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Postnatal Depression clinical trials

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NCT ID: NCT05046405 Not yet recruiting - Clinical trials for Postnatal Depression

Home-based Transcranial Direct Current Stimulation in Postpartum Depression: the Feasibility Study and Pilot Study

4MUMs
Start date: October 2, 2022
Phase: N/A
Study type: Interventional

Postpartum Depression (PPD) is a Major Depressive (MD) Disorder occurring within the 12 months after delivery with negative effects to the mother, the child and the family and an estimated prevalence in Europe of 10-15%. Non-invasive Transcranial Direct Current Stimulation (tDCS) has been suggested to PPD, as it combines antidepressant effects with low risks, being equivalent to pharmacotherapy, and showing faster response than psychotherapy. tDCS uses a weak electric current applied to the scalp, modulating neurons' firing rate and neuroplasticity of cerebral circuits to counteract dysfunctional connectivity and inter-hemispheric imbalance in MD. tDCS portability led to its introduction as a home-based intervention and trials assessing home-based tDCS in MD were successful, proved its feasibility and showed good acceptance and benign effect in patients' self-efficacy. Hence, combining home-based tDCS with eHealth systems to support data collection and teleHealth for remote health care has shown positive results in other neuropsychiatric disorders. To uptake tDCS to PPD, further research is needed. To pursue the needed regulatory steps, current consensus on the primary hypothesis of efficacy is that future phase-III studies must be supported by the identification of biotypes of depression and should include cost-effectiveness analysis to model its economic advantage and inform Health Technology Analysis. 4MUMs, within an iterative user-centred and co-design approach will adopt a combined intervention (home-based tDCS + eHealth system + teleHealth system) for PPD, conduct a dynamic feasibility study of the data collection procedures and intervention, and test these in a single-arm pilot study towards the first large-sample multicentre Phase-III RCT protocol aimed at testing home-based tDCS efficacy in PPD.

NCT ID: NCT04857593 Recruiting - Social Isolation Clinical Trials

Online Singing Interventions for Postnatal Depression in Times of Social Isolation: a Single Arm Study

SHAPER-PNDO
Start date: January 4, 2021
Phase: N/A
Study type: Interventional

Melodies for Mums (M4M) is an intervention developed and tested as part of a collaboration between the Royal College of Music, Imperial College London and University College London from 2015-2017. The programme involved weekly singing classes for mothers and babies delivered in groups of 8-12 participants in Children's Centres for 10 weeks. M4M was tested in a three-arm RCT involving 134 mothers with PND (with an Edinburgh Postnatal Depression Scale (EPDS) score above 10), compared with a comparison group (10 weeks of creative play classes) or care as usual (wait-list control). The study found that mothers with moderate-severe symptoms of PND who participated in the programme with their baby had a significantly faster improvement in symptoms than mothers in usual care. Specifically, the mothers in the singing group had an average EPDS score of 15.7 at baseline (moderate depression), which dropped to 10.3 by week 6 and 9.4 by week 10. This improvement equated to an average 35% decrease in depressive symptoms across the first 6 weeks, by which point 65% of the singing group no longer had an EPDS above 13. While funding has been secured to upscale this intervention as part of the SHAPER-PND programme, funded by the Wellcome Trust, the recent lockdown has not only halted the programme in its face-to-face format, but also prompted the interest in developing an online version that can be used (1) if the requirement for social distancing, even when the lockdown is relaxed, makes impossible the delivery of the programme; and (2) to broaden the reach to a nationwide delivery and extending to a wider population that may not have been able to attend in-person sessions due to geographical constraints or severity of symptoms. M4M online is a 6-week intervention for mothers with PND. The original M4M programme would be delivered face-to-face in groups of 8-12 mothers in weekly sessions lasting one hour. However, due to the current situation with COVID-19, we will therefore modify the original face-to-face intervention for this online study, as follows: - Groups of around 15-17 women to ensure that all participants can be visible on one screen during online delivery to create a stronger community and connection - Offer 6 weeks of intervention, also building on the evidence from the face-to-face intervention that by 6 weeks there is already a significant improvement in depressive symptoms compared with control interventions - Introduce a two-week lead-in period before the beginning of the six-session course, where mothers will be able to use WhatsApp and at least one (monitored) Zoom session to get to know each other.

NCT ID: NCT04834622 Recruiting - Clinical trials for Postnatal Depression

Community Singing Interventions for Postnatal Depression: a Hybrid Type II Effectiveness-implementation Trial

SHAPER-PND
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Postnatal depression (PND) affects over 13% of new mothers but there is still not an ideal treatment for all cases. Pharmaceutical and psychotherapy have offered solutions but there are challenges in treatment uptake and adherence and long waiting-lists for psychotherapy. Many mothers attend group activities with their babies, some including music and singing. Community group singing has shown improvement in mental health and singing to babies has shown improvement in mother-infant interaction and reduced infant distress. In this realm, Melodies for Mums (M4M) is a programme based in Lambeth and Southwark providing 10-week singing and music sessions for mothers with postnatal depression (PND) and their babies in community Children's Centres or online, according to government social distancing guidelines. Studies have demonstrated its effectiveness in reducing symptoms of PND faster than usual care or social groups, and preliminary process evaluations have suggested its suitability. It has also been identified as a strong way of engaging mothers from minority backgrounds who are less likely to seek professional support for their mental health. However, the programme is reliant on short-term grants and has not been implemented in clinical care. Therefore, there is a clear need to invest more research into this programme to help it achieve its potential. The investigators aim to conduct M4M in a clinical trial aimed at women experiencing symptoms of postnatal depression in the boroughs of Southwark, Lambeth and Lewisham. The investigators will collect data on the wellbeing of the women through a series of interviews and questionnaires and the investigators will also collect biological samples for stress and immunity markers from mothers and babies. In the long term the investigators intend to establish defined clinical referral pathways for patients from primary (GPs, community, among others) and secondary care (specialist doctor, hospital clinic) settings. In addition, the investigators will collect further evidence of the clinical, implementation and economic effectiveness of the intervention.

NCT ID: NCT04820920 Recruiting - Clinical trials for Postnatal Depression

Online LTP+CaCBT for Treating Depression in British Mothers of African/Caribbean Heritage

Start date: September 14, 2021
Phase: N/A
Study type: Interventional

The pilot trial aims to test the feasibility, acceptability and cultural appropriateness of online LTP+CaCBT for treating postnatal depression and to improve the mental health and wellbeing of mothers and their children in the UK.

NCT ID: NCT04745494 Completed - Clinical trials for Postnatal Depression

Studies of Mothers With Postnatal Depression

Start date: May 12, 2017
Phase: N/A
Study type: Interventional

This study investigates the effects of a single dose of oxytocin (OT) delivered via a nasal spray in women with and without traits of postnatal depression (PND).

NCT ID: NCT04706442 Completed - Anxiety Clinical Trials

Effectiveness of 'Supportive Parenting App' on Parental and Newborn Outcomes

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

The Supportive Parenting App is a theory-based perinatal educational intervention for couples administered through a mobile application. The intervention comprise of knowledge-based content, informational videos and audio, discussion forum, peer volunteer chat group, and a frequently asked questions (FAQ) expert advice section. The aims of the study are to: 1. develop theory-based supportive parenting App (SPA) intervention for both first-time and experienced parents across perinatal period 2. examine its effectiveness on parental outcomes: including maternal depression at 12 months postpartum (primary outcome), paternal depression, parental anxiety, parenting self-efficacy, help - seeking behavior (social support), parental bonding and parenting satisfaction (secondary outcomes); and new-born outcomes: physical, social and emotional developments (secondary outcomes) 3. evaluate SPA's cost-effectiveness as compared to standard perinatal care across major restructured hospitals, and 4. examine the perceptions of parents in receiving this intervention. When compared with those in the control group receiving standard care: 1. parents receiving SPA intervention will have better- emotional well-being (reduced depression and anxiety);parenting self-efficacy; social support; bonding and satisfaction. 2. new-borns of parents receiving SPA will have better physical, social and emotional development 3. It will be more cost-effective to provide SPA than the standard care

NCT ID: NCT04644081 Not yet recruiting - Clinical trials for Postnatal Depression

LTP+CaCBT for Treating Postnatal Depression and Improving Child Wellbeing in Jos Nigeria

LTP+CaCBT
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The project aims to test the feasibility, acceptability, cultural appropriateness and effectiveness of LTP+CaCBT for treating postnatal depression and to enhance the mental health and wellbeing of mothers and their children in the low-income areas of Jos Nigeria. This project also aims to provide primary healthcare workers with culturally sensitive requisite skills and support to embed the proposed intervention into routine care practice and increase access to evidence-based intervention.

NCT ID: NCT04396509 Completed - Clinical trials for Postnatal Depression

Effects of Type of Delivery Mode and Gestational Age on Maternal Bonding

Start date: June 1, 2018
Phase:
Study type: Observational

To evaluate the effects of gestational age and other factors on maternal attachment relationship. There are different results in studies examining the effects of birth type on postpartum depression and mother-infant interaction. The aim of this study was to evaluate factors which affected mother-infant bond (MIB) using maternal attachment inventory (MAI).

NCT ID: NCT04368208 Completed - Clinical trials for Postnatal Depression

Impact of Giving Birth During the Covid 19 Pandemia on Postnatal Women's Depression

DEPRECOVID
Start date: April 29, 2020
Phase:
Study type: Observational

Postnatal depression is an important problematic in French population with approximatively 10 -20% of women who suffer from postnatal depression. This pathology may have strong negative impact on both women and neonate's health. The women's satisfaction degree in front of childbirth is an important factor associated with postnatal depression since women unsatisfied of their childbirth and/or women with a complicated childbirth are more encline to suffer from postnatal depression. It is likely that the actual context of Covid 19 pandemia and the change in obstetrical cares organization may have a negative impact on women's satisfaction about their childbirth and so a negative impact on the risk of postnatal depression.

NCT ID: NCT04347499 Completed - Clinical trials for Postnatal Depression

Culturally Adapted CBT Based Guided Self-Help in Patients With Postnatal Depression

Start date: August 5, 2019
Phase: N/A
Study type: Interventional

This is a randomized controlled assessor-blind clinical trial comparing CaCBT based guided self-help (using a manual titled Khushi Aur Khatoon) against treatment as usual (TAU)