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Exploration of the diversity in the diatom genus Homoeocladia across Micronesia revealed several clusters of undescribed species based on variations around several characters. Using ultrastructural data from scanning electron microscopy, we describe seventeen new species in three of these morphological groups. (1) A group with external thickenings includes eight new species with costae and/or bordered areolae on valve face and/or conopea and/or peri-raphe zone, and one with similar areolae but no ornamentation; this group includes the previously described H. jordanii. (2) Large, linear species, resembling H. asteropeae and H. tarangensis; we describe three new species close to the latter. (3) A sinuous-areolae group includes five new species with areola openings shaped like “~”, “s”, or “z” on the valve and/or girdle bands, or both, and leads to reconsideration of the diagnosis of Homoeocladia schefterae and the recognition that the globally widespread species in this complex is H. coacervata sp. nov. The three groups are based solely on morphology and no genetic relationships are implied within or between the groups, other than having the characteristics of the recently redefined genus Homoeocladia. However, the high diversity of species in Homoeocladia suggests the genus is a good candidate to test for species flocks in this region and in at least one other comparable location, incorporating DNA sampling through either culturing or metabarcoding.

Plain English summary We wanted to create practical guidance for people who are interested in developing plain language summaries of publications (PLS for short). PLS are summaries of scientific research published in journals or presented at conferences and are written in language that is easy to read and understand. We focused on how to involve patients in developing PLS, as they are often an important audience for these summaries. We brought together a group of people who had experience in PLS and patient involvement. As a working group, we wrote the first version of the ‘How-To’ Guide. Then we asked for feedback from others experienced in patient involvement and also from members of the general public. We got feedback on how we could improve what was in the guidance and also on how useful and user-friendly the guidance was. We used this feedback to create the final version of the ‘How-To’ Guide which is freely available online from https://pemsuite.org/How-to-Guides/WG5.pdf .

Introduction People with lived expertise in managing mental health challenges can be an important source of knowledge and support for other people facing similar challenges, and for carers to learn how best to help. However, opportunities for sharing lived expertise are limited. Living libraries support people with lived expertise to be ‘living books’, sharing their experiences in dialogue with ‘readers’ who can ask questions. Living libraries have been piloted worldwide in health-related contexts but without a clear model of how they work or rigorous evaluation of their impacts. We aim to develop a programme theory about how a living library could be used to improve mental health outcomes, using this theory to codesign an implementation guide that can be evaluated across different contexts.Methods and analysis We will use a novel integration of realist synthesis and experience-based codesign (EBCD) to produce a programme theory about how living libraries work and a theory and experience informed guide to establishing a library of lived experience for mental health (LoLEM). Two workstreams will run concurrently: (1) a realist synthesis of literature on living libraries, combined with stakeholder interviews, will produce several programme theories; theories will be developed collaboratively with an expert advisory group of stakeholders who have hosted or taken part in a living library and will form our initial analysis framework; a systematic search will identify literature about living libraries; data will be coded into our analysis framework, and we will use retroductive reasoning to explain living libraries’ impacts across multiple contexts. Individual stakeholder interviews will help refine and test theories; (2) data from workstream 1 will inform 10 EBCD workshops with people with experience of managing mental health difficulties and health professionals to produce a LoLEM implementation guide; data from this process will also inform the theory in workstream 1.Ethics and dissemination Ethical approval was granted by Coventry and Warwick National Health Service Research Ethics Committee on 29 December 2021 (reference number 305975). The programme theory and implementation guide will be published as open access and shared widely through a knowledge exchange event, a study website, mental health provider and peer support networks, peer reviewed journals and a funders report.PROSPERO registration details CRD42022312789.

Introduction Diagnosing underlying arrhythmia in emergency department (ED) syncope patients is difficult. There is a evidence that diagnostic yield for detecting underlying arrhythmia is highest when cardiac monitoring devices are applied early, ideally at the index visit. This strategy has the potential to change current syncope management from low diagnostic yield Holter to higher yield ambulatory monitoring, reduce episodes of syncope, reduce risk of recurrence and its potential serious consequences, reduce hospital admissions, reduce overall health costs and increase quality of life by allowing earlier diagnosis, treatment and exclusion of clinically important arrhythmias.Methods and analyses This is a UK open prospective parallel group multicentre randomised controlled trial of an immediate 14-day ambulatory patch heart monitor vs standard care in 2234 patients presenting acutely with unexplained syncope. Our patient focused primary endpoint will be number of episodes of syncope at 1 year. Health economic evaluation will estimate the incremental cost per syncope episode avoided and quality-adjusted life year gained.Ethics and dissemination Informed consent for participation will be sought. The ASPIRED trial received a favourable ethical opinion from South East Scotland Research Ethics Committee 01 (21/SS/0073). Results will be disseminated via scientific publication, lay summary and visual abstract.Trial registration number ISRCTN 10278811.

This paper reports an innovative, hybrid teaching model for a junior level lab course. This model leverages in-person lab operation by adding a student-led online learning mode. Both course outcomes and student outcomes were evaluated. Student feedback was collected, and its analysis showed both positive and negative impacts in this hybrid model. This work is not only valuable for developing online lab courses but also in terms of long-term development of distance learning.

Plain English summary Some patients are leading or helping with medical research to improve understanding of their condition and patient care. To share research findings, patients can author articles published in scientific journals. These articles are reviewed by experts and are known as peer-reviewed publications. Patient authors can provide unique and valuable insights from their experience of living with a condition. Demonstrating that patients can be authors would be easier if there was a quick way to find patient-authored publications. In this article, we describe who a patient author is and what patient-authored publications are. We identify factors that may encourage patients to author research publications. We highlight the practical guidance available to help patient authors and those working with them. To help future research about patient authorship, we need a way to find patient-authored publications. One way is for patients to include a standard search term, such as ‘Patient Author’ in the affiliation section of their publication. Like all authors, patient authors can list more than one affiliation, such as their workplace if they wish. We used the ‘Patient Author’ search term to look at publications in PubMed, a free resource to access scientific publications. We found the number of patient-authored publications using the ‘Patient Author’ tag increased nine times from 2020 and 2021. We encourage patients, funders, researchers and publishers to use a standard metatag or an agreed set of metatags. This could make it easier to find and raise awareness of patient-authored publications.

BackgroundMental health (MH) peer online forums offer robust support where internet access is common, but healthcare is not, e.g., in countries with under-resourced MH support, rural areas, and during pandemics. Despite their widespread use, little is known about who posts in such forums, and in what mood states. The discussion platform Reddit is ideally suited to study this as it hosts forums (subreddits) for MH and non-MH topics. In bipolar disorder (BD), where extreme mood states are core defining features, mood influences are particularly relevant.ObjectivesThis exploratory study investigated posting patterns of Reddit users with a self-reported BD diagnosis and the associations between posting and emotions, specifically: 1) What proportion of the identified users posts in MH versus non-MH subreddits? 2) What differences exist in the emotions that they express in MH or non-MH subreddit posts? 3) How does mood differ between those users who post in MH subreddits compared to those who only post in non-MH subreddits?MethodsReddit users were automatically identified via self-reported BD diagnosis statements and all their 2005-2019 posts were downloaded. First, the percentages of users who posted only in MH (non-MH) subreddits were calculated. Second, affective vocabulary use was compared in MH versus non-MH subreddits by measuring the frequency of words associated with positive emotions, anxiety, sadness, anger, and first-person singular pronouns via the LIWC text analysis tool. Third, a logistic regression distinguished users who did versus did not post in MH subreddits, using the same LIWC variables (measured from users' non-MH subreddit posts) as predictors, controlling for age, gender, active days, and mean posts/day.Results1) Two thirds of the identified 19,685 users with a self-reported BD diagnosis posted in both MH and non-MH subreddits. 2) Users who posted in both MH and non-MH subreddits exhibited less positive emotion but more anxiety and sadness and used more first-person singular pronouns in their MH subreddit posts. 3) Feminine gender, higher positive emotion, anxiety, and sadness were significantly associated with posting in MH subreddits.ConclusionsMany Reddit users who disclose a BD diagnosis use a single account to discuss MH and other concerns. Future work should determine whether users exhibit more anxiety and sadness in their MH subreddit posts because they more readily post in MH subreddits when experiencing lower mood or because they feel more able to express negative emotions in these spaces. MH forums may reflect the views of people who experience more extreme mood (outside of MH subreddits) compared to people who do not post in MH subreddits. These findings can be useful for MH professionals to discuss online forums with their clients. For example, they may caution them that forums may underrepresent people living well with BD.

Background Despite increasing evidence for the effectiveness of individual psychological interventions for bipolar disorder, research on older adults is lacking. We report the first randomised controlled trial of psychological therapy designed specifically for older adults with bipolar disorder. Aims To evaluate the feasibility and acceptability of recovery-focused therapy, designed in collaboration with older people living with bipolar disorder. Method A parallel, two-armed, randomised controlled trial comparing treatment as usual with up to 14 sessions of recovery-focused therapy plus treatment as usual, for older adults with bipolar disorder. Results Thirty-nine participants (67% female, mean age 67 years) were recruited over a 17-month period. Feasibility and acceptability of recruitment, retention (>80% observer-rated outcomes at both 24 and 48 weeks) and intervention processes were demonstrated. The majority of participants started therapy when offered, adhered to the intervention (68% attended all sessions and 89% attended six or more sessions) and reported positive benefits. Clinical assessment measures provide evidence of a signal for effectiveness on a range of outcomes including mood symptoms, time to relapse and functioning. No trial-related serious adverse events were identified. Conclusions Recovery-focused therapy is feasible, acceptable and has the potential to improve a range of outcomes for people living with bipolar disorder in later life. A large-scale trial is warranted to provide a reliable estimate of its clinical and cost-effectiveness.

Introduction Atrial fibrillation (AF) is the most common arrhythmia globally. It is associated with a fivefold risk in stroke, but early diagnosis and effective treatment can reduce this risk. AF is often underdiagnosed, particularly in low-income and middle-income countries (LMICs) where screening for AF is not always feasible or considered common practice in primary care settings. Epidemiological data on AF in LMICs is often incomplete particularly in vulnerable populations. This LMIC research collaborative aims to identify the prevalence of AF in the Northern Sri Lankan community.Methods and analysis A cross-sectional household survey piloted and codesigned through a series of community engagement events will be administered in all five districts in Northern Province, Sri Lanka. A multistage cluster sampling approach will be used starting at district level, then the Divisional Secretariats followed by Grama Niladhari divisions. Twenty households will be selected from each cluster. The study aims to recruit 10 000 participants aged 50 years or older, 1 participant per household. Demographic and socioeconomic characteristics, well-being and lifestyle and anthropometric measurements will be collected using a digital data platform (REDCap, Research Electronic Data Capture) by trained data collectors. Participants will be screened for AF using a fingertip single-lead ECG via a smartphone application (AliveCor) with rhythm strips reviewed by a consultant cardiologist. Prevalence of AF and risk factors will be established at province and district-levels. Adjusted ORs and population attributable fractions for AF risk factors will be determined.Ethics and dissemination This study was approved by the Ethics Review Committee of Faculty of Medicine at University of Jaffna. Written informed consent will be obtained from all participants. Findings will be disseminated through publication in a peer-reviewed journal and presentations at conferences. The findings will enable early treatment for new AF diagnoses and inform interventions to improve community-based management of AF in LMICs.

BackgroundRelatives of people with psychosis or bipolar disorder experience high levels of distress but are typically not offered the support they need. Online peer forums may offer a solution, but knowledge about who uses them, how, and why is limited. This study reported on online forum use during the Relatives Education and Coping Toolkit (REACT) trial. ObjectiveWe aimed to report who used the forum and why; how sociodemographic factors are associated with participation; the relationship among frequency, type of use, and outcomes; and how the forum was used. MethodsThe relationships between key sociodemographic characteristics, levels of forum use, and distress were statistically analyzed. We used thematic and semantic analyses to understand the reasons for relatives joining the forum and the key topics initiated by them. We also used the University Centre for Computer Corpus Research on Language Semantic Analysis System to compare how relatives and REACT supporters (moderators) used the forum. ResultsA total of 348 participants with full forum use data from REACT were included in this study. The forum was accessed by 59.4% (207/348) of the relatives across the entire age range, with no significant associations between sociodemographic factors and forum participation, or between level or type of use and relatives’ distress levels. Relatives joined the forum primarily to find people in similar circumstances, express concerns, and talk about stressful events. Relatives were most concerned about recent events, negative emotions linked to caring, experiences of conflict or threat, and concerns about suicide. These posts underscored both the challenges the relatives were facing and the fact that they felt safe sharing them in this context. ConclusionsAlthough only a proportion of REACT participants engaged actively with its forum, they were widely distributed across age and other sociodemographic groupings. Relatives used the forum for information, support, and guidance and to offer detailed information about their experiences. The topics raised highlighted the burden carried by relatives and the potential value of easy-access, moderated, peer-supported forums in helping relatives to manage the challenges they faced.

Introduction Atrial fibrillation (AF) is a common arrhythmia associated with 30% of strokes, as well as other cardiovascular disease, dementia and death. AF meets many criteria for screening, but there is limited evidence that AF screening reduces stroke. Consequently, no countries recommend national screening programmes for AF. The Screening for Atrial Fibrillation with ECG to Reduce stroke (SAFER) trial aims to determine whether screening for AF is effective at reducing risk of stroke. The aim of the pilot study is to assess feasibility of the main trial and inform implementation of screening and trial procedures.Methods and analysis SAFER is planned to be a pragmatic randomised controlled trial (RCT) of over 100 000 participants aged 70 years and over, not on long-term anticoagulation therapy at baseline, with an average follow-up of 5 years. Participants are asked to record four traces every day for 3 weeks on a hand-held single-lead ECG device. Cardiologists remotely confirm episodes of AF identified by the device algorithm, and general practitioners follow-up with anticoagulation as appropriate. The pilot study is a cluster RCT in 36 UK general practices, randomised 2:1 control to intervention, recruiting approximately 12 600 participants. Pilot study outcomes include AF detection rate, anticoagulation uptake and other parameters to incorporate into sample size calculations for the main trial. Questionnaires sent to a sample of participants will assess impact of screening on psychological health. Process evaluation and qualitative studies will underpin implementation of screening during the main trial. An economic evaluation using the pilot data will confirm whether it is plausible that screening might be cost-effective.Ethics and dissemination The London—Central Research Ethics Committee (19/LO/1597) and Confidentiality Advisory Group (19/CAG/0226) provided ethical approval. Dissemination will be via publications, patient-friendly summaries, reports and engagement with the UK National Screening Committee.Trial registration number ISRCTN72104369.

BackgroundDespite the rapid growth in the sophistication of research on bipolar disorder (BD), the field faces challenges in improving quality of life (QoL) and symptom outcomes, adapting treatments for marginalized communities, and disseminating research insights into real-world practice. Community-based participatory research (CBPR)-research that is conducted as a partnership between researchers and community members-has helped address similar gaps in other health conditions. This paper aims to improve awareness of the potential benefits of CBPR in BD research.MethodsThis paper is a product of the International Society for Bipolar Disorders (ISBD) Taskforce on Community Engagement which includes academic researchers, healthcare providers, people with lived experience of BD, and stakeholders from BD community agencies. Illustrative examples of CBPR in action are provided from two established centres that specialize in community engagement in BD research: the Collaborative RESearch Team to study psychosocial issues in BD (CREST.BD) in Canada, and the Spectrum Centre for Mental Health Research in the United Kingdom.Results and discussionWe describe the philosophy of CBPR and then introduce four core research areas the BD community has prioritized for research: new treatment approaches, more comprehensive outcome assessments, tackling stigma, and enhanced understanding of positive outcomes. We then describe ways in which CBPR is ideal for advancing each of these research areas and provide specific examples of ways that CBPR has already been successfully applied in these areas. We end by noting potential challenges and mitigation strategies in the application of CBPR in BD research.ConclusionsWe believe that CBPR approaches have significant potential value for the BD research community. The observations and concerns of people with BD, their family members, and supports clearly represent a rich source of information. CBPR approaches provide a collaborative, equitable, empowering orientation to research that builds on the diversity of strengths amongst community stakeholders. Despite the potential merits of this approach, CBPR is as yet not widely used in the BD research field, representing a missed opportunity.

The current article focuses on the morphological and molecular characterization of the often inconspicuous genus Amicula. This recently erected genus from brackish and marine sediments was monotypic but here we describe two new tropical species: Amicula micronesica sp. nov. and Amicula vermiculata sp. nov. Once considered an incertae sedis genus regarding its higher rank taxonomy, its position among the family Diploneidaceae is proposed here by molecular phylogenetics. The complete plastid and mitochondrial genomes of Amicula micronesica sp. nov. are also presented here. It appears that the 177614-bp long mitogenome is the biggest yet recorded among stramenopiles, due to its invasion by 57 introns. Moreover, it utilizes the genetic code 4 for translation instead of the code 1 usually found among diatoms.

Background: There is evidence to suggest that older people with Bipolar Disorder (BD) are more likely to demonstrate poor levels of functioning and score lower on well-being scales compared to non-clinical controls, even when in remission (Depp et al., 2006). To our knowledge, this is the first review paper to identify how quality of life and functioning has been measured in an older adult BD population. Methods: We conducted a systematic review of studies including a quantitative measure of psychosocial functioning or quality of life and older people over the age of 50 with a formal diagnosis of BD I or II. Results: Eleven studies (N = 726, mean age range 59.8 to 71.1) were included in the review, demonstrating a significant lack of research in the area compered to younger people with BD. The most commonly used measure of functioning was the Global Assessment of Functioning Scale (GAF) and results indicated that older adults with BD demonstrate a wide range of functioning. Limitations: The review used a comprehensive and systematic search strategy, however, very few eligible studies were available for review. The pooled analyses and reported means must be interpreted with caution due to the relatively small sample sizes. Conclusions: Older people with BD present with a wide range of functioning, ranging ‘major impairment’ to ‘superior’ scores. No existing validated measure assessing the psychosocial functioning or quality of life of older people with BD could be identified. Such a tool should be developed for use in future research.

BackgroundHealth researchers are increasingly using natural language processing (NLP) to study various mental health conditions using both social media and electronic health records (EHRs). There is currently no published synthesis that relates specifically to the use of NLP methods for bipolar disorder, and this scoping review was conducted to synthesize valuable insights that have been presented in the literature. ObjectiveThis scoping review explored how NLP methods have been used in research to better understand bipolar disorder and identify opportunities for further use of these methods. MethodsA systematic, computerized search of index and free-text terms related to bipolar disorder and NLP was conducted using 5 databases and 1 anthology: MEDLINE, PsycINFO, Academic Search Ultimate, Scopus, Web of Science Core Collection, and the ACL Anthology. ResultsOf 507 identified studies, a total of 35 (6.9%) studies met the inclusion criteria. A narrative synthesis was used to describe the data, and the studies were grouped into four objectives: prediction and classification (n=25), characterization of the language of bipolar disorder (n=13), use of EHRs to measure health outcomes (n=3), and use of EHRs for phenotyping (n=2). Ethical considerations were reported in 60% (21/35) of the studies. ConclusionsThe current literature demonstrates how language analysis can be used to assist in and improve the provision of care for people living with bipolar disorder. Individuals with bipolar disorder and the medical community could benefit from research that uses NLP to investigate risk-taking, web-based services, social and occupational functioning, and the representation of gender in bipolar disorder populations on the web. Future research that implements NLP methods to study bipolar disorder should be governed by ethical principles, and any decisions regarding the collection and sharing of data sets should ultimately be made on a case-by-case basis, considering the risk to the data participants and whether their privacy can be ensured.

IntroductionBipolar disorder is a severe and chronic mental health problem that persists into older adulthood. The number of people living with this condition is set to rise as the UK experiences a rapid ageing of its population. To date, there has been very little research or service development with respect to psychological therapies for this group of people.Methods and analysisA parallel two-arm randomised controlled trial comparing a 14-session, 6-month Recovery-focused Cognitive-Behavioural Therapy for Older Adults with bipolar disorder (RfCBT-OA) plus treatment as usual (TAU) versus TAU alone. Participants will be recruited in the North-West of England via primary and secondary mental health services and through self-referral. The primary objective of the study is to evaluate the feasibility and acceptability of RfCBT-OA; therefore, a formal power calculation is not appropriate. It has been estimated that randomising 25 participants per group will be sufficient to be able to reliably determine the primary feasibility outcomes (eg, recruitment and retention rates), in line with recommendations for sample sizes for feasibility/pilot trials. Participants in both arms will complete assessments at baseline and then every 3 months, over the 12-month follow-up period. We will gain an estimate of the likely effect size of RfCBT-OA on a range of clinical outcomes and estimate parameters needed to determine the appropriate sample size for a definitive, larger trial to evaluate the effectiveness and cost-effectiveness of RfCBT-OA. Data analysis is discussed further in the Analysis section in the main paper.Ethics and disseminationThis protocol was approved by the UK National Health Service (NHS) Ethics Committee process (REC ref: 15/NW/0330). The findings of the trial will be disseminated through peer-reviewed journals, national and international conference presentations and local, participating NHS trusts.Trial registration numberISRCTN13875321; Pre-results.

A 47-year-old woman with an implantable cardiac defibrillator and breast cancer underwent left breast mastectomy with simultaneous reconstruction using a breast tissue expander. She was found to have intermittent disabling of tachyarrhythmia detection and therapy functions of her implantable cardiac defibrillator that were triggered by the breast tissue expander magnetic port. (Level of Difficulty: Beginner.)

Abstract Background Carers of people with psychosis are at a greater risk of physical and mental health problems compared to the general population. Yet, not all carers will experience a decline in health. This predicament has provided the rationale for research studies exploring what factors predict poor wellbeing in carers of people with psychosis. Our study builds on previous research by testing the predictive value of demographic variables on carer wellbeing within a single regression model. Methods To achieve this aim, we conducted secondary analysis on two trial data sets that were merged and recoded for the purposes of this study. Results: Contrary to our hypotheses, only carer gender and age predicted carer wellbeing; with lower levels of carer wellbeing being associated with being female or younger (aged under 50). However, the final regression model explained only 11% of the total variance. Conclusions Suggestions for future research are discussed in light of the limitations inherent in secondary analysis studies. Further research is needed where sample sizes are sufficient to explore the interactive and additive impact of other predictor variables.

Abstract Background Suicide is a leading cause of death globally. Suicide deaths are elevated in those experiencing severe mental health problems, including schizophrenia. Psychological talking therapies are a potentially effective means of alleviating suicidal thoughts, plans, and attempts. However, talking therapies need to i) focus on suicidal experiences directly and explicitly, and ii) be based on testable psychological mechanisms. The Cognitive AppRoaches to coMbatting Suicidality (CARMS) project is a Randomised Controlled Trial (RCT) which aims to investigate both the efficacy and the underlying mechanisms of a psychological talking therapy for people who have been recently suicidal and have non-affective psychosis. Methods The CARMS trial is a two-armed single-blind RCT comparing a psychological talking therapy (Cognitive Behavioural Suicide Prevention for psychosis [CBSPp]) plus Treatment As Usual (TAU) with TAU alone. There are primary and secondary suicidality outcome variables, plus mechanistic, clinical, and health economic outcomes measured over time. The primary outcome is a measure of suicidal ideation at 6 months after baseline. The target sample size is 250, with approximately 125 randomised to each arm of the trial, and an assumption of up to 25% attrition. Hence, the overall recruitment target is up to 333. An intention to treat analysis will be used with primary stratification based on National Health Service (NHS) recruitment site and antidepressant prescription medication. Recruitment will be from NHS mental health services in the North West of England, UK. Participants must be 18 or over; be under the care of mental health services; have mental health problems which meet ICD-10 non-affective psychosis criteria; and have experienced self-reported suicidal thoughts, plans, and/or attempts in the 3 months prior to recruitment. Nested qualitative work will investigate the pathways to suicidality, experiences of the therapy, and identify potential implementation challenges beyond a trial setting as perceived by numerous stake-holders. Discussion This trial has important implications for countering suicidal experiences for people with psychosis. It will provide definitive evidence about the efficacy of the CBSPp therapy; the psychological mechanisms which lead to suicidal experiences; and provide an understanding of what is required to implement the intervention into services should it be efficacious. Trial registration ClinicalTrials.gov ( NCT03114917 ), 14th April 2017. ISRCTN (reference ISRCTN17776666 https://doi.org/10.1186/ISRCTN17776666 ); 5th June 2017). Registration was recorded prior to participant recruitment commencing.

Abstract Background The Relatives Education And Coping Toolkit (REACT) is an online supported self-management toolkit for relatives of people with psychosis or bipolar designed to improve access to NICE recommended information and emotional support. Aims Our aim was to determine clinical and cost-effectiveness of REACT including a Resource Directory (RD), versus RD-only. Methods A primarily online, observer-blind randomised controlled trial comparing REACT (including RD) with RD only (registration ISRCTN72019945 ). Participants were UK relatives aged > = 16, with high distress (assessed using the GHQ-28), and actively help-seeking, individually randomised, and assessed online. Primary outcome was relatives’ distress (GHQ-28) at 24 weeks. Secondary outcomes were wellbeing, support, costs and user feedback. Results We recruited 800 relatives (REACT = 399; RD only = 401) with high distress at baseline (GHQ-28 REACT mean 40.3, SD 14.6; RD only mean 40.0, SD 14.0). Median time spent online on REACT was 50.8 min (IQR 12.4–172.1) versus 0.5 min (IQR 0–1.6) on RD only. Retention to primary follow-up (24 weeks) was 75% (REACT n = 292 (73.2%); RD-only n = 307 (76.6%)). Distress decreased in both groups by 24 weeks, with no significant difference between the two groups (− 1.39, 95% CI -3.60, 0.83, p = 0.22). Estimated cost of delivering REACT was £62.27 per person and users reported finding it safe, acceptable and convenient. There were no adverse events or reported side effects. Conclusions REACT is an inexpensive, acceptable, and safe way to deliver NICE-recommended support for relatives. However, for highly distressed relatives it is no more effective in reducing distress (GHQ-28) than a comprehensive online resource directory. Trial registration ISRCTN72019945 prospectively registered 19/11/2015.

Abstract Background Despite the potential of digital health interventions to improve the delivery of psychoeducation to people with mental health problems and their relatives, and substantial investment in their development, there is little evidence of successful implementation into clinical practice. We report the first implementation study of a digital health intervention: Relatives Education And Coping Toolkit (REACT), into routine mental healthcare. Our main aim was to identify critical factors affecting staff uptake and use of this online self-management tool for relatives of people with psychosis or bipolar. Methods A mixed-methods, theory-driven (Normalisation Process Theory), iterative multiple case study approach using qualitative analysis of interviews with staff and quantitative reporting of uptake. Carer researchers were part of the research team. Results In all, 281 staff and 159 relatives from Early Intervention teams across six catchment areas (cases) in England registered on REACT; 129 staff took part in qualitative interviews. Staff were positive about REACT helping services improve support and meet clinical targets. Implementation was hindered by: high staff caseloads and difficulties prioritising carers; perception of REACT implementation as research; technical difficulties using REACT; poor interoperability with trust computer systems and care pathways; lack of access to mobile technology and training; restricted forum populations; staff fears of risk, online trolling, and replacement by technology; and uncertainty around REACT’s long-term availability. Conclusions Digital health interventions, such as REACT, should be iteratively developed, evaluated, adapted and implemented, in partnership with the services they aim to support, and as part of a long term national strategy to co-develop integrated technology-enabled mental healthcare. Implementation strategies must instil a sense of ownership for staff and ensure they have adequate IT training, appropriate governance protocols for online working, and adequate mobile technologies. Wider contextual factors including adequate funding for mental health services and prioritisation of carer support, also need to be addressed for successful implementation of carer focussed digital interventions. Trial registration Study registration: ISCTRN 16267685 .