The consequences of the new European reclassification of non-invasive brain stimulation devices and the medical device regulations pose an existential threat to research and treatment: An invited opinion paper.

A significant amount of European basic and clinical neuroscience research includes the use of transcranial magnetic stimulation (TMS) and low intensity transcranial electrical stimulation (tES), mainly transcranial direct current stimulation (tDCS). Two recent changes in the EU regulations, the introduction of the Medical Device Regulation (MDR) (2017/745) and the Annex XVI have caused significant problems and confusions in the brain stimulation field. The negative consequences of the MDR for non-invasive brain stimulation (NIBS) have been largely overlooked and until today, have not been consequently addressed by National Competent Authorities, local ethical committees, politicians and by the scientific communities. In addition, a rushed bureaucratic decision led to seemingly wrong classification of NIBS products without an intended medical purpose into the same risk group III as invasive stimulators. Overregulation is detrimental for any research and for future developments, therefore researchers, clinicians, industry, patient representatives and an ethicist were invited to contribute to this document with the aim of starting a constructive dialogue and enacting positive changes in the regulatory environment.

Limited output transcranial electrical stimulation 2023 (LOTES-2023): Updates on engineering principles, regulatory statutes, and industry standards for wellness, over-the-counter, or prescription devices with low risk.

The objective and scope of this Limited Output Transcranial Electrical Stimulation 2023 (LOTES-2023) guidance is to update the previous LOTES-2017 guidance. These documents should therefore be considered together. The LOTES provides a clearly articulated and transparent framework for the design of devices providing limited output (specified low-intensity range) transcranial electrical stimulation for a variety of intended uses. These guidelines can inform trial design and regulatory decisions, but most directly inform manufacturer activities - and hence were presented in LOTES-2017 as "Voluntary industry standard for compliance controlled limited output tES devices". In LOTES-2023 we emphasize that these standards are largely aligned across international standards and national regulations (including those in USA, EU, and South Korea), and so might be better understood as "Industry standards for compliance controlled limited output tES devices". LOTES-2023 is therefore updated to reflect a consensus among emerging international standards, as well as best available scientific evidence. "Warnings" and "Precautions" are updated to align with current biomedical evidence and applications. LOTES standards applied to a constrained device dose range, but within this dose range and for different use-cases, manufacturers are responsible to conduct device-specific risk management.

Psychometric properties of the University of California Los Angeles Loneliness Scale version 3: the European Portuguese version / Propiedades psicométricas de la Escala de Soledad de Los Ángeles versión 3: la versión portuguesa europea

Currently, the golden standard measure to assess loneliness is the University of California, Los Angeles Loneliness scale version 3 (UCLA v3). Objective. The aim of this study was to analyze the psychometric properties of UCLA v3 for the European Portuguese population. Method. A sample of 282 participants was surveyed in Portugal. Results. Confirmatory factor analysis (CFA) supported a model portraying a global loneliness bifactor solution for positive and negative wording items, which achieved optimal fitness. Multi-group CFA indicates scalar and metric invariance across gender. Loneliness test scores (global score, positive items and negative items) correlated with well-established mental health indicators such as psychological stress, depressive and anxiety symptomatology, or psychological inflexibility. Internal consistency of the loneliness test scores was optimal for the global measure (a = .91; ? = .91) as well as for the positive (a = .87; ? = .87) and the negative factors (a = .86; ? = .88). Conclusions. Results support UCLA v3 as a reliable and valid measure of loneliness for future research studies interested in examining the prevalence of loneliness and impact in health in the context of Covid-19 in the Portuguese population and as a health indicator in health promotion and clinical.(AU)

Actualmente, la medida estándar mayormente utilizada para evaluar la soledad es la versión 3 de la escala de Soledad de la Universidad de California de Los Angeles (UCLA v3). Objetivo. Analizar las propiedades psicométricas de UCLA v3 para la población portuguesa europea. Método. Una muestra total de 282 personas fue encuestada en línea en Portugal. Resultados. El análisis factorial confirmatorio (AFC) respaldó un modelo que representa una solución global de soledad con dos factores relativos al contenido positivo y negativo de los ítems, y logrando un ajuste óptimo. El AFC multigrupo indicó invariancia métrica y escalar según género. Los puntajes de la prueba de soledad (puntaje global; ítems positivos e ítems negativos) correlacionaron con indicadores de salud bien establecidos como el estrés psicológico, la sintomatología depresiva y ansiosa o la inflexibilidad psicológica. La consistencia interna de los puntajes de la escala de soledad fue óptima tanto para la medida global (a = .91; ? = .91) como para las medidas positiva (a = .87; ? = .87) y negativa (a = .86; ? = .88). Conclusiones. Los resultados apoyan a la UCLA v3 como una medida confiable y válida de la soledad para futuros estudios de investigación interesados en examinar la prevalencia de la soledad y su impacto en la salud en el contexto de Covid-19 en la población portuguesa, y como un indicador de salud en programas de promoción de salud y de intervenciones clínicas.(AU)

The impact of COVID-19 on breastfeeding rates: An international cross-sectional study.

BACKGROUND: Breastfeeding promotes children's health and is associated with positive effects to maternal physical and mental health. Uncertainties regarding SARS-CoV-2 transmission led to worries experienced by women and health professionals which impacted breastfeeding plans. We aimed to investigate the impact of self-reported and country-specific factors on breastfeeding rates during the COVID-19 pandemic. METHODS: This study is part of a broader international prospective cohort study about the impact of the COVID-19 pandemic on perinatal mental health (Riseup-PPD-COVID-19). We analysed data from 5612 women, across 12 countries. Potential covariates of breastfeeding (sociodemographic, perinatal, physical/mental health, professional perinatal care, changes in healthcare due to the pandemic, COVID-19 related, breastfeeding support, governmental containment measures and countries' inequality levels) were studied by Generalized Linear Mixed-Effects Models. RESULTS: A model encompassing all covariates of interest explained 24% of the variance of breastfeeding rates across countries (first six months postpartum). Overall, first child (ß = -0.27), age of the child (ß = -0.29), preterm birth (ß = -0.52), admission to the neonatal/pediatric care (ß = -0.44), lack of breastfeeding support (ß = -0.18), current psychiatric treatment (ß = -0.69) and inequality (ß = -0.71) were negatively associated with breastfeeding (p < .001). Access to postnatal support groups was positively associated with breastfeeding (ß = 0.59; p < .001). In countries with low-inequality, governmental measures to contain virus transmission had a deleterious effect on breastfeeding (ß = -0.16; p < .05) while access to maternity leave protected breastfeeding (ß = 0.50; p < .001). DISCUSSION: This study shows that mother's COVID-19 diagnosis and changes in healthcare and birth/postnatal plans did not influence breastfeeding rates. Virtual support groups help women manage breastfeeding, particularly when their experiencing a first child and for those under psychiatric treatment. The complex associations between covariates and breastfeeding vary across countries, suggesting the need to define context-specific measures to support breastfeeding.

Effects of transcranial direct current stimulation on neural activity and functional connectivity during fear extinction

Background/Objective: Anxiety disorders are highly prevalent and negatively impact daily functioning and quality of life. Transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex (dlPFC), especially in the right hemisphere impacts extinction learning; however, the underlying neural mechanisms are elusive. Therefore, we aimed to investigate the effects of cathodal tDCS stimulation to the right dlPFC on neural activity and connectivity patterns during delayed fear extinction in healthy participants. Methods: We conducted a two-day fear conditioning and extinction procedure. On the first day, we collected fear-related self-reports, clinical questionnaires, and skin conductance responses during fear acquisition. On the second day, participants in the tDCS group (n = 16) received 20-min offline tDCS before fMRI and then completed the fear extinction session during fMRI. Participants in the control group (n = 18) skipped tDCS and directly underwent fMRI to complete the fear extinction procedure. Whole-brain searchlight classification and resting-state functional connectivity analyses were performed. Results: Whole-brain searchlight classification during fear extinction showed higher classification accuracy of threat and safe cues in the left anterior dorsal and ventral insulae and hippocampus in the tDCS group than in the control group. Functional connectivity derived from the insula with the dlPFC, ventromedial prefrontal cortex, and inferior parietal lobule was increased after tDCS. Conclusion: tDCS over the right dlPFC may function as a primer for information exchange among distally connected areas, thereby increasing stimulus discrimination. The current study did not include a sham group, and one participant of the control group was not randomized. Therefore, to address potential allocation bias, findings should be confirmed in the future with a fully randomized and sham controlled study. (AU)

Effects of transcranial direct current stimulation on neural activity and functional connectivity during fear extinction.

Background/Objective: Anxiety disorders are highly prevalent and negatively impact daily functioning and quality of life. Transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex (dlPFC), especially in the right hemisphere impacts extinction learning; however, the underlying neural mechanisms are elusive. Therefore, we aimed to investigate the effects of cathodal tDCS stimulation to the right dlPFC on neural activity and connectivity patterns during delayed fear extinction in healthy participants. Methods: We conducted a two-day fear conditioning and extinction procedure. On the first day, we collected fear-related self-reports, clinical questionnaires, and skin conductance responses during fear acquisition. On the second day, participants in the tDCS group (n = 16) received 20-min offline tDCS before fMRI and then completed the fear extinction session during fMRI. Participants in the control group (n = 18) skipped tDCS and directly underwent fMRI to complete the fear extinction procedure. Whole-brain searchlight classification and resting-state functional connectivity analyses were performed. Results: Whole-brain searchlight classification during fear extinction showed higher classification accuracy of threat and safe cues in the left anterior dorsal and ventral insulae and hippocampus in the tDCS group than in the control group. Functional connectivity derived from the insula with the dlPFC, ventromedial prefrontal cortex, and inferior parietal lobule was increased after tDCS. Conclusion: tDCS over the right dlPFC may function as a primer for information exchange among distally connected areas, thereby increasing stimulus discrimination. The current study did not include a sham group, and one participant of the control group was not randomized. Therefore, to address potential allocation bias, findings should be confirmed in the future with a fully randomized and sham controlled study.

Examining the evidence on complementary and alternative therapies to treat peripartum depression in pregnant or postpartum women: study protocol for an umbrella review of systematic reviews and meta-analyses.

INTRODUCTION: Complementary and alternative therapies (CATs) refer to a diverse range of approaches that can be used as add-on or an alternative to conventional therapies. While a number of individual studies and systematic reviews (SRs) or meta-analyses (MAs) have investigated the effectiveness of specific types of CATs to treat depressive symptoms at specific moments of the perinatal period, an overarching synthesis of the literature is currently lacking. We will conduct an umbrella review of SRs and MAs to assess to which extent CATs are associated with depressive symptoms reduction during pregnancy or after childbirth. METHODS AND ANALYSIS: We will search a broad set of electronic databases (MEDLINE via Ovid, Embase.com, CINAHL via EBSCOhost, PsycINFO via Ovid, AMED and Google Scholar). We will include SRs with or without MAs meeting the following criteria: (1) the review should focus mostly on individual studies reporting a randomised controlled design; (2) diagnosis should be made during pregnancy or during the post partum using a clinical interview according to DSM or ICD criteria; (3) the reviewed intervention should start during pregnancy or in the first postpartum year and meet the criteria for being considered as CAT. The main outcome will be depressive symptoms reduction during pregnancy or after childbirth. Secondary outcomes will include the remission of depression according to DSM criteria and intervention acceptability. Overlap between reviews will be described, quantified and discussed. We will rate the quality of the included SRs or MAs using the AMSTAR-2 tool. MAs will be performed by using the data from the individual RCT studies included in the SRs or MAs. Sensitivity analyses restricted to studies with a low-moderate risk of bias will be realised. Publication bias will be examined visually by using a funnel plot, and formally using the Egger's test and test of excess significance. ETHICS AND DISSEMINATION: We intend to publish the results of the umbrella review in an international peer-reviewed journal. Oral presentations in congresses and internal diffusion through the Rise up-PPD European COST Action network are also planned. PROSPERO REGISTRATION NUMBER: CRD42021229260.

Home-based transcranial direct current stimulation in dual active treatments for symptoms of depression and anxiety: A case series.

Transcranial direct current stimulation (tDCS) is a potential treatment strategy across some psychiatric conditions. However, there is high heterogeneity in tDCS efficacy as a stand-alone treatment. To increase its therapeutic potential, researchers have begun to explore the efficacy of combining tDCS with psychological and pharmacological interventions. The current case series details the effect of 6-10 weeks of self-administered tDCS paired with a behavioral therapy smartphone app (Flow™), on depressive and anxiety symptoms, in seven patients (26-51 years old; four female) presenting distinctive psychiatric disorders (major depression, dysthymia, illness anxiety disorder, obsessive-compulsive disorder, and anxiety disorders). tDCS protocol consisted of an acute phase of daily 30 min sessions, across 10 workdays (2 weeks Monday-to-Friday; Protocol 1) or 15 workdays (3 weeks Monday-to-Friday; Protocol 2). A maintenance phase followed, with twice-weekly sessions for 4 or 3 weeks, corresponding to 18 or 21 sessions in total (Protocol 1 or 2, respectively). The Flow tDCS device uses a 2 mA current intensity, targeting the bilateral dorsolateral prefrontal cortex. The Flow app offers virtually guided behavioral therapy courses to be completed during stimulation. We assessed depressive symptoms using MADRS-S and BDI-II, anxious symptoms using STAI-Trait, acceptability using ACCEPT-tDCS, and side effects using the Adverse Effects Questionnaire, at baseline and week 6 of treatment. Six patients underwent simultaneous cognitive-behavioral psychotherapy and two were on antidepressants and benzodiazepines. According to the Reliable Change Index (RCI), for depressive symptoms, we found clinically reliable improvement in five patients using MADRS-S (out of seven; RCI: -1.45, 80% CI; RCI: -2.17 to -4.82, 95% CI; percentage change: 37.9-66.7%) and in four patients using BDI-II (out of five; RCI: -3.61 to -6.70, 95% CI; percentage change: 57.1-100%). For anxiety symptoms, clinically reliable improvement was observed in five patients (out of six; RCI: -1.79, 90% CI; RCI: -2.55 to -8.64, 95% CI; percentage change: 12.3-46.4%). Stimulation was well-tolerated and accepted, with mild tingling sensation and scalp discomfort being the most common side effects. This case series highlights the applicability, acceptability, and promising results when combining home-based tDCS with psychotherapy and pharmacotherapy to manage depression and anxiety symptoms in clinical practice.

Changes in perinatal mental healthcare during the COVID-19 pandemic: a protocol for a collaborative research study between the COST actions RISEUP-PPD and DEVOTION.

INTRODUCTION: Significant changes in routine maternity care have been introduced globally in response to the COVID-19 pandemic to reduce infection risk, but also due to lack of medical facilities, staff shortages and the unpredictable nature of the disease. However, it is yet to be established if specialised perinatal mental health (PMH) services have been similarly affected. As a Task Force in PMH and COVID-19 pandemic within Riseup-PPD COST Action, this study aims to identify changes in PMH practices, policies and protocols during the COVID-19 pandemic in Europe. METHODS AND ANALYSIS: An online survey of experts in the PMH who are members of the COST Action 'Riseup-PPD' and the COST Action ''DEVOTION" across 36 European countries will be conducted. A questionnaire on changes in PMH care practices during the COVID-19 Pandemic will be administered. It consists of open-ended questions, checklists and ratings on a 7-point scale addressing seven domains of interest in terms of PMH: (1) policies, guidelines and protocols; (2) PMH care practices at a national level; (3) evidence of best practice; (4) barriers to usual care; (5) resources invested; (6) benefits of investment in the policies and (7) short-term and long-term expectations of the policies. Data will be collected using Qualtrics. Descriptive statistics will be reported and differences between countries will be examined using the χ2 statistic or Student's t-test. ETHICS AND DISSEMINATION: Ethical approval was obtained from The Ethics Committee for Research in Life and Health Sciences of the University of Minho (Portugal) to undertake an anonymous online survey. The findings will be disseminated to professional audience through peer-review publication and presentations and shared widely with stakeholders, policy-makers and service user groups. A position paper will be developed to influence policy-making at a European level to alleviate the adversities caused by COVID-19. TRIAL REGISTRATION NUMBER: NCT04779775.

Neurobiological Correlates of Fatherhood During the Postpartum Period: A Scoping Review.

During the postpartum period, the paternal brain suffers extensive and complex neurobiological alterations, through the experience of father-infant interactions. Although the impact of such experience in the mother has been increasingly studied over the past years, less is known about the neurobiological correlates of fatherhood-that is, the alterations in the brain and other physiological systems associated with the experience of fatherhood. With the present study, we aimed to perform a scoping review of the available literature on the genetic, neuroendocrine, and brain correlates of fatherhood and identify the main gaps in the current knowledge. PubMed, Scopus, and Web of Science electronic databases were searched for eligible studies on paternal neuroplasticity during the postpartum period, over the past 15 years. Reference lists of relevant key studies and reviews were also hand-searched. The research team independently screened the identified studies based on the established inclusion criteria. Extracted data were analyzed using tables and descriptive synthesis. Among the 29 studies that met our inclusion criteria, the vast majority pertained to neuroendocrine correlates of fatherhood (n = 19), followed by brain activity or connectivity (n = 7), association studies of candidate genes (n = 2), and brain structure correlates (n = 1). Collectively, studies published during the past 15 years suggest the existence of significant endocrine (testosterone, oxytocin, prolactin, and cortisol levels) and neurofunctional alterations (changed activity in several brain networks related to empathy and approach motivation, emotional processing and mentalizing, emotion regulation, dorsal attention, and default mode networks) as a result of fatherhood, as well as preliminary evidence of genetic variability accounting for individual differences during the postpartum period in fathers. No studies were so far published evaluating epigenetic mechanisms associated with the paternal brain, something that was also the focus of the current review. We highlight the need for further research that examines neuroplasticity during the experience of fatherhood and that considers both the interplay between hormones and simultaneous assessment of the different biomarkers (e.g., associations between hormones and neural activity); data collection protocols and assessment times should also be refined.

Association between cortical thickness and anxiety measures: A scoping review.

Cortical thickness has been increasingly studied in the context of structural-brain-behavior associations, such as anxiety; however, the literature is scattered across methods and research fields. This scoping review aims to summarize the available data concerning the association between cortical thickness and anxiety-related measures and identify the current research gaps. Searches were conducted in PubMed, PsycINFO/PsycARTICLES, Web of Science, OpenGrey and Networked Digital Library of Theses and Dissertations, and reference lists of key studies. Two researchers independently screened the abstracts and full-text reports according to the eligibility criteria, as well as extracted and charted the data. Quantitative and descriptive syntheses were conducted. The included publications (n = 18) reported cross-sectional studies, and 17 used surface-based approaches to estimate cortical thickness. Differences in regional cortical thickness were found to be associated with different anxiety-related measures/processes. Brain regions of interest include the medial orbitofrontal cortex, the ventromedial prefrontal cortex, the insula, the temporo-parietal areas, and the anterior cingulate cortex. However, caution should be warranted when interpreting the available results, as there is high variability in the field across anxiety-related measures, distinctive anxiety disorders, and data processing conditions and analysis. More research into this association is needed, to replicate and clarify existing findings.

Offline tDCS modulates prefrontal-cortical-subcortical-cerebellar fear pathways in delayed fear extinction.

Transcranial direct current stimulation (tDCS) has been studied to enhance extinction-based treatments for anxiety disorders. However, the field shows conflicting results about its anxiolytic effect and only a few studies have observed the extinction of consolidated memories. We looked to study the effect of offline 1 mA tDCS over the right dorsolateral pre-frontal cortex across the fear pathways, in consolidated fear response during delayed extinction. Participants (N = 34 women) underwent in a two-day fear conditioning procedure. On day 1, participants were assigned to the control group (N = 18) or the tDCS group (N = 16) and went through a fear acquisition procedure. On day 2, the tDCS group received 20 min tDCS before extinction and while inside the MRI scanner. The control group completed the extinction procedure only. The tDCS session (for the tDCS group) and the fMRI scan (for both groups) were completed just on the second day. Univariate fMRI analysis showed stimulation-dependent activity during late extinction with the tDCS group showing decreased neural activity during the processing of threat cues (CS +) and increased activity during the processing of safety cues (CS -), in prefrontal, postcentral and paracentral regions, during late extinction. ROI to whole-brain psychophysiological interaction (PPI) analysis showed the tDCS effect on the connectivity between the left dorsolateral prefrontal cortex three cortical-amygdalo-hippocampal-cerebellar pathway clusters during the processing of the CS + in late extinction (TFCE corrected; p < 0.05). Increased neuronal activity during the processing of safety cues and stronger coupling during the processing of threat cues might be the mechanisms by which tDCS contributes to stimuli discrimination.

Remotely delivered cognitive therapy for social anxiety disorder in adolescence: Preliminary efficacy evidence based on changes throughout treatment.

Cognitive therapy has been established as the frontline treatment for adults with social anxiety disorder (SAD); its efficacy with socially anxious adolescents is incipient but promising. This work investigated change in social anxiety symptoms reported by adolescents and their therapist as they go through remotely delivered 10-session cognitive therapy (i.e., CT@TeenSAD). Participants were 21 adolescents (81% females; M age = 16.10) diagnosed with SAD. They reported on change on their social anxiety symptoms at the beginning of each session; their therapist reported on how their symptoms had improved at the end of each session. Results, though preliminary, show that sessions had a significant impact on self- and therapist reported change, with consistent and continuous improvement across intervention sessions. Gender did not impact on that change, but therapist did: though the same pattern of change emerged for both therapists, it was more evident for the therapist with the greatest previous clinical experience. Overall, current findings align with the cognitive therapy framework of progressive gains throughout therapy. They also add evidence on the applicability and usefulness of an online cognitive approach to adolescents diagnosed with SAD.

Efficacy of non-invasive brain stimulation in decreasing depression symptoms during the peripartum period: A systematic review.

BACKGROUND: Non-invasive brain stimulation (NIBS) techniques have been suggested as alternative treatments to decrease depression symptoms during the perinatal period. These include brain stimulation techniques that do not require surgery and that are nonpharmacological and non-psychotherapeutic. NIBS with evidence of antidepressant effects include repetitive transcranial magnetic stimulation (rTMS), transcranial electric stimulation (TES) and electroconvulsive therapy (ECT). OBJECTIVES: This systematic review aims to summarize evidence on NIBS efficacy, safety and acceptability in treating peripartum depression (PPD). METHODS: We included randomized, non-randomized and case reports, that used NIBS during pregnancy and the postpartum. The reduction of depressive symptoms and neonatal safety were the primary and co-primary outcomes, respectively. RESULTS: rTMS shows promising results for the treatment of PPD, with clinically significant decreases in depressive symptoms between baseline and end of treatment and overall good acceptability. Although the safety profile for rTMS is adequate in the postpartum, caution is warranted during pregnancy. In TES, evidence on efficacy derives mostly from single-arm studies, compromising the encouraging findings. Further investigation is necessary concerning ECT, as clinical practice relies on clinical experience and is only described in low-quality case-reports. LIMITATIONS: The reduced number of controlled studies, the lack of complete datasets and the serious/high risk of bias of the reports warrant cautious interpretations. CONCLUSIONS AND IMPLICATIONS: Existing evidence is limited across NIBS techniques; comparative studies are lacking, and standard stimulation parameters are yet to be established. Although rTMS benefits from the most robust research, future multicenter randomized clinical trials are needed to determine the position of each NIBS strategy within the pathways of care.

Breastfeeding during COVID-19: A Narrative Review of the Psychological Impact on Mothers.

The COVID-19 pandemic has altered the normal course of life, with measures to reduce the virus spread impacting motherhood expectations and, in particular, breastfeeding practices. This study aimed to review evidence regarding the impact of COVID-19 on breastfeeding plans and how these relate to women's psychological outcomes. Searches were conducted on PubMed and Web of Science for studies in English, Spanish, and Portuguese between January 2020 and January 2021. All study designs and pre-prints were considered. Twelve studies were included. Reports suggest that COVID-19 impacts differently on breastfeeding plans, which in turn leads to distinctive mental health outcomes. Positive breastfeeding experiences have been observed when mothers perceive that they have more time for motherhood, which may be associated with better mental health outcomes. Negative breastfeeding experiences have been observed when mothers are separated from their newborns, when mothers struggle with breastfeeding, or when mothers perceive decreased family and professional support, which seems to be associated with worse mental health outcomes. These preliminary results highlight the need for further research into the association between COVID-19, breastfeeding expectations, and maternal mental health. Filling this gap will foster the development of guidelines and interventions to better support mothers experiencing the obstacles of COVID-19 pandemic.

Impact of the Covid-19 pandemic on perinatal mental health (Riseup-PPD-COVID-19): protocol for an international prospective cohort study.

BACKGROUND: Corona Virus Disease 19 (COVID-19) is a new pandemic, declared a public health emergency by the World Health Organization, which could have negative consequences for pregnant and postpartum women. The scarce evidence published to date suggests that perinatal mental health has deteriorated since the COVID-19 outbreak. However, the few studies published so far have some limitations, such as a cross-sectional design and the omission of important factors for the understanding of perinatal mental health, including governmental restriction measures and healthcare practices implemented at the maternity hospitals. Within the Riseup-PPD COST Action, a study is underway to assess the impact of COVID-19 in perinatal mental health. The primary objectives are to (1) evaluate changes in perinatal mental health outcomes; and (2) determine the risk and protective factors for perinatal mental health during the COVID-19 pandemic. Additionally, we will compare the results between the countries participating in the study. METHODS: This is an international prospective cohort study, with a baseline and three follow-up assessments over a six-month period. It is being carried out in 11 European countries (Albania, Bulgaria, Cyprus, France, Greece, Israel, Malta, Portugal, Spain, Turkey, and the United Kingdom), Argentina, Brazil and Chile. The sample consists of adult pregnant and postpartum women (with infants up to 6 months of age). The assessment includes measures on COVID-19 epidemiology and public health measures (Oxford COVID-19 Government Response Tracker dataset), Coronavirus Perinatal Experiences (COPE questionnaires), psychological distress (BSI-18), depression (EPDS), anxiety (GAD-7) and post-traumatic stress symptoms (PTSD checklist for DSM-V). DISCUSSION: This study will provide important information for understanding the impact of the COVID-19 pandemic on perinatal mental health and well-being, including the identification of potential risk and protective factors by implementing predictive models using machine learning techniques. The findings will help policymakers develop suitable guidelines and prevention strategies for perinatal mental health and contribute to designing tailored mental health interventions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04595123 .

The COVID-19 Pandemic Can Impact Perinatal Mental Health and the Health of the Offspring.

The COVID-19 ongoing pandemic constitutes a major challenge for countries throughout the world due to the rapid spread of SARS-CoV-2 and devastating consequences in health. No one is free from COVID-19 impact. In this regard, pregnant women are not the exception. The COVID-19 outbreak represents a massive source of stressful agents for women and their babies during the perinatal period. The COVID-19 pandemic has been suggested to potentially have short- and long-term detrimental effects on pregnant women and the baby. These adverse consequences range from mental to medical diseases. During the last centuries, several dreadful and fatal incidents have put pregnant women and their babies at higher risk of mortality and health deterioration. For example, it has been informed that women exposed to the 1918 flu pandemic (commonly known as the Spanish flu) while pregnant showed higher rates of premature delivery in the short term. Long-term consequences have also been reported and individuals (both males and females) who were exposed to the 1918 flu pandemic while in utero had a higher risk of developing schizophrenia, diabetes, coronary heart disease or cancer throughout their lifespan.

Emerging issues and questions on peripartum depression prevention, diagnosis and treatment: a consensus report from the cost action riseup-PPD.

BACKGROUND: Peripartum depression [PPD] is a public health problem which has been widely studied. Nonetheless, study findings and clinical guidelines for PPD treatment differ among countries and the condition is still underdiagnosed and undertreated, suggesting the importance of a global understanding of PPD. The Riseup-PPD Cost Action aims to establish a Pan-European and multidisciplinary network of researchers dedicated to the global understanding of PPD. METHODS: A literature search was performed in different databases (e.g., Medline, PsychInfo) including a combination of terms related with PPD diagnosis, prevention, treatment and cost-effectiveness of its management. A narrative synthesis of the literature, together with a critical overview of the current issues/questions to be addressed within the topic of PPD were performed. RESULTS: Emerging issues include challenges regarding definition and timing of PPD; heterogeneity in severity, timing of onset and assessment tools; comparative effectiveness of preventive and treatment interventions; help seeking for PPD; improving health professional's awareness of PPD; and cost-effectiveness of PPD management. LIMITATIONS: The main limitation is the non-systematic nature of the literature search. CONCLUSIONS: The Riseup-PPD network will deal with these challenges through four lines of action: (1)provide an updated and comprehensive synthesis of existing knowledge that can contribute to inform clinical recommendations and guidelines for PPD management; (2) clarify inconsistent findings concerning diagnosis, prevention and treatment of PPD; (3) develop new lines of research in the field of PPD; and (4) develop international recommendations for PPD diagnosis, prevention and treatment, ultimately influencing maternal mental health policymaking at global and local levels.

The effect of cathodal tDCS on fear extinction: A cross-measures study.

BACKGROUND: Extinction-based procedures are often used to inhibit maladaptive fear responses. However, because extinction procedures show efficacy limitations, transcranial direct current stimulation (tDCS) has been suggested as a promising add-on enhancer. OBJECTIVE: In this study, we tested how cathodal tDCS over the right dorsolateral prefrontal cortex affects extinction and tried to unveil the processes at play that boost the effectiveness of extinction procedures and its translational potential to the treatment of anxiety disorders. METHODS: We implemented a fear conditioning paradigm whereby 41 healthy women (mean age = 20.51 ± 5.0) were assigned to either cathodal tDCS (n = 27) or sham tDCS (n = 16). Fear responses were measured with self-reports, autonomic responses, and implicit avoidance tendencies. RESULTS: Cathodal tDCS shows no statistically significant effect in extinction, according to self-reports, and seems to even negatively affect fear conditioned skin conductance responses. However, one to three months after the tDCS session and extinction, we found a group difference in the action tendencies towards the neutral stimuli (F (1, 41) = 12.04, p = .001, ηp2 = .227), with the cathodal tDCS group (as opposed to the sham group) showing a safety learning (a positive bias towards the CS-), with a moderate effect size. This suggests that cathodal tDCS may foster stimuli discrimination, leading to a decreased generalization effect. DISCUSSION: Cathodal tDCS may have enhanced long-term distinctiveness between threatening cues and perceptively similar neutral cues through a disambiguation process of the value of the neutral stimuli-a therapeutic target in anxiety disorders. Future studies should confirm these results and extend the study of cathodal tDCS effect on short term avoidance tendencies.