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Postpartum Depression clinical trials

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NCT ID: NCT03654261 Completed - Clinical trials for Postpartum Depression

1-Day CBT Workshops for PPD

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Postpartum depression (PPD) affects up to 20% of women and has profound effects on women and their families. Clinical practice guidelines recommend that the majority of women with PPD receive psychotherapy. A previously validated 1-day CBT workshop has been adapted for depression for use with women experiencing PPD and living in the community. 476 women will be randomized to active treatment or a 12 week wait list in each setting and compare changes in depression, mother-infant attachment, service utilization, quality of life, and offspring behaviour.

NCT ID: NCT03427528 Completed - Depression Clinical Trials

Development, Feasibility and Acceptability of Fathers and Babies (FAB): A Pilot Study

Start date: February 15, 2018
Phase: N/A
Study type: Interventional

During this project the investigators will develop and pilot test a companion intervention for fathers (Fathers and Babies-FAB), to supplement the Mothers and Babies Course (MB) that provides stress and mood management tools for home visiting clients. Focus groups with prior study participants, their male partners, and home visiting staff will be used to develop the FAB curriculum and protocol. FAB text messages aim to improve the mental health of the male partner and help him support his partner's mental health. Feasibility, acceptability, and outcome measures will be supplemented with assessments of fathers' mental health and partners' relationships. Participant assessments will be conducted at baseline, 3 and 6 months in this uncontrolled pilot study. The public health significance and innovation of this project is substantial. If the investigators are able to integrate MB-TXT and MB-DAD into home visiting programs and generate improved mental health outcomes for home visiting clients and their partners, the investigators will be prepared to replicate this intervention across home visiting programs nationally at a time when home visitation as a service delivery model for families with infants and young children is rapidly proliferating through federal funding.

NCT ID: NCT03420755 Completed - Clinical trials for Postpartum Depression

Integrating Text Messages Into the Mothers and Babies Course

Start date: June 7, 2017
Phase: N/A
Study type: Interventional

This project is aimed at enhancing the effectiveness and scalability of the Mothers and Babies 1-on-1 Course (MB) among home visiting programs. MB is a manualized 12-session postpartum depression prevention intervention guided by cognitive-behavioral therapy and attachment theory. Each session lasts 15-20 minutes and is delivered as part of a regularly scheduled home visit. Previous MB trials suggest that the intervention is less successful for women who exhibit smaller changes in hypothesized intervention mechanisms and less fully engaged in completion of personal projects. This study will determine the feasibility and acceptability of conducting MB-TXT, in which home visiting clients receive MB supplemented by a series of weekly text messages focused on skill reinforcement, personal project reminders, and self-monitoring of depressive symptoms. The investigators will also calculate a preliminary effect size that could be used to calculate sample size necessary for a future fully powered randomized controlled trial that examines MB-TXT efficacy. The investigators will use a stepped wedge design—a form of randomized controlled trial that involves sequential, but random, roll-out of the intervention over multiple time periods. The investigators have created two HV program clusters. Both clusters will initially implement MB 1-on-1 and will recruit MB participants for one quarter (i.e., three months) before crossing over to recruit MB-TXT participants for one quarter. MB-TXT's core curriculum is identical to MB 1-on-1 and adds a series of text messages throughout the curriculum. Feasibility and acceptability data will be collected from clients and home visitors to assess percentages of received text messages, home visitor adherence to sending texts at specified intervals, and clients' perceptions of text message utility and clarity. If the investigators are able to integrate MB-TXT and home visiting programs and generate improved mental health outcomes for clients, the investigators will be prepared to replicate this intervention across home visiting programs nationally at a time when home visiting as a service delivery model is rapidly proliferating via federal Maternal Infant and and Early Childhood Home Visiting (MIECHV) program funding.

NCT ID: NCT03415321 Completed - Clinical trials for Postpartum Depression

Development of Postnatal Mobile Support Application

Start date: April 4, 2019
Phase: N/A
Study type: Interventional

A mobile support application will be developed that will support mothers in the postpartum period and will be tested the effects of application on anxiety and depression symptoms.The study will consist of two phases. The first phase of the action research (participant design method) method will be done to provide postpartum mobile support application. In the second stage, postpartum mobile support application will be evaluated for the anxiety and depression symptoms of the mothers after six weeks of use.

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: 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: NCT02979444 Completed - Clinical trials for PostPartum Depression

Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression

Start date: August 2016
Phase: N/A
Study type: Interventional

There is considerable evidence that most perinatal women at risk for postpartum depression do not engage in mental health services, even when referred by home visiting (HV) programs, primary care physicians, obstetricians, or gynecologists. Thus, interventions that can be delivered via alternative settings-e.g., HV programs-are essential to prevent the onset of major depression and worsening of depressive symptoms among perinatal women. This Patient Centered Outcomes Research Institute (PCORI) funded project aims to evaluate whether the Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is more efficacious than usual care (i.e., home visiting without the MB enhancement). It will also examine if MB, when led by paraprofessional home visitors, is not inferior to MB delivered by mental health professionals. The results of this study will inform decision-making by HV programs regarding provision of MB to perinatal women at risk for developing major depression.

NCT ID: NCT02978326 Completed - Clinical trials for Postpartum Depression

A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression

Start date: January 4, 2017
Phase: Phase 3
Study type: Interventional

The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the Columbia Suicide Severity Rating Scale (C-SSRS).

NCT ID: NCT02942017 Completed - Clinical trials for Postpartum Depression

A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)

Start date: July 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 μg/kg/h for 60 hours reduces depressive symptoms in participants with moderate postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score.

NCT ID: NCT02942004 Completed - Clinical trials for Postpartum Depression

A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)

Start date: August 1, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score.