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Depression, Postpartum clinical trials

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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: NCT06365645 Not yet recruiting - Stress Clinical Trials

Feasibility & Acceptability of App-based Cognitive Behavioral Therapy for Postpartum Depression Prevention

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

Postpartum depression (PPD) affects up 10-15% of mothers overall, but the rate of PPD can be as high as 25% among mothers with personal or obstetric risk factors. The Mothers & Babies Program (MB) is a cognitive behavioral therapy (CBT)-based program that has been shown to prevent PPD among high-risk mothers without a prior history of depression. MB has been so consistently effective that the United States Preventive Services Task Force recommends this program be given to high-risk pregnant patients. Originally designed to be given in-person and via groups, MB has been adapted to be given in person one-on-one in clinic or at home and via text message. However, MB has yet to be adapted to a smartphone application (app). Via evidence-based qualitative research and end-user centered design, MB has been adapted to a novel app, M.Bapp. This study aims to examine the feasibility and acceptability of M.Bapp as a study intervention for perinatal patients as well as provide preliminary estimates of effect for the intervention.

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: NCT06342310 Not yet recruiting - Clinical trials for Postpartum Depression

RE104 Safety and Efficacy Study in Postpartum Depression

Start date: May 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms in participants with moderate-to-severe postpartum depression (PPD) as compared to active-placebo.

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: NCT06310720 Not yet recruiting - Clinical trials for Postpartum Depression

Postpartum Video Education in High Risk Populations

Start date: March 2024
Phase: N/A
Study type: Interventional

This is a prospective, single-center, randomized control study to determine if video education at the time of postpartum discharge improves patient knowledge on the warning signs for the top three causes of severe maternal morbidity (infection, hemorrhage, and blood pressure disorders) in the first seven days following delivery for self-identified, Black, Latinx, other with two or more self-identified races, Medicaid, and/or uninsured postpartum individuals. Participants will be randomized to written discharge education + video education (intervention) vs standard discharge education (control). They will complete a baseline questionnaire and a post-discharge education questionnaire during their postpartum stay to assess for knowledge improvement. The investigators hypothesize that video education will improve patient's knowledge of severe maternal morbidity warning signs.

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.

NCT ID: NCT06277661 Not yet recruiting - Clinical trials for Postpartum Depression

The Mom and Infant Outcomes (MOMI) Study

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

The investigator's long-term goal is to mitigate pregnancy-related mortality (PRM) risk by systematically delivering integrated clinical and supportive care that is effective, equitable, and scalable. The investigator's central hypothesis is that the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS) will mitigate postpartum (PP) risk and reduce disparities in PP risk by improving biopsychosocial profiles and facilitating access to evidence-based clinical and supportive care. 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 384 mother-infant dyads (192/group) following pregnancy affected by a cardiometabolic and/or mental health condition. The investigators will enroll participants on PP day 1 and collect data at baseline and 6 months and 1 year PP. The investigators will collect implementation and service data across sites.

NCT ID: NCT06273423 Not yet recruiting - Clinical trials for Postpartum Depression

Feasibility Evaluation of a Dance Fitness Program

Start date: October 2024
Phase: N/A
Study type: Interventional

The objective of this pilot project is to assess the feasibility, acceptability, and mental health impact of OULA for women with postpartum depression (PPD).