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Depression, Postpartum clinical trials

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NCT ID: NCT06253390 Recruiting - Clinical trials for Postnatal Depression

New Cognitive Treatment for Peripartum Depression

MCT-DPP
Start date: January 10, 2024
Phase: N/A
Study type: Interventional

The peripartum period is the period between the last month of pregnancy and up to a year after childbirth. It can be considered a difficult time for women, as it is a period of transition during which vulnerability to psychiatric disorders and in particular to major depressive disorder (MDD) (Vesga-Lopez, Blanco, Olfson, Grant & Hasin, 2008). Depression with peripartum onset (PPD) is characterised by the fact that the onset of symptoms may occur during pregnancy or within four weeks of delivery, but may also persist for up to 12 months after delivery (American Psychiatric Association, 2013). PPD affects 10 to 20% of women who have given birth (Tebeka et al. 2021). In addition, the psychological distress experienced by the mother during the peripartum period can disrupt interactions with her newborn (Lefkovics et al. 2014). Depression during this period can therefore have long-term consequences, not only for the women who suffer it, but also for their children (Gavin et al. 2005). We now know that women with PPD have deficits in metacognition. Metacognition is the body of knowledge, processes and practices that enable individuals to control and evaluate their own cognitive activities, thereby enabling them to regulate them (Flavell, 1976). Patients with PPD therefore have difficulty identifying, controlling and evaluating their own cognitive activities. These deficits may also represent a risk factor for the development of PPD if they are present at an early stage (Diop et al. 2022). In patients with PPD, metacognitive therapies appear to be effective in reducing symptoms. In 2013, Bevan, Wittkowski and Wells conducted a pilot study to test the effects associated with metacognitive therapy in depression. This was the first published study to evaluate the effects of metacognitive therapy on patients with depression in the peripartum period. It shows promising results which it would be interesting to replicate, as this is a pilot study. A metacognitive training program for depression (D-MCT) was developed by Jelinek, Hauschildt, Moritz and Dubreucq in 2016, it is a brief group intervention that is easy to manage to participants. To date, no study has yet tested this specific program in patients with PPD, but it has been able to show its effectiveness in reducing the metacognitive deficits. In the light of the scientific literature, the aims of this study are, firstly, to demonstrate the efficacy of D-MCT therapy in subjects with post-partum depression. Secondly, to examine the effects of this therapy on mother-child interactions. The investigators make the following assumptions: - Women in the experimental group showed a greater reduction in depressive symptoms and an improvement in metacognitive functioning than those in the control group. - Women in the experimental group showed a reduction in depressive symptoms after therapy (v2) and maintenance of this improvement (v3). - Improvement in the quality of mother-child bonding for women who took part in the program compared with those in the control group. - Improvement in the quality of mother-child bonding after the program (v2 and v3) for women in the experimental group compared with when they entered the program.

NCT ID: NCT06250933 Recruiting - Premature Birth Clinical Trials

The Meleis Theory on Postpartum Depression, Breastfeeding, and Maternal Self-Efficacy in Women Experiencing Preterm Birth

Start date: January 10, 2024
Phase: N/A
Study type: Interventional

A randomized controlled study will be conducted to evaluate the impact of nursing intervention based on Meleis' Transition Theory on postpartum depression, maternal self-efficacy, and breastfeeding self-efficacy in women who have experienced preterm birth. The postpartum period represents a transitional and adaptive phase for mothers as they embrace a new role. However, the occurrence of preterm birth and the necessity of neonatal intensive care unit (NICU) care for the newborn can initiate emotional distress in mothers, particularly when facing the admission of their infants to the intensive care setting. Consequently, the transition to new roles for mothers becomes challenging. A healthy transition to the maternal role is crucial for mothers who have experienced preterm birth, positively influencing maternal self-efficacy and breastfeeding practices while reducing the likelihood of postpartum depression. Therefore, the transition to motherhood in women with preterm births is of paramount importance for both the mother and the premature infant, warranting careful consideration and discussion. Women who have experienced preterm birth will constitute the population of the study. During the research period, women who have experienced preterm birth and whose infants are admitted to the neonatal intensive care unit (NICU) will form the population of the study, and the sample will consist of women who consent to participate in the study during the study period. The sample size was estimated using power analysis (G Power 3.1.9.4.) program with a power of (1-β=0.90) and a significance level of (α=0.05), taking into account the mean and standard deviation of a similar study in the literature (Kadiroğlu and Güdücü Tüfekci 2022) (63.53±8.67 for the experimental group; 56.63±9.73 for the control group). The sample size of the study was calculated to be sufficient with a total of 64 women, with 32 women in each group. Considering potential losses during the study process, and in order not to compromise the statistical power of the research, an additional 20% of women were included in the study, resulting in a total of 76 women to be included in the study. Within the scope of the research, data will be obtained through the 'Personal Data Form' containing information about the socio-demographic characteristics of the participating women, as well as the 'Edinburgh Postnatal Depression Scale,' 'Perceived Maternal Self-Efficacy Scale,' and the 'Breastfeeding Self-Efficacy Scale.

NCT ID: NCT06246214 Active, not recruiting - Clinical trials for Depression, Postpartum

From Prevention to Treatment: How Biological Rhythms Can Maintain Perinatal Mental Health

Start date: January 4, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Depression and anxiety are significant public health issues during pregnancy and the postnatal period, particularly affecting those in developing countries. Disruptions in biological rhythms, sleep problems, and low exposure to daylight are associated with a higher risk of these mental health issues. The perinatal period poses unique challenges to the temporal program, with evidence indicating that sleep disturbances significantly increase the risk of postnatal depression. A Randomised Clinical Trial (RCT) is being conducted to assess the effectiveness of Blue Light Therapy (BlueLT) in treating depressive and anxiety symptoms during the postpartum. The RCT will also investigate the alignment of rest-activity and internal body time as mediating factors. This study will focus on various chronobiological factors, including rest-activity rhythms, light exposure levels, temperature rhythms, sleep duration and phase, social jetlag, and BodyTime (assessed through a single blood sample). The goal is to recruit 50 women with postpartum depression, with 25 in the BlueLT intervention group and 25 in the ControlLT placebo group, alongside 100 healthy controls. The BlueLT device uses a short-wavelength LED lamp mainly composed by a wavelength peak on blue spectrum, while the ControlLT device has a dim long-wavelength LED. A Healthy Control group will also be included to account for changes unrelated to depression diagnosis or placebo/treatment effects. Exclusion criteria involve a history of major depressive or anxiety disorder, current psychotic disorder, night shift work, active suicidal thoughts, unstable medical conditions interfering with data collection, and newborns with severe health conditions. The study aims to evaluate the impact of BlueLT on postpartum depression and understand the role of chronobiological factors in the health/disease process.

NCT ID: NCT06242717 Recruiting - Quality of Life Clinical Trials

Postpartum Screening for Anxiety and Comorbid Conditions

PPA
Start date: November 9, 2023
Phase:
Study type: Observational

The goal of this project is to facilitate the design of individualized postpartum anxiety (PPA) screening strategies in British Columbia (BC), Canada. A cohort of postpartum people (n=550) will be invited to complete the following seven questionnaires at 4-8 weeks after delivery: 1. State-Trait Anxiety Inventory 2. Edinburgh Postnatal Depression Scale 3. Multidimensional Scale of Perceived Social Support 4. PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress-Anger, Short Form 5-a 5. Short Form Brief Pain Inventory 6. WHOQOL-BREF for assessing quality of life 7. PROMIS Sleep Disturbance Short Form 8-b and PROMIS Sleep-Related Impairment Short Form 8-a The investigators will evaluate the feasibility of screening for postpartum anxiety and comorbid conditions through a web-based platform in a diverse BC population. They will assess the usability of the platform and questionnaires through 12-15 follow-up interviews with study participants and responses to the System Usability Scale. Their analysis will also identify patient characteristics and comorbidities (e.g., anger, pain, sleep disturbance) associated with a positive screen for postpartum anxiety.

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: NCT06221280 Enrolling by invitation - Postoperative Pain Clinical Trials

Effects of Nerve Blocks on Pain After Caesarean Section and Postpartum Depression

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

At the end of your cesarean section surgery, which is started by applying medication to the spinal cavity from your waist, pain medication will be applied between the relevant muscle and its covering from your lower abdomen or back with the help of ultrasonography and a special block needle. Then, a patient-controlled pain device with a serum containing painkillers will be connected to your vascular access, and its use and purpose will be explained to you. You will be asked about your pain condition and the severity score of your pain, if any, at certain hourly intervals. At the end of 24 hours, a pain device will be removed, your satisfaction will be questioned and your complaints, if any, will be recorded. Immediately before surgery and 4-6 days after your surgery. An evaluation survey consisting of 10 questions will be asked to you within a 5-minute period during the weeks, at a time when you are free, and your answers will be recorded.

NCT ID: NCT06208852 Recruiting - Clinical trials for Post-partum Depression

Virtual Patient Navigation During a Pandemic

Start date: June 29, 2023
Phase: N/A
Study type: Interventional

The sub-study will involve a rigorous mixed-methods design. The qualitative phase of the sub-study will consist of semi-structured interviews. During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services. This information will be used to adapt an evidence-based patient navigation intervention for virtual use and an engagement measure. For the intervention phase of the sub-study, 30 women with persistent postpartum depression symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period.

NCT ID: NCT06207916 Completed - PTSD Clinical Trials

International Survey of Childbirth-Related Trauma - Swedish Part

SwIntersect
Start date: September 1, 2021
Phase:
Study type: Observational

The goal of this cross-sectional observational study is to analyze childbirth-related PTSD, traumatic birth experiences and stress symptoms postpartum. The main questions it aims to answer are: - What is the prevalence of traumatic birth experiences, PTSD and stress symptoms in a Swedish postnatal sample? - What are the risk factors for postnatal mental ill-health? Additional goals are to make cross-cultural translations of the instruments City BiTS and Birth Satisfaction Scale - Revised. Participants will answer an online surveys including several instruments measuring postnatal stress and mental ill-health.

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: NCT06148831 Recruiting - Clinical trials for Postpartum Depression

Carrying for the Culture

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

Suboptimal postpartum health outcomes in the US, including low rates of lactation and high rates of postpartum depression, contribute to high rates of perinatal mortality and morbidity as well as long-term and intergenerational health outcomes. Black birthing parents and infants are at the highest risk, with the lowest rates of lactation and the highest rates of postpartum depression. Yet most interventions to support lactation and postpartum mental health are based on models of care that are unrepresentative of Black and global majority communities. The principal investigator's previous Randomized Controlled Trial (RCT) using soft infant carriers to increase parent-infant physical contact was effective in increasing lactation and decreasing postpartum depression in a sample of Latinx postpartum parents. Infant carrying, or "babywearing," is a culturally relevant prevention strategy based on models of parenting representative of Black and global majority communities. In this study, the investigators use strategies from implementation research and clinical effectiveness research to assess an infant carrier intervention within a community-based, culturally specific perinatal home visiting program for Black birthing parents.