Demographic characteristics, gambling engagement, mental health, and associations with harmful gambling risk among UK Armed Forces serving personnel.

INTRODUCTION: Harmful gambling negatively impacts individuals, families and communities. Growing international evidence indicates that the Armed Forces (AF) community may be at a comparatively higher risk of experiencing harm from gambling than the general population. The current study sought to identify general predictors of harmful gambling and gambling engagement among UK AF serving personnel (AFSP). METHODS: We conducted a cross-sectional, exploratory survey to identify associations between demographic factors, mental health, gambling engagement and gambling type in a sample (N=608) of AFSP. RESULTS: Most of the sample reported past-year gambling, with 23% having experienced harm. Male gender, younger age and lower educational attainment all predicted harmful gambling, as did mental health variables of prior generalised anxiety and post-traumatic stress symptomatology. Strategy-based gambling and online sports betting were also predictive of experiencing harm from gambling. CONCLUSIONS: The risk of harm from gambling is associated with demographic, mental health and gambling engagement variables among AFSP. Better understanding of these predictors is important for the development of individualised treatment approaches for harmful gambling.

Exploring early discontinuation of mental health outpatient treatment: language, demographics and clinical characteristics among migrant populations in Japan.

BACKGROUND: The fast-growing migrant population in Japan and globally poses challenges in mental healthcare, yet research addressing migrants' mental health treatment engagement remains limited. OBJECTIVE: This study examined language proficiency, demographic and clinical characteristics as predictors of early treatment discontinuation among migrants. METHODS: Electronic health record data from 196 adult migrants, identified from 14 511 patients who received mental health outpatient treatment during 2016 and 2019 at three central hospitals in the Tokyo-Yokohama metropolitan region of Japan, were used. We conducted multivariable regression models to identify predictors of early discontinuation within 3 months. FINDINGS: The study cohort (65% women, age range: 18-90 years, from 29 countries or regions) included 23% non-Japanese speakers. Japanese and non-Japanese speakers had similar discontinuation rates (26% vs 22%). Multivariable models revealed younger age (OR=0.97; 95% CI: 0.95, 0.99; p=0.016) and those with a primary diagnosis other than a schizophrenia spectrum disorder (OR=3.99; 95% CI: 1.36, 11.77; p=0.012) or a neurotic, stress-related and somatoform disorder (OR=2.79; 95% CI: 1.14, 6.84; p=0.025) had higher odds of early discontinuation. These effects were more pronounced among the Japanese speakers with significant language-by-age and language-by-diagnoses interactions. CONCLUSION: Younger age and having a primary diagnosis other than a schizophrenia spectrum disorder or a neurotic, stress-related and somatoform disorder increased vulnerability for discontinuing mental health treatment early in Japanese-speaking migrants but not for migrants with limited Japanese proficiency. CLINICAL IMPLICATIONS: Understanding language needs within a context of mental health treatment should go beyond assumed or observed fluency. Unmet language needs might increase vulnerability for treatment disengagement among migrants. Targeted clinical efforts are crucial for enhancing early treatment engagement and informing health practices in Japan and countries with growing migrant populations.

Mentalisation-based online intervention for psychologically distressed parents: protocol of a non-randomised feasibility trial of the Lighthouse Parenting Programme-Online (LPP-Online).

INTRODUCTION: Online-based interventions provide a low-threshold way to reach and support families. The mentalisation-based Lighthouse Parenting Programme is an established intervention aimed at preventing psychopathological development in children. The objective of this study is to examine the feasibility of an online adaptation of the Lighthouse Parenting Programme (LPP-Online), evaluating (a) recruitment capability, compliance, acceptability and satisfaction with the intervention; (b) the psychometric properties of and the acceptability regarding the adjunct psychological evaluation; and (c) the employed materials and resources. The study will also obtain a preliminary evaluation of participants' responses to the intervention. METHOD AND ANALYSIS: In this monocentric, one-arm, non-randomised feasibility trial, n=30 psychologically distressed parents with children aged 0 to 14 years will participate in the LPP-Online for a duration of 8 weeks. The intervention consists of online group sessions and individual sessions, 38 smartphone-based ecological momentary interventions (EMI), and psychoeducational materials (website, booklet). At baseline (T0) and the end of the intervention (T1), parents complete self-report questionnaires as well as 7-day ecological momentary assessments (EMA) via smartphone. During the intervention, additional EMA are completed before and after the daily EMI. An interview regarding parents' subjective experience with the intervention will be conducted at T1. The feasibility of the intervention, the psychological evaluation and the resources will be examined using descriptive and qualitative analyses. The preliminary evaluation of the parents' response to the intervention will be conducted by analysing pre-post changes in questionnaire measures and the 7-day EMA as well as data of additional EMA completed before and after the daily EMI. ETHICS AND DISSEMINATION: Ethical approval of the study has been obtained from the local ethics board (Faculty of Behavioural and Cultural Studies, University of Heidelberg). Consent to participate will be obtained before starting the assessments. Results will be disseminated as publications in peer-reviewed scientific journals and at international conferences. REGISTRATION DETAILS: German Clinical Trials Register (DRKS00027423), OSF (https://doi.org/10.17605/OSF.IO/942YW).

Evaluation of the Friendship Bench' Circle Kubatana Tose (CKT): an add-on support group intervention - a mixed-methods pilot interventional cohort study protocol.

INTRODUCTION: Mental disorders are endemic. However, the mental health treatment gap remains high, especially in low-resource settings. Task-shifting is a universally recommended strategy to mitigate the care gap. The Friendship Bench (FB), a task-shifting, low-intensity psychotherapy programme founded in Zimbabwe, is effective in managing anxiety and depression. The FB programme offers clients the choice of joining add-on mental health support groups known as Circle Kubatana Tose (CKT). These groups offer an opportunity for continued psychoeducation, social support and economic strengthening. However, the evidence base for the effectiveness of add-on support groups is sparse. We hypothesise that participation in CKT is associated with increased adherence to treatment regimens, social support and well-being. This mixed-methods prospective cohort study seeks to evaluate the intermediate effects (6-month follow-up) of CKT groups, including process outcome evaluation. METHODS AND ANALYSIS: We will recruit participants (N=178) receiving mental healthcare from the FB in Harare primary care clinics. Follow-up assessments will occur at enrolment, 6 weeks, 3 months and 6 months, assessing changes in common mental disorders (depression and anxiety), social support, positive psychological indices (hope and resilience), health-related quality of life, working alliance, economic outcomes (net income) and implementation outcome (feasibility, acceptability/satisfaction and uptake of services). Quantitative data will be analysed using descriptive analysis, bivariate statistics, Cox proportional hazard models and generalised mixed models (maximum likelihood estimation). Qualitative data will be analysed using thematic analysis. DISSEMINATION AND ETHICS: Ethical approval was granted by the Medical Research Council of Zimbabwe (MRCZ/A/2427). The findings will inform the potential utility of add-on support groups in the management of anxiety and depression using task-shifting. Dissemination study outcomes will be disseminated in academic journals, social media, conferences and policy briefs.

Capacity to Consent to Treatment of Substance Use Disorders at Ontario's Consent and Capacity Board: A Review of Past Reported Decisions.

Capacity to consent to treatment of substance use disorders at Ontario's Consent and Capacity Board: A review of past reported decisions.

An Ontario review of legal cases which have considered patients' ability to consent to substance use treatmentsPlain Language SummaryIn general, prescribers must consider whether informed consent was provided prior to starting a treatment. A patient is presumed to be capable to consent to a proposed treatment but could be incapable with respect to any medical treatment. While incapacity is often considered for psychiatric treatments, it could be relevant to substance use treatment like methadone or suboxone, which are also called "Opioid Agonist Therapies" or OAT. OAT is lifesaving and prevents relapse and overdose when a person has an opioid use disorder. If a patient is found incapable of consenting to a treatment, a Substitute Decisions Maker would become the decision maker. In such cases, the patient has the ability to contest or disagree with the finding, and this results in a tribunal hearing at the Consent and Capacity Board in Ontario (CCB). In certain circumstances, the CCB publishes what are known as its Reasons for Decision (RDs), which explain the tribunal's reasoning in coming to a decision in favour of the physician or the person found incapable. This information is publicly searchable. Our methods involved a search of all available CCB RDs in Ontario for search terms related to substance use treatment, such as "methadone". We found that between June 1, 2003 (the date on reporting of RDs began) and June 27, 2023, only 71 RDs involved substance use search terms, out of a total of 10,463 reported RDs. Only one case involved the CCB upholding a finding of incapacity with respect to methadone treatment. These results imply that there are few cases in which the CCB has considered incapacity with respect to substance use treatment, although it is possible that these cases are reported at a lower frequency than other cases.

Assessing biomarkers of remission in female patients with anorexia nervosa (REMANO): a protocol for a prospective cohort study with a nested case-control study using clinical, neurocognitive, biological, genetic, epigenetic and neuroimaging markers in a French specialised inpatient unit.

BACKGROUND: Anorexia nervosa (AN) is a severe psychiatric disorder associated with frequent relapses and variability in treatment responses. Previous literature suggested that such variability is influenced by premorbid vulnerabilities such as abnormalities of the reward system. Several factors may indicate these vulnerabilities, such as neurocognitive markers (tendency to favour delayed reward, poor cognitive flexibility, abnormal decision process), genetic and epigenetic markers, biological and hormonal markers, and physiological markers.The present study will aim to identify markers that can predict body mass index (BMI) stability 6 months after discharge. The secondary aim of this study will be focused on characterising the biological, genetic, epigenetic and neurocognitive markers of remission in AN. METHODS AND ANALYSIS: One hundred and twenty-five (n=125) female adult inpatients diagnosed with AN will be recruited and evaluated at three different times: at the beginning of hospitalisation, when discharged and 6 months later. Depending on the BMI at the third visit, patients will be split into two groups: stable remission (BMI≥18.5 kg/m²) or unstable remission (BMI<18.5 kg/m²). One hundred (n=100) volunteers will be included as healthy controls.Each visit will consist in self-reported inventories (measuring depression, anxiety, suicidal thoughts and feelings, eating disorders symptoms, exercise addiction and the presence of comorbidities), neurocognitive tasks (Delay Discounting Task, Trail-Making Test, Brixton Test and Slip-of-action Task), the collection of blood samples, the repeated collection of blood samples around a standard meal and MRI scans at rest and while resolving a delay discounting task.Analyses will mainly consist in comparing patients stabilised 6 months later and patients who relapsed during these 6 months. ETHICS AND DISSEMINATION: Investigators will ask all participants to give written informed consent prior to participation, and all data will be recorded anonymously. The study will be conducted according to ethics recommendations from the Helsinki declaration (World Medical Association, 2013). It was registered on clinicaltrials.gov on 25 August 2020 as 'Remission Factors in Anorexia Nervosa (REMANO)', with the identifier NCT04560517 (for more details, see https://clinicaltrials.gov/ct2/show/record/NCT04560517). The present article is based on the latest protocol version from 29 November 2019. The sponsor, Institut National de la Santé Et de la Recherche Médicale (INSERM, https://www.inserm.fr/), is an academic institution responsible for the monitoring of the study, with an audit planned on a yearly basis.The results will be published after final analysis in the form of scientific articles in peer-reviewed journals and may be presented at national and international conferences. TRIAL REGISTRATION NUMBER: clinicaltrials.govNCT04560517.

Severe psychiatric disorders are associated with increased risk of dementia.

BACKGROUND: Individuals with psychiatric disorders have an increased risk of developing dementia. Most cross-sectional studies suffer from selection bias, underdiagnosis and poor population representation, while there is only limited evidence from longitudinal studies on the role of anxiety, bipolar and psychotic disorders. Electronic health records (EHRs) permit large cohorts to be followed across the lifespan and include a wide range of diagnostic information. OBJECTIVE: To assess the association between four groups of psychiatric disorders (schizophrenia, bipolar disorder/mania, depression and anxiety) with dementia in two large population-based samples with EHR. METHODS: Using EHR on nearly 1 million adult individuals in Wales, and from 228 937 UK Biobank participants, we studied the relationships between schizophrenia, mania/bipolar disorder, depression, anxiety and subsequent risk of dementia. FINDINGS: In Secure Anonymised Information Linkage, there was a steep increase in the incidence of a first diagnosis of psychiatric disorder in the years prior to the diagnosis of dementia, reaching a peak in the year prior to dementia diagnosis for all psychiatric diagnoses. Psychiatric disorders, except anxiety, were highly significantly associated with a subsequent diagnosis of dementia: HRs=2.87, 2.80, 1.63 for schizophrenia, mania/bipolar disorder and depression, respectively. A similar pattern was found in the UK Biobank (HRs=4.46, 3.65, 2.39, respectively) and anxiety was also associated with dementia (HR=1.34). Increased risk of dementia was observed for all ages at onset of psychiatric diagnoses when these were divided into 10-year bins. CONCLUSIONS: Psychiatric disorders are associated with an increased risk of subsequent dementia, with a greater risk of more severe disorders. CLINICAL IMPLICATIONS: A late onset of psychiatric disorders should alert clinicians of possible incipient dementia.

Medical students' attitudes towards well-being and welfare: a systematic review protocol.

INTRODUCTION: Medical education poses serious stressors on medical students, as they report overall higher rates of psychiatric comorbidities compared with students enrolled in other university-level courses. The high rates of poor well-being reported should be considered a concern, as students represent the future workforce of healthcare professionals. Although there has been an increased interest towards well-being and burn-out in medical students, there is still much to be elucidated. Indeed, there is an overall lack of understanding of which attitudes medical students have towards well-being and welfare, something that could be used to develop targeted practice to improve medics' quality of life and reduce overall burn-out.This review will aim at evaluating and reporting the current research available on medical students' attitudes towards well-being and welfare. We will take into account which countries have published data on the topic, and we will analyse papers written during the COVID-19 period separately, giving this particular time frame a separate outlook. METHODS AND ANALYSIS: This systematic review protocol has been developed following Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. A systematic search including "medical students" AND "wellbeing" AND "perceptions" was carried out on MEDLINE, Embase and Scopus databases. The Mixed Method Appraisal Tool will be used to assess the quality of the available studies and risk of bias. Studies will be screened using predetermined inclusion and exclusion criteria. Data will be summarised narratively and in tabular forms. A narrative subgroup analysis of the COVID-19 period will be carried out, and a country-wise approach will be used to describe which areas have published relevant studies. ETHICS AND DISSEMINATION: This will be the first systematic review looking at the reported attitudes that medical students have towards well-being and welfare. This will provide an account of the available data on the topic, and a starting point to understand where further research is needed in the future. PROSPERO REGISTRATION NUMBER: CRD42023471022.

Mortality and adverse events associated with statin use in primary care patients with depression: a real-world, population-based cohort study.

BACKGROUND: New National Institute for Health and Care Excellence (NICE) guidance endorses the prescription of statins in larger population groups for the prevention of cardiovascular and cerebrovascular morbidity and mortality, especially in people with severe mental illness. However, the evidence base for their safety and risk/benefit balance in depression is not established. OBJECTIVES: This study aims to assess the real-world mortality and adverse events of statins in depressive disorders. METHODS: Population-based, nationwide (England), between-subject, cohort study. We used electronic health records (QResearch database) of people aged 18-100 years with first-episode depression, registered with English primary care practices over January 1998-August 2020 for 12(+) months, divided into statin users versus non-users.Primary safety outcomes included all-cause mortality and any adverse event measured at 2, 6 and 12 months. Multivariable logistic regression was employed to control for several potential confounders and calculate adjusted ORs (aORs) with 99% CIs. FINDINGS: From over 1 050 105 patients with depression (42.64% males, mean age 43.23±18.32 years), 21 384 (2.04%) died, while 707 111 (67.34%) experienced at least one adverse event during the 12-month follow-up. Statin use was associated with lower mortality over 12 months (range aOR2-12months 0.66-0.67, range 99% CI 0.60 to 0.73) and with lower adverse events over 6 months (range aOR2-6months 0.90-0.96, range 99% CI 0.91 to 0.99), but not at 1 year (aOR12months 0.99, 99% CI 0.96 to 1.03). No association with any other individual outcome measure (ie, any other neuropsychiatric symptoms) was identified. CONCLUSIONS: We found no evidence that statin use among people with depression increases mortality or other adverse events. CLINICAL IMPLICATIONS: Our findings support the safety of updated NICE guidelines for prescribing statins in people with depressive disorders.

Mentalising imagery therapy for family dementia caregivers: protocol for a scoping review.

INTRODUCTION: Dementia is a growing public health concern, and providing long-term care for individuals affected by this condition is challenging for their family caregivers. While researchers have explored various intervention options to provide psychological support for dementia caregivers, mentalising imagery therapy (MIT) has gained significant recognition as an effective programme. Despite its significance and effectiveness, there is a lack of comprehensive scoping reviews of MIT in dementia caregiving. Thus, conducting such a review can provide valuable insights into the status and outcomes of MIT, identify gaps in existing research and provide recommendations for a more effective clinical practice. METHODS AND ANALYSIS: This study proposes a scoping review conducted according to the Joanna Briggs Institute, Arksey and O'Malley's methodological framework, as well as the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Review Extension. PubMed, Web of Science, Embase, Scopus, CINAHL and PsycINFO databases will be searched while grey literature will be retrieved via Google Scholar. Covidence will be used to manage the literature selection process and remove duplicate publications. Two researchers will independently screen the literature according to the inclusion criteria, with any discrepancies resolved through discussions with a third researcher. Data will be presented in a structured tabular format, with a narrative synthesis providing an overview of the findings on the identified research gaps and the effectiveness of MIT in the field of dementia caregiving. ETHICS AND DISSEMINATION: In a scoping review, no ethical approval is necessary. The results will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: The scoping review protocol has been registered with Open Science Framework (https://doi.org/10.17605/OSF.IO/FHRG8).

Canadian Network for Mood and Anxiety Treatments (CANMAT) 2023 Update on Clinical Guidelines for Management of Major Depressive Disorder in Adults: Réseau canadien pour les traitements de l'humeur et de l'anxiété (CANMAT) 2023 : Mise à jour des lignes directrices cliniques pour la prise en charge du trouble dépressif majeur chez les adultes.

BACKGROUND: The Canadian Network for Mood and Anxiety Treatments (CANMAT) last published clinical guidelines for the management of major depressive disorder (MDD) in 2016. Owing to advances in the field, an update was needed to incorporate new evidence and provide new and revised recommendations for the assessment and management of MDD in adults. METHODS: CANMAT convened a guidelines editorial group comprised of academic clinicians and patient partners. A systematic literature review was conducted, focusing on systematic reviews and meta-analyses published since the 2016 guidelines. Recommendations were organized by lines of treatment, which were informed by CANMAT-defined levels of evidence and supplemented by clinical support (consisting of expert consensus on safety, tolerability, and feasibility). Drafts were revised based on review by patient partners, expert peer review, and a defined expert consensus process. RESULTS: The updated guidelines comprise eight primary topics, in a question-and-answer format, that map a patient care journey from assessment to selection of evidence-based treatments, prevention of recurrence, and strategies for inadequate response. The guidelines adopt a personalized care approach that emphasizes shared decision-making that reflects the values, preferences, and treatment history of the patient with MDD. Tables provide new and updated recommendations for psychological, pharmacological, lifestyle, complementary and alternative medicine, digital health, and neuromodulation treatments. Caveats and limitations of the evidence are highlighted. CONCLUSIONS: The CANMAT 2023 updated guidelines provide evidence-informed recommendations for the management of MDD, in a clinician-friendly format. These updated guidelines emphasize a collaborative, personalized, and systematic management approach that will help optimize outcomes for adults with MDD.

Efficacy and safety of acupuncture therapy for Parkinson's disease with neuropsychiatric symptoms: protocol for a systematic review and meta-analysis.

INTRODUCTION: Neuropsychiatric symptoms (NPS) are common non-motor symptoms among patients with Parkinson's disease (PD) and significantly impact their overall quality of life detrimentally. Several studies have reported the clinical effect of acupuncture therapy in treating NPS in PD. Therefore, the objective of this systematic review is to evaluate the potential inclusion of acupuncture therapy as an integral component of complementary treatment for PD with NPS. METHODS AND ANALYSIS: From their inception until 1 December 2023, we will search eight databases, including PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure, China Science Periodical Database, Chinese Citation Database and China Biology Medicine disc for randomised controlled trials examining the effectiveness of acupuncture for PD with NPS. Literature screening and data extraction will be carried out independently by the authors. RevMan V.5.3 software will be used for meta-analysis, while the Cochrane risk-of-bias tool will assess the potential for bias. ETHICS AND DISSEMINATION: This systematic review protocol does not require ethical approval because it does not include private information or data of participants. This article will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42022324494.

Protocol for a randomised controlled trial of ketamine versus ketamine and behavioural activation therapy for adults with treatment-resistant depression in the community.

INTRODUCTION: Although short-term benefits follow parenteral ketamine for treatment-resistant major depressive disorder (TR-MDD), there are challenges that prevent routine use of ketamine by clinicians. These include acute dissociative effects of parenteral ketamine, high relapse rates following ketamine dosing and the uncertain role of psychotherapy. This randomised controlled trial (RCT) seeks to establish the feasibility of evaluating repeated oral doses of ketamine and behavioural activation therapy (BAT), compared with ketamine treatment alone, for TR-MDD. We also aim to compare relapse rates between treatment arms to determine the effect size of adding BAT to oral ketamine. METHODS AND ANALYSIS: This is a prospectively registered, two-centre, single-blind RCT. We aim to recruit 60 participants with TR-MDD aged between 18 and 65 years. Participants will be randomised to 8 weeks of oral ketamine and BAT, or 8 weeks of oral ketamine alone. Feasibility will be assessed by tracking attendance for ketamine and BAT, acceptability of treatment measures and retention to the study follow-up protocol. The primary efficacy outcome measure is the Montgomery-Asberg Depression Rating Scale (MADRS) measured weekly during treatment and fortnightly during 12 weeks of follow-up. Other outcome measures will assess the tolerability of ketamine and BAT, cognition and activity (using actigraphy). Participants will be categorised as non-responders, responders, remitters and relapsed during follow-up. MADRS scores will be analysed using a linear mixed model. For a definitive follow-up RCT study to be recommended, the recruitment expectations will be met and efficacy outcomes consistent with a >20% reduction in relapse rates favouring the BAT and ketamine arm will be achieved. ETHICS AND DISSEMINATION: Ethics approval was granted by the New Zealand Central Health and Disability Ethics Committee (reference: 2023 FULL18176). Study findings will be reported to participants, stakeholder groups, conferences and peer-reviewed publications. TRIAL REGISTRATION NUMBER: UTN: U1111-1294-9310, ACTRN12623000817640p.

Evaluation of a manualised neurofeedback training in psychosomatic-psychotherapeutic outpatient treatment (Neuro-pp-out): study protocol for a clinical mixed-methods pilot study.

INTRODUCTION: Electroencephalographic neurofeedback (NFB), as a non-invasive form of brainwave training, has been shown to be effective in the treatment of various mental health disorders. However, only few results regarding manualised and standardised NFB trainings exist. This makes comparison as well as replication of studies difficult. Therefore, we developed a standard manual for NFB training in patients with mental health disorders attending a psychosomatic outpatient clinic. The current study aims at investigating the conduction of a standardised manual for NFB training in patients with mental health disorders. If successful, the study provides new opportunities to investigate NFB in a more controlled and comparable manner in clinical practice. METHODS AND ANALYSIS: 30 patients diagnosed with a mental health disorder will be included. After the educational interview, patients will undergo baseline diagnostics (T0). The subsequent intervention consists of 10 sessions of NFB training aiming at increasing sensorimotor rhythm and alpha-frequency amplitudes and decreasing theta-frequency and high beta-frequency amplitudes to induce relaxation and decrease subjective stress. All patients will undergo a post-treatment diagnostic assessment (T1) and a follow-up assessment 8 weeks following the closing session (T2). Changes in amplitude bands (primary outcome) will be recorded with electroencephalography during pre-assessments, post-assessments and follow-up assessments and during NFB sessions. Physiological (respiratory rate, blood volume pulse, muscle tension) and psychometric parameters (distress, perceived stress, relaxation ability, depressive and anxiety symptoms, insomnia, self-efficacy and quality of life) will be assessed at T0, T1 and T2. Moreover, satisfaction, acceptance and usability will be assessed at T1 after NFB training. Further, qualitative interviews about the experiences with the intervention will be conducted with NFB practitioners 6 months after the study starts. Quantitative data will be analysed using repeated measures analysis of variance as well as mediation analyses on mixed linear models. Qualitative data will be analysed using Mayring's content analysis. ETHICS AND DISSEMINATION: The study was approved by the ethics committee of the Medical Faculty of the University of Duisburg-Essen (23-11140-BO) and patient enrolment began in April 2023. Before participation, written informed consent by each participant will be required. Results will be published in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: Prospectively registered on 28 March 2023 in the German clinical trials register, DRKS00031497.

Repurposing of dextromethorphan as an adjunct therapy in patients with major depressive disorder: a randomised, group sequential adaptive design, controlled clinical trial protocol.

BACKGROUND: Therapeutic latency, lack of efficacy and adverse drug reactions are the major concerns in current antidepressant therapies. To overcome these treatment hurdles, add-on therapy to conventional antidepressant medications may lead to better therapeutic outcomes. The present randomised controlled trial has been planned to evaluate the efficacy and safety of add-on dextromethorphan to selective serotonin reuptake inhibitors (SSRIs) in major depressive disorder (MDD). METHODS AND ANALYSIS: A randomised, double-blind, add-on, placebo-controlled, group sequential design clinical trial will be conducted on patients with MDD who will be randomly assigned to the control and the test group in a 1:1 ratio. Patients in the test group will get dextromethorphan 30 mg once daily, whereas patients in the control group will receive a placebo once daily as an add-on to ongoing SSRI treatment for 8 weeks. All patients will be evaluated for the primary outcome (change in the Montgomery-Åsberg Depression Rating Scale score) and secondary outcomes (treatment response rate, remission rate, Clinical Global Impression, serum brain-derived neurotrophic factor, serum dextromethorphan and treatment-emergent adverse events) over the period of 8 weeks. Intention-to-treat analysis will be done for all parameters using suitable statistical tools. ETHICS AND DISSEMINATION: This study was approved by the Institutional Ethics Committee of All India Institute of Medical Sciences, Bhubaneswar, India, and the study conformed to the provisions of the Declaration of Helsinki and ICMR's ethical guidelines for biomedical research on human subjects (2017). Written informed consent will be obtained from the participants before recruitment. The results of this study will be published in peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05181527.

Prevalence and social determinants of anxiety and depression among adults in Ghana: a systematic review and meta-analysis protocol.

INTRODUCTION: Anxiety and depression pose a significant global health challenge, especially affecting adults in low-income and middle-income countries. In many low-income and middle-income countries, including those in sub-Saharan Africa, social determinants such as access to affordable health services, conflict, food insecurity, and poverty may be associated with the prevalence of anxiety and depression, further contributing to health disparities. To mitigate the burden of anxiety and depression in sub-Saharan Africa, it is essential to develop country-level tailored mental health policies and strategies. For example, Ghana is working towards improving mental health via its 12 year Mental Health policy launched in 2021. However, the prevalence of anxiety and depression among adults in Ghana, along with associated social determinants remains largely unknown, posing challenges for mental health planning, resource allocation and developing targeted interventions. This systematic review seeks to (1) examine the prevalence of anxiety and depression among adults in Ghana and (2) explore social determinants potentially associated with anxiety and depression. METHODS AND ANALYSIS: Electronic databases (eg, African Index Medicus, CINAHL, EMBASE, MEDLINE, and PsycINFO) will be searched with all screening steps conducted by two independent reviewers. Secondary search strategies, including grey literature searches, will be used. Studies reporting on the prevalence of anxiety, depression and/or a combined symptom measure (ie, psychological distress) among adults in Ghana, using validated instruments will be included. If data allows, random-effects-meta-analyses will be performed to estimate pooled prevalence rates of anxiety and depression. Potential clinical and methodological moderators will be examined using subgroup analyses and meta-regression. A narrative synthesis will explore social determinants potentially associated with anxiety and depression among adults in Ghana. ETHICS AND DISSEMINATION: Ethical approval is not required as no primary data will be collected. Results will be disseminated via a peer-reviewed publication and presentations at academic conferences. Plain language summaries will be provided to relevant non-governmental organisations working in Ghana. PROSPERO REGISTRATION NUMBER: CRD42023463078.

Comorbid physical health burden of serious mental health disorders in 32 European countries.

BACKGROUND: Mental health disorders (MHDs) are associated with physical health disparities, but underlying excess risk and health burden have not yet been comprehensively assessed. OBJECTIVE: To assess the burden of comorbid physical health conditions (PHCs) across serious MHDs in Europe. METHODS: We estimated the relative prevalence risk of PHCs associated with alcohol use disorders (AUD), bipolar disorder (BD), depressive disorders (DD) and schizophrenia (SZ) across working-age populations of 32 European countries in 2019 based on a targeted literature review. Excess physical health burden was modelled using population-attributable fractions and country-level prevalence data. FINDINGS: We screened 10 960 studies, of which 41 were deemed eligible, with a total sample size of over 18 million persons. Relative prevalence of PHCs was reported in 54%, 20%, 15%, 5% and 7% of studies, respectively, for SZ, DD, BD, AUD or mixed. Significant relative risk estimates ranged from 1.44 to 3.66 for BD, from 1.43 to 2.21 for DD, from 0.81 to 1.97 for SZ and 3.31 for AUD. Excess physical health burden ranged between 27% and 67% of the total, corresponding to 84 million (AUD), 67 million (BD), 66 million (DD) and 5 million (SZ) PHC diagnoses in Europe. A 1% reduction in excess risk assuming causal inference could result in two million fewer PHCs across investigated MHDs. CONCLUSIONS: This is the first comprehensive study of the physical health burden of serious MHDs in Europe. The methods allow for updates, refinement and extension to other MHDs or geographical areas. CLINICAL IMPLICATIONS: The results indicate potential population health benefits achievable through more integrated mental and physical healthcare and prevention approaches.

Corrigendum: Safety, feasibility, tolerability, and clinical effects of repeated psilocybin dosing combined with non-directive support in the treatment of obsessive-compulsive disorder: protocol for a randomized, waitlist-controlled trial with blinded ratings.

[This corrects the article DOI: 10.3389/fpsyt.2023.1278823.].

Influence of study characteristics, methodological rigour and publication bias on efficacy of pharmacotherapy in obsessive-compulsive disorder: a systematic review and meta-analysis of randomised, placebo-controlled trials.

QUESTION: We examined the effect of study characteristics, risk of bias and publication bias on the efficacy of pharmacotherapy in randomised controlled trials (RCTs) for obsessive-compulsive disorder (OCD). STUDY SELECTION AND ANALYSIS: We conducted a systematic search of double-blinded, placebo-controlled, short-term RCTs with selective serotonergic reuptake inhibitors (SSRIs) or clomipramine. We performed a random-effect meta-analysis using change in the Yale-Brown Obsessive-Compulsive Scale (YBOCS) as the primary outcome. We performed meta-regression for risk of bias, intervention, sponsor status, number of trial arms, use of placebo run-in, dosing, publication year, age, severity, illness duration and gender distribution. Furthermore, we analysed publication bias using a Bayesian selection model. FINDINGS: We screened 3729 articles and included 21 studies, with 4102 participants. Meta-analysis showed an effect size of -0.59 (Hedges' G, 95% CI -0.73 to -0.46), equalling a 4.2-point reduction in the YBOCS compared with placebo. The most recent trial was performed in 2007 and most trials were at risk of bias. We found an indication for publication bias, and subsequent correction for this bias resulted in a depleted effect size. In our meta-regression, we found that high risk of bias was associated with a larger effect size. Clomipramine was more effective than SSRIs, even after correcting for risk of bias. After correction for multiple testing, other selected predictors were non-significant. CONCLUSIONS: Our findings reveal superiority of clomipramine over SSRIs, even after adjusting for risk of bias. Effect sizes may be attenuated when considering publication bias and methodological rigour, emphasising the importance of robust studies to guide clinical utility of OCD pharmacotherapy. PROSPERO REGISTRATION NUMBER: CRD42023394924.