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Depression, Postpartum clinical trials

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NCT ID: NCT05552053 Recruiting - Depression Clinical Trials

Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women

RISE
Start date: June 1, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Perinatal Mood and Anxiety Disorders (PMADs) encompass a range of mental health disorders that occur during pregnancy and up to one year postpartum. Approximately 13% of women experience PMADs. This rate doubles for those with adverse perinatal outcomes (APO) and triples in Black women. Recent research points to racism as one significant source of these health disparities. Cultural adaptations to improve communication with providers decrease rates of depression in minority patients as well as improve adherence to treatment, insight and alliance. Discrimination stress and worries about experiencing medical consequences are thought to increase systemic inflammation, a mechanism known to drive mental and physical symptoms. Inflammation has been implicated in both PMADs and APO, suggesting a shared underlying etiology. Evidence from our work suggests that inflammation contributes to the pathophysiology of PMADs. The proposed pilot randomized control trial will allow the investigators to build on promising preliminary results and identify whether our culturally relevant mobile Health (mHealth) intervention is effective in improving outcomes among Black pregnant women randomized to the intervention compared to a control group. The culturally relevant modules include building communication and self-advocacy skills and provide a support network. The primary objective of this research is to provide guidance for clinical care of Black women during the perinatal period, with the goal to improve mental health and physical health outcomes. A secondary goal is to examine novel inflammatory signatures that change as a function of the intervention to reduce PMADs in this population. As inflammation may be diagnostic of PMADs, identification of its role may shed light of potential intervention targets and provide critical knowledge to improve women's long-term health. PMAD symptoms will be assessed prospectively in 150 Black pregnant women, half of whom will be randomized to receive the culturally relevant mHealth intervention. The investigators hypothesize that women in the intervention group will have reduced rates of PMADs and APOs, an increase in adherence to mental health treatment and will report increased self-advocacy skills, increased communication with providers, and reduced levels of discrimination related stress. Participants will also have improved biological risk indicators including lower circulating C-reactive protein and a transcription profile of differentially expressed inflammatory genes, marked by a decreased activity of inflammatory transcription factors from blood spots. Given the high burden of both PMADs and APOs among Black mothers and the numerous consequences on maternal and child outcomes, it is imperative that investigators develop and implement effective interventions, and test the biological mechanisms that might drive these effects. This work is interdisciplinary, building on a network of community advocates to implement a novel mHealth intervention informed by real world experiences designed to enhance self-advocacy, reduce stress and prevent adverse outcomes

NCT ID: NCT05551195 Terminated - Clinical trials for Postpartum Depression

[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]

Start date: November 16, 2022
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.

NCT ID: NCT05543746 Recruiting - Clinical trials for Postpartum Depression

Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression

BRX-PPD
Start date: August 5, 2022
Phase:
Study type: Observational

This is a feasibility study of performing repeated EEG recordings and assessment of affective states during open-label administration of BRX to women with postpartum depression. Study phases will include screening, enrollment, intervention, and follow-up. Subjects will be screened for study eligibility criteria through clinical assessments and self-report. Enrolled subjects will be admitted to the UNC Women's Hospital, where five serial EEG recordings will be obtained, along with frequent assessments of affective state, before, during, and after a 60-hour IV infusion of BRX. Follow-up procedures will include assessments of PPD and affective symptoms, as well as an exit interview with the study team. If feasibility outcomes are achieved, exploratory EEG analyses will be performed with AMICA (adaptive mixture independent component analysis), community detection, and microstate assessment. Exploratory analyses of data collected by facial expression detection software (iMotions Affectiva) are also planned.

NCT ID: NCT05520580 Completed - Post Operative Pain Clinical Trials

Effect of Mother's Push at Cesarean Delivery Mother's PUSHING AT CS A RANDOMIZED CONTROLLED TRIAL

Start date: May 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of the mother's active pushing during cesarean delivery.

NCT ID: NCT05518162 Recruiting - Clinical trials for Post-partum Depression

Treatment of Post-partum Depression Using an Behavioral Intervention Called ROSE (Reach Out, Stay Strong, Essentials for Mothers of Newborns) Delivered Using an Electronic App

Start date: July 17, 2023
Phase: N/A
Study type: Interventional

A randomized trial of pregnant people at risk for postpartum depression comparing the InBloom app (n = 76) to ROSE (n = 76; weekly scheduled group), and two control groups. We will assess Depression at baseline and 1, 2 and 3 months, ROI at 3 months, Satisfaction at 1 and 3 months and Perceived Access at 1 and 3 months. Subject participation will last up to 8 months (minimum 17 weeks pregnant through 3 months postpartum).

NCT ID: NCT05484999 Active, not recruiting - Clinical trials for Postpartum Depression

The Maternal Well-Being Study

MWB
Start date: May 16, 2022
Phase: N/A
Study type: Interventional

This project aims to understand the local feasibility and acceptability of MamaMeals (a home-delivered nutritious, postpartum meal delivery program) and MamaMatters (a moderated social media-based peer support group) among peripartum women who are eligible for federal supplemental nutrition assistance programs such as The Special Supplemental Nutrition Program for Women, Infants and Children (WIC) or Supplemental Nutrition Assistance Program (SNAP). The investigators will conduct a prospective randomized controlled trial (RCT) of these two interventions among postpartum individuals. Analyses will be performed to determine the relative risk of postpartum depressive or anxiety symptoms (primary outcome) and overall well-being and maternal/infant health (secondary/exploratory outcomes) between groups. Findings from this pilot intervention study will inform a future, large RCT exploring the effectiveness of MamaMeals and/or MamaMatters on reducing postpartum mental health symptoms and cardiovascular morbidity among individuals with food insecurity during and after pregnancy.

NCT ID: NCT05444179 Not yet recruiting - Clinical trials for Postpartum Depression

Nutrition and Physical Activity Intervention on Psychosocial Well-Being of Postpartum Mothers

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

This study aims to examine the effectiveness of nutrition and physical intervention to improve psychosocial well-being of postpartum mothers with preterm infants. The focus was highlighted towards the mothers of preterm infants who were cared in Neonatal Intensive Care Unit (NICU) as these parents might have a higher stress level than the full-term infants. The intervention consisted of a module designed for postpartum mothers, incorporating nutrition and physical activity entitled Mommies can Eat & Exercise with No Stress (MomEENS).

NCT ID: NCT05423093 Recruiting - Clinical trials for Postpartum Depression

Virtual Group Psychoeducational Discussions With Spanish-Speaking Mothers of Infants in Pediatric Primary Care

Start date: June 9, 2022
Phase: N/A
Study type: Interventional

The goal of the proposed research is to test the feasibility and acceptability of a virtual group session which is intended to be offered universally to Spanish-speaking parents of newborns/infants attending pediatric primary care. The virtual session is intended to (1) enhance patient/family education about postpartum depression (PPD) and (2) Provide an orientation to families regarding relevant clinic and community psychosocial support resources available. The investigators will conduct a single-arm, open pilot of the session, which will be co-delivered by existing clinic staff (including social work and community outreach staff). Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs. The overall aim of the project is to Develop and pilot a virtual group augmentation of standard individual well-child care to improve (1) clinic screening procedures, discussion about and initial management of maternal depressive symptoms with immigrant Latinas and (2) patient symptom recognition, symptom disclosure, and subsequent treatment engagement

NCT ID: NCT05400382 Not yet recruiting - Pain, Postoperative Clinical Trials

Mindfulness to Reduce Post-cesarean Pain and Prevent Postpartum Depression

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

This study will test the effect of a mobile mindfulness-based intervention on reducing post-cesarean delivery pain and preventing postpartum depression.

NCT ID: NCT05400161 Recruiting - Child Development Clinical Trials

Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms: Impact on Child Development

Start date: November 18, 2022
Phase: N/A
Study type: Interventional

The long-term goal is to develop effective parenting strategies to facilitate optimal child development for mothers suffering with PPD symptoms. The overall objective for this application is to study whether this program combined with online depression treatment leads to more responsive parenting (target) and signals improved child language, socioemotional and cognitive development (outcomes) compared to depression treatment alone. Findings from this application can be used to inform a future study to test the effectiveness and implementation of this social media-based parenting program.