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Postpartum Depression clinical trials

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NCT ID: NCT05700760 Not yet recruiting - Clinical trials for Postpartum Depression

The ROSE Scale-up Study: Informing a Decision About ROSE as Universal PPD Prevention

ROSES-II
Start date: June 1, 2023
Phase: Phase 3
Study type: Interventional

The Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program is an evidence-based intervention that prevents half of cases of postpartum depression and was one of two interventions recommended by the US Preventive Services Task Force in 2019. All effectiveness trials of ROSE and of the other recommended PPD prevention intervention included only low-income women a single risk factor that doubles incidence of PPD. Thus, the existing evidence base for PPD prevention consists primarily of women at increased risk for PPD. Based on data from the PIs' current implementation study of ROSE, many healthcare and community agencies in this implementation trial (78%) find it is more feasible for them to provide or offer ROSE to every woman as part of their standard workflow, than it is to create a screening and referral process for at risk women. In addition to being more feasible for agencies, universal prevention may also be advantageous because the cost of a screening false negative (resulting in a preventable case of PPD; $32,000) far exceeds the cost of ROSE delivery ($50-$300/woman). Effectiveness of ROSE among low-income women at risk for PPD is known (ROSE prevents ~50% of PPD cases). To inform a recommendation about using ROSE as universal vs. selective or indicated prevention, we need to determine the effectiveness of ROSE among general populations of women, including women screening negative for PPD risk. Thus, this project will assess ROSE effectiveness across PPD risk levels and across prevention approaches in a sample of 2,320 women from a large regional health system (based in Detroit, MI). Each proposed aim gathers a piece of information missing that is needed to guide decision-making about ROSE as universal prevention. We will assess ROSE as universal, selective, and indicated prevention in terms of: (1) ROSE effectiveness relative to a control for each prevention approach in preventing PPD and improving functioning; (2) cost outcome, (3) equity and (4) scalability of each prevention approach; and (5) mechanisms of ROSE effects across PPD risk levels. We will integrate results to advise about ROSE as universal prevention. This definitive PPD prevention trial will show how best to get an evidence-based program to those who need it in settings where they receive perinatal care by addressing a pragmatic and novel question (should ROSE be universal prevention?) and by examining equity and cost-outcome of universal vs. other prevention approaches.

NCT ID: NCT05698394 Active, not recruiting - Clinical trials for Postpartum Depression

Effect of Low-dose Esketamine on Maternal Depression at 2 Years After Childbirth

Start date: June 19, 2020
Phase: Phase 4
Study type: Interventional

Postpartum depression refers to the depression after childbirth, which is a common mental disorder in women. The pathogenesis of postpartum depression is not fully understood, and may be related to a variety of factors. Prenatal depression is an important risk factor for postpartum depression. Our recent multicenter randomized controlled trial, "Effect of Low-dose esketamine on the incidence of postpartum depression in women with prenatal depression", explored the effect of immediate postpartum intravenous infusion of low-dose esketamine on the incidence of postpartum depression in women with prenatal depression. The preliminary results showed that it reduced the incidence of postpartum depression at 42 days. Since there were no studies on the effect of intravenous esketamine infusion after delivery on long-term postpartum depression, this study is a long-term follow-up of the previous randomized trial. We aim to explore the effect of low-dose intravenous esketamine after delivery on the incidence of 2-year maternal depression after delivery in women with prenatal depressive symptoms.

NCT ID: NCT05693792 Not yet recruiting - Clinical trials for Postpartum Depression

A Six-Month Prospective Follow-Up Study of WB001

Start date: February 1, 2023
Phase:
Study type: Observational

This study is a 6-month follow-up study to WB001-001 conducted to assess and evaluate the durability of the effect of {WB001+TAU} beyond the 8-week treatment period.

NCT ID: NCT05676918 Recruiting - Clinical trials for Postpartum Depression

Maternal Well-being in the Postnatal Stage

BIEMAT
Start date: January 16, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to design and validate an online intervention aimed at promoting well-being in women with postpartum depression. For this, the design of a multicomponent protocol consisting of empirically validated positive interventions and comparing these with a group Cognitive Behavioral Therapy (CBT) is proposed, following the National Institute for Health and Care Excellence (NICE) recommendations for the treatment of depression. Participants will be screened for inclusion in the program if they meet clinical criteria. After that, they will be randomly assigned to a CBT group or a positive psychology intervention group.

NCT ID: NCT05664529 Enrolling by invitation - Clinical trials for Postpartum Depression

Mother-Child Interactions During Feeding

Start date: August 1, 2022
Phase:
Study type: Observational

The feeding process is based on a mutual relationship and interaction, as it takes place with the active participation of the child and the parent. Feeding problems are among the most common behavioral problems in early childhood. Inappropriate eating habits can cause growth retardation, unhealthy food preferences, and obesity. Parent-child interaction during feeding is particularly important in developing healthy feeding behavior. The aim of this study is to evaluate the interaction between mother and child during feeding, by using the Feeding Scale in Turkish children aged 6-36 months. A cross sectional, observational study will be conducted to explore mother-child relationship during feeding period by using Chatoor Feeding Scale.

NCT ID: NCT05622305 Recruiting - Clinical trials for Postpartum Depression

Public Health Nurse-Delivered 1-Day CBT Workshops for PPD

Start date: October 11, 2022
Phase: N/A
Study type: Interventional

Public Health Nurses (PHN) received training to deliver a day-long Cognitive Behavioural Therapy (CBT)-based workshop for treating postpartum depression (PPD). Participants in the study are randomly assigned to the treatment group (1-day CBT workshop) or control group (usual postnatal care). Data will be collected from all participants at baseline, 3 and 6 months. The study will aim to determine if online day-long CBT-based workshops delivered by public health nurses can be added to treatment as usual to improve postpartum depression more than treatment as usual alone, iif the workshops are cost-effective, and if the workshops can stably improve depression, its common comorbidities and reduce adverse effects on the family. Hypotheses: Online 1-Day CBT-Based Workshops delivered by PHNs will be an effective (and cost-effective) way to stably improve PPD, its comorbidities, and reduce its adverse effects on the family.

NCT ID: NCT05585164 Recruiting - Clinical trials for Postpartum Depression

Engage & Connect: A Psychotherapy for Postpartum Depression

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

This study tests a novel psychotherapy, Engage & Connect, tailored to reduce postpartum depression. The study includes 9 weeks of psychotherapy, delivered remotely. It will examine changes in social isolation, processing of social rewards and depression severity over 9 weeks of treatment.

NCT ID: NCT05551195 Recruiting - 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.