[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"postnatal-depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:postnatal-depression":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,42,78,114,145,173,196,223,244],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100535558","new-cognitive-treatment-for-peripartum-depression-100535558",false,"NCT06253390","New Cognitive Treatment for Peripartum Depression","Effect of the Metacognitive Training Programme (D-MCT) in Patients With Peripartum Depression","MCT-DPP","Inclusion Criteria:\n\n* Women over 18 years\n* Meets the diagnostic criteria for depressive disorder with peripartum onset (PPD) (APA, 2013) and has already given birth\n* EPDS score over 10\n* Have given their consent to take part in the study\n* Be affiliated to a social security system\n* Have an adequate knowledge of written, understood and spoken French (French mother tongue or primary education in the French education system) All women with PPD, whether breastfeeding or not, can be included in the study. Baby care can be organised if mothers are unable to have their babies looked after. This service is provided by nurses from the UPPE in the unit's reception room, which has all the equipment needed to care for infants. Mothers meet the nurses before the group and tell them what they expect, and the nurses give them feedback when they come to collect their baby.\n\nExclusion Criteria:\n\n* \\- Be the subject of a protection measure\n* Being a minor\n* Meets the diagnostic criteria for schizophrenia spectrum disorders (brief psychotic disorder; schizophrenic disorder; schizoaffective disorder; delusional disorder; brief psychotic disorder with peripartum onset)\n* Meet the criteria for substance abuse or dependence (alcohol, drugs)\n* With insufficient command of the French language\n* People with a deceased child\n* People who do not meet the diagnostic criteria for depressive disorder with peripartum onset (APA, 2013)\n* People who do not agree to take part in the study","FEMALE","18 Years","45 Years",{"count":21,"type":22},96,"ESTIMATED","INTERVENTIONAL",[25],"NA","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).\n\nThe 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).\n\nIn 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.\n\nIn 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.\n\nThe investigators make the following assumptions:\n\n* Women in the experimental group showed a greater reduction in depressive symptoms and an improvement in metacognitive functioning than those in the control group.\n* Women in the experimental group showed a reduction in depressive symptoms after therapy (v2) and maintenance of this improvement (v3).\n* Improvement in the quality of mother-child bonding for women who took part in the program compared with those in the control group.\n* 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.",[28],"Postnatal Depression","RECRUITING","2026-02-18",{"date":32,"type":33},"2026-02-20","ACTUAL",{"date":35,"type":33},"2024-01-10",{"date":37,"type":22},"2028-12",{"name":39,"class":40},"CHU de Reims","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100551147","integration-of-stepped-care-for-perinatal-mood-and-anxiety-disorders-among-women-attending-mch-clinics-100551147","NCT06456307","Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics","IPMH","Inclusion Criteria:\n\n* Pregnant and ≥28 weeks gestation\n* Attending ANC care at the facility\n* ≥14 years old\n* Screen positive for PMAD symptoms (PHQ-2≥3 and\u002For GAD-2≥3)\n* Willing to return to the MCH and PMTCT clinic for study visits\n\nExclusion Criteria:\n\n* Less than 28 weeks gestation\n* Any woman at high risk of self-harm based on a study self-harm assessment protocol,\n* Has cognitive impairments or psychotic symptoms",true,"14 Years",{"count":52,"type":22},2970,[25],"Perinatal mood and anxiety disorders (PMAD), defined as depression and anxiety during pregnancy or up to 1 year postpartum, account for substantial morbidity and mortality among birthing people globally especially in low- and middle-income countries. Several evidence-based interventions are recommended for identification and management of PMAD by non-specialist providers in resource-limited settings. This cluster-randomized trial seeks to evaluate the effect of a stepped-care intervention for screening and treatment of PMAD among perinatal women, on clinical and implementation outcomes.",[56,57,28],"Depression, Anxiety","Antenatal Depression",[59,60,61,62,63,64,65,66],"perinatal mood and anxiety disorders","telepsychiatry","Problem management plus","Integrated Perinatal Mental Health","Pregnancy","Postpartum","Depression","Anxiety","2025-12-03",{"date":69,"type":33},"2025-12-10",{"date":71,"type":33},"2025-02-17",{"date":73,"type":22},"2028-03",{"name":75,"class":76},"Kenyatta National Hospital","OTHER_GOV",2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":95,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":41},"100583059","effectiveness-of-an-online-biopsychosocial-intervention-to-improve-well-being-and-mental-health-during-pregnancy-100583059","NCT06871397","Effectiveness of an Online Biopsychosocial Intervention to Improve Well-being and Mental Health During Pregnancy","Effectiveness of an Online Biopsychosocial Intervention to Improve Well-being and Mental Health During Pregnancy: A Randomized Clinical Trial","BienGestar","Inclusion Criteria:\n\n* Pregnant women\n* Pregnancy of less than 15 weeks of gestation\n* More than 18 years old age\n* Able to read, write, and understand Spanish\n* In possession of a smartphone\n* Able to manage smartphone apps\n* Have signed a written informed consent document\n\nExclusion Criteria:\n\n* Having a high-risk pregnancy that entails transfer to another specialized health centre\n* Having diagnosis of disease that may affect the central nervous system, such as brain pathology or traumatic brain injury\n* Having other psychiatric diagnosis or acute psychiatric illness, such as substance dependence or abuse, a presence of schizophrenia or other psychotic disorders or risk for suicide\n* To be under psychopharmacological medication or under psychopharmacological treatment.",{"count":87,"type":22},228,[25],"This study aims to develop and implement a preventive intervention through a mobile application to help pregnant women feel better emotionally and cope with the changes of pregnancy in a more positive way. The idea is to offer practical and accessible tools that allow them to better manage stress, emotions and preparation for motherhood. The intervention proposed in this study is based on psychological strategies that have proven to be effective, such as relaxation exercises, techniques to manage stress and strategies to improve mood, strengthen the relationship with the partner and foster the bond with the baby before its birth.\n\nThe application is designed to accompany pregnant women from the beginning of pregnancy to the postpartum period. It has different programs that include weekly activities on various important topics, such as physical health care, emotional management, connection with the baby during pregnancy, preparation for childbirth and the first months of the newborn's life.\n\nTo evaluate the effectiveness of this tool, a study will be carried out with pregnant women treated by the Catalan Health Service. Participants will be randomly assigned to one of two study groups: the experimental group (in which participants, in addition to the usual medical care offered during pregnancy, will have access to the programs and activities of the app organized in a weekly plan of 5 activities and will have to answer the study questionnaires at weeks 16 and 36 of pregnancy and postpartum) or the control group (in which participants will receive the usual medical care offered during pregnancy, but will not have access to the programs and activities of the app and will have to answer the study questionnaires at weeks 16 and 36 of pregnancy and postpartum).\n\nWomen who use the app are expected to experience greater emotional well-being and a lower risk of developing mental health problems during pregnancy. In addition, they may feel more prepared for motherhood, take better care of their health, have a more positive birth experience and a lower risk of postpartum depression. These women are also expected to develop a stronger bond with their baby and adapt better to the new stage of motherhood.",[91,92,93,94,28],"Prenatal Anxiety","Prenatal Depression","Wellbeing","Obstetrical Complications",[96,97,98,99,100,101,102,103,104],"wellbeing","anxiety","depression","eHealth","maternal mental health","health promotion","cognitive behavioral intervention","randomized controlled trial","pregnancy","2025-07-14",{"date":107,"type":33},"2025-07-17",{"date":109,"type":33},"2025-04-03",{"date":111,"type":22},"2026-09-30",{"name":113,"class":40},"University Rovira i Virgili",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":23,"phases":124,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":4},"100592236","clinical-and-cost-effectiveness-of-learning-through-play-plus-culturally-adapted-cognitive-behaviour-therapy-for-postnatal-depression-in-nigeria-100592236","NCT06990802","Clinical and Cost-effectiveness of Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy for Postnatal Depression in Nigeria","LTP+CaCBT","Inclusion Criteria:\n\n* 18 years and above\n* A mother with a child (0-3 years)\n* Able to provide full consent for their participation\n* A resident of the trial catchment areas\n* Able to complete a baseline assessment\n* Score 5 or above on Patient Health Questionnaire (PHQ-9)\n* available for follow-up at 4 and 6 months post-enrolment\n\nExclusion Criteria:\n\n* Less than 18 years\n* Medical disorder that would prevent participation in a clinical trial, such as Tuberculosis or heart failure\n* Temporary residents are unlikely to be available for follow-up\n* Active suicidal ideation or any other severe mental disorder\n* Patients currently undergoing severe mental health treatment\n* Non-residents of the trial environs\n* Unable to consent\n* Unable to speak and understand English language\n* Other significant physical or learning disability","49 Years",{"count":123,"type":22},432,[25],"Background: We aim to examine the effectiveness of Learning Through Play and Cognitive Behaviour Therapy (LTP+CaCBT), a culturally appropriate psychosocial intervention to address postnatal depression among Nigerian women and improve the well-being of their children. Women of reproductive age (ages 16 to 49) comprise about 60 million of Nigeria's 230 million people. About 30% of these mothers experience postnatal depression. The global health challenge our research addresses is that one in three women worldwide experience postnatal depression and suicidal thoughts after childbirth, with long-term negative consequences on their children and families. Since 30% of Nigerian mothers suffer from postnatal depression, they have significant risks of transferring intergenerational mental health problems to their children. Over 250 million children are at risk of lacking developmental support in low- or middle-income countries, including Nigeria, due to postnatal depression, and this limits the children from reaching their full potential in life. The treatment gap for postnatal depression in Nigeria is huge due to a shortage of mental health specialists. Culturally appropriate, nonspecialist-delivered interventions are very limited in Nigeria. Our proposal aims to address this gap in treating postnatal depression using non-specialists called Indigenous Community Health Workers (CHWs), who are more culturally knowledgeable, as the World Health Organisation recommended in their task-shifting strategy.\n\nMethods: We will evaluate the treatment, costs and implementation outcomes of LTP+CaCBT with 432 depressed mothers. Eligible participants (mother-child pairs) will be randomly selected to receive LTP+CaCBT and Treatment As Usual (TAU) or TAU alone. Our LTP+CaCBT intervention is a manualised 12-session (90-minute each) of mother-child play activities delivered in-person by CHWs under the supervision of clinical psychologists\u002Fpsychiatrists. The eligible mothers (aged 16-49 years who have children between ages 0-36 months) will be assessed for depression before the intervention and then again at 4 months and 6 months afterwards. We will conduct interviews and focus group discussions to understand participants' and CHWs' experiences of the intervention",[28,127],"Child Health",[129,130,131,132,133,134],"Postnatal depression","Child health","Intervention","Parenting","Childbirth","Maternal mental health","NOT_YET_RECRUITING","2025-05-17",{"date":138,"type":33},"2025-05-25",{"date":140,"type":22},"2026-07",{"date":142,"type":22},"2028-07",{"name":144,"class":40},"Nottingham Trent University",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":170,"locationsCount":172},"100575885","transdiagnostic-internet-cognitive-behavior-therapy-for-mixed-anxiety-and-depressive-symptoms-in-postnatal-women-100575885","NCT06778096","Transdiagnostic Internet Cognitive-behavior Therapy for Mixed Anxiety and Depressive Symptoms in Postnatal Women","postnataIiCBT","Inclusion Criteria:\n\n* 18 years and older\n* Being within 12 months postpartum\n* Fluent in spoken and written French\n* Self-reported clinical score ≥10 for anxiety and\u002For depressive symptoms based on the Generalised Anxiety Disorder-7 (GAD-7) and the Edinburgh Postnatal Depression Scale 10-item scale (EPDS)\n* Access to a computer\u002Ftablet and internet connection\n* Agreement to share primary provider contact information\n\nExclusion Criteria:\n\n* Self-reported diagnosis of schizophrenia or bipolar disorder\n* Current substance abuse or dependence\n* Current use of benzodiazepines\n* Beginning psychological therapy (\\\u003C 4 weeks ago) or medication (\\\u003C 8 weeks ago) for depression\u002Fanxiety\n* Severe depression (EPDS score ≥ 23) or active suicidal intentions (EPDS question 10 = 3, yes quite often)",{"count":153,"type":22},226,[25],"This research project aims to examine the acceptability and efficacy of a French-Canadian adaptation of a postnatal anxiety and depression program. The main question it aims to answer is:\n\n\\[1\\] When the adapted postnatal Internet-delivered cognitive behavioral therapy (iCBT) is added to treatment as usual (TAU) in community-based care for women with anxiety and depressive symptoms, is the iCBT+TAU condition more effective to reduce symptoms than TAU alone?\n\nParticipants will:\n\npostnatal iCBT group -\\> Answer questionnaires before, after (week 6) and 4 weeks after the intervention (week 10); do the 6-week non-guided iCBT program for anxiety and depressive symptoms during the postnatal period.\n\nWaitlist, TAU group -\\> Answer questionnaires at enrolment, at week 6 and week 10. Participants will have access to the intervention after they complete their last questionnaires.",[66,28],[158,159,160,161,162,66,65,163],"Cognitive Behavioral Therapy","Internet","Non-guided","Transdiagnostic","Randomized clinical trial","Postnatal","2025-05-07",{"date":166,"type":33},"2025-05-13",{"date":168,"type":22},"2025-05",{"date":140,"type":22},{"name":171,"class":40},"Université de Sherbrooke",4,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":49,"sex":180,"minAge":18,"maxAge":19,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":41},"100558905","a-virtual-support-intervention-for-postnatal-well-being-100558905","NCT06557200","A Virtual Support Intervention for Postnatal Well-being","Empowering Early Parenthood: A Digital Psychoeducational Support Intervention for Postnatal Well-being","Inclusion Criteria:\n\n* Pakistani female aged 18-45 years\n* Recent childbirth (within 0-6 weeks)\n* Access to a smartphone or computer with internet connectivity\n* Able to understand and communicate in Urdu or English\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Pre-existing severe mental illness (e.g., schizophrenia, bipolar disorder)\n* Current substance abuse or dependence\n* Limited or no access to the internet or smartphone\n* Inability to understand or communicate in Urdu or English\n* Pregnancy complications requiring intensive care\n* Infants with severe medical conditions requiring hospitalization","ALL",{"count":182,"type":22},1400,[25],"Postnatal depression (PND) and anxiety are significant public health concerns affecting a substantial proportion of new mothers worldwide. These conditions can have profound consequences for both maternal and infant well-being, including increased risk of\n\n1. maternal morbidity\n2. impaired parent-infant bonding\n3. long-term developmental challenges for the child.",[28,186],"Mother-Infant Interaction","2024-08-13",{"date":189,"type":33},"2024-08-16",{"date":191,"type":22},"2024-08-15",{"date":193,"type":22},"2025-08-10",{"name":195,"class":40},"Universiti Putra Malaysia",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":17,"minAge":203,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":207,"briefSummary":208,"conditions":209,"keywords":210,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":41},"100504744","a-problem-solving-intervention-for-women-with-suicidal-ideation-during-postnatal-period-in-pakistan-100504744","NCT05852314","A Problem-Solving Intervention for Women With Suicidal Ideation During Postnatal Period in Pakistan","Culturally Adapted Manual-Assisted Problem-Solving Intervention for Women With Suicidal Ideation in Postnatal Period in Pakistan: A Feasibility Trial","Inclusion Criteria:\n\n1. 16 to 44-year-old mothers with children 0 - 30 months old\n2. Residents of the trial site catchments area\n3. Able to provide informed consent\n4. Presenting with suicidal ideation as measured by the Beck Suicidal Ideation Scale (BSSI) (must score 1 or 2 on item 4 and 5)\n5. Not requiring in-patient psychiatric treatment.\n\nExclusion Criteria:\n\nWe will exclude mothers with any physical or psychiatric condition severe enough to prevent study participation.","16 Years","44 Years",{"count":206,"type":22},90,[25],"The aim of this study is to determine the feasibility and acceptability of culturally adapted CMAP for suicidal Ideation for women in postnatal period.\n\nObjectives\n\n1. To adapt existing CMAP Intervention for suicidal ideation (CMAP-SI) in postnatal period.\n2. To investigate whether CMAP-SI is feasible and acceptable among women presenting suicidal Ideations in postnatal period; and\n3. To test whether there is an indication for the effects of the CMAP in reducing suicidal thoughts among women in postnatal period.\n4. To explore participants experiences with CMAP-SI Intervention.",[28],[28,211,212,213],"Suicidal Ideation","LMICs","CMAP","2024-08-09",{"date":216,"type":33},"2024-08-12",{"date":218,"type":33},"2023-07-10",{"date":220,"type":22},"2024-12",{"name":222,"class":40},"Pakistan Institute of Living and Learning",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":230,"enrollmentInfo":231,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":4},"100450651","tackling-postnatal-depression-culturally-adapted-learning-through-play-plus-ltp-intervention-for-british-mothers-of-african-and-caribbean-origin-100450651","NCT05148260","Tackling Postnatal Depression: Culturally Adapted Learning Through Play Plus (LTP+) Intervention for British Mothers of African and Caribbean Origin","Tackling Postnatal Depression: Culturally Adapted Learning Through Play Plus (LTP+) Intervention for Depressed British Mothers of African and Caribbean Origin","Inclusion Criteria\n\nOnly British mothers of African and Caribbean heritage:\n\n* experiencing emotional distress due to childbirth or parenting and scored 5 or above on the patient health questionnaire (PHQ-9)\n* who have children age 0-3 years\n* residents of designated communities and available for follow-up\n* are 18 years and above\n* able to give informed consent.\n\nExclusion Criteria\n\nAre mothers:\n\n* with a medical condition that would prevent their participation such as active suicidal ideation, tuberculosis, or heart failure\n* temporary residents are unlikely to be available for follow up\n* who are less than 18 years\n* unable to provide consent.\n* with non-British African and Caribbean heritage.","60 Years",{"count":232,"type":22},80,[25],"By 2030, depression will be the leading global disease burden. Postnatal depression due to childbirth\u002Fparenting leads to long-term negative consequences for mothers, their children and their families. The British African\u002FCaribbean communities are worse hit by the unprecedented impact of post-Covid-19-syndromes, leading to an exponential increase in postnatal depression. Yet, the uptake of mental healthcare by British mothers of African and Caribbean origin is low due to limited access to culturally appropriate care. Theories of attachment and cognitivism were innovatively integrated to examine Learning-Through-Play plus (LTP+) intervention for postnatal depression using a pilot randomised controlled trial. The proposed LTP+ is co-developed and ecologically friendly because it is manualised and can be delivered by non-mental health specialists such as trained community health workers who are more culturally knowledgeable. Findings will be disseminated through academic publications\u002Fpresentations, policy briefs, original animated videos and podcast series laying the foundations for a psychosocial approach to tackling postnatal depression",[28],"2022-11-15",{"date":238,"type":33},"2022-11-18",{"date":240,"type":22},"2023-09-01",{"date":242,"type":22},"2026-08-30",{"name":144,"class":40},{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":251,"targetDuration":4,"studyType":23,"phases":253,"briefSummary":254,"conditions":255,"keywords":256,"overallStatus":135,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":266,"locationsCount":4},"100442824","home-based-transcranial-direct-current-stimulation-in-postpartum-depression-the-feasibility-study-and-pilot-study-100442824","NCT05046405","Home-based Transcranial Direct Current Stimulation in Postpartum Depression: the Feasibility Study and Pilot Study","4MUMs","Inclusion Criteria:\n\n* Medication-free women with moderate to severe MD episode according to the Montgomery Asberg Depression Rating Scale (MADRS\\>7), and peripartum onset, diagnosed before delivery or between the second week and month 6 postpartum\n* Between 18-45 years of age\n* Pregnancy to term\n* Uncomplicated delivery to a healthy newborn\n* Must be able to manage the technical aspects of the intervention.\n\nExclusion Criteria:\n\n* tDCS contraindications\n* Previous experience with tDCS\n* Mental health disorder other than unipolar depression or anxiety\n* Suicidal ideation.",{"count":252,"type":22},50,[25],"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.\n\nTo 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.\n\n4MUMs, 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.",[28],[65,163,28,257,258,259],"Transcranial Direct Current Stimulation","Feasibility study","Pilot Study","2021-09-07",{"date":262,"type":33},"2021-09-16",{"date":264,"type":22},"2022-10-02",{"date":111,"type":22},{"name":267,"class":40},"Ana Ganho Ávila"]