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Depression, Postpartum clinical trials

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NCT ID: NCT03351465 Withdrawn - Depression Clinical Trials

CALM for Pregnant and Post-Partum Women

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

Anxiety and depression is common along pregnant mothers and has been found to increase risk for negative outcomes in both mothers and infants. These risks can include low infant birth weight, negative mother-infant interactions, and delayed developmental outcomes. Evidenced-based interventions to support pregnant women experiencing symptoms of depression or anxiety are not well studied or widely available, particularly for low-income women of color. These women may not have access to the type of healthcare that would best support their needs and/or they may not be familiar with or trust clinicians who deliver mental health interventions. The current randomized-controlled trial (RCT) aims to address these gaps in the literature by testing the feasibility and efficacy of a doula-supported, computer-assisted delivery of a cognitive behavioral therapy (CBT) intervention designed to reduce pregnancy-related anxiety, depression, and prevent perinatal mood disorders. The 120 participants in the study (60 Black women and 60 Hispanic/Latina women) will be randomized to either receive the Coordinated Anxiety Learning and Management (CALM) intervention (n=60) or treatment as usual (n=60). Participants assigned to the intervention will complete 6-8 sessions of CALM with a language and ethnically/racially-matched doula who has been trained as a CALM specialist in order to increase participant comfort and reduce the stigma associated with mental health services. Women in both groups will complete assessments of their pregnancy-related anxiety, general anxiety, depressive symptoms, and satisfaction with treatment (CALM or treatment as usual) at baseline, 12-weeks post-baseline, and 10-weeks post-birth. It is hypothesized that women assigned to the CALM intervention will have significantly less anxiety and depressive symptoms post-treatment and post-partum compared to the women assigned to treatment as usual. The results of the current RCT will be used to test the efficacy of the CALM intervention for pregnant women or color and to inform efforts for potential future scalability.

NCT ID: NCT03346551 Recruiting - Clinical trials for Postnatal Depression

Postnatal Depression, Attachment and Self-defining Memories

PNDattachMEMO
Start date: October 13, 2017
Phase: N/A
Study type: Interventional

The specificity of postnatal depression (PND) was acted as full entity within the depressions, by B. Pitt in 1968, through the description of a specific nosography which describes "an atypical depression of the post-partum ". Actually, the epidemiological studies agree on prevalence from 10 to 15 % of PND. With two peaks of frequency, the first one around the 6th and 12th week comment native and the second during the second half-year. This rate of PND represents in France 75000 to 100000 women a year. The professionals of the perinatal period are interested in this disorder because of the consequences for the woman herself, and of the impact on the premature interactions mother-baby. These interactions and the direct effects of the PND on the mother will have for influence an important slowing down on the development of the baby. Moreover, the study of Lemaitre and Candilis in 1999, brings the figure of 15 % of the PND which will have an impact on the development of the baby. The sensation of the depression testifies of a process of change and of psychic conflict favored by the psychic transparency of the pregnancy. Although the first treaty on this specific nosography dates more than 150 years of numerous questions stay suspends it. These questions and the reflections which surround them found on their path tools ensuing from the theory of the attachment, formalized by John Bowlby. For more than three decades, these profiles of attachment, specified by Mary Ainsworth: secure, anxious-ambivalent, anxious-avoided and disorganized later, disrupted, is studied, estimated and their evolution during a life is observed. Thanks to these models well known for the same person at a time t, it is now their effects in the interpersonal relations which are studied. Between the people but also on the person himself, its image of her, and its autobiographical memory. The autobiographical memory represents a central component of the human memory. At a very general level, it's possible to define it as the capacity of a person to remember its past experiences. The review of the literature on the functioning of the episodic autobiographical memory during the depression highlights three main results: the too bi generalization of the memories, the congruence in the humor and the frequency of the intrusive memories characterized by an involuntary reminder, fast and effortlessly (Lemogne and al., 2006; Lemogne and al., 2012). The authors specify that there are links between strategies of avoidance of the intrusive memories and the phenomenon of generalization. These links ask to be explored within a model integrating, self and episodic autobiographical memory in the field of the depression. The use of the memories defining the one could allow to study more specifically this kind of memories. The memories defining the one were introduced to Ape and Moffitt (1991) to characterize a specific category of autobiographical memories. The memories defining the one are important personal memories which help a person to understand whom this person is as individual. In a way, they build the life story and support the personal identity. Connected to other similar memories, the self-defining memories contain numerous sensory details and are often associated to a strong emotional charge. They are also connected to long-term purposes, to concerns or to unsolved conflicts. Recent studies used the self-defining memories (French version adapted by Mr van der Linden's team, Switzerland) as tool to understand better the psychological disorders from which certain people suffer. The studies show that the self-defining memories undergo modifications the characteristics of which are in connection with every pathology (works of the team of J.M. Danion). In 1994, Moffit and al. studied a group of students with evaluation of the depressive symptomatology. They established that the presenting subjects of high scores of depression develop more generalized memories than the other participants when is asked to them a self-defining memorie positive. For the memories with negative valence, no difference is found among the tested students. There are no data in the literature on the self-defining memories and the postnatal depression. Besides, there is only a single search, not published which explores the links between the attachment and the memories defining the one (Tagini, Conway and Meins, looks for not published, quoted by Conway, to Ape and Tagini, on 2004). The authors present the results according to the styles of attachment. So, autobiographical memories would vary according to the cognitive and emotional dimensions, in connection with differences in the style of attachment. In every style of attachment would correspond certain specificities in the contents and in the form of the self-defining memories.

NCT ID: NCT03336541 Completed - Clinical trials for Postpartum Depression

Low-dose Ketamine and Postpartum Depression in Parturients With Prenatal Depression

Start date: November 23, 2017
Phase: Phase 4
Study type: Interventional

Postpartum depression is common in mothers early after childbirth and produces harmful effects not only on mothers, but also on infants and young children. Parturients with prenatal depression are at increased of postpartum depression. Low-dose ketamine can be used for antidepressant therapy. We hypothesize that low-dose ketamine has a therapeutic effect on parturients with prenatal depression. This study is designed to investigate whether low-dose ketamine administered during cesarean delivery can decrease the incidence of postpartum depression in parturients with prenatal depression.

NCT ID: NCT03309163 Completed - Caesarean Section Clinical Trials

Effect of Tramadol in Prevention of Postpartum Depression

ETPPD
Start date: October 9, 2017
Phase: Phase 4
Study type: Interventional

The incidence of postpartum depression in Europe and the United States is about 10%, while in China the incidence rate of 15.7-39.8%. Postpartum depression is one of the most common diseases of perinatal distress, but the current research of high-quality prevention and treatment of postpartum depression is still very lack. The study suggests that the risk of postpartum depression in cesarean delivery is significantly higher than that in vaginal delivery. Therefore, postpartum depression in cesarean delivery may require more attention and treatment.Tramadol is a non-opioid central analgesic that relieves common to severe pain, and tramadol has an inhibitory effect on norepinephrine and serotonin systems and has the potential to reduce depression and anxiety. Therefore, for the analgesic demand and antidepressant demand for maternal who undergoing cesarean section, tramadol may be an optimized and effective analgesic for the prevention and treatment of postpartum depression.

NCT ID: NCT03300713 Recruiting - Clinical trials for Depression, Postpartum

MOther-Child Interaction Assessment TRAINING for Pediatricians

MOCITRAINING
Start date: December 2, 2017
Phase: N/A
Study type: Interventional

The originality of the MOCITRAINING study lies in the integration of infant and maternal care during the pediatric consultation and the assessment of the impact of this type of care in the short and medium term on The MOCITRAINING program could contribute to improving the quality of parent-child interactions.

NCT ID: NCT03285139 Completed - Clinical trials for Postpartum Depression

Peer Administered CBT for PPD

PL-CBT
Start date: January 3, 2018
Phase: N/A
Study type: Interventional

Postpartum depression (PPD) affects up to 20% of women and has profound effects on mothers and their infants. Unfortunately, fewer than 15% of women with PPD receive evidence-based care. This is at least partly due to significant difficulties faced by women in accessing cognitive behavioural therapy (CBT), a preferred 1st line treatment. In Ontario at present, there is a significant lack of personnel trained to deliver CBT. This study will utilize a randomized controlled trial design (with wait list controls) and recruit 70 participants to determine if women with a past history of PPD (i.e., lay peers) can be trained to deliver effective group CBT to women with current PPD. If peers can be trained to provide effective CBT, more women would receive treatment and the burden of PPD on women, families, and the healthcare system would be significantly reduced.

NCT ID: NCT03283254 Completed - Clinical trials for Postpartum Depression (PPD)

PREPP: Preventing Postpartum Depression

PREPP
Start date: February 12, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03267563 Active, not recruiting - Clinical trials for Depression, Postpartum

Minimum Intervention to Maintain a Postpartum Depression Prevention Program in Clinics Serving Low-income Women

ROSE
Start date: June 12, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03228394 Completed - Depression Clinical Trials

A Clinical Trial of Intravenous (IV) Ganaxolone in Women With Postpartum Depression

Start date: June 27, 2017
Phase: Phase 2
Study type: Interventional

This study will evaluate the Safety, Pharmacokinetics and Efficacy of IV Administration of Ganaxolone in Women with Postpartum Depression

NCT ID: NCT03221556 Completed - Clinical trials for Post Partum Depression

Improving Outcomes for Low-Income Mothers With Depression

Start date: February 5, 2018
Phase: N/A
Study type: Interventional

This is a randomized comparative effectiveness trial to improve outcomes among pregnant and post-partum women with symptoms of depression. Both interventions under study will be based in the patient-centered medical home setting at Boston Medical Center - specifically, in prenatal clinic or in the general pediatrics clinic. The study is a type 1 hybrid effectiveness-implementation trial of 230 mothers with clinically significant depressive symptomatology. Of the 230 subjects, half will receive the Engagement-Focused Care Coordination intervention; the other half will receive the Problem Solving Education intervention. Outcomes for mothers will be assessed every 2 months throughout a 12 month follow-up period. This trial is funded by a contract with PCORI, the Patient-Centered Outcomes Research Institute.