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Depression, Postpartum clinical trials

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NCT ID: NCT06462638 Not yet recruiting - Preterm Birth Clinical Trials

COntact RElationship in Neonatal Intensive Care Unit

CORE in NICU
Start date: November 1, 2024
Phase:
Study type: Observational

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.

NCT ID: NCT06456307 Not yet recruiting - Depression, Anxiety Clinical Trials

Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics

IPMH
Start date: January 2025
Phase: N/A
Study type: Interventional

Perinatal mood and anxiety disorders (PMAD), defined as depression and anxiety during pregnancy or up to 1 year postpartum, account for substantial morbidity and mortality among birthing people globally especially in low- and middle-income countries. Several evidence-based interventions are recommended for identification and management of PMAD by non-specialist providers in resource-limited settings. This cluster-randomized trial seeks to evaluate the effect of a stepped-care intervention for screening and treatment of PMAD among perinatal women, on clinical and implementation outcomes.

NCT ID: NCT06445933 Not yet recruiting - Clinical trials for Postpartum Depression

Vitamin B6 and Depression in Pregnant and Peri-partum Women

Start date: June 5, 2024
Phase: N/A
Study type: Interventional

Perinatal depression is a highly prevalent and serious health issue during pregnancy. According to statistics, approximately one out of every ten postpartum women experiences this condition. Symptoms can manifest as mood fluctuations or emotional lows. Unfortunately, these symptoms are often overlooked by patients themselves or misinterpreted by others as normal adjustments to the new role of motherhood. Consequently, timely assistance and support are frequently lacking. To address this, the investigators urgently need effective preventive measures for perinatal depression before it escalates. Recent research suggests that simple oral supplementation of vitamin B6 may help prevent and alleviate perinatal depression to some extent. Vitamin B6 plays several crucial roles in the body, including regulating neurotransmission and mental health. Therefore, it could contribute to maintaining emotional stability and psychological balance. In contemporary times, numerous screening methods for perinatal depression involve questionnaires. However, these methods presuppose an awareness of the possibility of perinatal depression. Individuals who are unaware of these questionnaires may go undetected. Hence, our aim is to investigate whether cardiac electrophysiology results obtained through a wearable device could offer a more objective evaluation of the status of perinatal depression. Our plan involves conducting a prospective study to delve deeper into the preventive and therapeutic effects of vitamin B6 on perinatal depression in pregnant women. Through systematic experiments and data analysis, the investigators aim to explore the impact of vitamin B6 dosage, duration, and timing of administration. Ultimately, the investigators hope to provide evidence-based recommendations and guidance for clinical practice. The investigators' goal is to offer new insights and methods to protect the mental health of expectant mothers, ensuring a pleasant and healthy pregnancy journey for each one.

NCT ID: NCT06442774 Not yet recruiting - Pregnancy Related Clinical Trials

MamaConecta: Digital Tool for Maternal Mental Health

DDT
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to validate a digital health tool, Dana app, that enhances well-being and supports mental health monitoring for women during the perinatal period. The primary purpose is to improve maternal well-being, early detection of mental health issues, and aid in the diagnosis and monitoring by healthcare professionals in women transitioning into motherhood. The main questions it aims to answer are: - Does the app improve overall maternal well-being during the perinatal period? - Can the app increase the early detection rates of perinatal mental health disorders? - Can the app be an effective tool to support healthcare professionals to diagnose perinatal mental health problems? - How effective is the app in improving obstetric outcomes and the psychological and cognitive development of infants? Researchers will compare the group using the app with a control group not using the digital tool to see if Dana provides significant improvements in maternal and infant health outcomes. Participants will: - Use the mobile application from 12-14 weeks of gestation until 24 months postpartum. - Undergo regular assessments to monitor their emotional state, lifestyle, clinical, and obstetric data. - Participate in evaluations for their infants' psychological and cognitive development at various stages from birth to two years old. This trial is conducted at multiple centers, including Hospital Vall d'Hebron, the Sexual and Reproductive Health Care Services (ASSIR) in Tarragona and ASSIR Litoral (Barcelona), Hospital del Mar, following CONSORT standards. The study aligns with the Health and Culture priorities of the Spanish Government's Scientific, Technical, and Innovation Research Plan 2021-2023.

NCT ID: NCT06390540 Not yet recruiting - Clinical trials for Postpartum Depression

Mobile-Based Exercise in Postpartum Period

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Postpartum depression is a global mental health problem affecting 13 million women worldwide each year. It is defined as minor or major depression that occurs up to one year after birth and is estimated to affect 5 to 25% of mothers who have just given birth . Postpartum depression can cause negative consequences not only on the mother but also on the newborn and the whole family. The main goal in the postpartum period is to maintain the well-being of mother and baby. However, if a depression is experienced during this period, the main goal is to take action to reduce its severity. Exercise is a potentially promising method to prevent postpartum depression. However, more studies are needed to determine the effects of exercise on women who live in rural Türkiye and have limited access to health services. Therefore, this study aims to determine the effect of a mobile-based exercise program applied to women giving birth in rural areas on postpartum depression, mother-baby attachment and baby crying behavior.

NCT ID: NCT06379074 Not yet recruiting - Stress Clinical Trials

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

MOTHERS
Start date: May 6, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06366035 Not yet recruiting - Mental Health Issue Clinical Trials

LoVE4MUM: Virtual Engagement for Preventing Postpartum Depression

LoVE4MUM
Start date: April 22, 2024
Phase: N/A
Study type: Interventional

Postpartum depression is a serious concern affecting mothers and their infants, especially with limited traditional support. This pilot study evaluates the effectiveness of a novel mobile app called LoVE4MUM, developed based on Cognitive Behavioral Therapy and Psychoeducation principles, in preventing postpartum depression. The pilot trial involves 64 mothers randomly assigned to receive either standard care or standard care plus the LoVE4MUM. Primary outcome is improvement in depression, with secondary outcomes including mental health literacy and automatic negative thoughts. This research aims to provide initial evidence on the potential of mobile health tools to support maternal mental health, paving the way for future accessible and effective interventions.

NCT ID: NCT06364488 Not yet recruiting - Depression Clinical Trials

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

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06316193 Not yet recruiting - Stress Clinical Trials

The Use of the Diary in Neonatal Pathology: a Mixed-method Study for Collecting and Analyzing the Experience of Parents and Health Care Personnel.

DiaPaNeo
Start date: April 15, 2024
Phase:
Study type: Observational

The study is mixed-methods (qualitative + quantitative observational cross-sectional) and the aims are to explore the use of diaries by parents of newborns admitted to Neonatal Pathology and to describe some variables related to their experience during their children's hospitalization, such as: stress level, postpartum depression and perceived support. The diary that will be analyzed is already part of current clinical practice. Study population: - Parents of premature infants with gestational age less than or equal to 35 weeks and infants with birth weight less than or equal to 2kg admitted to Neonatal Pathology of San Raffaele Hospital. - Health workers of the O.U. of Neonatal Pathology.

NCT ID: NCT06285916 Not yet recruiting - Clinical trials for Postpartum Depression

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

NuMom
Start date: February 2024
Phase: Phase 2
Study type: Interventional

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.