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Depression, Postpartum clinical trials

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NCT ID: NCT05873569 Recruiting - Clinical trials for Postpartum Depression

Preventing Postpartum Depression in Immigrant Latinas

Start date: October 15, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05852314 Recruiting - Clinical trials for Postnatal Depression

A Problem-Solving Intervention for Women With Suicidal Ideation During Postnatal Period in Pakistan

Start date: July 10, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to determine the feasibility and acceptability of culturally adapted CMAP for suicidal Ideation for women in postnatal period. Objectives 1. To adapt existing CMAP Intervention for suicidal ideation (CMAP-SI) in postnatal period. 2. To investigate whether CMAP-SI is feasible and acceptable among women presenting suicidal Ideations in postnatal period; and 3. To test whether there is an indication for the effects of the CMAP in reducing suicidal thoughts among women in postnatal period. 4. To explore participants experiences with CMAP-SI Intervention.

NCT ID: NCT05830266 Recruiting - Clinical trials for Postpartum Depression

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

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05826327 Recruiting - Clinical trials for Postpartum Depression

Effects of Epidural Labor Analgesia With Esketamine on the Incidence of Postpartum Depression in Parturients

Start date: May 1, 2023
Phase: Phase 4
Study type: Interventional

Postpartum depression is a common psychological abnormality during the puerperium, which seriously affects maternal and neonatal health. Esketamine, the S-enantiomer of ketamine, is twice as potent as ketamine and can be safely used for cesarean section and labor analgesia. However, it is not clear whether esketamine used for epidural labor analgesia can significantly reduce the incidence of postpartum depression. This study intends to explore the incidence of maternal prenatal depression and to investigate the effect of esketamine for epidural labor analgesia on postpartum depression and maternal and neonatal outcomes in parturients with prenatal depression through a multi-center, large-scale and high-quality clinical trail, in order to provide a clinical basis and theoretical basis for the application of esketamine used for epidural labor analgesia in postpartum depression and further reduce the incidence of postpartum depression, promote maternal and infant health, and ensure maternal and infant safety .

NCT ID: NCT05821569 Recruiting - Clinical trials for Depression, Postpartum

Cerebral Synchronization Between Mothers and Their Newborns During Breastfeeding

Start date: January 9, 2024
Phase:
Study type: Observational

Different reciprocal positions of mother and newborn during breastfeeding may be adopted. Other than the one derived from UNICEF guidelines, or standard position, an approach called biological nurturing has been recently proposed. It aims to promote the activation of neonatal primitive reflexes, breast problems reduction (e.g. cracked or sore nipple) and, overall, spontaneity and naturalness of mother-newborn dyad behaviour during feeding. The study of newborn cortical activation by functional near-infrared spectroscopy (fNIRS), a safe and minimally invasive functional neuroimaging technique based on haemoglobin absorption of near-infrared light, showed that baby's cortex exhibit a wide activation associated with breastfeeding. Moreover, preliminary and not yet published data, collected by fNIRS hyperscanning (e.g. the simultaneous detection of brain functional activation from two individuals living the same experience) in the Nursery of our Institute, evidenced that mother-newborn dyads adopting a biological nurturing approach to breastfeeding show a neural synchronization between their frontal cortex during such experience. Basing on this new evidence, it is now worth to understand if a biological nurturing approach to breastfeeding may promote such neural synchronization, even when postpartum depressive symptoms are present. Accordingly, biological nurturing may result to be protective for the neural basis of mother-newborn relationship, also in case of a postnatal affective suffering and helping to prevent its potential long term consequences on maternal wellbeing and infant neurodevelopment as well. Moreover, since oxytocin is a neuropeptide with widespread influence on parental function, including lactation and nurturing maternal behaviour physiology, if a biological nurturing approach to breastfeeding may promote the oxytocin level in the mother and/or in the newborn is worth to understand as well, taking into account again possible relations with postpartum depression symptoms. the aim of this study is to evaluate, by fNIRS hyperscanning, if the frontal cerebral cortex functional synchronization of mother-newborn dyads, who adopt a reciprocal positioning according to the biological nurturing approach during breastfeeding, differs from that of mother-newborn dyads adopting the standard position, taking into account the intensity of mother's postpartum depressive symptoms.

NCT ID: NCT05813782 Recruiting - Clinical trials for Depression, Postpartum

The Effect of Baby Massage on Postpartum Depression and Maternal Attachment

Start date: September 3, 2022
Phase: N/A
Study type: Interventional

This study was conducted to determine the effect of baby massage on postpartum depression and maternal attachment in the postpartum period.

NCT ID: NCT05804708 Recruiting - Clinical trials for Postpartum Depression

Phase 2 Clinical Trial of GH001 in Postpartum Depression

Start date: March 2, 2023
Phase: Phase 2
Study type: Interventional

This study is a multicenter, open-label, single-arm Phase 2 clinical trial. Approximately 15 female participants with clinically diagnosed postpartum depression (PPD) will be included in this study. The participants will receive an individualized dosing regimen (IDR) with at least one and up to three doses of GH001 administered within a single day.

NCT ID: NCT05784116 Recruiting - Clinical trials for Depression, Postpartum

Immune/Inflammatory Biomarkers in Postpartum Depression

PPDINFLAME
Start date: April 1, 2022
Phase:
Study type: Observational

This will be a very straightforward study assessing changes of immune/inflammatory peripheral biomarkers before/after delivery with postpartum mood and the psychopathological features of postpartum depression (PPD), and with MRI measures of functional and structural brain integrity. Multimodal assessment of peripheral cytokines, PBMC gene expression, FACS immunophenotyping, and IDO activation, will be validated with (a) clinical data about the presentation of PPD, (b) self- and observer ratings of psychopatology, (c) results coming from neuropsychological assessment of cognitive functions, and (d) multimodal brain imaging outcomes (WM integrity, functional connectivity, GM volumes). It is expected that worsening or stabilization of mood, and the diagnosis of PPD, will be paralleled by worsening or stabilization of these measures, thus providing new markers to estimate the susceptibility to the disorder, to identify targets for treatment, and to predict and monitor treatment efficacy.

NCT ID: NCT05772897 Recruiting - Clinical trials for Postpartum Depression

Parenting Skills Group for Mothers With Postpartum Depression

Start date: August 3, 2023
Phase: N/A
Study type: Interventional

The goal of this longitudinal study is to study the effects of a parenting skills group (Circle of Security Parenting, aka COSP) in mothers with postpartum depression. The main questions it aims to answer are: - Will changes in methylation of the OXTR rs53576 be apparent in mother and/or infant after having gone through the 8-week COSP program? - Will COSP participation be associated with improved symptoms of postpartum depression (over and above standard care), attachment style, and relational characteristics of the mother-infant dyad? - Will COSP participation be associated with changes in social behavior in the infant, and if so, do they persist throughout childhood? Participants will - Participate in an 8-week COSP program delivered remotely via Zoom. - Provide buccal swabs (mother and infant) to assess changes in methylation of OXTR rs53576 pre- versus post-intervention. - Complete a series of assessment questionnaires delivered remotely. - Videotape a play-based assessment in their home. - Receive infant developmental testing Researchers will compare characteristics of waitlist controls to those participating in the COSP program at the mid-way point of the program to see if the two groups differ.

NCT ID: NCT05766475 Recruiting - Clinical trials for Postpartum Depression

In-person vs. Virtual Delivery of a Group-based Prevention of Postpartum Depression

Start date: March 13, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test whether an established preventive intervention (group interpersonal therapy) delivered virtually shows the same benefits for preventing postpartum depression as it does when delivered in person.