventionalSponsor: Inonu UniversityUpdated: Apr 16, 2026Locations: 1
Eligibility criteria

Women aged between 18 and 45 years [+5]

History of psychiatric disorders [+4]

Status: Recruiting

Preventing Postpartum Depression in Immigrant Latinas

Postpartum depression (PPD) affects 10-20% of women, with immigrant Latinas disproportionately affected. PPD prevention and treatment is limited among immigrant Latinas due to an array of structural and cultural factors, suggesting the need to deliver interventions outside of traditional healthcare settings. Virtual interventions have the potential to reduce barriers to mental health services for immigrant Latinas, but there is little research on the effectiveness of virtual interventions to reduce PPD symptoms. Mothers and Babies is an evidence-based group intervention based on principles of cognitive-behavioral therapy and attachment theory aimed at PPD prevention. Mothers and Babies was adapted for delivery via a virtual group format (Mothers and Babies Virtual Group; MB-VG), with a pilot study suggesting good feasibility and acceptability as well as improved mental health outcomes for immigrant Latinas. The proposed project is a Type 1 Effectiveness-Implementation randomized controlled trial among pregnant individuals and new mothers at risk for PPD based on elevated depressive symptoms and/or other established risk factors who are enrolled in early childhood programs across Maryland. A total of 300 women will be enrolled; 150 will receive MB-VG while 150 will receive usual family support services. The project aims to evaluate: 1) the effectiveness of MB-VG to reduce depressive symptoms, prevent onset of PPD, and improve parenting self-efficacy and responsiveness; 2) implementation of MB-VG; and 3) contextual factors influencing MB-VG effectiveness and implementation. Trained early childhood center staff will deliver MB-VG sessions, with intervention participants receiving virtual group sessions via Zoom using any electronic device (smartphone, tablet, laptop). Maternal self-report surveys are conducted at baseline, 1 week, 3 months, and 6 months post-intervention, with structured clinical interviews also conducted at 3- and 6-months post-intervention. The study is the first to deliver a virtual PPD preventive intervention to immigrant Latinas and to evaluate its impact. Given its virtual delivery modality, MB-VG can be easily replicated and scaled to other family support programs and settings serving immigrant Latinas. If effective and implemented broadly, more immigrant Latinas will receive mental health services and fewer will suffer the negative consequences associated with PPD.

Participants needed: 300
Trial details
Age: 16+Biological sex: FemaleType: InterventionalSponsor: Northwestern UniversityUpdated: Apr 9, 2026Locations: 1
Eligibility criteria

Self-identify as Latina [+5]

Individuals who score >14 on the EPDS are exhibiting moderately severe to severe... [+1]

Status: Not yet recruiting

Efficacy of Yoga-Based Intervention in Improving Mother-Child Bonding in Maternal Depression

Perinatal depression (PND), defined as a depressive episode occurring from the antenatal period through 12 months following childbirth, has a reported prevalence of 12-22%, with higher rates in low- and middle-income countries (LMICs) including India. PND has a multifaceted and detrimental impact on both the mother and the child during a critical window of the child's emotional, cognitive, and physical development. Mother-infant bonding - the affective relationship that develops between a mother and her infant - is significantly impaired by maternal depression. Impaired bonding leads to poor antenatal attachment, earlier cessation of breastfeeding, risk of child maltreatment and neglect, and diminished reciprocal emotional and cognitive growth in the infant. The maternal brain undergoes significant neurobiological adaptations during the perinatal period to facilitate recognition of infant emotional cues, reward-driven bonding experiences, and reciprocal emotional responses. These include changes in oxytocin signalling, cortisol regulation, and functional connectivity of brain regions involved in maternal behaviour. Perinatal depression disrupts these neurobiological processes. Yoga-based interventions offer a safe, cost-effective, culturally acceptable, non-pharmacological approach. Yoga has demonstrated efficacy in improving depression and anxiety in perinatal populations. Its mechanisms include modulation of the HPA axis, reduction of cortisol, enhancement of oxytocin release, and promotion of mindful interoceptive awareness - directly relevant to the neurobiological disruptions in PND. This randomised controlled trial evaluates the efficacy of a structured 3-week bedside yoga intervention as an add-on to treatment as usual in improving mother-infant bonding scores, depression scores, and peripheral oxytocin and cortisol levels in mothers with perinatal depression. The study additionally explores the baseline neural correlates of mother-infant bonding using Event Related Potentials (ERP) and functional MRI (fMRI) of the brain.

Participants needed: 52
Trial details
Age: 19-45Biological sex: FemaleType: InterventionalSponsor: All India Institute of Medical SciencesUpdated: Apr 7, 2026
Eligibility criteria

• Mothers aged 19 to 45 years presenting with an index depressive episode with o... [+2]

• Severe mental health conditions including psychotic features [+5]

Status: Not yet recruiting

Implementation of a Clinical Decision Support Tool for Postpartum Depression

This study will evaluate the use of an automated process in the electronic health record (EHR) that will help providers to detect patients at risk of developing postpartum depression (PPD).

Participants needed: 160
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Weill Medical College of Cornell UniversityUpdated: Apr 2, 2026Locations: 3
Eligibility criteria

18 years or older [+2]

Does not speak inclusion [+3]

Status: Recruiting

Gestational Diabetes and Perinatal Depression: an Intervention Program

Background: The gestational diabetes mellitus and perinatal depression are both global public health issues with high prevalence. Non-perinatal diabetes mellitus and depression are confirmed to have reciprocal influence, which is bidirectional relationship. However, there are still no any confirmations of relationship in the perinatal period. The reason could be that these kinds of studies mostly had been done for postpartum depression, they had rarely been discussed with a clearly sequential influence between gestational diabetes mellitus and perinatal depression. Additionally, there have not been so many Asian countries which been done this kind of studies, therefore, this study will focus on the relationship of gestational diabetes mellitus and perinatal depression. Purpose: This study will discuss the bidirectional relationship of gestational diabetes mellitus and perinatal depression. In the other words, the prenatal depression influences on gestational diabetes mellitus, and vice versa. Those changeable factors, such as social support, health behavior, prenatal body index, weight gain during pregnancy, perinatal complications…etc, will be tested for whether they could be regulators or not between the gestational diabetes mellitus and perinatal depression.Afterwards, a part of participants with diagnosis of gestational diabetes mellitus will receive the intervention of health education to influence the health behavior, then depression and other obstetrics and gynecological results will be tested for effects.

Participants needed: 600
Trial details
Age: 20+Biological sex: AllType: InterventionalSponsor: National Taiwan University HospitalUpdated: Mar 23, 2026Locations: 1
Eligibility criteria

1. The diagnosis of gestational diabetes mellitus. [+4]

Status: Recruiting

Poor Sleep During Pregnancy as Risk Factor for Post-partum Stress and Mental Health

Improving maternal mental health is a worldwide health priority. Nevertheless, several scientific sources highlighted lack of empirical data which could drive clinical practice. The present project addresses psychobiological mechanisms leading to peripartum mental disorders. It focuses on one key risk factor for psychopathology, which is poor sleep continuity. The project aims to describe the link between maternal poor sleep quality and the cascade of events which may enhance vulnerability to stress and risk for mental disorders and to evaluate the efficacy of an online automated psychological prenatal intervention directed to sleep problems in preventing these negative outcomes.

Participants needed: 114
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of Rome G. MarconiUpdated: Mar 2, 2026Locations: 2
Eligibility criteria

age ≥ 18 yrs. old; [+4]

severe diagnosis of relevant somatic disorder; [+3]

Status: Recruiting

A Long-Term Study of Patient-Reported Changes in Postpartum Depression Symptoms in People Starting Zuranolone

In this study, researchers will learn how postpartum depression symptoms may change after people first start taking zuranolone. This is a drug available for doctors to prescribe for people with postpartum depression, also known as PPD. After giving birth, people with PPD can suffer from symptoms like tiredness, sadness, and a loss of interest in their daily activities. This is known as an "observational" study, which collects health information about study participants without changing their medical care. Participants for this study will be found in the United States using a database from Accredo Specialty Pharmacy. This will include anyone who has a new prescription for zuranolone and were pregnant in the last 12 months before joining the study. The main goal of this study is to learn more about how zuranolone affects the participants' PPD symptoms. This will be done using a questionnaire called the Edinburgh Postnatal Depression Scale, also known as the EPDS. The main question that researchers want to answer is: • Do PPD symptoms change after treatment with zuranolone based on EPDS scores measured at Day 15? Researchers will also learn about : * Changes in participants' EPDS scores at Day 45 and Day 90 in the study * Changes in EPDS scores at Day 15, Day 45, and Day 90 in a group of participants who have moderately severe PPD before starting zuranolone * How many participants breastfeed their babies while taking zuranolone * How many participants report not starting new medicine after finishing their zuranolone treatment The study will be done as follows: * People with PPD who get a new zuranolone prescription through Accredo Specialty Pharmacy will be contacted by email or phone to ask them about their interest in participating in the study. * Before taking their first dose of zuranolone, participants will be asked to answer written questions about their symptoms using the online EPDS survey. 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 survey, 15 days, 45 days, and 90 days after taking the first dose of zuranolone. Each survey will take about 10-15 minutes to finish.

Participants needed: 200
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: BiogenUpdated: Feb 10, 2026Locations: 1
Eligibility criteria

Participants with a prescription for zuranolone via Accredo Specialty Pharmacy. [+3]

Prior fill of zuranolone or brexanolone in last 12 months. [+5]

Status: Not yet recruiting

The Effect of Art-Based Mandala Coloring Activity on Postpartum Anxiety and Postpartum Depression

The postpartum period is a critical time for women's physical and psychological health, during which significant hormonal, emotional, and social changes occur. During this period, many women experience increased stress, anxiety, and emotional vulnerability while adapting to new parental responsibilities and caring for a newborn. When these challenges are not adequately managed, they may contribute to the development of postpartum anxiety and postpartum depression, which can negatively affect maternal well-being, mother-infant bonding, breastfeeding practices, and child development. Despite the importance of postpartum mental health, non-pharmacological and easily accessible supportive interventions remain limited. This randomized controlled experimental study aims to evaluate the effect of a structured, art-based mandala coloring activity on postpartum anxiety and postpartum depression among postpartum women. The study will be conducted at Afyonkarahisar Health Sciences University Health Practice and Research Center, Obstetrics and Gynecology Clinic, and will include women who have recently given birth at this institution. Eligible participants will be randomly assigned to either an intervention group or a control group. Women in the intervention group will receive individual training in mandala coloring before hospital discharge and will be provided with mandala coloring materials for home use. They will be encouraged to engage in the mandala coloring activity over an eight-week period and will be followed through regular telephone contacts. In addition to monitoring participation in the activity, individualized supportive counseling will be provided based on participants' needs. Women in the control group will receive routine postpartum care without any additional intervention. Postpartum anxiety and postpartum depression levels will be assessed at multiple time points during the study to examine changes over time. This study seeks to determine whether mandala coloring, as a low-cost and non-pharmacological art-based activity, may serve as a supportive approach to improve psychological well-being during the postpartum period. The findings may contribute to the development of accessible interventions aimed at supporting maternal mental health in the early postpartum period.

Participants needed: 60
Trial details
Age: 18-49Biological sex: FemaleType: InterventionalSponsor: Afyonkarahisar Health Sciences UniversityUpdated: Jan 7, 2026
Eligibility criteria

Able to speak and understand Turkish [+7]

Have previously received psychological or psychiatric treatment or are receiving... [+7]

Status: Not yet recruiting

Postpartum 1-Day CBT Pilot Study (Türkiye)

This pilot randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary effects of a culturally adapted, one-day online Cognitive Behavioral Therapy (CBT)-based group workshop for women with postpartum depression in Türkiye. The intervention was adapted from a validated model developed in Ontario, Canada, using Bernal's cultural adaptation framework. Participants will be randomly assigned in a 1:1 ratio to either a workshop group, who will receive the one-day online CBT-based workshop within the first month after enrollment, or a control group who will continue to receive usual postpartum care throughout the study period. Data will be collected at baseline and at the 3-month follow-up using the Edinburgh Postnatal Depression Scale (EPDS), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), the Frequency of Actions and Thoughts Scale (FATS), and the TÜRBAD Satisfaction Questionnaire (TÜRBAD-SQ). The study will assess feasibility indicators including recruitment, randomization procedures, completion of study questionnaires, retention through the 3-month follow-up, and adherence to the one-day workshop. Acceptability and preliminary changes in depressive, anxiety, and cognitive-behavioral outcomes will also be explored. This pilot trial represents the first culturally adapted, one-day online CBT-based group intervention for postpartum depression in Türkiye and will inform the design of a future large-scale randomized controlled trial.

Participants needed: 60
Trial details
Age: 18-45Biological sex: FemaleType: InterventionalSponsor: Marmara UniversityUpdated: Dec 5, 2025Locations: 1
Eligibility criteria

Female participants aged 18-45 years [+5]

Current psychotic, bipolar, organic mental, or substance use disorder [+4]

Status: Recruiting

Understanding the Role of Doulas in Supporting People With PMADs

Detailed Description The doula-led intervention developed during the first phase of this project will be pilot tested for feasibility. Following the recruitment procedures described in the recruitment and retention plan, approximately 75 participants will be enrolled into the study. Twenty-five of the participants will receive regular doula care and 25 of the participants will receive care from a doula trained in the PMAD doula training throughout their pregnancy, childbirth, and postpartum time period, following the intervention procedures developed in Aim 2 of this study. Twenty-five women will not receive care from a doula and will receive perinatal care as usual. Women in all groups will take surveys via REDCap during their enrollment in the intervention, at 1 month postpartum, 3 months, and 6 months postpartum (at the conclusion of the intervention). All participants who receive the PMAD doula intervention will complete checklists after each session with their doula, to assess fidelity to the intervention. Participant communication with their doula via patient notebook will also be assessed for fidelity to the intervention.

Participants needed: 75
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of MontanaUpdated: Nov 14, 2025Locations: 1
Eligibility criteria

Participants must be over the age of 18 [+2]

They are under the age of 18 [+3]

Status: Recruiting

Postpartum Care in the NICU (PeliCaN) Transitions

This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.

Participants needed: 20
Trial details
Age: 16+Biological sex: FemaleType: InterventionalSponsor: University of PennsylvaniaUpdated: Oct 14, 2025Locations: 1
Eligibility criteria

HUP postpartum patients who are at least 16 years old at the time their newborns... [+3]

Unable to read or sign informed consent [+3]

Status: Recruiting

Engage & Connect: A Psychotherapy for Postpartum Depression

This randomized controlled trial compares a novel psychotherapy, Engage \& Connect, with a Symptom Review and Psychoeducation intervention, tailored to reduce postpartum depression. The study includes 9-weeks interventions, delivered remotely. It will examine changes in social isolation, processing of social rewards and depression severity over 9 weeks of treatment.

Participants needed: 60
Trial details
Biological sex: FemaleType: InterventionalSponsor: Weill Medical College of Cornell UniversityUpdated: Sep 25, 2025Locations: 1
Eligibility criteria

Up to 1 year post-delivery [+4]

Intent or plan to attempt suicide in the near future [+5]

Status: Recruiting

Mother-infant Bonding in the Brain: a Mindfulness-based Intervention

The study investigates the effectiveness of the mindfulness-based intervention "Mindful with your Baby" in women with babies between 5-9 months postpartum who experience heightened levels of postpartum depression, anxiety and/or parental stress. The intervention "Mindful with your Baby" is one of the very few interventions for maternal postnatal mental health issues that takes the bond between mother and infant into account. It is hypothesized that the "Mindful with your Baby" intervention will reduce levels of postpartum depression, anxiety and parental stress, and improve mother-infant behavioral interaction and increase neural synchrony between mother and infant brains.

Participants needed: 64
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Tilburg UniversityUpdated: Sep 19, 2025Locations: 1
Eligibility criteria

Pregnant women (18+y). [+3]

Gemelli pregnancy (or higher order pregnancy). [+6]

Status: Recruiting

Non-invasive Detection of Iron Deficiency in Obstetrics

Validation of non-invasive measurement of zinc protoporphyrin for detection of iron deficiency in pregnancy. In addition, the impact of iron deficiency on the incidence of postpartum depression, restless legs syndrome, obstetric complications and quality of life will be examined.

Participants needed: 500
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Wuerzburg University HospitalUpdated: Jul 24, 2025Locations: 1
Eligibility criteria

any timepoint during or up to 3 months after pregnancy [+2]

previous participation in this study [+2]

Status: Recruiting

RCT of At-Home tDCS for Depression in Pregnancy

This is a randomized, sham-controlled trial to determine whether treatment with transcranial direct current stimulation (tDCS) is superior to a sham condition at reducing the symptoms of depression in pregnant people with moderate to severe depression. The study aims to enrol 156 participants across all sites. Data collection occurs at baseline, immediately after treatment, every 4 weeks during pregnancy and 4-, 12-, 26- and 52-weeks postpartum

Participants needed: 156
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Women's College HospitalUpdated: May 28, 2025Locations: 2
Eligibility criteria

Adult, ≥18 years of age [+4]

Active alcohol or substance use disorder in previous 12 months as assessed by GA... [+9]

Status: Recruiting

Maternal Well-being in the Postnatal Stage

The objective of this study is to design and validate an online intervention aimed at promoting well-being in women with postpartum depression. For this, the design of a multicomponent protocol consisting of empirically validated positive interventions and comparing these with a group Cognitive Behavioral Therapy (CBT) is proposed, following the National Institute for Health and Care Excellence (NICE) recommendations for the treatment of depression. Participants will be screened for inclusion in the program if they meet clinical criteria. After that, they will be randomly assigned to a CBT group or a positive psychology intervention (PPI) group.

Participants needed: 98
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Universidad Complutense de MadridUpdated: May 21, 2025Locations: 1
Eligibility criteria

Women who have been mothers in the last year

Women who have been mothers in the last month, [+2]

Status: Recruiting

Maternal Stress on Human Milk and Infant Outcomes

The overarching purpose of this study is to determine if a modified 8-week mindfulness-based intervention (with a focus on self-compassion; MBSC) or 8 weeks of 2000 IU vitamin D supplementation will reduce stress and increase self-compassion in mothers of preterm infants and beneficially modify the human milk produced, and subsequently improve infant health.

Participants needed: 500
Trial details
Age: 18-50Biological sex: FemaleType: InterventionalSponsor: University of IdahoUpdated: May 18, 2025Locations: 1
Eligibility criteria

Mothers of newborn infants at Kootenai Health NICU and the Palouse region

Status: Recruiting

COntact RElationship in Neonatal Intensive Care Unit

The present research project aims to explore the value that contact relationships between caregivers and the preterm infant may have in terms of promoting developmental and maturational processes,by attending to the neurobehavioral states of the infant in response to maternal and paternal voice. The study is aimed at furthering the still underdeveloped knowledge regarding the possible effects of the paternal voice on the neurobehavioral states of the preterm infant in the crib, comparing them with the effects of exposure to the maternal voice and the voice of a familiar but non-parental figure, such as the NICU nurse. These behavioral states will also be observed as a function of the psychological condition of the parents, investigating the presence of a possible postpartum depressive condition and/or anxiety of the mother and symptomatology attributable to perinatal affective disorders in the fathers, which are often overlooked; and again, the neurobehavioral responses of the infants will be correlated with the neurophysiological responses of the parents/nurses who interact with them through voice and touch. The research aims to have a direct impact on both parents and health care personnel: in addition to questionnaires dedicated to screening parents for perinatal psychological disorders, artificial intelligence systems will be used to intercept possible postpartum depression early by recording the maternal voice, enabling the activation of a psychological support intervention and reducing the negative impact that a postpartum depression has on the early mother-child relationship. In addition, information on parent-child interactive modalities will be able to further guide the intake of assignment and particularly the accompaniment of parents during the time of hospitalization.

Participants needed: 80
Trial details
Age: 18-50Biological sex: AllType: ObservationalSponsor: Istituto per la Ricerca e l'Innovazione BiomedicaUpdated: May 1, 2025Locations: 1
Eligibility criteria

For infants: Infants with gestational age between 33 and 36 weeks, weighing arou... [+1]

For infants: Presence of congenital anomalies, neurological disorders, genetic s... [+1]

Status: Recruiting

Improving Maternal Sleep and Mental Health

The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent/mitigate postpartum mood disorders by augmenting maternal sleep and/or enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual/traditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question\[s\] it aims to answer \[is/are\]: Aim 1: Determine the effect of the SB on infant sleep and maternal sleep. \[primary hypothesis or outcome measure 2\]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU. Military-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum.

Participants needed: 342
Trial details
Age: 18-45Biological sex: FemaleType: InterventionalSponsor: University of Colorado, Colorado SpringsUpdated: Feb 10, 2025Locations: 1
Eligibility criteria

Pregnant women with a singleton gestation who have a military affiliation [+5]

Presence of depression assessed over the phone using the Structured Clinical Int... [+6]