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NCT06253390
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). The investigators 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.
NCT04332146
Postnatal psychopathology have adverse impact on both mothers and infants. Few postnatal women with depressive symptoms receive treatment, and pharmacological intervention has not been well accepted due to the medication side-effects. Recently, mindfulness-based interventions were found to be beneficial for symptoms in perinatal and antenatal women with depression. These non-pharmacological interventions require less resources and are more feasible for postnatal women to practice at home. To date, no randomized controlled trial has examined mindfulness-based intervention program as a treatment for women with postnatal depression. The proposed randomized controlled trial aims to examine the effects of an 8-week mindfulness-based intervention program on symptom and cognition for postnatal females with depressive symptoms. A total of 70 postnatal women with depressive symptoms will be recruited from the psychiatric outpatient clinics in Hong Kong, and will be randomized into two groups: 1) an 8-week mindfulness-based intervention program (n=35); 2) a booklet-based psychoeducation control group (n=35). All participants will be assessed for depression, anxiety, stress, cognition, role functioning, quality of life, sleep quality and mindfulness ability at the baseline, 8 weeks, and 3 months after intervention. The intervention sessions will be held once weekly lasting 90 minutes for 8 weeks. The investigators primarily hypothesize that participants in the mindfulness-based intervention group will improve depressive symptom after 8 weeks compared with the control group. Secondary, the mindfulness-based intervention will improve anxiety, stress, cognitive functions, sleep quality, quality of life and mindfulness ability.
NCT04857593
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.
NCT06207916
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.
NCT05891717
New mothers experience postpartum depression after childbirth, which commonly include mood swings, crying spells, anxiety and difficulty sleeping. Resistance training (RT) is one of the most popular methods of exercise for improving physical fitness. This study will be a randomized clinical trial. It divide into two groups. Data will be collected from Jinnah Hospital Lahore, Family Health hospital, Johar town. Data will be taken from 36 postpartum females. Participants will be divided into 2 groups 18 women in each group: 1st group will be treated with resistance training group and 2nd group will be active comparison flexibility training group. In this study Exercises self-efficacy scale, Epidemiological studies Depression scale and MAPP-QOL (Maternal Postpartum Quality Life Questionnaire) will be used as subjective measurements.
NCT02497677
Infant mental health is a significant public health issue as early adversity and expose to childhood stress has life-long consequences for the affected children. Helping families at risk correct their adverse effects on the infant has the potential to halt a negative spiral effect where vulnerable parents fail to cope with an at-risk child - which in turn, adds to the child's vulnerability, negatively affects the parents, and so forth. Over a four year period, an estimated 17.600 dyads will be screened in the City of Copenhagen using standardized screening instruments in detecting infant social withdrawal (ADBB) and maternal postnatal depression (EPDS). A sample of 314 eligible parent(s) will enter into a clinical, randomized control trial to test the efficacy of an 8 week group counseling program, Circle of Security Parenting (COS-P) compared to Care as Usual(CAU) in enhancing maternal sensitivity, child attachment and cognitive development. CIMHP is the first large-scale randomized controlled study to test the efficacy of COS-P in promoting parental sensitivity, child attachment and cognitive development in Denmark. Results will provide evidence regarding the efficacy of an American short term indicated parenting group program when implemented in a Scandinavian country.
NCT05382884
The SUPPORT Study aims to evaluate the effectiveness and usability of postpartumcare.ca, a web-enabled resource for postpartum depression (PPD) and postpartum anxiety (PPA), created based on the input of birthing parents in British Columbia (BC) affected by these disorders.
NCT05275413
The proposed study is to test the effectiveness of a culturally-attuned, family-based mobile health (mHealth) intervention in reducing symptoms of postnatal depression and promoting health among expectant mothers in Hong Kong. Using a family perspective, the proposed mHealth intervention will engage family members, including expectant fathers and grandparents, in providing support to expectant mothers. Expectant mothers and their family members will be recruited at antenatal clinics at two public hospitals in Hong Kong and randomized to receive the family-based mHealth intervention (experimental), the mother-only mHealth intervention (experimental), or the health education (control). Maternal depression, anxiety and stress, perceived social support, health-related quality of life, and perceived family cohesion will be assessed at recruitment and four weeks after childbirth. For family members, symptoms of anxiety and stress, health-related quality of life, and perceived family cohesion will be measured.
NCT03791749
Breastfeeding has various benefits for the mother and infant. It has the capability of reducing the risk of short term and long term problems for the infant, such as gastroenteritis, respiratory infections, type II diabetes and obesity, and of providing benefits for neurodevelopment. Breast milk offers even greater benefits for preterm infants. Some of the advantages of breastfeeding are related to the constituents of breast milk such as the macronutrients and bioactive factors, the hormones associated with breastfeeding such as oxytocin, and the behavioural aspects of breastfeeding (maternal sensitivity to infant cues). Despite these advantages, breastfeeding rates are below target levels mainly due to the challenges that women face that hinder breastfeeding success. Interventions aimed at improving policies, practices, and maternal support have been developed. However, other interventions that target specific modifiable barriers to breastfeeding can be useful. The aim of this study is to investigate a simple support intervention for breastfeeding mothers of late preterm and early term infants on maternal stress reduction and infant weight gain. The investigators also aim to study the potential mechanisms by which this effect could be achieved (breast milk composition and volume, mother and infant behaviour).
NCT04706442
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
NCT04820920
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.
NCT05046405
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.
NCT03196726
Randomized-controlled trial on the effectiveness of managing postnatal depression mothers at primary care clinics using Cognitive-behavioural therapy treatment by nurses as adjunct to management by Medical Officer as compared to Medical Officer alone
NCT03346551
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.
NCT01507649
Purpose: To evaluate the effectiveness of a telephone-based intervention using cognitive-behavioral approach in preventing postnatal depression and improving quality of life in first-time Chinese mothers. Hypothesis: Women who receive the telephone-based cognitive-behavioral intervention will have a lower level of depressive symptoms (primary outcome) and a higher level of quality of life at 6 weeks and 6 months postpartum than those who receive the usual postpartum care. Design and subjects: Randomized controlled trial is used. A sample of postpartum women with high risk of postnatal depression (EPDS \> 9, n = 498) will be randomly assigned to either the experimental (n = 249) or the control groups (n = 249). The experimental group receives the intervention and the control group receives usual postpartum care. Study instruments: EPDS and Medical Outcomes Study Short Form Health Survey (SF-12). Interventions: The intervention is based on the cognitive-behavioral approach. It consists of five, 30-minutes sessions delivered weekly from postpartum week one to week five via telephone. Main outcome measures and analysis: Outcomes on postnatal depression and quality of life will be measured by EPDS and SF-12, respectively, at 6 weeks and 6 months postpartum. A repeated-measures multivariate analysis of variance will be used to compare differences between two groups.
NCT01002027
The study evaluates three best-practice care pathways for postnatal depression (PND) by comparing sole General Practitioner (GP) management to GP management in combination with CBT-based counselling from either a Psychologist or a Maternal and Child Health Nurse (MCHN).