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Examining the relationship between the oral microbiome, alcohol intake and alcohol-comorbid neuropsychological disorders: protocol for a scoping review

Por: Maki · K. A. · Crayton · C. B. · Butera · G. · Wallen · G. R.
Introduction

Heavy alcohol use and alcohol use disorder (AUD) continues to rise as a public health problem and increases the risk for disease. Elevated rates of anxiety, depression, sleep disruption and stress are associated with alcohol use. Symptoms may progress to diagnosed neurophysiological conditions and increase risk for relapse if abstinence is attempted. Research on mechanisms connecting the gastrointestinal microbiome to neuropsychological disorders through the gut-brain axis is well-established. Less is known how the oral microbiome and oral microbial-associated biomarkers may signal to the brain. Therefore, a synthesis of research studying relationships between alcohol intake, alcohol-associated neurophysiological symptoms and the oral microbiome is needed to understand the state of the current science. In this paper, we outline our protocol to collect, evaluate and synthesise research focused on associations between alcohol intake and AUD-related neuropsychological disorders with the oral microbiome.

Methods and analysis

The search strategy was developed and will be executed in collaboration with a medical research librarian. Studies will be screened by two independent investigators according to the aim of the scoping review, along with the outlined exclusion and inclusion criteria. After screening, data will be extracted and synthesised from the included papers according to predefined demographic, clinical and microbiome methodology metrics.

Ethics and dissemination

A scoping review of primary sources is needed to synthesise the data on relationships between alcohol use, neuropsychological conditions associated with AUD and the oral microbiome. The proposed scoping review is based on the data from publicly available databases and does not require ethical approval. We expect the results of this synthesis will identify gaps in the growing literature and highlight potential mechanisms linking the oral-brain axis to addiction and other associated neuropsychological conditions. The study findings and results will be disseminated through journals and conferences related to psychology, neuroscience, dentistry and the microbiome.

Geographical variation in perceptions, attitudes and barriers to mental health care-seeking across the UK: a cross-sectional study

Por: Wang · R. A. H. · Smittenaar · P. · Thomas · T. · Kamal · Z. · Kemp · H. · Sgaier · S. K.
Objectives

To examine the relative importance of the drivers of mental health care-seeking intention and how these, along with intention itself, are geographically distributed across integrated care systems (ICS) and health boards (HBs) in the UK. Also, to examine the degree of acceptance of virtual modes of care.

Design

Community-based cross-sectional survey.

Participants and setting

A national online survey of 17 309 adults between August and September 2021 recruited via a research technology company, Lucid. Sample size quotas were set to ensure coverage across the UK and match population distributions for gender, age and ethnicity. After exclusions, 16 835 participants remained (54% female, 89% white).

Main outcome measures

Care-seeking intention, using a continuous measure of likelihood and a categorical measure of estimated time to seek professional help for a future mental health difficulty.

Results

20.5% (95% CI 19.8% to 21.2%) reported that they would significantly delay or never seek mental healthcare, ranging from 8.3% to 25.7% across ICS/HBs. Multilevel regression analysis showed mental health knowledge was the most predictive of care-seeking intention, followed by attitudes towards others with mental illness and a combination of stigma, negative attitudes to treatment and instrumental barriers to accessing care. The model explained 17% of the variance. There was substantial geographical variation in prevalence of preclinical symptoms of depression and anxiety, attitudes to mental health, and barriers to care, leading to complex ICS/HB profiles. Remote and self-guided therapies did not pose as a major barrier to care with more than half of respondents likely or very likely to use them.

Conclusions

Our locally relevant and actionable findings suggest possible interventions that may improve care-seeking intention and indicate which of these interventions need to be geographically tailored to have maximal effect.

Home-based Intervention with Semaglutide Treatment of Neuroleptic-Related Prediabetes (HISTORI): protocol describing a prospective, randomised, placebo controlled and double-blinded multicentre trial

Por: Ganeshalingam · A. A. · Uhrenholt · N. G. · Arnfred · S. · Gaede · P. H. · Bilenberg · N. · Frystyk · J.
Introduction

Subjects with schizophrenia have a 2–3 fold higher mortality rate than the general population and a reduced life expectancy of 10–20 years. Approximately one-third of this excess mortality has been attributed to obesity-related type 2 diabetes (T2D) and to cardiovascular disease. Glucagon-like peptide-1 (GLP-1) analogues increase satiety and delay gastric emptying, thereby reducing food intake and weight. GLP-1 analogues also exert beneficial effects on cardiovascular outcomes in high-risk patients with T2D.

Our aim is to investigate whether 30 weeks add-on treatment with the GLP-1 analogue semaglutide can reduce HbA1c sufficiently to reverse pre-diabetes and the metabolic syndrome in overweight schizophrenic patients.

Methods and analysis

We will perform a 30 week, two-armed, multicentre, superiority, double-blinded, randomised trial investigating the effect of weekly injections of semaglutide versus placebo in mental health facilities in Region of Southern Denmark and Region of Zealand, Denmark. In total, 154 adults with schizophrenia spectrum disease, aged 18–60 years treated with second generation antipsychotic treatment, HbA1c 39–47 mmol/mol and body mass index >27 kg/m2 will be randomised to injections of 1.0 mg semaglutide or placebo. The primary outcome is changes in HbA1c. Secondary outcomes encompass metabolic measures, psychotic symptoms and quality of life. Exploratory outcomes encompass insulin sensitivity, cardiovascular risk profile, medication adherence, general well-being and physical activity.

Ethics and dissemination

This study will be carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. This research has obtained approval from both the Danish Medicines Agency and The Regional Committees on Health Research Ethics for Southern Denmark.

Trial registration number

NCT05193578 European Clinical Trials Database Number (EudraCT) 2020-004374-22, Regional Ethical Committee number S-20200182.

Hierarchy of demographic and social determinants of mental health: analysis of cross-sectional survey data from the Global Mind Project

Por: Bala · J. · Newson · J. J. · Thiagarajan · T. C.
Objectives

To understand the extent to which various demographic and social determinants predict mental health status and their relative hierarchy of predictive power in order to prioritise and develop population-based preventative approaches.

Design

Cross-sectional analysis of survey data.

Setting

Internet-based survey from 32 countries across North America, Europe, Latin America, Middle East and North Africa, Sub-Saharan Africa, South Asia and Australia, collected between April 2020 and December 2021.

Participants

270 000 adults aged 18–85+ years who participated in the Global Mind Project.

Outcome measures

We used 120+ demographic and social determinants to predict aggregate mental health status and scores of individuals (mental health quotient (MHQ)) and determine their relative predictive influence using various machine learning models including gradient boosting and random forest classification for various demographic stratifications by age, gender, geographical region and language. Outcomes reported include model performance metrics of accuracy, precision, recall, F1 scores and importance of individual factors determined by reduction in the squared error attributable to that factor.

Results

Across all demographic classification models, 80% of those with negative MHQs were correctly identified, while regression models predicted specific MHQ scores within ±15% of the position on the scale. Predictions were higher for older ages (0.9+ accuracy, 0.9+ F1 Score; 65+ years) and poorer for younger ages (0.68 accuracy, 0.68 F1 Score; 18–24 years). Across all age groups, genders, regions and language groups, lack of social interaction and sufficient sleep were several times more important than all other factors. For younger ages (18–24 years), other highly predictive factors included cyberbullying and sexual abuse while not being able to work was high for ages 45–54 years.

Conclusion

Social determinants of traumas, adversities and lifestyle can account for 60%–90% of mental health challenges. However, additional factors are at play, particularly for younger ages, that are not included in these data and need further investigation.

Cohort profile: BioMD-Y (biopsychosocial factors of major depression in youth) - a biobank study on the molecular genetics and environmental factors of depression in children and adolescents in Munich

Por: Scherff · A. D. · Feldmann · L. · Piechaczek · C. · Pehl · V. · Wagenbüchler · P. · Wermuth · I. · Ghotbi · N. · Allgaier · A.-K. · Freisleder · F. J. · Beins · E. C. · Forstner · A. J. · Nöthen · M. M. · Czamara · D. · Rex-Haffner · M. · Ising · M. · Binder · E. · Greimel · E. · Sch
Purpose

BioMD-Y is a comprehensive biobank study of children and adolescents with major depression (MD) and their healthy peers in Germany, collecting a host of both biological and psychosocial information from the participants and their parents with the aim of exploring genetic and environmental risk and protective factors for MD in children and adolescents.

Participants

Children and adolescents aged 8–18 years are recruited to either the clinical case group (MD, diagnosis of MD disorder) or the typically developing control group (absence of any psychiatric condition).

Findings to date

To date, four publications on both genetic and environmental risk and resilience factors (including FKBP5, glucocorticoid receptor activation, polygenic risk scores, psychosocial and sociodemographic risk and resilience factors) have been published based on the BioMD-Y sample.

Future plans

Data collection is currently scheduled to continue into 2026. Research questions will be further addressed using available measures.

Co-design and evaluation of a youth-informed organisational tool to enhance trauma-informed practices in the UK public sector: a study protocol

Por: Hugh-Jones · S. · Butcher · I. · Bhui · K.
Introduction

A trauma-informed approach (TIA) means working with awareness that people’s histories of trauma may shape the way they engage with services, organisations or institutions. Young people with adverse childhood experiences may be at risk of retraumatisation by organisational practices in schools and universities and by employers and health agencies when they seek support. There are limited evidence-based resources to help people working in the public sector to work with adolescents in trauma-informed ways and the needs of adolescents have not been central in resource development. This study contributes to public sector capacity to work in trauma-informed ways with adolescents by codesigning and evaluating the implementation of a youth-informed organisational resource.

Methods and analysis

This is an Accelerated Experience-based Co-design (AEBCD) Study followed by pre–post evaluation. Public sector organisations or services, and adolescents connected with them, will collaboratively reflect on lived experience data assembled through creative arts practice, alongside data from epidemiological national data sets. These will present knowledge about the impact of adverse childhood experiences on adolescents’ mental health (stage 1). Collaboratively, priorities (touch points) for organisational responses will be identified (stage 2), and a low-burden resource will be codesigned (stage 3) and offered for implementation (stage 4) and evaluation (stage 5) in diverse settings. The study will provide insights into what adolescents and public sector organisations in the UK want from a TIA resource, the experience of services/organisations in implementing this and recommendations for resource development and implementation.

Ethics and dissemination

The UK National Health Service Health Research Authority approved this study (23/WM/0105). Learning will be shared across study participants in a workshop at the end of the study. Knowledge products will include a website detailing the created resource and a youth-created film documenting the study process, the elements of the codesigned resource and experiences of implementation. Dissemination will target academic, healthcare, education, social care, third sector and local government settings via knowledge exchange events, social media, accessible briefings, conference presentations and publications.

Psychological adjustment to death anxiety: a qualitative study of Chinese patients with advanced cancer

Por: Chen · F. · Ou · M. · Xia · W. · Xu · X.
Objectives

Death anxiety (DA) refers to the negative emotions experienced when a person reflects on the inevitability of their own death, which is common among patients with cancer. It is crucial to understand the causes, coping styles and adjustment processes related to DA. The purpose of this qualitative study is to explore the adaptation process and outcome of patients with advanced cancer with DA and to provide evidence-based support for the development of targeted intervention measures to improve the mental health of such patients.

Design

This cross-sectional qualitative study sampled patients with advanced cancer (n=20). Grounded theory procedures were used to analyse transcripts and a theoretical model generated.

Setting

All interviewees in this study were from a tertiary oncology hospital in Hunan Province, China. The data analysis followed the constructive grounded theory method, involving constant comparison and memo writing.

Participants

A purposive and theoretical sampling approach was used to recruit 20 patients with advanced cancer with diverse characteristics.

Results

A total of 20 participants were included in the study. Four stages of DA in patients with advanced cancer were extracted from the interview data: (1) death reminder and prominence; (2) perception and association; (3) defence and control; (4) transformation and Acceptance.

Conclusions

This study highlights the psychological status and coping strategies of dynamic nature of patients with advanced cancer when confronted with negative emotions associated with death. It emphasises the importance of timely identification of DA in psychological nursing for patients with advanced cancer and the need for targeted psychological interventions based on their specific psychological processes.

Implications

Knowing interventions that aim to promote the integration of internal and external resources, enhance self-esteem and facilitate a calm and accepting attitude towards death could ultimately reduce the overall DA of patients with advanced cancer.

Telephone-based telepsychiatry consultations: a qualitative exploration of psychiatrists experiences in Oman

Por: Al-Mahrouqi · T. · Al-Alawi · K. · Al-Sabahi · F. · Al-Harrasi · A. · Al-Sinawi · H. · Al-Balushi · N. · Al-Shekaili · M. · Al-Alawi · M.
Objectives

The utilisation of tele-mental health services has the potential to address challenges in mental health services within the Eastern Mediterranean Region. However, the adoption of tele-mental health in Oman remains limited. Therefore, this study aimed to explore the experiences of psychiatrists with telephone consultations, offering valuable insights to advance the field of telepsychiatry.

Design

This is a qualitative exploratory study. The analysis of the data involved the application of manifest content analysis.

Setting

The semi-structured interviews were conducted with the psychiatrists at Al Masarra Hospital.

Participants

A total of 10 semi-structured interviews were conducted.

Results

The study reveals that psychiatrists encounter communication challenges in telephone consultations, such as the absence of visual cues, confirming patient identity, conducting comprehensive assessments and effectively communicating with younger patients who may lack developed social skills or patients with specific health conditions. Infrastructure limitations, such as outdated medical records, lack of electronic prescriptions and limited availability of child/adolescent psychiatric medications, further restrict the effectiveness of telepsychiatry consultations. In contrast, telephone appointments offer convenience and flexibility for psychiatrists, allowing them to manage non-clinical responsibilities and provide focused consultations tailored to individual needs. In addition, it benefits patients by improving appointment adherence, diminishing stigma and financial savings compared with in-person consultations.

Conclusions

Tele-mental health has emerged as a promising avenue for enhancing mental healthcare services in Oman. Addressing psychiatrists’ challenges is crucial to further developing and strengthening these services.

Scoping review of assessment tools for, magnitudes of and factors associated with problem drinking in population-based studies

Por: Dagne · K. · Myers · B. · Mihretu · A. · Teferra · S.
Background

The term "problem drinking" includes a spectrum of alcohol problems ranging from excessive or heavy drinking to alcohol use disorder. Problem drinking is a leading risk factor for death and disability globally. It has been measured and conceptualised in different ways, which has made it difficult to identify common risk factors for problem alcohol use. This scoping review aims to synthesise what is known about the assessment of problem drinking, its magnitude and associated factors.

Methods

Four databases (PubMed, Embase, PsycINFO, Global Index Medicus) and Google Scholar were searched from inception to 25 November 2023. Studies were eligible if they focused on people aged 15 and above, were population-based studies reporting problem alcohol use and published in the English language. This review was reported based on guidelines from the ‘Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews Checklist’. Critical appraisal was done using the Newcastle-Ottawa Scale.

Results

From the 14 296 records identified, 10 749 underwent title/abstract screening, of which 352 full-text articles were assessed, and 81 articles were included for data extraction. Included studies assessed alcohol use with self-report quantity/frequency questionnaires, criteria to determine risky single occasion drinking, validated screening tools, or structured clinical and diagnostic interviews. The most widely used screening tool was the Alcohol Use Disorder Identification Test. Studies defined problem drinking in various ways, including excessive/heavy drinking, binge drinking, alcohol use disorder, alcohol abuse and alcohol dependence. Across studies, the prevalence of heavy drinking ranged from

Conclusions

Due to differences in measurement, study designs and assessed risk factors, the prevalence of and factors associated with problem drinking varied widely across studies and settings. The alcohol field would benefit from harmonised measurements of alcohol use and problem drinking as this would allow for comparisons to be made across countries and for meta-analyses to be conducted.

Trial registration number

Open Science Framework ID: https://osf.io/2anj3.

Effectiveness of an online intervention for parents/guardians of children aged 4-7 years who are concerned about their childs emotional and behavioural development: protocol for an online randomised controlled trial (EMERGENT study)

Por: Frings · D. · Reavey · P. · Chew · J. · Leahy · M. · Allabyrne · C. · Herteliu · C.
Introduction

The demand for resources to support emotional and behavioural development in early childhood is ever increasing. However, conventional interventions are lacking in resources and have significant barriers. The Embers the Dragon programme helps address the growing unmet need of children requiring support. The delivery of the current project seeks to help support parents, reduce the burden placed on pressed services (eg, Child and Adolescent Mental Health Services) and to help improve the emotional and behavioural development of children.

Methods and analysis

This project aims to investigate the efficacy and acceptability of Embers on parenting and children’s psychosocial outcomes. 364 parents/guardians of children aged between 4 and 7 will be recruited via the internet, schools and general practitioners (GPs). This is an online waitlist-controlled trial with three arms: (1) control arm, (2) access to Embers arm and (3) access to Embers+school. Participants will be randomised (1:1) into (1) or (2) to evaluate the use of Embers at home. To evaluate scalability in schools, (3) will be compared with (2), and (1) to test efficacy against treatment as usual (not receiving the intervention). Qualitative interviews will also be conducted. Primary outcomes are the Parental Self-efficacy Scale, Strengths and Difficulties Questionnaire and qualitative interviews. Outcomes will be compared between the three groups at baseline, 8, 16 and 24 weeks.

Ethics and dissemination

Ethical approval has been granted by the London South Bank University ethics panel (ETH2324-0004). To recruit via GPs, NHS ethical approval has been applied for, and the IRAS (331410) application is under consideration by the Central Bristol REC. The results of the project will be submitted for publication in a peer-reviewed journal. Parents/guardians will provide informed consent online prior to taking part in the study. For the interviews, assent will be taken from children by the researchers on the day.

Trial registration number

ISRCTN58327872

A scoping review to map the research on the mental health of students and graduates during their university-to-work transitions

Por: Edmonds · D. M. · Zayts-Spence · O. · Fortune · Z. · Chan · A. · Chou · J. S. G.
Objectives

This scoping review maps the extant literature on students’ and graduates’ mental health experiences throughout their university-to-work transitions. The current review investigates the methodological features of the studies, the main findings, and the theories that the studies draw on to conceptualise mental health and transitions.

Design

This project used a scoping review methodology created and developed by Peters and colleagues and the Joanna Briggs Institute. The review searched academic databases and screened existing studies that met predetermined inclusion criteria.

Data sources

Seven academic databases and Google Scholar were searched with sets of search terms.

Eligibility

The included studies examined participants who were final-year university students or those who had graduated from university within a 3-year period. Studies published in English since 2000 and from any country were included. The review included studies examining the negative dimensions of mental health. The review excluded studies focusing on medical students and graduates.

Data extraction

Basic information about the studies and their findings on mental health and university-to-work transitions was retrieved. The findings are presented in tables and in a qualitative thematic summary.

Results

The scoping review included 12 studies. Mental health was often not explicitly defined and it’s theoretical foundations were not clearly articulated. The review identified factors, including a lack of social support and economic precarity, as sources of adverse mental health. Other protective factors in these studies—variables that guard against mental health problems—were identified, such as career preparedness and having a good job.

Conclusions

Despite the methodological focus on the negative aspects of mental health, people’s mental health experiences during university-to-work transitions are not uniformly negative. Clear conceptualisations of mental health in future studies will aid in developing resources to improve well-being.

Trial registration number

This scoping review adhered to a protocol previously published in this journal and that is registered on the Open Science Framework website (https://osf.io/gw86x).

Common practices for sociodemographic data reporting in digital mental health intervention research: a scoping review

Por: Kirvin-Quamme · A. · Kissinger · J. · Quinlan · L. · Montgomery · R. · Chernenok · M. · Pirner · M. C. · Pajarito · S. · Rapoport · S. · Wicks · P. · Darcy · A. · Greene · C. J. · Robinson · A.
Background

The ability of digital mental health interventions (DMHIs) to reduce mental health disparities relies on the recruitment of research participants with diverse sociodemographic and self-identity characteristics. Despite its importance, sociodemographic reporting in research is often limited, and the state of reporting practices in DMHI research in particular has not been comprehensively reviewed.

Objectives

To characterise the state of sociodemographic data reported in randomised controlled trials (RCTs) of app-based DMHIs published globally from 2007 to 2022.

Methods

A scoping review of RCTs of app-based DMHIs examined reporting frequency for 16 sociodemographic domains (eg, gender) and common category options within each domain (eg, woman). The search queried five electronic databases. 5079 records were screened and 299 articles were included.

Results

On average, studies reported 4.64 (SD=1.79; range 0–9) of 16 sociodemographic domains. The most common were age (97%) and education (67%). The least common were housing situation (6%), residency/location (5%), veteran status (4%), number of children (3%), sexual orientation (2%), disability status (2%) and food security (

Conclusions

This review describes the widespread underreporting of sociodemographic information in RCTs of app-based DMHIs published from 2007 to 2022. Reporting was often incomplete (eg, % female only), unclear (eg, the conflation of gender/sex) and limited (eg, only options representing majority groups were reported). Trends suggest reporting has somewhat improved in recent years. Diverse participant populations must be welcomed and described in DMHI research to broaden learning and the generalisability of results, a prerequisite of DMHI’s potential to reduce disparities in mental healthcare.

Examining behaviour change techniques (BCTs) in technology-based interventions for enhancing social participation in people with mild cognitive impairment (MCI) or dementia: a scoping review protocol

Por: Zhu · D. · Al Mahmud · A. · Liu · W.
Introduction

Technology-based interventions have improved the social participation of older adults with mild cognitive impairment (MCI) or dementia. Nevertheless, how these interventions modify social participation remains to be seen, and what efficient behaviour change techniques (BCTs) have been used. As such, this study aims to conduct a scoping review, identifying the features and BCTs behind technology-based interventions that improve social participation for individuals with MCI or dementia.

Methods and analysis

The scoping review method will be used to search journal articles from electronic databases, such as PsycINFO, PubMed, MEDLINE, Web of Science, Scopus and reference lists. Following the population, concept and context structure, this study focuses on adults over 60 diagnosed with MCI or dementia. It delves into technology-based interventions, specifically focusing on BCTs, features and overall effectiveness for improving social participation. The research considers contextual factors, exploring the diverse settings where these interventions are used, including homes, healthcare facilities and community centres. This approach aims to provide nuanced insights into the impact of technology-based interventions on social participation in the targeted demographic. Two authors will independently screen titles, abstracts and full texts using Covidence software. Disagreements will be resolved through consensus or a third reviewer, and reasons for exclusion will be documented. We will conduct a detailed analysis of BCTs to pinpoint effective strategies applicable to future technology-based intervention designs. Through this scoping review, we aim to provide valuable insights that guide the direction of future research. Specifically, we seek to inform the development of effective technology-based interventions tailored to support social participation for people with MCI or dementia.

Ethics and dissemination

Ethical approval is not necessary, as this review will use available articles from electronic databases. The outcome of the study will be published in a peer-reviewed journal.

Protocol registration number

https://osf.io/tkzuf/

Prevalence of depression, stress and suicide tendency among individuals with long COVID and determinants: a protocol of a systematic review and meta-analysis

Background

It is well known that the COVID-19 pandemic has had a devastating impact on mental health, especially among individuals with long COVID. This systematic review and meta-analysis aims to investigate the prevalence of depression, stress and suicide tendencies among individuals with long COVID, as well as to explore the factors that contribute to these conditions.

Methods and analysis

A comprehensive review of literature will be conducted in various databases of including PubMed, including Medline, Embase, PsycINFO, CINAHL and Cochrane Library. The studies to be included in this review will be published in the English language, and the time frame of included studies will be from the date of inception of COVID-19 until 30 December 2023. Two independent reviewers will identify studies for inclusion based on a screening questionnaire, and the JBI standardised critical appraisal checklist for studies reporting prevalence data will be used to assess the methodological quality. The strength of the body of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. To analyse the data, a robust Bayesian approach will be applied using the STATA software package (V.14; STATA) and JASP software. The findings of this systematic review and meta-analysis will provide valuable insights into the prevalence of depression, stress and suicide tendencies among individuals with long COVID, as well as the factors that contribute to these conditions.

Ethics and dissemination

There is no research ethics board approval required. The dissemination plan is to publish results in a peer-reviewed academic journal.

PROSPERO registration number

CRD42022346858.

Association of Long COVID with mental health disorders: a retrospective cohort study using real-world data from the USA

Por: Zhang · Y. · Chinchilli · V. M. · Ssentongo · P. · Ba · D. M.
Objectives

Mental health disorders (MHD) rank third for US adult hospitalisations. Given the substantial prevalence of ‘Long COVID’ in SARS-CoV-2 survivors, this study aims to assess its association with increased MHD risk using extensive real-world data.

Design

A retrospective cohort study with propensity score matching was conducted. We used the International Classification of Diseases, 10th Revision codes to identify individuals with Long COVID status and COVID-19 histories. Multivariable stratified Cox proportional hazards regression analysis was conducted to determine the association of Long COVID status with MHD.

Setting

Data were sourced from the TriNetX database, spanning records from 1 October 2021 to 16 April 2023.

Participants

Two distinct cohorts were established: one comprising individuals diagnosed with Long COVID and another comprising individuals with no history of Long COVID or COVID-19. At the start of the study, none of the participants had a recorded MHD.

Primary and secondary outcome measures

The main outcome of interest was a composite diagnosis of MHD. Secondary outcomes were individual mental health conditions.

Results

The study included 43 060 control participants without Long COVID and 4306 Long COVID participants, demonstrating well-balanced distribution across all covariates. After adjusting for 4 demographic factors and 10 comorbidities, Long COVID was associated with MHD (adjusted HR, aHR 2.60; 95% CI 2.37 to 2.85). In subgroup analysis, Long COVID was associated with major depression disorder (aHR 3.36; 95% CI 2.82 to 4.00) and generalised anxiety disorder (aHR 3.44; 95% CI 2.99 to 3.96).

Conclusions

In this retrospective large real-world cohort study, Long COVID was associated with an increased risk of incident MHD. The MHD impact is significant considering the vast number of patients with Long COVID. Enhanced MHD screening among COVID-19 survivors should be a priority.

What works for whom and why? Treatment effects and their moderators among forcibly displaced people receiving psychological and psychosocial interventions: study protocol for an individual patient data meta-analysis

Por: Kurath · J. · Akhtar · A. · Karyotaki · E. · Sijbrandij · M. · Cuijpers · P. · Bryant · R. · Morina · N.
Introduction

Forcibly displaced people (FDP) have a high risk of developing mental disorders such as post-traumatic stress (PTS) disorder. Providing adequate mental healthcare for FDP is crucial but despite overall efficacy of many existing interventions, a large proportion of FDP does not benefit from treatment, highlighting the necessity of further investigating factors contributing to individual differences in treatment outcome. Yet, the few studies that have explored moderators of treatment effects are often insufficiently powered. Therefore, the present Individual Patient Data meta-analysis (IPD-MA) will investigate treatment effects and their moderators—variables related to beneficiaries, providers, intervention and study characteristics in relation to PTS outcomes.

Methods and analysis

A systematic literature search will be conducted from database inception in the databases PsycINFO, Cochrane, Embase, PTSDpubs and Web of Science. Only studies published in English, German, French, Spanish, Portuguese, and Dutch will be considered. Retrieved records will be screened for eligibility. Randomised controlled trials on adult FDP receiving psychological and psychosocial interventions aimed at alleviating symptoms such as PTS compared with a control condition without intervention will be included in this IPD-MA. Subsequently, authors of eligible studies will be contacted to request individual patient data (IPD). All datasets obtained will be synthesised into one large dataset which will be analysed using a one-stage approach by conducting mixed-effects linear regression models (ie, primary analysis). Additionally, aggregate data meta-analyes will be run using a two-stage approach by conducting multivariate regression models including all IPD (transformed) and available meta-data from study reports (ie, secondary analysis). PTS will serve as primary outcome measure, while mental health outcomes other than PTS, attendance, attrition, treatment non-response and adverse outcomes will be examined as secondary outcomes.

Ethics and dissemination

This IPD-MA does not require ethical approval. The results will be published in international peer-reviewed journals.

PROSPERO registration number

CRD42022299510.

Cohort profile: The Scottish SHARE Mental Health (SHARE-MH) cohort - linkable survey, genetic and routinely collected data for mental health research

Por: Iveson · M. H. · Ball · E. L. · Doherty · J. · Pugh · C. · Vashishta · S. · Palmer · C. N. A. · McIntosh · A.
Purpose

The SHARE Mental Health (SHARE-MH) cohort was established to address the paucity of clinical and genetic data available for mental health research. The cohort brings together detailed mental health questionnaire responses, routinely collected electronic health data and genetic data to provide researchers with an unprecedented linkable dataset. This combination of data sources allows researchers to track mental health longitudinally, across multiple settings. It will be of interest to researchers investigating the genetic and environmental determinants of mental health, the experiences of those interacting with healthcare services, and the overlap between self-reported and clinically derived mental health outcomes.

Participants

The cohort consists of individuals sampled from the Scottish Health Research Register (SHARE). To register for SHARE, individuals had to be over the age of 16 years and living in Scotland. Cohort participants were recruited by email and invited to take part in an online mental health survey. When signing up for SHARE, participants also provided written consent to the use of their electronic health records and genetic data—derived from spare blood samples—for research purposes.

Findings to date

From 5 February 2021 to 27 November 2021, 9829 individuals completed a survey of various mental health topics, capturing information on symptoms, diagnoses, impact and treatment. Survey responses have been made linkable to electronic health records and genetic data using a single patient identifier. Linked data have been used to describe the cohort in terms of their demographics, self-reported mental health, inpatient and outpatient hospitalisations and dispensed prescriptions.

Future plans

The cohort will be improved through linkage to a broader variety of routinely collected data and to increasing amounts of genetic data obtained through blood sample diversion. We see the SHARE-MH cohort being used to drive forward novel areas of mental health research and to contribute to global efforts in psychiatric genetics.

Evaluation of a codesigned group cognitive-behavioural therapy intervention for trans young people (TAG TEAM): protocol for a feasibility trial and a subsequent pilot RCT

Por: Chinsen · A. · Cronin · T. J. · Pace · C. C. · Tollit · M. A. · Pang · K. C.
Introduction

Trans young people are at a higher risk of mental health difficulties such as depression, anxiety and suicidality than their cisgender peers, due in part to their experiences of minority stress. This protocol describes a feasibility trial and subsequent pilot randomised controlled trial (RCT) of a codesigned group cognitive–behavioural therapy intervention for trans young people, named Trans Adolescent Group ThErapy for Alleviating Minority stress (TAG TEAM).

Methods and analysis

To evaluate TAG TEAM, we will conduct a feasibility trial followed by a pilot RCT with trans young people aged 14–16 years who have been referred to the Royal Children’s Hospital Gender Service in Melbourne, Australia. In the feasibility trial, we aim to enrol 32 participants who will be randomised at a 1:1 ratio to either in-person or online intervention arms. Participants will be assessed at baseline and post-treatment, with a nested qualitative evaluation post-treatment. Primary outcomes are the feasibility and acceptability of the intervention and the study design and associated procedures, including comparison of the in-person and online delivery modes. In the subsequent pilot RCT, we aim to enrol 64 participants who will be randomised at a 1:1 ratio to an intervention or waitlist control arm, with delivery mode determined by the feasibility trial. Participants will complete assessments at baseline, post-treatment and 3-month follow-up. Primary outcomes are the feasibility and acceptability of the RCT study design. In both the feasibility trial and pilot RCT, participants will complete assessments related to mood, anxiety, suicidality, quality of life, minority stress, family support and social transition. Quantitative data will be analysed using descriptive statistics. Qualitative data will be analysed using thematic and interpretive analysis.

Ethics and dissemination

The Royal Children’s Hospital Human Research Ethics Committee has approved this study (#91162). Informed consent will be obtained in writing from all participants and a legal guardian. Findings will inform the development of a full-scale RCT to evaluate the efficacy of TAG TEAM and will be disseminated through conferences and peer-reviewed journals.

Trial registration number

ACTRN12623000302651, ACTRN12623000318684.

Enhancing emotion regulation with an in situ socially assistive robot among LGBTQ+ youth with self-harm ideation: protocol for a randomised controlled trial

Por: Williams · A. J. · Cleare · S. · Borschmann · R. · Tench · C. R. · Gross · J. · Hollis · C. · Chapman-Nisar · A. · Naeche · N. · Townsend · E. · Slovak · P. · On behalf of Digital Youth · Creswell · Fonagy · Arseneault · Lloyd · Mendes · Holter · Jirotka · Lazar · Patalay · Kelly · Ka
Introduction

Purrble, a socially assistive robot, was codesigned with children to support in situ emotion regulation. Preliminary evidence has found that LGBTQ+ youth are receptive to Purrble and find it to be an acceptable intervention to assist with emotion dysregulation and their experiences of self-harm. The present study is designed to evaluate the impact of access to Purrble among LGBTQ+ youth who have self-harmful thoughts, when compared with waitlist controls.

Methods and analysis

The study is a single-blind, randomised control trial comparing access to the Purrble robot with waitlist control. A total of 168 LGBTQ+ youth aged 16–25 years with current self-harmful ideation will be recruited, all based within the UK. The primary outcome is emotion dysregulation (Difficulties with Emotion Regulation Scale-8) measured weekly across a 13-week period, including three pre-deployment timepoints. Secondary outcomes include self-harm (Self-Harm Questionnaire), anxiety (Generalised Anxiety Disorder-7) and depression (Patient Health Questionnaire-9). We will conduct analyses using linear mixed models to assess primary and secondary hypotheses. Intervention participants will have unlimited access to Purrble over the deployment period, which can be used as much or as little as they like. After all assessments, control participants will receive their Purrble, with all participants keeping the robot after the end of the study. After the study has ended, a subset of participants will be invited to participate in semistructured interviews to explore engagement and appropriation of Purrble, considering the young people’s own views of Purrble as an intervention device.

Ethics and dissemination

Ethical approval was received from King’s College London (RESCM-22/23-34570). Findings will be disseminated in peer review open access journals and at academic conferences.

Trial registration number

NCT06025942.

Realist synthesis protocol on the effectiveness of a rapid response system in managing mental state deterioration in acute hospital settings

Por: Dziruni · T. B. · Hutchinson · A. M. · Keppich-Arnold · S. · Bucknall · T.
Introduction

Patient mental state deterioration impacts patient outcomes, staff and increases costs for healthcare organisations. Mental state is broadly defined to include not only mental health but a broad range of cognitive, emotional and psychological well-being factors. Mental state deterioration is inconsistently identified and managed within acute and tertiary medical settings. This protocol aims to synthesise the evidence to test and refine initial programme theories that outline the functioning of a rapid response system.

Methods and analysis

This synthesis will be guided by Pawson’s key steps in realist reviews. We will clarify the scope of synthesis through an initial literature search, focusing on understanding the functioning of rapid response system in managing patients presenting with mental state deterioration in acute hospital settings. Initial programme theories will be refined by developing a search strategy to comprehensively search electronic databases for relevant English language peer-reviewed studies. Additionally, we will search the grey literature for sources to supplement theory testing. An abstraction form will be developed to record the characteristics of literature sources. We will use spreadsheets to code and report contextual factors, underlying mechanisms, and outcome configurations.

Ethics and dissemination

As this study is a realist synthesis protocol, ethics approval is not required. Synthesis findings will be published in a peer-reviewed journal and presented at scientific conferences.

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