View clinical trials related to Depression, Postpartum.
Filter by:The purpose of this study is to learn more about pregnant women's' experience with Reach Out, Stay Strong, Essentials for mothers of newborns (ROSE) and to evaluate the effectiveness of the ROSE program in preventing and reducing post-partum depressive symptoms, decreasing stress, and increasing social support among pregnant women.
Depression and anxiety that occur around the time of pregnancy can adversely impact a person's health and well-being, and their child's health and development. Fewer than 20% of affected people are adequately treated, often because of under-use of medications. Measurement based care (MBC) is a model of care where psychiatric symptoms are routinely tracked and reviewed together by a patient and their doctor to better manage symptoms. It has not been systematically evaluated for perinatal depression and anxiety. The overall objective of this study is to test the feasibility of MBC in this population to inform a future large randomized controlled trial for definitive evaluation. In order to avoid known barriers to MBC, electronic MBC (eMBC) will be used. With eMBC, patients can enter their symptoms into their electronic medical records before their appointment so that they can be evaluated by their doctor during the appointment. In this pilot study, the feasibility of recruitment for a future efficacy trial, including feasibility of recruitment, and retention, acceptability and adherence to a trial protocol will be evaluated.
The aim of this study is to explore the feasibility of delivering clinical mindfulness groups for families affected with postpartum depression and anxiety (PPDA). Families with PPDA are a vulnerable population who already face challenges during the postpartum period, but now the Covid-19 era has brought extra challenges - lower availability of family members or support systems to help in person, older children at home as childcare facilities are closed, etc. Clinical mindfulness groups are now being run online to support this population, with the current barriers of having to stay at home. Through this study, we want to capture the challenges that both clinicians and participants might face using virtual platforms (e.g. technical difficulties), to see whether online delivery of clinical mindfulness groups is feasible.
Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term. One of the most distressing immediate complications of this severe perineal injury is perineal pain. Women can also experience postpartum depression, dyspareunia, and altered sexual function after OASIS. This is a randomized controlled trial to study the effects of three interventions (placebo, low dose intravenous ketamine plus epidural morphine, or epidural morphine alone) on acute pain after OASIS. The objective of this study is to assess the incidence of perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.
The overall purpose of this application is to evaluate the efficacy of an intervention designed to decrease health disparities in pregnant, emotionally distressed, minority women. This randomized controlled trial will test a six session (spaced over 18 weeks) cognitive behavioral skills building (CBSB) prenatal care intervention (specifically designed and based on prior research for pregnant minority women experiencing emotional distress) at three sites (Jacobi Medical Center, New York City and The Ohio State University Total Health and Wellness Clinic, and The Ohio State University Wexner Medical Center OB/GYN Columbus, Ohio.
The primary aim of this study is to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, and thereby (1) reduce the incidence and/or severity of postpartum maternal depression and (2) improve the quality of the mother-infant interaction and subsequent child development. Specifically, the study team will investigate: (1) the effectiveness of the intervention compared to usual care; (2) if the effects of the intervention can be detected in the assessments of the quality of mother-infant interaction; (3) if there are prenatal and/or postnatal biomarkers that can help identify infants whose behavior is more likely to play a role in their mothers' depression; (4) if these markers differentiate which infants will be most responsive to the intervention(s); and (5), if assessments of brain function at birth and at 4-6 weeks of age provide biological nodal points for identifying the effects of the intervention on infant brain development. Participants will be recruited during their 2nd trimester, and will be randomly separated into one of two groups: a group that receives coaching in parenting techniques (4 in-person coaching sessions and 1 phone session) or one that receives treatment as usual.
Postpartum depression (PPD) is common and can have lasting consequences for mother and child. ROSE is an intervention to prevent PPD, delivered during pregnancy in outpatient prenatal settings. ROSE has been found to significantly reduce cases of PPD in multiple randomized trials in community prenatal settings with racially and ethnically diverse low-income pregnant women. Requests for ROSE training and recent policy changes supporting payment for comprehensive perinatal services to underserved populations suggest a context ripe for embedding ROSE in prenatal clinics long-term. Given the need for return on investment studies about sustainment efforts, we propose a Sequential Multiple Assignment Randomized (SMART) Trial of the effectiveness and cost-effectiveness of a stepwise approach to sustainment of ROSE in 90 outpatient clinics providing prenatal care to pregnant women on public assistance in 6 U.S. states. In Year 1, all clinics will receive enhanced implementation as usual (EIAU; initial training + tools for sustainment). At the first time at which a clinic is determined to be at risk for failure to sustain (i.e., at 3, 6, 9, 12, 15 months), that clinic will be randomized to receive either: (1) no additional implementation support (i.e., EIAU only), or (2) low-intensity coaching and feedback (LICF). If clinics receiving LICF are still found to be at risk at subsequent assessments, they will be randomized to either (1) EIAU + LICF only, or (2) high-intensity coaching and feedback (HICF). Additional study follow-up interviews will occur at 18, 24, and 30 months, but no implementation intervention will occur after 18 months. Outcomes include: 1. Sustainment of core program elements at each time point and total length of time ROSE services were provided and were provided with at least moderate fidelity. 2. Health impact (PPD rates over time at each clinic) and reach. 3. ROI (costs, cost-offsets, and cost-effectiveness) of each sustainment step. Hypothesized mechanisms include sustainment of clinical and organizational capacity to deliver core elements, and engagement/ownership. The study will also examine predictors, tailoring variables, and implementation processes to determine which kinds of clinics need which level of sustainment support and when. To our knowledge, this study will be the first randomized trial evaluating the ROI of a stepped approach to sustainment, a critical unanswered question in implementation science.
Postnatal depression affects about 10-15% of women after childbirth. Approximately 3-5% of women experience a moderate-to-severe depression that requires medical attention. This study aims to investigate the implication of pain relief choice in reducing the postnatal depression of women who deliver their babies.
Postpartum depression (PPD) is a major public health issue. Known as "the thief that steals motherhood" since symptoms obstruct a mother's capacity for understanding and enjoying her baby, PPD affects approximately 1 in 5 moms. Built via "serve and return" interactions (e.g. baby smiles, mom smiles back), sensitive and responsive exchanges are the foundation for healthy child development but are diminished by PPD, resulting in interactions that place children at risk for behavioural and cognitive problems. Infants perceive PPD as stressful; stressors stimulate the brain's hypothalamic pituitary adrenal axis (HPA) and trigger stress hormone (cortisol) release, which, in turn, negatively affects developing infant brains by decreasing brain volume. Infants' critical periods of brain development are vulnerable to long-term effects of cortisol, explaining some of the problematic developmental outcomes observed in children of depressed mothers. How can the investigators support depressed mothers and their infants? Successfully treating PPD does not always benefit mother-child relationships; however, this research builds on a successful pilot that demonstrated that nurse-guided video feedback improved mother-infant interactions in the context of PPD. By improving interaction quality, depressed mothers may be motivated to engage in more play and, in turn, infants who appear interested and ready to interact are more likely to elicit positive, enjoyable experiences from mothers. Building on the pilot, the investigators will trial the effectiveness of VID-KIDS (Video-Feedback Interaction Guidance for Improving Interactions Between Depressed Mothers and their Infants) on maternal-infant interaction and infant cortisol patterns as well as infant development, maternal symptoms of depression and anxiety, and parenting self-efficacy. If successful, future aims are to 1) integrate VID-KIDS into existing services of Calgary Public Health; and 2) commercialize VID-KIDS for dissemination.
Infant mental health is a significant public health issue as early adversity and expose to childhood stress has life-long consequences for the affected children. Helping families at risk correct their adverse effects on the infant has the potential to halt a negative spiral effect where vulnerable parents fail to cope with an at-risk child - which in turn, adds to the child's vulnerability, negatively affects the parents, and so forth. Over a four year period, an estimated 17.600 dyads will be screened in the City of Copenhagen using standardized screening instruments in detecting infant social withdrawal (ADBB) and maternal postnatal depression (EPDS). A sample of 314 eligible parent(s) will enter into a clinical, randomized control trial to test the efficacy of an 8 week group counseling program, Circle of Security Parenting (COS-P) compared to Care as Usual(CAU) in enhancing maternal sensitivity, child attachment and cognitive development. CIMHP is the first large-scale randomized controlled study to test the efficacy of COS-P in promoting parental sensitivity, child attachment and cognitive development in Denmark. Results will provide evidence regarding the efficacy of an American short term indicated parenting group program when implemented in a Scandinavian country.