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Depression, Postpartum clinical trials

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

The Mom and Infant Outcomes (MOMI) Study

Start date: July 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).

NCT ID: NCT06253676 Not yet recruiting - Clinical trials for Post Partum Depression

Sensing Technologies for Maternal Depression Treatment in Low-Resource Settings

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

In certain low- and middle- income country settings, there is a disproportionate level of untreated postpartum depression that presents both acute and long-term risks to a mother's well-being. Although there is increasing willingness among health systems to involve non-specialists, such as community health workers, in the delivery of psychosocial interventions for postpartum depression, the effectiveness of these interventions has been mixed. The incorporation of digital technology, though, has the potential to improve the effectiveness of non-specialist-delivered interventions. The goal of this clinical trial is to evaluate the acceptability and clinical efficacy of the StandStrong intervention- a non-specialist, passive sensing technology-informed (i.e., digital) mental health intervention- as compared to a standard non-specialist mental health intervention among postpartum-depressed mothers in Nepal. Successful completion of the trial will contribute to the optimization of psychosocial intervention delivery for the postpartum context in low- and middle-income country settings.

NCT ID: NCT06237569 Not yet recruiting - Postoperative Pain Clinical Trials

Dose Low Dose Ketamine in Casesarian

Start date: June 1, 2024
Phase:
Study type: Observational [Patient Registry]

The results of ketamine, ketamine and midazolom and placebo can be copied after birth in cesareans subjected to spinal anesthesia.

NCT ID: NCT06175104 Not yet recruiting - Clinical trials for Neurodevelopmental Disorders

HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis

HeartGPS
Start date: January 2024
Phase: N/A
Study type: Interventional

Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.

NCT ID: NCT06144294 Not yet recruiting - Anxiety Disorders Clinical Trials

Whole-Body Hyperthermia for Mood and Anxiety Disorders

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

This study aims to examine the scientific mechanisms of whole-body hyperthermia (WBH), a novel, rapidly acting, single session antidepressant and anxiolytic therapy. It also aims to determine its feasibility and acceptability in women with postpartum depression (PPD). The study will enroll four cohorts of participants: healthy postpartum controls; postpartum women with PPD; healthy adult controls; and adults with major depressive disorder or anxiety disorders in a longitudinal protocol.

NCT ID: NCT06131255 Not yet recruiting - Clinical trials for Post-partum Depression

DRACULA1 Partum Depression: an Integrated Molecular-pharmaco-imaging Study")

Start date: January 1, 2024
Phase:
Study type: Observational

Post-partum depression (PPD) is a prevalent subtype of major depressive disorder that causes a significant distress to the woman and substantial impact on the whole family. Many studies implicate the glutamatergic system in pathological processes relevant to PPD disorders. There is evidence that cell adhesion molecules (CAMs) play a key role in how glutamatergic circuits wire up during development and how glutamatergic synapses, once formed, operate. However, it is unclear how dysregulation in diverse CAMs alter glutamatergic circuitries responsible for emotional and social behavior. Here, the investigators propose to evaluate the molecular and neurobiological underpinnings of PPD focusing on CAMs at glutamatergic synapses by using an integrated approach from mouse models to human patients. Moreover, the investigators will also perform a pilot study to investigate the impact of selective antidepressants, known to be linked to CAMs, in both human and mice.

NCT ID: NCT06048263 Not yet recruiting - Clinical trials for Postpartum Depression

The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case Series

SMILES
Start date: May 1, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this open label case series is to learn about the feasibility of conducting a future randomised controlled trial to evaluate how well the Perinatal SMILES intervention works in improving post-cesarean mood in low-income women. The main questions it aims to answer are: 1. Is it feasible to recruit a sufficient number of participants? 2. Is it feasible to administer Perinatal SMILES and 3. Is it feasible to collect participant outcomes? To profile EEG in participants at rest and in response to TMS, before and after subcutaneous ketamine Participants will: 1. Complete five sessions of interpersonal therapy 2. Receive two skin injections of ketamine, approximately 24 hours apart, in the first four postpartum day 3. Receive additional therapy sessions before (to prepare for ketamine) and after (interpersonal therapy) each ketamine injection 4. Undergo assessments of brain electrical activity (at rest and evoked by trans-cranial magnetic stimulation) before and at three timepoints in the 10 hours after each ketamine injection 5. Complete mood assessments over the first 12 postpartum weeks

NCT ID: NCT06042166 Not yet recruiting - Clinical trials for Postpartum Depression

A Postpartum Adaptation Study of the Connecting and Reflecting Experience Parenting Program

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

Experiencing postpartum mood and/or anxiety disorders (like postpartum depression; PMADs) can make parenting challenging, but group therapy may help both these parents and their babies. This study will test whether postpartum parents with PMADs find a 12-session parenting group therapy to be likable, doable, and helpful for mental health, parenting stress, and relationship with their infant. The therapy that is being tested is called the Connecting and Reflecting Experience (CARE) parenting program, which has not yet been used specifically with postpartum parents with PMADs, but has been found to be appealing and helpful among parents/caregivers of older children with mental health conditions. CARE focuses on parents' ability to consider how their own and their children's thoughts, feelings, intentions, and other mental states shape behavior and parent-child relationships. Participants in the study will be asked to fill out surveys before, during, and after participating in the group therapy. Adults may be eligible to participate in the study if they gave birth to an infant who is now 3 to 12 months old, are receiving postpartum medical and/or mental health care at Montefiore Medical Center, and have experienced postpartum depression and/or anxiety.

NCT ID: NCT06004232 Not yet recruiting - Clinical trials for Postpartum Depression

Prenatal Yoga to Prevent Postpartum Depression

PRY-D
Start date: July 2024
Phase: N/A
Study type: Interventional

Although psychological interventions exist for the prevention of PPD, a yoga-based intervention to prevent PPD among at-risk women utilizes a similar theoretical foundation (i.e., mindfulness), may be more acceptable to women of minority status, and may confer additional physical activity benefits. The purpose of this pilot study is to determine the effectiveness of using a virtually delivered prenatal yoga intervention for the prevention of PPD among at-risk women in a diverse health care system and explore preliminary factors which influence implementation of the intervention. This study has 2 phases: Phase 1 will evaluate facilitators and barriers to intervention implementation among patient, clinician, and health system stakeholders, followed by an open trial, and Phase 2 will include conducting an 8-session pilot randomized controlled trial to assess the feasibility and acceptability of the proposed prenatal yoga intervention among women with a history of depression, as well as the onset and course of PPD and mediating factors. The specific aims are to: 1) Optimize delivery of a yoga intervention within a healthcare system to prevent PPD through examining facilitators and barriers of implementation, 2) Examine feasibility, acceptability and satisfaction of the intervention within a health care system, and 3) Evaluate preliminary effectiveness of the intervention on PPD and proposed mechanisms. For Phase 1, separate focus groups with patient stakeholders and clinician and administrative stakeholders will inform intervention implementation, and an open trial to refine and optimize the intervention. For Phase 2, women with a history of depression who are 8-28 weeks pregnant will be randomized to the intervention group (n=24) or treatment-as-usual (n=24) and will complete survey measures at baseline, post-intervention, and 1 and 3 months postpartum. It is hypothesized that the intervention will be feasible and acceptable, engage women of racial/ethnic minority status, and contribute to lower rates of PPD onset. Embodiment and mindfulness are the proposed mediators. Knowledge gained from this study can support prevention efforts for PPD and improve the adverse public health impact of this disorder.