Clinical Research Directory

mHealth India Postnatal Health Intervention Effectiveness

The goal of this study is to assess the effectiveness of a culturally-tailored mobile interactive education and support group intervention to supplement standard postpartum care activities in comparison to standard care alone on health-related behaviors and health outcomes in a randomized controlled trial among 2100 postpartum Indian women living in 3 geographically diverse Indian states to estimate the impact on maternal and neonatal health-related knowledge, health-related behaviors, and health outcomes. The investigators also seek to characterize mechanisms of impact including knowledge, social support, self-efficacy, and behavior change, and determine the cost-effectiveness.

ROSE in Sunset Park

The purpose of this study is to learn more about pregnant women's' experience with Reach Out, Stay Strong, Essentials for mothers of newborns (ROSE) and to evaluate the effectiveness of the ROSE program in preventing and reducing post-partum depressive symptoms, decreasing stress, and increasing social support among pregnant women.

OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression

Postpartum Depression (PPD) is defined as depression that occurs after childbirth, with intense symptoms that last longer than "baby blues". PPD differs greatly from "baby blues", a term used to describe the typical sadness, worry and tiredness that women experience after childbirth, which often resolves within a week or two on its own. The symptoms of PPD interfere with many aspects of daily living and can have unhealthy short-term and long-term outcomes, both for the mother and baby. One-third of women in the U.S. with PPD are identified in clinical settings, yet only half of those begin psychotherapy treatment. Unfortunately, mothers whose newborns are in the Neonatal Intensive Care Unit (NICU) are at high risk for developing PPD, necessitating early identification and evidence-based treatment. Cognitive behavioral therapy (CBT) and interpersonal therapy (IPT) are the two most effective psychotherapy treatments for PPD, yet no randomized controlled clinical trials were found that directly compared the two types of treatment or determined whether combining the two approaches is more helpful for PPD than either approach alone. This clinical trial aims to compare the effectiveness of a 4-week intervention of either CBT or IPT for PPD in NICU mothers and to determine whether a sequential 8-week intervention (IPT then CBT, or CBT then IPT) is more beneficial.

Accelerated iTBS for Post Partum Depression

Study 1: The investigators are studying the feasibility and tolerability of 10x/day intermittent theta burst (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over the course of 6 days for women with post-partum depression. The investigators further aim to characterize the anticipated anti-depressant effect of this treatment paradigm. Study 2: The investigators are studying the feasibility and tolerability of 12 sessions/day of intermittent theta burse (excitatory) transcranial magnetic stimulation to the left dorsolateral prefrontal cortex over 5 days for women with post-partum depression. The investigators aim to compare the two different treatment schedules.

Accelerated TMS for Perinatal Depression

We are studying a treatment for depression called accelerated Transcranial Magnetic Stimulation (TMS) among pregnant and postpartum individuals. TMS is a focal, non-invasive form of brain stimulation that is cleared by the Food and Drug Administration for depression. Typically, traditional TMS involves daily treatments for 6-8 weeks. In this study, we will offer an accelerated form of TMS that involves multiple daily treatments for 5 days.

mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression

Postpartum depression (PPD) is associated with significant health consequences for mothers and children, and the current COVID-19 pandemic has had a major impact on the mental health of particularly vulnerable populations including pregnant Black and Latina women. There is an urgent need for evidence-based, accessible, and scalable mental health care options for these high-risk, vulnerable women. This study aims to: (a) compare the effectiveness of two digitally-delivered self-paced stress reduction programs in pregnant Black and Latina women at increased risk of PPD; and (b) examine barriers and facilitators to implementation within a large healthcare system.

Sensing Technologies for Maternal Depression Treatment in Low-Resource Settings

In certain low- and middle- income country settings, there is a disproportionate level of untreated postpartum depression that presents both acute and long-term risks to a mother's well-being. Although there is increasing willingness among health systems to involve non-specialists, such as community health workers, in the delivery of psychosocial interventions for postpartum depression, the effectiveness of these interventions has been mixed. The incorporation of digital technology, though, has the potential to improve the effectiveness of non-specialist-delivered interventions. The goal of this clinical trial is to evaluate the acceptability and clinical efficacy of the StandStrong intervention- a non-specialist, passive sensing technology-informed (i.e., digital) mental health intervention- as compared to a standard non-specialist mental health intervention among postpartum-depressed mothers in Nepal. Successful completion of the trial will contribute to the optimization of psychosocial intervention delivery for the postpartum context in low- and middle-income country settings.

Screening for Postpartum Depression Using EPDS and HAM-D in Mothers Within 72 Hours After Delivery at a Tertiary Care Center (SOS-Mamma Study)

Postpartum depression (PPD) is one of the most common complications affecting maternal mental health after childbirth, with an estimated prevalence of 10-20% in high-income countries. Despite its frequency and the availability of effective screening tools, early diagnosis remains largely underestimated in routine clinical care. This study, part of the national SOS-Mamma project funded by the Italian Ministry of Health, aims to systematically screen for signs of postpartum depression in women giving birth at a tertiary care obstetric unit (AOU Vanvitelli - UOC of Obstetrics and Gynecology, Naples, Italy). The goal is to promote early detection and timely referral to specialized care pathways. The study is a prospective, observational, monocentric, non-interventional, non-pharmacological study. All eligible women who deliver at the hospital will be invited to participate within the first 72 hours after childbirth. Participants will be asked to complete the Edinburgh Postnatal Depression Scale (EPDS) - a widely used self-report questionnaire - and will undergo a brief clinical interview using the Hamilton Depression Rating Scale (HAM-D), conducted by trained healthcare staff. The study's primary objective is to estimate the real-world incidence of postpartum depression within this population. Secondary objectives include identifying socio-demographic and obstetric risk factors associated with depressive symptoms, assessing the acceptability and feasibility of routine screening, and contributing to the development of a replicable model of care aligned with international recommendations (NICE, WHO, ISS). Collected data will be anonymized and analyzed to provide evidence on early indicators of PPD and guide improvements in clinical care. Women identified as being at risk (e.g., EPDS \>10 or presence of suicidal ideation) will be referred to specialist psychiatric services in accordance with clinical guidelines. Participation in the study is voluntary. All procedures comply with European data protection regulations and Good Clinical Practice (GCP) principles. No experimental treatments are involved, and no changes to standard care will be made based on study participation. By highlighting the need for structured mental health screening in the postpartum period, this study hopes to improve maternal wellbeing and reduce the long-term impact of undiagnosed depression on mothers and their children.

Video-Feedback Interaction Guidance for Improving Interactions Between Depressed Mothers and Their Infants ("VID-KIDS")

Postpartum depression (PPD) is a major public health issue. Known as "the thief that steals motherhood" since symptoms obstruct a mother's capacity for understanding and enjoying her baby, PPD affects approximately 1 in 5 moms. Built via "serve and return" interactions (e.g. baby smiles, mom smiles back), sensitive and responsive exchanges are the foundation for healthy child development but are diminished by PPD, resulting in interactions that place children at risk for behavioural and cognitive problems. Infants perceive PPD as stressful; stressors stimulate the brain's hypothalamic pituitary adrenal axis (HPA) and trigger stress hormone (cortisol) release, which, in turn, negatively affects developing infant brains by decreasing brain volume. Infants' critical periods of brain development are vulnerable to long-term effects of cortisol, explaining some of the problematic developmental outcomes observed in children of depressed mothers. How can the investigators support depressed mothers and their infants? Successfully treating PPD does not always benefit mother-child relationships; however, this research builds on a successful pilot that demonstrated that nurse-guided video feedback improved mother-infant interactions in the context of PPD. By improving interaction quality, depressed mothers may be motivated to engage in more play and, in turn, infants who appear interested and ready to interact are more likely to elicit positive, enjoyable experiences from mothers. Building on the pilot, the investigators will trial the effectiveness of VID-KIDS (Video-Feedback Interaction Guidance for Improving Interactions Between Depressed Mothers and their Infants) on maternal-infant interaction and infant cortisol patterns as well as infant development, maternal symptoms of depression and anxiety, and parenting self-efficacy. If successful, future aims are to 1) integrate VID-KIDS into existing services of Calgary Public Health; and 2) commercialize VID-KIDS for dissemination.

Relationship-Based Intervention for Post-Partum Depression

A short term dyadic psychotherapy intervention for mothers with Post-Partum depression and their babies in the first year of life was developed. The investigators believe that following dyadic intervention mothers will show improvement in depressive symptoms, the quality of the mother-child relationship will improve, and maternal and infant's oxytocin levels will rise.

Early Intervention to Protect the Mother-Child Relationship After Postpartum Depression

Postpartum depression (PPD) may impair the mother-infant relationship and lead to both short and long-term suboptimal development of the baby. This study aims to evaluate the effectiveness of a targeted intervention (HUGS: Happiness Understanding Giving and Sharing) for enhancing the mother-infant relationship.

Fresh RX: NHS 2020

This study is an evaluation of the Fresh Rx: Nourishing Healthy Starts program administered by Operation Food Search, a St. Louis-based nonprofit organization. The program provides food and nutrition supports to food insecure pregnant women in conjunction with integrative care services in order to improve health and birth outcomes for both the mother and the child. The purpose of this study is to test the efficacy of this approach through a field experiment, and to assess the extent to which these services can provide cost savings to the healthcare system.