View clinical trials related to Perinatal Depression.
Filter by: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.
The SMART app is a mobile application based psychosocial parenting intervention containing educational materials (articles, videos, audios, podcasts) on parenting, an integrated peer support chat function with experienced mothers and an integrated forum for interaction with other mother participants. The goal of this interventional study is to test the effectiveness of a mobile-app health based intervention, SMART, mothers in the perinatal period. The main questions this study aims to answer are: 1. What is the effect of a mobile-based health intervention, SMART, on maternal outcomes? 2. What is the effect of a mobile-based health intervention, SMART, on infant outcomes? 3. What is the cost-effectiveness of using SMART as compared to standard routine care? Researchers will compare results with a control group that will undergo standard routine care.
The goal of this observational study is to explore the impact of pregnancy depression on infant feeding, and to explore the two-way relationship between postpartum depression and infant feeding. Participants will be asked to finish questionnaires four times (24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum).
The goal of this clinical trial is to develop a hybrid E-zine health education intervention integrated within a mental Health package for adolescent perinatal depression. The main objective is to: - Develop a hybrid Health Educational Intervention offering health promotion and disease prevention services on climate change to perinatal adolescents and their caregivers. - Study the feasibility, acceptability, and usability of E-zineMH in a pilot trial among perinatal adolescents and their caregivers in comparison to a control arm that delivers face-to-face health education in routine antenatal clinics. Participants will be expected to attend routine antenatal appointments for the duration of the study. In addition to the face-to-face health education delivered to both groups, the intervention group will be exposed to e-magazines on climate change.
Perinatal depression and anxiety (PDA) are the leading causes of maternal mortality in developed countries. Women with a history of depression have a 20 fold higher risk of PDA at subsequent pregnancies. The adverse outcomes extend beyond maternal well-being to long-term deficits in children and families. The gut-brain axis is a newly recognized key player in mental health disorders. Specifically, the microbial composition of the gut along with their metabolites are directly involved in disease onset and course. Recent clinical studies have identified diet as the most powerful environmental factor in manipulating gut microbiome. Given vulnerability and resistance of pregnant women to pharmacotherapy, particularly in those with a predisposition to mood disorders, as well as pregnant women's high motivation and commitment to improving gestational diet, a dietary/supplemental intervention to 'optimize' gut microbiome, is a favored approach in disease management. The study investigators aim to exploit microbial responsiveness to diet together with this maternal motivation, to alter the risk and severity of a universal public health concern that has dire and long-term consequences for new moms and their children. The investigators of this trial, will first study the challenges in pursuing a study aimed at changing the microbiome of pregnant women with a history of mood disorders. Pregnant women in their second trimester will be recruited. Each will be assigned or randomized to one of four groups that will use a combination of diet, supplementation with probiotics, fish oil or no intervention. Each participant will meet with the study team virtually every 3 months until 1 year after delivery. At each study visit participants will be required to complete some questionnaires about their food intake, mood, and other health related measures and will provide a stool sample using the stool collection kits provided. The findings from this study will help strategize for a larger study that will allow for comparison of the effects of diet, and/or supplementation with Omega-3 Fatty Acids (O3FA) and probiotics on the microbiome and the onset and severity of PDA.
This hybrid effectiveness-implementation project will allow the team to evaluate and refine implementation in preparation for future multisite trials to ultimately move the Evidence-Based Intervention (EBI) to scale among diverse populations. The plan is to enroll 120 at-risk pregnant and postpartum women from rural, urban, and Latino populations. Using a randomized preference design to also evaluate patient and sociocultural factors in participation and symptom trajectory. Using the Implementation Research Logic Model, the team will evaluate the implementation feasibility and acceptability of a remote-access and on-demand MBCT PD prevention intervention that is integrated within maternal clinical care settings using an existing patient portal. Successful achievement of the study aims will result in a refined implementation protocol for future studies that are sufficiently powered to evaluate the effectiveness of an integrated Digital Mental Health Technology and to estimate the cost/benefit ratio
The hypotheses of the study are - There will be differences in perceived distress, dyadic coping strategies, social support, quality of life, and well-being in couples at Pre- and Post-Test Levels during the perinatal period in couples. - There will be differences in psychopharmacology on total scores of perceived distress, dyadic coping strategies, social support, quality of life, and well-being between the experimental and wait list-placebo control groups. - There will be differences in CBCT (condition: without Zikr) on total scores of perceived distress, dyadic coping strategies, social support, quality of life, and well-being between the experimental and wait list control group. - There will be differences in CBCT (condition: with Zikr) on total scores of perceived distress, dyadic coping strategies, social support, quality of life, and well-being between the experimental and wait list-placebo control groups. - There will be differences for combined psychopharmacology, and CBT (conditions: with Zikr, without Zikr ) dimensions on total scores of perceived distress, dyadic coping strategies, social support, quality of life, and well-being between experimental and wait list-placebo control group.
Center M is a digital health solution to Perinatal Depression (PD) which provides an alternative to Mindfulness Based Cognitive Therapy - Perinatal Depression (MBCT-PD). Center M shifts treatment to a telehealth model, reduces the number of sessions, and transitions home practice materials to a digital format. This study will include a clinical trial in which participants will be randomized to the Center M treatment with smartphone app delivery of homework compared to treatment as usual (TAU).
The study aims at identifying: 1. specific biological and molecular alterations associated with development of depression in pregnancy or risk of it. 2. specific biological and molecular alterations due to exposure to maternal depression in utero that are still present in the offspring, that could possibly mediate the development of negative outcomes, and which are the possible clinical moderators of the associated risk; 3. whether antidepressant therapies prescribed by personal physician and the use of digital tools can have a preventive effect in the transmission of the risk from mothers to babies and in the development of depressive symptoms in high-risk pregnant women; In order to achieve these, 80 pregnant women with depression, 80 at high-risk and 80 controls will be recruited and clinically monitored over pregnancy and postpartum along with their babies, specifically at these timepoints: 25th and 32nd weeks of gestation, 1 week postpartum, 4 weeks postpartum, 8 weeks postpartum, 12 months postpartum. Women, based on their clinician choice, will receive antidepressants and will be provided with a smartphone app to monitor them, using a combination of personalised, daily self-reported assessments and sensors for passive data collection to cover mental and physical health. Blood and saliva samples from pregnant women will be collected at the 25th and 32nd week of gestation to perform biological analyses. Saliva samples from babies will be collected at 8 weeks and 12 months postpartum to perform biological analyses. Clinical and psychological data will be collected from women at all timepoints.
This study aims to assess the feasibility and acceptability of the Maya Perinatal Cognitive Behavioral Skills App, a novel app for pregnant and postpartum individuals experiencing difficulties with mood, anxiety, or stress. Participants will complete the 12-module app to learn evidence-based strategies previously shown to help manage mood and anxiety. Assessments will include app feedback questionnaires, feedback interviews, a daily symptom tracker, and symptom measures. The study investigators hypothesizes that participants will find content to be helpful in developing skills to manage anxiety and mood difficulties during the perinatal period, and that the app interface, session structure, and pacing will be acceptable and feasible for this population. It is further hypothesized that increased Maya Perinatal Cognitive Behavioral Skills App use, engagement, and satisfaction will be associated with lower self-reported anxiety and mood symptoms.