The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 3: study protocol to evaluate sustainment in a hybrid type 2 effectiveness-implementation cluster-randomized trial.

BACKGROUND: Although research on the implementation of evidence-based psychological treatments (EBPTs) has advanced rapidly, research on the sustainment of implemented EBPTs remains limited. This is concerning, given that EBPT activities and benefits regularly decline post-implementation. To advance research on sustainment, the present protocol focuses on the third and final phase-the Sustainment Phase-of a hybrid type 2 cluster-randomized controlled trial investigating the implementation and sustainment of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for patients with serious mental illness and sleep and circadian problems in community mental health centers (CMHCs). Prior to the first two phases of the trial-the Implementation Phase and Train-the-Trainer Phase-TranS-C was adapted to fit the CMHC context. Then, 10 CMHCs were cluster-randomized to implement Standard or Adapted TranS-C via facilitation and train-the-trainer. The primary goal of the Sustainment Phase is to investigate whether adapting TranS-C to fit the CMHC context predicts improved sustainment outcomes. METHODS: Data collection for the Sustainment Phase will commence at least three months after implementation efforts in partnering CMHCs have ended and may continue for up to one year. CMHC providers will be recruited to complete surveys (N = 154) and a semi-structured interview (N = 40) on sustainment outcomes and mechanisms. Aim 1 is to report the sustainment outcomes of TranS-C. Aim 2 is to evaluate whether manipulating EBPT fit to context (i.e., Standard versus Adapted TranS-C) predicts sustainment outcomes. Aim 3 is to test whether provider perceptions of fit mediate the relation between treatment condition (i.e., Standard versus Adapted TranS-C) and sustainment outcomes. Mixed methods will be used to analyze the data. DISCUSSION: The present study seeks to advance our understanding of sustainment predictors, mechanisms, and outcomes by investigating (a) whether the implementation strategy of adapting an EBPT (i.e., TranS-C) to the CMHC context predicts improved sustainment outcomes and (b) whether this relation is mediated by improved provider perceptions of treatment fit. Together, the findings may help inform more precise implementation efforts that contribute to lasting change. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05956678 . Registered on July 21, 2023.

The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 3: Study protocol to evaluate sustainment in a hybrid type 2 effectiveness-implementation cluster-randomized trial.

treatments (EBPTs) has advanced rapidly, research on the sustainment of implemented EBPTs remains limited. This is concerning, given that EBPT activities and benefits regularly decline post-implementation. To advance research on sustainment, the present protocol focuses on the third and final phase - the Sustainment Phase - of a hybrid type 2 cluster-randomized controlled trial investigating the implementation and sustainment of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for patients with serious mental illness and sleep and circadian problems in community mental health centers (CMHCs). Prior to the first two phases of the trial - the Implementation Phase and Train-the-Trainer Phase - TranS-C was adapted to fit the CMHC context. Then, 10 CMHCs were cluster-randomized to implement Standard or Adapted TranS-C via facilitation and train-the-trainer. The primary goal of the Sustainment Phase is to investigate whether adapting TranS-C to fit the CMHC context predicts improved sustainment outcomes. Methods: Data collection for the Sustainment Phase will commence at least three months after implementation efforts in partnering CMHCs have ended and may continue for up to one year. CMHC providers will be recruited to complete surveys (N = 154) and a semi-structured interview (N = 40) on sustainment outcomes and mechanisms. Aim 1 is to report the sustainment outcomes of TranS-C. Aim 2 is to evaluate whether manipulating EBPT fit to context (i.e., Standard versus Adapted TranS-C) predicts sustainment outcomes. Aim 3 is to test whether provider perceptions of fit mediate the relation between treatment condition (i.e., Standard versus Adapted TranS-C) and sustainment outcomes. Mixed methods will be used to analyze the data. Discussion: The present study seeks to advance our understanding of sustainment predictors, mechanisms, and outcomes by investigating (a) whether the implementation strategy of adapting an EBPT (i.e., TranS-C) to the CMHC context predicts improved sustainment outcomes and (b) whether this relation is mediated by improved provider perceptions of treatment fit. Together, the findings may help inform more precise implementation efforts that contribute to lasting change. Trial Registration: ClinicalTrials.gov identifier: NCT05956678. Registered on July 21, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT05956678?term=NCT05956678&draw=2&rank=1.

The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 2: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial using train-the-trainer.

BACKGROUND: Train-the-trainer (TTT) is a promising method for implementing evidence-based psychological treatments (EBPTs) in community mental health centers (CMHCs). In TTT, expert trainers train locally embedded individuals (i.e., Generation 1 providers) to deliver an EBPT, who then train others (i.e., Generation 2 providers). The present study will evaluate implementation and effectiveness outcomes of an EBPT for sleep and circadian dysfunction-the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)-delivered to CMHC patients with serious mental illness by Generation 2 providers (i.e., trained and supervised within CMHCs via TTT). Specifically, we will investigate whether adapting TranS-C to fit CMHC contexts improves Generation 2 (a) patient outcomes and (b) providers' perceptions of fit. METHODS: TTT will be implemented in nine CMHCs in California, USA (N = 60 providers; N = 130 patients) via facilitation. CMHCs are cluster-randomized by county to Adapted TranS-C or Standard TranS-C. Within each CMHC, patients are randomized to immediate TranS-C or usual care followed by delayed treatment with TranS-C (UC-DT). Aim 1 will assess the effectiveness of TranS-C (combined Adapted and Standard), compared to UC-DT, on improvements in sleep and circadian problems, functional impairment, and psychiatric symptoms for Generation 2 patients. Aim 2 will evaluate whether Adapted TranS-C is superior to Standard TranS-C with respect to Generation 2 providers' perceptions of fit. Aim 3 will evaluate whether Generation 2 providers' perceived fit mediates the relation between TranS-C treatment condition and patient outcomes. Exploratory analyses will (1) evaluate whether the effectiveness of TranS-C for patient outcomes is moderated by generation, (2) compare Adapted and Standard TranS-C on patient perceptions of credibility/improvement and PhenX Toolkit outcomes (e.g., substance use, suicidality), and (3) evaluate other possible moderators. DISCUSSION: This trial has potential to (a) inform the process of embedding local trainers and supervisors to expand delivery of a promising transdiagnostic treatment for sleep and circadian dysfunction, (b) add to the growing body of TTT literature by evaluating TTT outcomes with a novel treatment and population, and (c) advance our understanding of providers' perceptions of EBPT "fit" across TTT generations. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT05805657 . Registered on April 10, 2023.

The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 2: Study protocol for a hybrid type 2 effectiveness-implementation cluster- randomized trial using train-the-trainer.

Background: Train-the-trainer (TTT) is a promising method for implementing evidence-based psychological treatments (EBPTs) in community mental health centers (CMHCs). In TTT, expert trainers train locally embedded individuals (i.e., Generation 1 providers) to deliver an EBPT, who then train others (i.e., Generation 2 providers). The present study will evaluate implementation and effectiveness outcomes of an EBPT for sleep and circadian dysfunction-the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)-delivered to CMHC patients with serious mental illness by Generation 2 providers (i.e., trained and supervised within CMHCs via TTT). Specifically, we will investigate whether adapting TranS-C to fit CMHC contexts improves Generation 2 (a) patient outcomes (b) providers' perceptions of fit. Methods: TTT will be implemented in nine CMHCs in California, United States (N= 60 providers; N= 130 patients) via facilitation. CMHCs are cluster-randomized by county to Adapted TranS-C or Standard TranS-C. Within each CMHC, patients are randomized to immediate TranS-C or usual care followed by delayed treatment with TranS-C (UC-DT). Aim 1 will assess the effectiveness of TranS-C (combined Adapted and Standard), compared to UC-DT, on improvements in sleep and circadian problems, functional impairment, and psychiatric symptoms for Generation 2 patients. Aim 2 will evaluate whether Adapted TranS-C is superior to Standard TranS-C with respect to Generation 2 providers' perceptions of fit. Aim 3 will evaluate whether Generation 2 providers' perceived fit mediates the relation between TranS-C treatment condition and patient outcomes. Exploratory analyses will: (1) evaluate whether the effectiveness of TranS-C for patient outcomes is moderated by generation, (2) compare Adapted and Standard TranS-C on patient perceptions of credibility/improvement and PhenX Toolkit outcomes (e.g., substance use, suicidality); and (3) evaluate other possible moderators. Discussion: This trial has potential to inform the process of (a) embedding local trainers and supervisors to expand delivery of a promising transdiagnostic treatment for sleep and circadian dysfunction, (b) adding to the growing body of TTT literature by evaluating TTT outcomes with a novel treatment and population, and (c) advancing our understanding of providers' perceptions of EBPT 'fit' across TTT generations. Trial registration: Clinicaltrials.gov identifier: NCT05805657. Registered on April 10, 2023. https://clinicaltrials.gov/ct2/show/NCT05805657.

The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 1: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial.

BACKGROUND: Serious mental illness (SMI) can have devastating consequences. Unfortunately, many patients with SMI do not receive evidence-based psychological treatment (EBPTs) in routine practice settings. One barrier is poor "fit" between EBPTs and contexts in which they are implemented. The present study will evaluate implementation and effectiveness outcomes of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) implemented in community mental health centers (CMHCs). TranS-C was designed to target a range of SMI diagnoses by addressing a probable mechanism and predictor of SMI: sleep and circadian problems. We will investigate whether adapting TranS-C to fit CMHC contexts improves providers' perceptions of fit and patient outcomes. METHODS: TranS-C will be implemented in at least ten counties in California, USA (N = 96 providers; N = 576 clients), via facilitation. CMHC sites are cluster-randomized by county to Adapted TranS-C or Standard TranS-C. Within each county, patients are randomized to immediate TranS-C or usual care followed by delayed treatment with TranS-C (UC-DT). Aim 1 will compare TranS-C (combined Adapted and Standard) with UC-DT on improvements in sleep and circadian problems, functional impairment, and psychiatric symptoms. Sleep and circadian problems will also be tested as a mediator between treatment condition (combined TranS-C versus UC-DT) and functional impairment/psychiatric symptoms. Aim 2 will evaluate whether Adapted TranS-C is superior to Standard TranS-C with respect to provider perceptions of fit. Aim 3 will evaluate whether the relation between TranS-C treatment condition (Adapted versus Standard) and patient outcomes is mediated by better provider perceptions of fit in the Adapted condition. Exploratory analyses will (1) compare Adapted versus Standard TranS-C on patient perceptions of credibility/improvement and select PhenX Toolkit outcomes and (2) evaluate possible moderators. DISCUSSION: This trial has the potential to (a) expand support for TranS-C, a promising transdiagnostic treatment delivered to patients with SMI in CMHCs; (b) take steps toward addressing challenges faced by providers in delivering EBPTs (i.e., high caseloads, complex patients, poor fit); and (c) advance evidence on causal strategies (i.e., adapting treatments to fit context) in implementation science. TRIAL REGISTRATION: Clinicaltrials.gov NCT04154631. Registered on 6 November 2019. https://clinicaltrials.gov/ct2/show/NCT04154631.

A global analysis of One Health Networks and the proliferation of One Health collaborations.

There has been a renewed focus on threats to the human-animal-environment interface as a result of the COVID-19 pandemic, and investments in One Health collaborations are expected to increase. Efforts to monitor the development of One Health Networks (OHNs) are essential to avoid duplication or misalignment of investments. This Series paper shows the global distribution of existing OHNs and assesses their collective characteristics to identify potential deficits in the ways OHNs have formed and to help increase the effectiveness of investments. We searched PubMed, Google, Google Scholar, and relevant conference websites for potential OHNs and identified 184 worldwide for further analysis. We developed four case studies to show important findings from our research and exemplify best practices in One Health operationalisation. Our findings show that, although more OHNs were formed in the past 10 years than in the preceding decade, investment in OHNs has not been equitably distributed; more OHNs are formed and headquartered in Europe than in any other region, and emerging infections and novel pathogens were the priority focus area for most OHNs, with fewer OHNs focusing on other important hazards and pressing threats to health security. We found substantial deficits in the OHNs collaboration model regarding the diversity of stakeholder and sector representation, which we argue impedes effective and equitable OHN formation and contributes to other imbalances in OHN distribution and priorities. These findings are supported by previous evidence that shows the skewed investment in One Health thus far. The increased attention to One Health after the COVID-19 pandemic is an opportunity to focus efforts and resources to areas that need them most. Analyses, such as this Series paper, should be used to establish databases and repositories of OHNs worldwide. Increased attention should then be given to understanding existing resource allocation and distribution patterns, establish more egalitarian networks that encompass the breadth of One Health issues, and serve communities most affected by emerging, re-emerging, or endemic threats at the human-animal-environment interface.

Trends in Termination of Pregnancy for Foetal Urological Abnormalities in England and Wales: a Cross-Sectional Study.

The detection of developmental abnormalities in the foetus is considered an essential component of antenatal screening. Among the most frequently identified sonographically, and possibly one of the easiest recognised, are those affecting the urinary tract, with an incidence of 1-4 in 1000 pregnancies. As such, foetal urological abnormalities represent up to 30% of all prenatally diagnosed congenital anomalies. We analysed information recorded on the Health and Social Act 4 (HSA4) forms submitted to the Department of Health and Social Care (DHSC) for 2015 to 2019. There were 915 cases of termination of pregnancy for foetal urological anomaly between 2015 and 2019 in England and Wales, representing 0.09% of total abortions. There has been a steady increase in cases, from 186 in 2015 to 222 in 2018, followed by a more recent decline in 2019 to 172. All 915 cases were justified under Ground E of The Abortion Act 1967. Most terminations of pregnancy for foetal urological anomaly were carried out at 20 weeks gestation. Isolated urinary tract single diagnoses were the commonest, with megacystis being the most prevalent, followed by bilateral renal agenesis and bilateral cystic kidneys. Nearly a third of cases (32.2%) were performed in women aged 30-34 years, and almost 4/5 of women (78.7%) were of White ethnicity. Foetal urological abnormality is a complex issue affecting a significant minority of pregnant women. When severe abnormalities are detected by prenatal diagnosis, most women choose to terminate the pregnancy.

Travel restrictions and infectious disease outbreaks.

BACKGROUND: A key purpose of the International Health Regulations (IHR) is to prevent unwarranted interruptions to trade and travel during large and/or transnational infectious disease outbreaks. Nevertheless, such outbreaks continue to disrupt the travel industry. This aspect of the IHR has received little attention in the academic literature despite its considerable impact on affected States and commercial activity. This article outlines the challenges and gaps in knowledge regarding the relationship between outbreaks and the travel sector and discusses the opportunities for further research and policy work to overcome these challenges. METHODOLOGY: We conducted a literature review on the relationship between outbreaks and travel restrictions, with a particular focus on the 2014-16 Ebola epidemic in West Africa. This review was complemented by an expert roundtable at Chatham House and further supported by case studies and qualitative interviews. RESULTS: Numerous travel stakeholders are affected by, and affect, large-scale infectious disease outbreaks. These stakeholders react in different ways: peer pressure plays an important role for both governments and the travel sector, and the reactions of the media and public influence and are influenced by these stakeholders. While various data sources on travel are available, and World Health Organization is mandated to work with States, there is no recognized coordinating body to disseminate timely, consistent, reliable and authoritative information and best practices to all stakeholders. CONCLUSION: This article highlights the interdependent relationship between various travel stakeholders. The reasons for interruption of travel during the 2014-16 Ebola outbreak were complex, with decisions by States only partly contributing to the cessation. Decisions by non-state actors, particularly the travel industry itself, contributed significantly and were based on a variety of factors. Further research, analysis and policy development are required to mitigate the health and economic consequences of infectious disease outbreaks. Any further research will also need to take account of COVID-19 travel-related issues.

Developing Vaccines for SARS-CoV-2 and Future Epidemics and Pandemics: Applying Lessons from Past Outbreaks.

The COVID-19 pandemic is a stark reminder of the heavy toll that emerging infectious diseases (EIDs) with epidemic and pandemic potential can inflict. Vaccine development, scale-up, and commercialization is a long, expensive, and risky enterprise that requires substantial upfront planning and offers no guarantee of success. EIDs are a particularly challenging target for global health preparedness, including for vaccine development. Insufficient attention has been given to challenges, lessons learned, and potential solutions to support and sustain vaccine industry engagement in vaccine development for EIDs. Drawing from lessons from the most recent Ebola epidemic in the Democratic Republic of the Congo, as well as the 2009 H1N1 influenza, 2014-2016 Ebola, and 2015-16 Zika outbreaks preceding it, we offer our perspective on challenges facing EID vaccine development and recommend additional solutions to prioritize in the near term. The 6 recommendations focus on reducing vaccine development timelines and increasing business certainty to reduce risks for companies. The global health security community has an opportunity to build on the current momentum to design a sustainable model for EID vaccines.

Emergent threats: lessons learnt from Ebola.

Recent disease outbreaks have demonstrated the severe health, economic and political crises that epidemics can trigger. The rate of emergence of infectious diseases is accelerating and, with deepening globalisation, pathogens are increasingly mobile. Yet the 2014-2015 West African Ebola epidemic exposed major gaps in the world's capacity to prevent and respond to epidemics. In the midst of the world's second largest ever recorded Ebola outbreak in the Democratic Republic of the Congo, we reflect on six of the many lessons learnt from the epidemic in West Africa, focusing on progress made and the challenges ahead in preparing for future threats. While Ebola and other emerging epidemics will remain a challenge in the years to come, by working in partnership with affected communities and across sectors, and by investing in robust health systems, it is within our power to be better prepared when they strike.

'LMICs as reservoirs of AMR': a comparative analysis of policy discourse on antimicrobial resistance with reference to Pakistan.

Antimicrobial resistance (AMR) has recently emerged as a salient global issue, and policy formulation to address AMR has become a contested space, with various actors sharing competing-and sometimes contradictory-explanations of the problem and the range of possible solutions. To facilitate national policy setting and implementation around AMR, more needs to be done to effectively engage policymakers in low- and middle-income countries (LMICs). However, there is a dearth of research on differences in issue framing by external agencies and LMIC's national policymakers on the problem of AMR; such analyses are imperative to identify areas of conflict and/or potential convergence. We compared representations of AMR across nine policy documents produced by multilateral agencies, donor countries and an LMIC at the forefront of the global response to AMR-Pakistan. We analysed the texts in relation to five narratives that have been commonly used to frame health issues as requiring action: economic impact, stunting of human development, consequences for health equity, health security threats and relationship with food production. We found that AMR was most frequently framed as a threat to human health security and economic progress, with several US, UK and international documents depicting LMICs as 'hotspots' for AMR. Human development and equity dimensions of the problem were less frequently discussed as reasons to address the growing burden of AMR. It is clear that no single coherent narrative on AMR has emerged, with notable differences in framing in Pakistani and external agency led documents, as well as across stakeholders primarily working on human vs animal health. While framing AMR as a threat to economic growth and human security has achieved high-level political attention and catalysed action from governments in high-income countries, our analysis suggests that conflicting narratives relevant to policymakers in Pakistan may affect policy-making and impede the development and implementation of integrated initiatives needed to tackle AMR.

Is the current surge in political and financial attention to One Health solidifying or splintering the movement?

INTRODUCTION: The global health field has witnessed the rise, short-term persistence and fall of several movements. One Health, which addresses links between human, animal and environmental health, is currently experiencing a surge in political and financial attention, but there are well-documented barriers to collaboration between stakeholders from different sectors. We examined how stakeholder dynamics and approaches to operationalising One Health have evolved further to recent political and financial support for One Health. METHODS: We conducted a mixed methods study, first by qualitatively investigating views of 25 major policymakers and funders of One Health programmes about factors supporting or impeding systemic changes to strengthen the One Health movement. We then triangulated these findings with a quantitative analysis of the current operations of 100 global One Health Networks. RESULTS: We found that recent attention to One Health at high-level political fora has increased power struggles between dominant human and animal health stakeholders, in a context where investment in collaboration building skills is lacking. The injection of funding to support One Health initiatives has been accompanied by a rise in organisations conducting diverse activities under the One Health umbrella, with stakeholders shifting operationalisation in directions most aligned with their own interests, thereby splintering and weakening the movement. While international attention to antimicrobial resistance was identified as a unique opportunity to strengthen the One Health movement, there is a risk that this will further drive a siloed, disease-specific approach and that structural changes required for wider collaboration will be neglected. CONCLUSION: Our analysis indicated several opportunities to capitalise on the current growth in One Health initiatives and funding. In particular, evidence from better monitoring and evaluation of ongoing activities could support the case for future funding and allow development of more precise guidelines on best practices.

From 1976 to 2018: reflections on early investigations into the Ebola virus.

In the late 1970s, early investigations into the Ebola virus informed the world's understanding of what was then an unknown disease. One such study, published by Bowen and colleagues in 1978, laid the foundations for future research into its prevention and treatment. However, nearly four decades later, scientific progress had not translated into action on the ground with no approved drugs, no vaccines, and no diagnostic tests available when the 2014-15 outbreak began in West Africa. Encouragingly, it appears that we have learned important lessons from the 2014-2015 outbreak, with a swift and rigorous response to the most recent outbreaks in Équateur Province, Democratic Republic of Congo, including the deployment of a vaccine. Ebola will certainly remain a challenge in the years to come and we as the global health community must ensure that innovative research translates into policy and action on the ground, with the full participation of affected communities.

Split between two worlds: automated sensing reveals links between above- and belowground social networks in a free-living mammal.

Many animals socialize in two or more major ecological contexts. In nature, these contexts often involve one situation in which space is more constrained (e.g. shared refuges, sleeping cliffs, nests, dens or burrows) and another situation in which animal movements are relatively free (e.g. in open spaces lacking architectural constraints). Although it is widely recognized that an individual's characteristics may shape its social life, the extent to which architecture constrains social decisions within and between habitats remains poorly understood. Here we developed a novel, automated-monitoring system to study the effects of personality, life-history stage and sex on the social network structure of a facultatively social mammal, the California ground squirrel (Otospermophilus beecheyi) in two distinct contexts: aboveground where space is relatively open and belowground where it is relatively constrained by burrow architecture. Aboveground networks reflected affiliative social interactions whereas belowground networks reflected burrow associations. Network structure in one context (belowground), along with preferential juvenile-adult associations, predicted structure in a second context (aboveground). Network positions of individuals were generally consistent across years (within contexts) and between ecological contexts (within years), suggesting that individual personalities and behavioural syndromes, respectively, contribute to the social network structure of these free-living mammals. Direct ties (strength) tended to be stronger in belowground networks whereas more indirect paths (betweenness centrality) flowed through individuals in aboveground networks. Belowground, females fostered significantly more indirect paths than did males. Our findings have important potential implications for disease and information transmission, offering new insights into the multiple factors contributing to social structures across ecological contexts.This article is part of the theme issue 'Interdisciplinary approaches for uncovering the impacts of architecture on collective behaviour'.