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Postpartum Depression clinical trials

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NCT ID: NCT04580901 Recruiting - Clinical trials for Postpartum Depression

IPT-G for Mums With Postpartum Depression

OPTIMUM
Start date: December 21, 2020
Phase: N/A
Study type: Interventional

Postpartum depression is a very common and costly illness with numerous, long-term deleterious effects for women, their offspring and families; yet most women are not treated. Group IPT delivered virtually offers women a 1st-line, low-cost intervention that overcomes existing treatment barriers. To test its acceptability and effectiveness, a RCT will be conducted to compare virtually delivered group IPT immediately to usual care in women in Ontario Canada who have postpartum depression.

NCT ID: NCT04487171 Recruiting - Covid19 Clinical Trials

Screening for Postpartum Depression and Associated Risk Factors Among Women Who Deliver in Four Hospital in France During the COVID-19 Epidemic

COVIE-19/20
Start date: July 21, 2020
Phase: N/A
Study type: Interventional

Postpartum depression (PPD) represent around 15% of birth in developed countries. The context of the COVID-19 epidemy represents a possible source of additional emotional distress. The objective of this study is to determine the screening prevalence and risk factors of postpartum depression, among women who deliver in fourth hospital in the North of France in the context of the COVID epidemy.

NCT ID: NCT04442529 Recruiting - Diabetes Clinical Trials

Mothers and Babies Qatar (MB-Q): A Postpartum Depression Intervention

MB
Start date: May 1, 2021
Phase: N/A
Study type: Interventional

Qatar Mothers and Babies is a 4-year collaboration between Northwestern University Feinberg School of Medicine and Sidra Medicine in Doha, Qatar that will generate and evaluate a cultural and contextual adaptation of the Mothers and Babies intervention for pregnant Arabic-speaking women in Qatar. The study will examine the feasibility and acceptability of the adapted intervention as well as its effectiveness in improving mental health outcomes among pregnant women receiving prenatal care at Sidra Medicine in Doha. Additionally, given the high prevalence of diabetes among this study population, the investigators are also interested in seeing if the Mothers and Babies interventions helps improve the management of this disease. Funded by the Qatar National Research Fund's National Priorities Research Program (NPRP), this project has the potential to guide future cultural adaptations of Mothers and Babies as well as other evidence-based interventions, and the delivery of Mothers and Babies to Arab and Arab-American women.

NCT ID: NCT04441879 Recruiting - Clinical trials for Postpartum Depression

bBeAMom: Effectiveness of a Cognitive-Behavioral Blended Intervention for Postpartum Depression

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

Be a mom program (a web-based cognitive-behavioral intervention) is being tested in another clinical trial as a preventive intervention for postpartum depression (NCT03024645). However, given its effectiveness in reducing depressive symptoms among women presenting early-onset postpartum depressive symptoms, Be a Mom can also have potential as a postpartum depression complement treatment tool. The main goal of this research is to apply and evaluate the acceptability and effectiveness of a blended cognitive-behavioral intervention for the treatment of postpartum depression (Be a Mom Coping with Depression) by integrating face-to-face sessions with the web-based program Be a Mom. The RCT will be a two-arm trial. Women who have had a child during the prior 12 months will be enrolled in the study. A minimum number of 110 women will be enrolled in the study. After agreeing to participate in the study, women will be screened and evaluated for the presence of clinically significant depressive symptoms (according to DSM-5) by a researcher (licensed psychologist). Participants who meet the eligibility criteria will be randomly assigned to one of the conditions: the blended intervention (Be a Mom Coping with Depression) or the control condition (online intervention - Be a Mom). The sample will be recruited online. Participation in this study will last 6 months. The blended intervention will last about 3 months. Participants in both conditions will be invited by the researchers via email to complete baseline, post-intervention and follow-up (3-months post-intervention) assessments. Assessments will include self-report questionnaires to assess several indicators (e.g., depressive and anxiety symptoms, quality of life, marital satisfaction, mother-child bonding, and maternal self-efficacy), mechanisms that may be involved in the treatment response (e.g., psychological flexibility, emotional regulation, and self-compassion) and user's acceptability and satisfaction.

NCT ID: NCT04364646 Recruiting - Depression Clinical Trials

Personalized Integrated Chronotherapy for Perinatal Depression

Start date: November 2, 2020
Phase: N/A
Study type: Interventional

Perinatal depression and anxiety are common, serious, and frequently overlapping disorders that increase morbidity and mortality in new mothers (including suicide) and result in poor infant/child outcomes. Current therapies often fail to produce recovery or are poorly tolerated, and many pregnant women seek non-pharmacologic therapy or forgo treatment when non-pharmacologic options are not available. Expectant and new mothers who experience circadian rhythm dysregulation are at increased risk for perinatal depression. This Confirmatory Efficacy Clinical Trial of Non-Pharmacological Interventions for Mental Disorders R01 seeks to test whether a Personalized Integrated Chronotherapy (PIC) intervention can improve treatment outcomes for pregnant patients seeking outpatient treatment for depression, with or without anxiety. PIC is a multicomponent treatment consisting of bright light therapy, sleep phase advance, and sleep stabilization/restriction that targets the Research Domain Criteria (RDoC) constructs of circadian rhythms and sleep-wake behavior. To increase sample size and diversity and accelerate recruitment, this study will be performed at 4 sites that differ in clinical structure and that have piloted the PIC intervention. The study will enroll expectant mothers diagnosed with major depressive disorder during 3rd trimester of pregnancy. Participants will be randomized to either: (a) usual care (UC, n = 110) or (b) PIC+UC (n = 110). PIC+UC will have pregnancy and postpartum components and will be administered via a personalized approach tailored to optimize the intervention based on each patient's individual circadian and sleep timing. After a baseline assessment, PIC will be prescribed during 5 dedicated clinical visits: three during 3rd trimester of pregnancy and 2 in the postpartum period. UC will consist of medication and/or psychotherapy. UC will be quantified in both groups to evaluate differences between the PIC+UC and UC groups. Mood will be measured in both groups by blinded clinician interview and patient self-report. The safety profile of the PIC intervention will be assessed by evaluation of side effects/adverse events. Importantly, the study will also examine the target mechanisms by which PIC is hypothesized to work and test the mediation effects of the circadian targets on improvement in mood symptoms. Participants will wear wrist actigraphy/light monitors continuously during weeks 28-40 of pregnancy and postpartum weeks 2-6 to assess light exposure and to estimate sleep timing and duration. Circadian phase (measured with salivary dim light melatonin onset) will be measured at baseline during pregnancy (~30 weeks' gestation), at 36 weeks' gestation, and at postpartum week 6. Exploratory aims will examine associations between infant sleep behavior and maternal circadian rhythms and factors relevant to future dissemination of PIC. If this intervention is effective, perinatal PIC could change clinical practice and have major public health impact due to the high prevalence of perinatal depression and anxiety, the negative effects of mood disorders on mothers and their children, and the need to provide effective, novel, non-pharmacologic therapies for women with perinatal mood disorders.

NCT ID: NCT04278456 Recruiting - Clinical trials for Postpartum Depression

Postpartum Depression

Start date: March 21, 2020
Phase:
Study type: Observational [Patient Registry]

Our aim was to diagnose and initiate early treatment for postpartum depression by detecting the changes of melatonin levels in c-sections with different antesthesia modalities.

NCT ID: NCT04138368 Recruiting - Clinical trials for Postpartum Depression

The Effect of Early Dyadic Psychotherapy for Mothers Suffering From PPD on Oxytocin Level and on Childrens' Emotional Development

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Background: Postpartum depression follows approximately 10-15% of deliveries. Maternal functional disability, particularly in the relationship with the infant, a hallmark of PPD, causes impairment in the mother's ability to bond with her infant. Subsequently, this impairment leads to deleterious long-term consequences for infant cognitive, neurological, and social-emotional growth, and is associated with psychiatric disorders in later life. Therefore, the development of effective short-term treatment in such a highly prevalent phenomenon is of a high clinical priority. While pharmacological and psychological treatments are effective in treating PPD , these interventions have failed to show a significant improvement in mother-child interaction quality and infant development. The Oxytocin System: Oxytocin (OXT) is a nine amino acid neuro-peptide, found exclusively in mammals and is released during labor and lactation. Among the central influences of OXT on human social behavior are increased trust, empathy and eye contact. Brain imaging found that maternal attachment activates regions in the brain's reward systems that are rich with oxytocin and vasopressin receptors . Such findings led researchers to speculate that OXT may be involved in linking and maintaining the connection between social recognition systems and feelings of pleasure . According to this speculation, pair bonding is a form of conditioned reward learning, whereby OXT promotes the reward in social encounters, thus enhancing the motivation to engage in such interaction . Disruptions to the oxytocin system in depression have been repeatedly observed, and woman suffering from PPD have lower plasma OXT concentrations in comparison to the control group . A recent small treatment study of OXT in women suffering from PPD did not show a positive effect on mood; however, it did show improved mother-child interactions. Studies suggest a bio-behavioral feedback loop of OXT, parenting, and infant social competence. Rationale and Hypotheses of the Current Research: We speculate that mothers suffering from PPD exhibit high levels of depression and low levels of OXT, hence experiencing the interaction with their child as less rewarding, which in turn promote further depressive symptoms and interfere with child development. The aims of this study are: 1. To assess the relationship between levels of oxytocin in mothers suffering from postpartum depression and their babies, before and after psychological dyadic treatment compered to supportive treatment. 2. To study the added value of dyadic treatment over conventional supportive treatment for PPD that does not focus specifically on the mother's relationship with her baby. 3. To show the effects of dyadic treatment for PPD mothers and their children on the child's emotional and behavioral development. Methods: Subjects: 50 Mothers will be interviewed and diagnosed as suffering from PPD according to DSM-IV-TR, will be enrolled within 2-8 months postpartum.

NCT ID: NCT04068662 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Intervention for IPV-exposed Pregnant Women

Start date: July 10, 2019
Phase: N/A
Study type: Interventional

The overarching goal of the proposed project is to evaluate a randomized clinical trial of the Pregnant Moms' Empowerment Program aimed at detecting its effects on maternal mental health, re-victimization, parenting sensitivity, and infant development. The project also seeks to examine theoretically-grounded mechanisms of change, including social support and empowerment. Women participating in the study will receive either the PMEP or participate in a contact-equivalent active control group during pregnancy, and will be interviewed at baseline, post-intervention and with their infants at 3 months and 1 year old. The study will occur at two sites - the University of Notre Dame and the University of Memphis. Participants will be recruited from the local community at both locations, with an equal number of women drawn from each site - Memphis, Tennessee (n=115) and South Bend, Indiana (n=115). Enrollment will continue for approximately 2.5 years, with an expected rate of 8 eligible women per month, based on a pilot study of the Pregnant Moms' Empowerment Program. The expected duration of the study for each participant will be approximately 1.5 years, with some variation due to women enrolling at different points in their pregnancy. The primary objective of the proposed project is to determine if the Pregnant Moms' Empowerment Program has positive effects on maternal mental health, re-victimization rates, parenting sensitivity, and infant development compared to women's participation in a contact-equivalent active control group. This objective will be evaluated using a multi-site randomized clinical trial design. Participants (N = 230) will be equally randomized into study arms. Eligible women will include those who are: 1) currently pregnant (primi or multiparous) and between 10 and 30 weeks gestation, 2) experienced IPV within the past year, 3) English speaking and 4) age 16 or older. The study will include 9 total visits: 4 assessments and 5 sessions for both study arms. In-person assessment visits will be completed by a trained research assistant; each visit will take approximately 2-3 hours, with post-partum assessments somewhat longer than prenatal assessments given the addition of the infant developmental assessment and parent-child observation task. Women will be compensated $30 for the first two assessments and $50 for the second two assessments. Following the final assessment, women will be invited to complete a daily diary (virtually) each day for 30 days. Each survey will take approximately 5-10 minutes to complete, and women will be compensated $2 for each completed survey. Women will also receive a $10 bonus for each set of 10 consecutive surveys. Treatment sessions will be 2 hours in duration. Women in the PMEP will complete a structured set of sessions: (1) supporting each other, support in the community, (2) identifying and understanding sources of distress, (3) cognitive and behavioral strategies to build resilience and resolve conflict, (4) perinatal health and infant care, and (5) positive parenting. Women in the active control condition will participate in facilitated discussions on a topic identified by the group. All sessions will be audio recorded so that treatment fidelity can be evaluated (for the Pregnant Moms' Empowerment Program) and so that content overlap can be assessed (for the active control condition).

NCT ID: NCT03965572 Recruiting - Clinical trials for Postpartum Depression

Factors and Outcomes Associated With Postpartum Cabergoline Use

Start date: June 7, 2019
Phase:
Study type: Observational

Cabergoline is frequently being requested by many postpartum women with a live newborn to suppress lactation. The aim of the study is to investigate which women desire such an intervention, and what side effects they are experiencing.

NCT ID: NCT03763435 Recruiting - Sleep Disorder Clinical Trials

The Effects of Pregnancy Classes and Contributing Factors to Postpartum Depression

Start date: December 7, 2018
Phase:
Study type: Observational

It is recommended by the American College of Obstetricians and Gynecologists' Committee on Obstetric Practice that all obstetricians screen each women for postpartum depression and anxiety with a validated instrument. Although much effort is made, the contributing factors still lack in the literature due to its multi-factorial nature and complexity. In addition, the effects of prenatal education classes remain understudied. Therefore, this study aims to demonstrate the prevalence, characteristics and contributing factors of the postpartum depression. In addition, the change in prevalence and characteristics of the postpartum depression among women who had prenatal classes and not will also be assessed.