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INTRODUCTION: Depression occurs in over 50% of individuals living with multiple sclerosis (MS) and can be treated using many modalities. Yet, it remains: under-reported by patients, under-ascertained by clinicians and under-treated. To enhance these three behaviours likely to promote evidence-based depression care, we engaged multiple stakeholders to iteratively design a first-in-kind digital health tool. The tool, MS CATCH (Care technology to Ascertain, Treat, and engage the Community to Heal depression in patients with MS), closes the communication loop between patients and clinicians. Between clinical visits, the tool queries patients monthly about mood symptoms, supports patient self-management and alerts clinicians to worsening mood via their electronic health record in-basket. Clinicians can also access an MS CATCH dashboard displaying patients mood scores over the course of their disease, and providing comprehensive management tools (contributing factors, antidepressant pathway, resources in patients neighbourhood). The goal of the current trial is to evaluate the clinical effect and usability of MS CATCH in a real-world clinical setting. METHODS AND ANALYSIS: MS CATCH is a single-site, phase II randomised, delayed start, trial enrolling 125 adults with MS and mild to moderately severe depression. Arm 1 will receive MS CATCH for 12 months, and arm 2 will receive usual care for 6 months, then MS CATCH for 6 months. Clinicians will be randomised to avoid practice effects. The effectiveness analysis is superiority intent-to-treat comparing MS CATCH to usual care over 6 months (primary outcome: evidence of screening and treatment; secondary outcome: Hospital Anxiety Depression Scale-Depression scores). The usability of the intervention will also be evaluated (primary outcome: adoption; secondary outcomes: adherence, engagement, satisfaction). ETHICS AND DISSEMINATION: University of California, San Francisco Institutional Review Board (22-36620). The findings of the study are planned to be shared through conferences and publishments in a peer-reviewed journal. The deidentified dataset will be shared with qualified collaborators on request, provision of CITI and other certifications, and data sharing agreement. We will share the results, once the data are complete and analysed, with the scientific community and patient/clinician participants through abstracts, presentations and manuscripts. TRIAL REGISTRATION NUMBER: NCT05865405.

INTRODUCTION: There are unmet mental health needs of depressed adolescents and young adults (AYAs) across the USA. Behavioural technology adequately integrated into clinical care delivery has potential to improve care access and efficiency. This multisite randomised controlled trial evaluates how a coach-enhanced digital cognitive behavioural intervention (dCBI) enhances usual care for depressed AYAs in paediatric practices with minority enriched samples. METHODS AND ANALYSIS: Participants (n=750) ages 16-22 who meet threshold criteria for depressive severity (Patient Health Questionnaire-9; PHQ-9 score 10-24) will be recruited through paediatric practices across three academic institutions (Boston, Pittsburgh and San Diego). Participants will be randomised to 12 weeks of dCBI+treatment as usual (TAU) (n=450) or TAU alone (n=300) in outpatient paediatric practices. Assessments will be completed at baseline, 6 weeks and 12 weeks with the primary outcome being improvement in clinician-rated and self-reported depressive severity (Childrens Depression Rating Scale-Revised and PHQ-9) and secondary outcomes being self-reported suicidal ideation (item 9 on PHQ-9), anxiety severity (Generalised Anxiety Disorder), general quality of life (Satisfaction with Life Scale) and general functioning (Childrens Global Assessment Scale). The study design is an intent-to-treat mixed effects regression with group, and covariates nested within the sites. ETHICS AND DISSEMINATION: All participants or their parent/guardian (under 18 years or unemancipated) will give informed consent to a study team member. All data are expected to be collected over 18 months. The Institutional Review Board (IRB) is a board at each institution in the United States that reviews and monitors research involving human subjects. IRB approval from the University of Pittsburgh was obtained on 30 November 2021 (STUDY21080150), from the University of California San Diegos Human Research Protection Program IRB on 14 July 2022 (802047), and from the Boston Childrens Hospital IRB on 25 October 2022 (P00040987). Full study results are planned to be published within 2 years of initial study recruitment (October 2024). Dissemination of findings will occur in peer-reviewed journals, professional conferences and through reports to participating entities and stakeholders. TRIAL REGISTRATION NUMBER: NCT05159713; ClinicalTrials.gov.

ObjectivesThere are indications that the COVID-19 pandemic has had a profound negative effect on psychological well-being. Here, we investigated this hypothesis using longitudinal data from a large global cohort of runners, providing unprecedented leverage for understanding how the temporal development in the pandemic pressure relates to well-being across countries.DesignProspective cohort study.SettingGlobal.ParticipantsWe used data from the worldwide Garmin-RUNSAFE cohort that recruited runners with a Garmin Connect account, which is used for storing running activities tracked by a Garmin device. A total of 7808 Garmin Connect users from 86 countries participated.Primary and secondary outcome measuresFrom 1 August 2019 (prepandemic) to 31 December 2020, participants completed surveys every second week that included the five-item WHO Well-Being Index (WHO-5). Pandemic pressure was proxied by the number of COVID-19-related deaths per country, retrieved from the Coronavirus Resource Centre at Johns Hopkins University. Panel data regression including individual- and time-fixed effects was used to study the association between country-level COVID-19-related deaths over the past 14 days and individual-level self-reported well-being over the past 14 days.ResultsThe 7808 participants completed a total of 125 409 WHO-5 records over the study period. We found a statistically significant inverse relationship between the number of COVID-19-related deaths and the level of psychological well-being-independent of running activity and running injuries (a reduction of 1.42 WHO-5 points per COVID-19-related death per 10 000 individuals, p

IntroductionDespite carrying a disproportionately high burden of depression, patients in low-income countries lack access to effective care. The collaborative care model (CoCM) has robust evidence for clinical effectiveness in improving mental health outcomes. However, evidence from real-world implementation of CoCM is necessary to inform its expansion in low-resource settings.MethodsWe conducted a 2-year mixed-methods study to assess the implementation and clinical impact of CoCM using the WHO Mental Health Gap Action Programme protocols in a primary care clinic in rural Nepal. We used the Capability Opportunity Motivation-Behaviour (COM-B) implementation research framework to adapt and study the intervention. To assess implementation factors, we qualitatively studied the impact on providers' behaviour to screen, diagnose and treat mental illness. To assess clinical impact, we followed a cohort of 201 patients with moderate to severe depression and determined the proportion of patients who had a substantial clinical response (defined as ≥50% decrease from baseline scores of Patient Health Questionnaire (PHQ) to measure depression) by the end of the study period.ResultsProviders experienced improved capability (enhanced self-efficacy and knowledge), greater opportunity (via access to counsellors, psychiatrist, medications and diagnostic tests) and increased motivation (developing positive attitudes towards people with mental illness and seeing patients improve) to provide mental healthcare. We observed substantial clinical response in 99 (49%; 95% CI: 42% to 56%) of the 201 cohort patients, with a median seven point (Q1:-9, Q3:-2) decrease in PHQ-9 scores (p

IntroductionResearch has highlighted relationships between the micro-organisms that inhabit our gastrointestinal tract (oral and gut microbiota) with host mood and gastrointestinal functioning. Mental health disorders and functional gastrointestinal disorders co-occur at high rates, although the mechanisms underlying these associations remain unclear. The Bugs and Brains Study aims to investigate complex relationships between anxiety/depression and irritable bowel syndrome (IBS) in two ways. First, its primary component will compare the gut and oral microbiota in females with anxiety/depression and/or IBS relative to controls, and investigate underlying physiological, endocrine and immune factors, as well as associations with diet and psychosocial factors. In an ancillary component, the study will also investigate gastrointestinal and mental health symptoms in a larger sample, and explore relationships with diet, exercise, oral health, substance use, medical history, early life adversity and psychosocial factors.Methods and analysisThe Bugs and Brains Study aims to recruit 160 females to the primary component: (1) 40 controls; (2) 40 participants with a depressive/anxiety disorder, but no IBS; (3) 40 participants with IBS, but no depressive/anxiety disorder and (4) 40 participants with both depressive/anxiety disorder and IBS. Participation is completed within 1 month, and involves comprehensive questionnaires, anthropometrics, a diagnostic clinical interview, collection of two saliva samples, and stool, urine and hair samples. This study aims to use a systems biology approach to characterise oral and gut microbial composition and function using 16S rRNA gene sequencing and nuclear MR spectroscopy. As part of the ancillary component, it will collect questionnaire data from 1000 participants aged 18-40 years, capturing mental health, gastrointestinal health, oral health, diet and psychosocial factors.Ethics and disseminationApproval was granted by the University of Melbourne Human Research Ethics Committee (#1749221). All participants voluntarily provided informed consent. Results will be published in peer-reviewed journals and presented at scientific conferences.

Abstract Background Although many studies have reported the biological basis of major depressive disorder (MDD), none have been put into practical use. Recently, we developed a generalizable brain network marker for MDD diagnoses (diagnostic marker) across multiple imaging sites using resting-state functional magnetic resonance imaging (rs-fMRI). We have planned this clinical trial to establish evidence for the practical applicability of this diagnostic marker as a medical device. In addition, we have developed generalizable brain network markers for MDD stratification (stratification markers), and the verification of these brain network markers is a secondary endpoint of this study. Methods This is a non-randomized, open-label study involving patients with MDD and healthy controls (HCs). We will prospectively acquire rs-fMRI data from 50 patients with MDD and 50 HCs and anterogradely verify whether our diagnostic marker can distinguish between patients with MDD and HCs. Furthermore, we will longitudinally obtain rs-fMRI and clinical data at baseline and 6 weeks later in 80 patients with MDD treated with escitalopram and verify whether it is possible to prospectively distinguish MDD subtypes that are expected to be effectively responsive to escitalopram using our stratification markers. Discussion In this study, we will confirm that sufficient accuracy of the diagnostic marker could be reproduced for data from a prospective clinical study. Using longitudinally obtained data, we will also examine whether the “brain network marker for MDD diagnosis” reflects treatment effects in patients with MDD and whether treatment effects can be predicted by “brain network markers for MDD stratification”. Data collected in this study will be extremely important for the clinical application of the brain network markers for MDD diagnosis and stratification. Trial registration Japan Registry of Clinical Trials ( jRCTs062220063 ). Registered 12/10/2022.

IntroductionDepression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separately. Increasing physical activity might be effective to simultaneously lower depressive symptoms and improve glycaemic control. Self-management apps are a cost-effective, scalable and easy access treatment to increase physical activity. However, cutting-edge technological applications often do not reach vulnerable populations and are not tailored to an individual's behaviour and characteristics. Tailoring of interventions using machine learning methods likely increases the effectiveness of the intervention.Methods and analysisIn a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm. The uniform random intervention group receives the same messages, but chosen from the messaging banks with equal probabilities. The control group receives a weekly mood message. We aim to recruit 276 adults from primary care clinics aged 18-75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5). We will compare passively collected daily step counts, self-report PHQ-8 and most recent haemoglobin A1c from medical records at baseline and at intervention completion at 6-month follow-up.Ethics and disseminationThe Institutional Review Board at the University of California San Francisco approved this study (IRB: 17-22608). We plan to submit manuscripts describing our user-designed methods and testing of the adaptive learning algorithm and will submit the results of the trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings.Trial registration numberNCT03490253; pre-results.

Background: Although many studies have reported the biological basis of major depressive disorder (MDD), none have been put into practical use. Recently, we developed a generalizable brain network marker for MDD diagnoses (diagnostic marker) across multiple imaging sites using resting-state functional magnetic resonance imaging (rs-fMRI). We have planned this clinical trial to establish evidence for the practical applicability of this diagnostic marker as a medical device. In addition, we have developed generalizable brain network markers for MDD stratification (stratification markers), and the verification of these brain network markers is a secondary endpoint of this study. Methods: This is a non-randomized, open-label study involving patients with MDD and healthy controls (HCs). We will prospectively acquire rs-fMRI data from 50 patients with MDD and 50 HCs and anterogradely verify whether our diagnostic marker can distinguish between patients with MDD and HCs. Furthermore, we will longitudinally obtain rs-fMRI and clinical data at baseline and 6 weeks later in 80 patients with MDD treated with escitalopram and verify whether it is possible to prospectively distinguish MDD subtypes that are expected to be effectively responsive to escitalopram using our stratification markers. Discussion: In this study, we will confirm that sufficient accuracy of the diagnostic marker could be reproduced for data from a prospective clinical study. Using longitudinally obtained data, we will also examine whether the "brain network marker for MDD diagnosis" reflects treatment effects in patients with MDD and whether treatment effects can be predicted by "brain network markers for MDD stratification". Data collected in this study will be extremely important for the clinical application of the brain network markers for MDD diagnosis and stratification. Trial registration: Japan Registry of Clinical Trials (jRCTs062220063). Registered 12/10/2022. [ABSTRACT FROM AUTHOR]

Objectives: To compare the level of knowledge of depression, recognition ability and attitudes towards depression among urban and rural residents in Beijing., Design: A cross-sectional study., Setting: Six districts in Beijing, China, 2021., Participants: A total of 6463 participants aged 18 years and above who had lived for more than 6 months over the last year in Beijing were selected in this study., Outcome: The awareness and recognition of depression and the views of residents towards people with depression., Results: A total of 2554 urban and 2043 rural residents completed the survey. Urban residents of Beijing exhibited a higher average total score on the Depression Knowledge Questionnaire [(20.4±3.3) vs (18.7±3.5), p<0.001] and a higher rate of correctly identifying individuals with depression (47.9% vs 36.6%, p<0.001) than their counterparts in rural areas. Residents who correctly identified people with depression had higher scores on the Depression Knowledge Questionnaire. Depression knowledge varied significantly among urban and rural residents. The multivariate linear regression analysis revealed that rural residents scored significantly lower on measures of depression knowledge compared with urban residents ( B =-0.83, 95% CI =-1.03 to -0.63, p<0.001). Older individuals (aged 50+) showed lower understanding compared with the 18-49 age group, with significant negative regression coefficients (Urban: B =-1.06, Rural: B =-1.35, both p<0.001). Higher educational levels were positively associated with greater depression knowledge (Urban: B =1.40, Rural: B =1.21, both p<0.001). Employment was linked to higher knowledge levels than unemployment (Urban: B =-0.60, Rural: B =-0.58, both p=0.00). A monthly income of 8000 yuan or more correlated with better depression understanding than lower incomes (Urban: B =0.81, Rural: B =1.04, both p<0.001). Additionally, in urban areas, unmarried residents scored higher in depression knowledge than those divorced ( B =-0.55, p=0.04). Residents in urban areas had relatively positive attitudes towards individuals with depression., Conclusions: Rural residents of Beijing had lower levels of knowledge and recognition of depression and more negative attitudes towards individuals with depression than those from urban areas. The health authority needs to focus on the poor level of knowledge and increase mental health resources in rural areas as a priority site for future psychological popularisation efforts., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Major depressive disorder (MDD), the second leading cause of disability globally, is considered to be associated with a consequent deterioration in the quality of life and can lead to a major economic burden on medical service and suicide-related costs. Previous research has shown that acupuncture may be beneficial for treating MDD. However, there is a lack of rigorous evidence from previous studies comparing acupuncture with antidepressant medications. This study aims to assess the therapeutic potential of acupuncture in the management of depressive disorders., Methods and Analysis: A multicentre, randomised, participant-blind, sham-controlled, 2×2 factorial clinical trial, Acupuncture and Escitalopram for Treating Major Depression Clinical Study, aims to compare the efficacy of acupuncture versus escitalopram in treating depression. This study will be conducted at three hospitals in China, enrolling 260 patients with moderate-to-severe major depression, as defined by DSM-5 criteria and Hamilton Depression Rating Scale (HDRS-17) Scores above 17. Participants will be randomly assigned in equal proportions to one of four groups (acupuncture/escitalopram, sham acupuncture/escitalopram, acupuncture/placebo and sham acupuncture/placebo) and undergo 30 sessions across 10 weeks. The primary outcome is change in HDRS-17 Score and secondary outcomes include BDI, Clinical Global Impression, Generalised Anxiety Disorder-7 and Mini-Mental State Examination Scores, alongside potential biological markers., Ethics and Dissemination: Ethical approval for the study was granted by the Ethics Committees of the Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine (2023-7th-HIRB-020), Shanghai Mental Health Centre (2022-86) and Shanghai Pudong New Area Hospital of Traditional Chinese Medicine (2023-003). Informed consent will be obtained from all participants. The study's findings are intended for publication in a scholarly journal., Trial Registration: NCT05901571., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: This study explored the mechanisms by which physical activity was associated with depressive symptoms in multi-ethnic (Han, Yi and Tibetan) adolescents in southwest China. The mediating role of insomnia in the association of physical activity with depressive symptoms, the moderating role of resilience in this mediation model and the moderating role of parental absence in the moderated mediation model were also examined., Design: A cross-sectional survey., Setting: In southwest China (Sichuan Province and Tibet Autonomous Region)., Participants: 3195 adolescents from a school-based survey conducted between April and October 2020., Methods: There were 3143 valid samples in this study (47.2% males with mean age=12.88±1.68 years). Structural equation models were developed to estimate the direct and mediating effect, and the moderating effect. Multigroup comparison was performed to examine the differences and similarities of the moderated mediation model across three parental absence subgroups: (1) both parents present, (2) one parent absent and (3) both parents absent., Results: As hypothesised, physical activity was significantly and positively associated with the reduction of depressive symptoms in adolescents. Insomnia partially mediated the effect of physical activity on depressive symptoms. In addition, resilience moderated the direct and indirect effects of physical activity (through insomnia) on depressive symptoms. Finally, the multigroup comparison indicated the moderating effect of parental absence on the moderated mediation model., Conclusions: Physical activity was associated with alleviating insomnia symptoms among adolescents, thus correlating with the improvement of their depressive symptoms. Resilience was associated with enhancing the beneficial effects of physical activity, further improving depressive symptoms among adolescents, especially those with both absent parents. It is evident that physical activity interventions should be further incorporated into public health programmes to foster the physical and mental health of left-behind adolescents in southwest China., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Depression and anxiety are increasingly prevalent in adolescents. The Brief Educational Workshops in Secondary Schools Trial investigated the effectiveness of a brief self-referral stress workshop programme for sixth-form students aged 16-18 years old., Objective: This study conducted a secondary analysis on the outcomes of participants with elevated depressive symptoms at baseline., Methods: This is an England-wide, multicentre, cluster randomised controlled trial to evaluate the clinical effectiveness and cost-effectiveness of a brief cognitive-behavioural therapy workshop (DISCOVER) compared with treatment-as-usual (TAU) (1:1). The primary outcome was depression symptoms (Mood and Feelings Questionnaire (MFQ)) at 6-month follow-up, using the intention-to-treat (ITT) population and analysed with a multilevel linear regression estimating a between-group adjusted mean difference (aMD). Cost-effectiveness, taking a National Health Service (NHS) and personal social services perspective, was explored using quality-adjusted life years (QALYs)., Findings: Between 4 October 2021 and 10 November 2022, 900 adolescents at 57 schools were enrolled. 314 students were identified as having elevated symptoms of depression at baseline (>27 on MFQ). In this prespecified subgroup, the DISCOVER arm included 142 participants and TAU included 172. ITT analysis included 298 participants. Primary analysis at 6 months found aMD to be -3.88 (95% CI -6.48, -1.29; Cohen's d=-0.52; p=0.003), with a similar reduction at 3 months (aMD=-4.00; 95% CI -6.58, -1.42; Cohen's d=0.53; p=0.002), indicating a moderate, clinically meaningful effect in the DISCOVER arm. We found an incremental cost-effectiveness ratio of £5255 per QALY, with a probability of DISCOVER being cost-effective at between 89% and 95% compared with TAU., Conclusions and Clinical Implications: DISCOVER is clinically effective and cost-effective in those with elevated depressive symptoms. This intervention could be used as an early school-based intervention by the NHS., Trial Registration Number: ISRCTN90912799., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Premature birth and very low birth weight (VLBW) are leading causes of neonatal mortality. Almost all premature infants experience hyperbilirubinaemia. Administering probiotics to breastfeeding mothers may positively affect infant outcomes. This trial aims to investigate whether probiotic supplementation for mothers with VLBW infants affects total serum bilirubin levels and postpartum depression scores (primary outcomes), as well as some other neonatal and maternal outcomes (secondary outcomes)., Methods and Analysis: This is a randomised, double-blind, placebo-controlled superiority trial with two parallel arms. Participants, caregivers and outcome assessors will be blinded. A total of 122 breastfeeding mothers of neonates with a birth weight of 1000-1500 g, along with their infants within 48 hours of birth, will be assigned to either the probiotic or placebo group in a 1:1 ratio through block randomisation, stratified by singleton and twin births. The intervention will involve oral administration of probiotics containing Lactobacillus paracasei 431 and Bifidobacterium lactis BB-12, or an indistinguishable placebo, for 42-45 days. Outcomes will be assessed through daily observations, laboratory assessments and the Edinburgh Postpartum Depression Scale. Adverse events will also be documented. Modified intention-to-treat analyses will be employed for the primary and secondary outcomes, excluding participants lost to follow-up from all postintervention assessments., Ethics and Dissemination: This study protocol has been approved by the Medical University of Tabriz Ethics Committee (IR.TBZMED.REC.1401.735). Findings will be disseminated through publication in a peer-reviewed journal and presentations at relevant conferences., Trial Registration Number: IRCT20100414003706N42., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Diabetes increases the risk of psychosocial health problems. Person-centred psychosocial care is therefore advocated. However, several barriers to implementation exist, including uncertainty about how to approach psychosocial problems in consultations., Objective: We aimed to explore which psychosocial outcomes patients and healthcare professionals consider important and whether certain characteristics are associated with this. We propose strategies for facilitating psychosocial diabetes care on this basis., Methods: The results of an international Delphi study aimed at achieving multi-stakeholder consensus on a diabetes outcome set were analysed. We compared the importance ratings of the two stakeholder groups for each psychosocial outcome. A multivariable linear regression analysis tested whether certain characteristics would predict the importance attributed to outcomes that were not generally considered important., Findings: Patients and healthcare professionals agreed on the importance of regularly assessing psychological well-being, diabetes distress and diabetes-specific quality of life, while they regarded it as less important to monitor depression, anxiety, eating problems, social support and sexual health. Being a woman, younger and living with type 1 diabetes were associated with considering it important to assess eating problems., Conclusions: We propose two psychosocial care pathways that reflect the outcome preferences of patients and healthcare providers. They follow a stepped approach, starting with the assessment of psychological well-being and quality of life and proceeding from there., Clinical Implications: Adopting this approach can facilitate the implementation of person-centred psychosocial diabetes care by reducing the burden and making psychosocial issues more accessible. This approach should be tested for feasibility, safety and effectiveness., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. Published by BMJ.)

Question: Mindfulness-based programmes (MBPs) and practices have demonstrated effects in mental health and well-being, yet questions regarding the target mechanisms that drive change across the population remain unresolved., Study Selection and Analysis: Five databases were searched for randomised controlled trials that evaluate the indirect effects (IEs) of an MBP or mindfulness practice in relation to mental health and well-being outcomes through psychological mechanisms., Findings: 27 eligible studies were identified, with only four exploring mechanisms in the context of specific mindfulness practices. Significant IEs were reported for mindfulness skills, decentering and attitudes of mindfulness (eg, self-compassion) across different outcomes, population samples, mental health strategies and active comparators. Evidence gap maps and requirements for testing and reporting IEs are provided to help guide future work., Conclusions: Mindfulness skills, decentering and attitudes of mindfulness may be key intervention targets for addressing the mental health of whole populations. However, future work needs to address significant knowledge gaps regarding the evidence for alternative mechanisms (eg, attention and awareness) in relation to unique outcomes (eg, well-being), mental health strategies (ie, promotion) and active comparators. High-quality trials, with powered multivariate mediation analyses that meet key requirements, will be needed to advance this area of work., Trial Registration Number: 10.17605/OSF.IO/NY2AH., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Traumatic brain injury (TBI) is a major cause of disability, with annual global incidence estimated as 69 million people. Survivors can experience long-term visual changes, altered mental state, neurological deficits and long-term effects that may be associated with mental illness. TBI is prevalent in military personnel due to gunshot wounds, and blast injury. This study aims to evaluate the relationship between evolving visual, biochemical and mental health changes in both military veterans and civilians, suffering from TBI, and detect preliminary indicators of prognosis for TBI recovery, and quality-of-life outcomes., Methods and Analysis: UNTANGLE is a 24-month prospective observational pilot study recruiting three patient groups: civilians with acute moderate-severe TBI, military veterans with diagnosis of a previous TBI and a control group of civilians or veterans with no history of a previous TBI. Patients will undergo visual, biochemical and mental health assessments, as well as patient-reported quality of life outcome measures over the course of a 1-year follow-up period., Ethics and Dissemination: Ethical approval has been obtained from the Health Research Authority and Health and Care Research Wales with a REC reference number of 23/NW/0203. The results of the study will be presented at scientific meetings and published in peer-reviewed journals, including both civilian and military-related publications. We will also present our findings at national and international meetings of learnt neuroscience and neuropsychiatry and military societies. We anticipate that our pilot study will inform a larger study on the long-term outcomes of TBI and quality of life, specific to military veterans, such that potential interventions may be accessed as quickly as possible., Trial Registration Number: ISRCTN13276511., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objectives: To evaluate the frequency and severity of depressive and anxiety symptoms and explore possible risk factors among caregivers of children with congenital ectopia lentis (CEL)., Design: A prospective cross-sectional study was conducted., Participants: 108 patients and 108 informal caregivers (mainly parents) were included. Participants were grouped based on whether patients had systemic abnormalities: group 1 were children without systemic abnormalities and group 2 were children with systemic abnormalities., Outcome Measures: The 9-item Patient Health Questionnaire (PHQ-9) and the 7-item Generalized Anxiety Disorder Scale (GAD-7) were used to assess depressive and anxiety symptoms, respectively., Results: More than half of caregivers (51.9%) have depressive or anxiety symptoms of some degree. 38.0% of caregivers suffered from both depressive and anxiety symptoms. 19.4% of caregivers had moderate to severe depressive symptoms (PHQ-9 score ≥10) while 16.7% reported moderate to severe anxiety symptoms (GAD-7 score ≥10). Between the two groups, the mean PHQ-9 and GAD-7 scores significantly differed (p=0.026 in PHQ-9; p=0.018 in GAD-7). The proportion of caregivers with moderate to severe symptoms was greater in group 2 than in group 1. In addition, there was a significant positive correlation between PHQ-9 and GAD-7 scores (r=0.827; p<0.001). Furthermore, best corrected visual acuity in the better eye of patients was positively correlated with both the PHQ-9 and GAD-7 scores (r=0.314, p<0.05 in PHQ-9; r=0.325, p<0.05 in GAD-7)., Conclusions: Depressive and anxiety symptoms were common in caregivers of children with CEL, especially among those whose children had other systemic disease manifestations or low vision. This study illustrates the importance of depressive and anxiety symptom screening for these caregivers to implement effective psychological interventions and support strategies., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Postpartum anaemia is often caused by iron deficiency with onset during the antepartum period and can be exacerbated by excessive blood loss at birth. Its prevalence is estimated as 50-80% in low-income and middle-income countries. It poses adverse consequences on the mother and negatively impacts her ability to care for her newborn. Prompt treatment of postpartum anaemia is thus important. Adherence to oral iron is reportedly low in Nigeria due to its side effects and forgetfulness by the mothers. Intravenous iron such as ferric carboxymaltose, given as a single dose, might help overcome adherence issues, but investigation in a high-quality randomised control trial in Nigeria is first required while evaluation of challenges around its implementation is also warranted., Objective: To determine the clinical effectiveness, tolerability and safety, of using intravenous ferric carboxymaltose (intervention) vs oral ferrous sulphate (control) for treating moderate to severe iron deficiency anaemia in postpartum women and to evaluate implementation of ferric carboxymaltose in treating postpartum anaemia in Nigeria., Methods and Analysis: This study is an open-label randomised controlled trial with a concurrent implementation study. It is a hybrid type 1 effectiveness-implementation design conducted in four states across Northern and Southern Nigeria. A total of 1400 eligible and consenting women with postpartum moderate to severe anaemia (haemoglobin concentration <100 g/L) will be randomised to intravenous ferric carboxymaltose; a single dose at 20 mg/kg to a maximum of 1000 mg infusion administered at enrolment (intervention) or oral ferrous sulphate; 200 mg (65 mg elemental iron) two times per day from enrolment until 6 weeks postpartum (control). The primary outcome, proportion of participants who are anaemic (Hb <110 g/L) at 6 weeks postpartum will be analysed by intention-to-treat. Haemoglobin concentration, full blood count, serum iron, serum ferritin, transferrin saturation and total iron binding capacity will be measured at specific intervals. Implementation outcomes such as acceptability and feasibility of using ferric carboxymaltose for postpartum anaemia treatment in Nigeria will be assessed., Ethics and Dissemination: This study is approved by the ethics committee of the teaching hospitals, Ministry of Health of the four states as required, National Health Research Ethics Committee and the drug regulatory agency, National Agency for Food and Drug Administration and Control (NAFDAC). Findings of this research will be presented at conferences and will be published in international peer-reviewed journals and shared with stakeholders within and outside Nigeria., Trial Registration Number: International standard randomised controlled trial number: ISRCTN51426226., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Older adults in care homes experienced some of the highest rates of mortality from SARS-CoV-2 globally and were subjected to strict and lengthy non-pharmaceutical interventions, which severely impacted their daily lives. The VIVALDI ASCOT and Ethnography Study aims to assess the impact of respiratory outbreaks on care home residents' quality of life, psychological well-being, loneliness, functional ability and use of space. This study is linked to the VIVALDI-CT, a randomised controlled trial of staff's asymptomatic testing and sickness payment support in care homes (ISRCTN13296529)., Methods and Analysis: This is a mixed-methods, longitudinal study of care home residents (65+) in Southeast England. Group 1-exposed includes residents from care homes with a recent COVID-19 or other respiratory infection outbreak. Group 2-non-exposed includes residents from care homes without a recent outbreak. The study has two components: (a) a mixed-methods longitudinal face-to-face interviews with 100 residents (n=50 from group 1 and n=50 from group 2) to assess the impact of outbreaks on residents' quality of life, psychological well-being, loneliness, functional ability and use of space at time 1 (study baseline) and time 2 (at 3-4 weeks after the first visit); (b) ethnographic observations in communal spaces of up to 10 care homes to understand how outbreaks and related restrictions to the use of space and social activities impact residents' well-being. The study will interview only care home residents who have the mental capacity to consent. Data will be compared and integrated to gain a more comprehensive understanding of the impact of outbreaks on residents' quality of life and well-being., Ethics and Dissemination: The VIVALDI ASCOT and Ethnography Study obtained ethical approval from the Health Research Authority (HRA) Social Care REC (24/IEC08/0001). Only residents with the capacity to consent will be included in the study. Findings will be published in scientific journals., Competing Interests: Competing interests: All the authors declare no financial relationships with any organisations that might have an interest in the submitted work and no other relationships or activities that could appear to have influenced the proposed work., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objective: To determine the prevalence and factors associated with anxiety and depression and the care-seeking behaviour among Nepalese population., Design and Settings: Secondary analysis of the data from nationally representative Nepal Demographic and Health Survey 2022., Participants: Analysed data of 12 355 participants (7442 females and 4913 males) aged 15-49 years., Outcome Measures: Depression and anxiety were assessed using Patient Health Questionnaire-9 (PHQ-9) and Generalised Anxiety Disorder Assessment (GAD-7) tools, respectively., Statistical Analysis: We performed weighted analysis to account for the complex survey design. We presented categorical variables as frequency, per cent and 95% confidence interval (CI), whereas numerical variables were presented as median, inter-quartile range (IQR) and 95% CI. We performed univariate and multivariable logistic regression to determine factors associated with anxiety and depression, and results were presented as crude OR (COR), adjusted OR (AOR) and their 95% CI., Results: The prevalence of depression and anxiety were 4.0% (95% CI 3.5 to 4.5) and 17.7% (95% CI 16.5 to 18.9), respectively. Divorced or separated participants were found to have higher odds of developing anxiety (AOR 2.40, 95% CI 1.74 to 3.31) and depression (AOR 3.16, 95% CI 1.84 to 5.42). Among ethnic groups, Janajati had lower odds of developing anxiety (AOR 0.77, 95% CI 0.65 to 0.92) and depression (AOR 0.67, 95% CI 0.49 to 0.93) compared with Brahmin/Chhetri. Regarding disability, participants with some difficulty had higher odds of developing anxiety (AOR 1.81, 95% CI 1.56 to 2.10) and depression (AOR 1.94, 95% CI 1.51 to 2.49), and those with a lot of difficulty had higher odds of anxiety (AOR 2.09, 95% CI 1.48 to 2.96) and depression (AOR 2.04, 95% CI 1.06 to 3.90) compared with those without any disability. Among those who had symptoms of anxiety or depression, only 32.9% (95% CI 30.4 to 34.4) sought help for the conditions., Conclusions: Marital status and disability status were positively associated with anxiety and depression, whereas Janajati ethnicity had relatively lower odds of experiencing anxiety and depression. It is essential to develop interventions and policies targeting females and divorced individuals to help reduce the burden of anxiety and depression in Nepal., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Poverty, HIV and perinatal depression represent a triple threat to public health in sub-Saharan Africa because of their combined negative effects on parenting and child development. In the resource-constrained context of low-income and middle-income countries, a lay-counsellor-delivered intervention that combines a psychological and parenting intervention could offer the potential to mitigate the consequences of perinatal depression while also optimising scarce resources for healthcare.Measuring the cost-effectiveness of such a novel intervention will help decision-makers to better understand the relative costs and effects associated with replicating the intervention, thereby supporting evidence-based decision-making. This protocol sets out the methodological framework for analysing the cost-effectiveness of a cluster randomised controlled trial (RCT) that compares a combined intervention to enhanced standard of care when treating depressed, HIV-positive pregnant women and their infants in rural South Africa., Methods and Analysis: This cost-effectiveness analysis (CEA) protocol complies with the Consolidated Health Economic Evaluation Reporting Standards 2022 checklist. A societal perspective will be chosen.The proposed methods will determine the cost and efficiency of implementing the intervention as per the randomised control trial protocol, as well as the cost of replicating the intervention in a non-research setting. The costs will be calculated using an appropriately adjusted version of the Standardised Early Childhood Development Costing Tool.Primary health outcomes will be used in combination with costs to determine the cost per improvement in maternal perinatal depression at 12 months postnatal and the cost per improvement in child cognitive development at 24 months of age. To facilitate priority setting, the incremental cost-effectiveness ratios for improvements in child cognitive development will be ranked against six other child cognitive-development interventions according to Verguet et al 's methodology (2022).A combination of activity-based and ingredient-based costing approaches will be used to identify, measure and value activities and inputs for all alternatives. Outcomes data will be sourced from the RCT team., Ethics and Dissemination: The University of Oxford is the sponsor of the CEA. Ethics approval has been obtained from the Human Sciences Research Council (HSRC, #REC 5/23/08/17), South Africa and the Oxford Tropical Research Ethics Committee (OxTREC #31-17), UK.Consent for publication is not applicable since no participant data are used in this protocol.We plan to disseminate the CEA results to key policymakers and researchers in the form of a policy brief, meetings and academic papers., Trial Registration Details: ISRCTN registry #11 284 870 (14/11/2017) and SANCTR DOH-27-102020-9097 (17/11/2017)., Competing Interests: Competing interests: The authors, including the principal investigators, declare no financial or non-financial competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background: It has been reported that patients with geriatric psychiatric disorders include many cases of the prodromal stages of neurodegenerative diseases. Abnormal 123 I-2β-carbomethoxy-3β-(4-iodophenyl)-N-(3-fluoropropyl) nortropane dopamine transporter single-photon emission computed tomography (DAT-SPECT) reveals a nigrostriatal dopaminergic deficit and is considered useful to detect dementia with Lewy bodies and Parkinson's disease as well as progressive supranuclear palsy and corticobasal degeneration. We aimed to determine the proportion of cases that are abnormal on DAT-SPECT in patients with geriatric psychiatric disorders and to identify their clinical profile., Methods: The design is a cross-sectional study. Clinical findings of 61 inpatients aged 60 years or older who underwent DAT-SPECT and had been diagnosed with psychiatric disorders, but not neurodegenerative disease or dementia were analysed., Results: 36 of 61 (59%) had abnormal results on DAT-SPECT. 54 of 61 patients who had DAT-SPECT (89%) had undergone 123 I-metaiodobenzylguanidine myocardial scintigraphy ( 123 I-MIBG scintigraphy); 12 of the 54 patients (22.2%) had abnormal findings on 123 I-MIBG scintigraphy. There were no cases that were normal on DAT-SPECT and abnormal on 123 I-MIBG scintigraphy. DAT-SPECT abnormalities were more frequent in patients with late-onset (55 years and older) psychiatric disorders (69.0%) and depressive disorder (75.7%), especially late-onset depressive disorder (79.3%)., Conclusion: Patients with geriatric psychiatric disorders include many cases showing abnormalities on DAT-SPECT. It is suggested that these cases are at high risk of developing neurodegenerative diseases characterised by a dopaminergic deficit. It is possible that patients with geriatric psychiatric disorders with abnormal findings on DAT-SPECT tend to show abnormalities on DAT-SPECT first rather than on 123 I-MIBG scintigraphy., Competing Interests: Competing interests: STa has received honoraria for his participation as a speaker at educational events sponsored by Sumitomo Pharma and Viatris. MF has received honoraria for his participation as a speaker at educational events sponsored by Eisai and Mochida Pharma. MT has received honoraria for his participation as a speaker at educational events sponsored by Otsuka Pharma, Sumitomo Pharma, Tsumura, Lundbeck Japan, Eisai, Meiji Seika Pharma, Viatris, Mitsubishi Tanabe Pharma, Janssen Pharma and Takeda Pharma. MT has received unrestricted research funding from Otsuka Pharma, Sumitomo Pharma, Eisai and Mochida Pharma (paid to the institution)., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To develop a new questionnaire for the diagnostic assessment of depression adapted to the primary care setting by combining psychiatric criteria and heuristics of general practitioners (GPs). Psychometric evaluation of the new questionnaire and first validity evidence., Design: The questionnaire was developed using cognitive interviews with think-aloud technique. Factorial validity was then examined in a cross-sectional study., Setting: Primary care. Five general practices in Bavaria, Germany., Participants: 15 GPs, 4 psychiatrists/psychotherapists and 13 patients participated in cognitive expert interviews. A primary care sample of N=277 consecutive patients participated in the cross-sectional study., Methods: After consultation with experts and literature research, the questionnaire contained a self-rating part for patients and an external part for GPs. Items were then iteratively optimised using cognitive interviews. Factorial validity was examined. To estimate internal consistency, Cronbach's α was calculated. Validity was assessed by correlating the new questionnaire and the Patient Health Questionnaire-9 (PHQ-9)., Results: The preliminary version of the two-part 'Questionnaire for the assessment of DEpression SYmptoms in Primary Care' (DESY-PC) comprised 52 items for patients (DESY-PAT-1: questions about patient's environment; DESY-PAT-2: questions about depression-specific symptoms) and 21 items for GPs (DESY-GP). The analysis of the DESY-PAT-1 revealed a one-factor solution ('environmental factors') with Cronbach's α of 0.55. The items of the DESY-PAT-2 were assigned to three factors, 'depressive cognitions', 'suicidality' and 'symptoms of fatigue', with Cronbach's α of 0.86, 0.79 and 0.85, respectively. Factorial analysis revealed two factors for the DESY-GP: 'depression symptoms' and 'medical history/external factors'. Cronbach's α was 0.90 and 0.59, respectively. After factorial analysis, the DESY-PAT was reduced to 28 items, and the DESY-GP was reduced to 15 items. Correlations of the DESY-PC with the PHQ-9 were high and significant, indicating convergent validity., Conclusions: The new questionnaire represents an innovative extension of depression questionnaires and could be particularly suitable for general practices., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Depression in ageing adults is a public health problem. Worldwide studies have identified social and health risk factors for depressive symptoms. However, little is known about their longitudinal determinants in Mexico., Objectives and Setting: To find the prevalence of depressive symptoms and their longitudinal individual and contextual risk factors in Mexican adults aged 50 and older., Design: Secondary data of 6460 persons aged 50 years and older from the Mexican Health and Aging Study were analysed using a 'between-within' panel data analysis approach., Results: The prevalence of depressive symptoms increased from 35% in 2003 to 38% in 2015. The significantly longitudinal factors associated with these symptoms were getting older (OR 1.02, 95% CI 1.01 to 1.03), being a woman (OR 2.39, 95% CI 2.16 to 2.64), less time spent in formal education (0 years and less than 6 years OR 1.52, 95% CI 1.32 to 1.75 and OR 1.33, 95% CI 1.19 to 1.50, respectively), lower net worth (OR 1.13, 95% CI 1.08 to 1.17), being recently unemployed (OR 1.25, 95% CI 1.10 to 1.25), increased (OR 1.17, 95% CI 1.10 to 1.25) or increasing number (OR 1.23, 95% CI 1.15 to 1.31) of chronic conditions, poor (OR 4.68, 95% CI 4.26 to 5.15) or worsened (OR 1.71, 95% CI 1.61 to 1.81) self-rated health and having impairments on instrumental activities of daily living (IADLs) (OR 2.94 95% CI 2.35 to 3.67) or a new IADL impairment (OR 1.67, 95% CI 1.48 to 1.89), as well as having impairments on ADLs (OR 1.51, 95% CI 1.23 to 1.86) or a new ADL impairment (OR 1.34, 95% CI 1.21 to 1.48)., Conclusions: The prevalence of depressive symptoms in Mexican adults aged 50 and older is high. Our findings show that they are longitudinally associated with the individual's demographic, socioeconomic, health and disability characteristics. Efforts in public policy should focus on preventing chronic conditions and disability, as well as fighting inequalities to reduce the prevalence of depressive symptoms., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Competing Interests: Competing interests: No, there are no competing interests.

Introduction: Hypertension and depression often coexisted, leading to poor health outcome and significant challenges in healthcare management. Since no guidelines or consensus are available for health professionals to manage this comorbidity, identifying interventions in current literature is crucial for gaining a clear picture of evidence and informing future research directions and clinical practice. This scoping review is designed to address this gap by systematically mapping the range of potential interventions for managing comorbid hypertension and depression., Methods and Analysis: Following the Joanna Briggs Institute guidelines for scoping review, this review will comprehensively search databases including PUBMED, Embase, PsycINFO, CINAHL, Cochrane Library Databases, Chinese Biomedical Literature Database and Chinese National Knowledge Infrastructure. Grey literature will be sourced from Google Scholar. A year limit of January 2004-December 2023 will be applied to retrieve the most current peer-reviewed articles in English and Chinese language only. Two reviewers will individually screen and the process will be documented in Preferred Reporting Items for Systematic Reviews and Meta-Analyses for scoping reviews. This review will explore a range of non-pharmacological and multicomponent interventions including psychosocial support, educational programmes, telemedicine and integrated healthcare models. Data extraction will follow the Template for Intervention Description and Replication checklist to ensure detailed and standardised reporting of intervention components. The synthesis of findings will employ both quantitative and qualitative methods to provide a comprehensive overview of the intervention landscape., Ethics and Dissemination: This scoping review, which involves secondary data analysis of publicly available sources, does not require ethical approval. Findings will be disseminated through peer-reviewed publications and presentations at relevant conferences., Study Registration: Open Science Framework registry (osf.io/j7gt8) in Centre for Open Science on 29 January 2024., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Circadian rhythms influence cognitive performance which peaks in the morning for early chronotypes and evening for late chronotypes. It is unknown whether cognitive interventions are susceptible to such synchrony effects and could be optimised at certain times-of-day., Objective: A pilot study testing whether the effectiveness of cognitive bias modification (CBM) for facial emotion processing was improved when delivered at a time-of-day that was synchronised to chronotype., Methods: 173 healthy young adults (aged 18-25) with an early or late chronotype completed one online session of CBM training in either the morning (06:00 hours to 10:00 hours) or evening (18:00 hours to 22:00 hours)., Findings: Moderate evidence that participants learnt better (higher post-training balance point) when they completed CBM training in the synchronous (evening for late chronotypes, morning for early chronotypes) compared with asynchronous (morning for late chronotypes, evening for early chronotypes) condition, controlling for pre-training balance point, sleep quality and negative affect. There was also a group×condition interaction where late chronotypes learnt faster and more effectively in synchronous versus asynchronous conditions., Conclusions: Preliminary evidence that synchrony effects apply to this psychological intervention. Tailoring the delivery timing of CBM training to chronotype may optimise its effectiveness. This may be particularly important for late chronotypes who were less able to adapt to non-optimal times-of-day, possibly because they experience more social jetlag., Clinical Implications: To consider delivery timing of CBM training when administering to early and late chronotypes. This may generalise to other psychological interventions and be relevant for online interventions where the timing can be flexible., Competing Interests: Competing interests: IP-V is a co-director of Jericoe, a company that designs and sells software for psychological assessment. JS has family stock ownership in the following healthcare companies: CVS, AbbVie, Merk, Pfizer, Bristol Myers Squibb, Johnson & Johnson and Abbot Laboratories. His research has been supported by the US National Institutes of Health, State of Colorado, Brain and Behavior Research Foundation and Children’s Hospital Foundation., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background: The present study aimed to evaluate psychological impact of COVID-19 outbreak on postgraduate trainees in Pakistan by quantifying the symptoms of depression, anxiety and acute stress disorder and by analysing potential risk factors associated with these symptoms.Methods: Following Institutional Review Board approval, a cross-sectional study was conducted among 10,178 postgraduate trainees following COVID-19 outbreak through e-log system of College of Physicians and Surgeons of Pakistan. The nine-item Patient Health Questionnaire, seven-item Generalised Anxiety Disorder scale and Stanford Acute Stress Reaction Questionnaire were used to collect data. Statistical analyses were conducted using SPSS.26. Descriptive statistics, Mann-Whitney U test, the χ2 test and logistic regression analysis were performed. The significance level was set at α=0.05.Results: The prevalence of depressive symptoms, generalised anxiety disorder and acute stress disorder were 26.4%, 22.6% and 4.4%, respectively. Female postgraduate trainees, senior trainees and front-line workers reported experiencing more anxiety, depression and acute stress symptoms (p value<0.001). Logistic regression showed that being a front-line and senior staff member and female was associated with higher risk of experiencing symptoms of depression, anxiety and acute stress.Conclusions: Our study findings raise concerns about the psychological well-being of postgraduate trainees during the acute COVID-19 outbreak in Pakistan. It is necessary to employ strategies to minimise the psychological distress and provide adequate psychosocial support for postgraduate trainees during crisis situation such as COVID-19 pandemic. [ABSTRACT FROM AUTHOR]

Background: The prevalence of major depressive disorder (MDD) is on the rise globally, and the use of antidepressant medications for its treatment does not usually result in full remission. However, the combination of physical exercise and psychotherapy for the treatment of MDD increase the rate of full remission among patients. This three-armed, parallel-group, double-blinded randomised controlled trial (RCT) aims to assess and compare the effects between the combination of exergame and acceptance and commitment therapy (e-ACT) programme, ACT only and treatment-as-usual (TAU) control groups on the severity of depression and anxiety symptoms, the degree of experiential avoidance and quality of life (QoL) and the serum levels of depression biomarkers (such as brain-derived neurotrophic factor, C-reactive protein and vascular endothelial growth factor) among patients with MDD across three time points., Methods and Analysis: This RCT will recruit 126 patients with MDD who will be randomised using stratified permuted block randomisation into three groups, which are the combined e-ACT programme, ACT-only and TAU control groups in a 1:1:1 allocation ratio. The participants in the e-ACT and ACT-only intervention groups will undergo once a week intervention sessions for 8 weeks. Assessments will be carried out through three time points, such as the pre-intervention assessment (t 0 ), assessment immediately after completion of the intervention at 8 weeks (t 1 ) and assessment at 24 weeks after completion of the intervention (t 2 ). During each assessment, the primary outcome to be assessed includes the severity of depression symptoms, while the secondary outcomes to be assessed are the severity of anxiety symptoms, experiential avoidance, QoL and depression biomarkers., Ethics and Dissemination: Approval of this study was obtained from the Human Research Ethics Committee of Universiti Sains Malaysia (USM/JEPeM/PP/23050420). The findings of the study will be published in academic peer-reviewed journals., Trial Registration Number: NCT05812001 (ClinicalTrials.gov). Registered on 12 April 2023., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Chronic stress can cause an imbalance within the autonomic nervous system, thereby affecting cardiovascular and mental health. Physical activity (PA) may have a positive effect on the autonomic nervous system and stress-related disorders, such as depression and burnout. Heart rate variability (HRV) is a non-invasive marker of the autonomic nervous system. However, limited and inconsistent data exist on the exact relationship between HRV, PA and depression and burnout symptoms. The HARMODI study aims to explore whether HRV is a feasible marker of depression and burnout symptoms and aims to evaluate the role of PA in the treatment of stress-related disorders., Methods and Analyses: This is an observational study with a cross-sectional up to 8 week follow-up study design. A total of 153 patients, undergoing psychiatric inpatient treatment with burnout syndrome (Z73) and depressive episode (F32 or F33) or adjustment disorder (F43.2), will be recruited. Data on depression and burnout symptoms, HRV recordings (24-hour, supine, standing and exercise stress test), cognitive function, cardiorespiratory fitness, cardiovascular health, balance and strength will be collected at baseline (T1) and after up to 8 weeks (T2). Continuous data on PA and Ecological Momentary Assessments of exhaustion, mood and tension will be monitored daily throughout inpatient treatment. Multiple regression models, adjusted for potential confounders, will assess the association between HRV as the primary outcome, PA and depression and burnout severity score., Ethics and Dissemination: The protocol has been approved by Swiss Ethics Committee, Cantonal Ethics Committee Zürich. Results of HARMODI will be disseminated through peer-reviewed journals and conference presentations., Trial Registration Number: NCT05874856., Competing Interests: Competing interests: WT is funded through an industry-sponsored PhD by the Clinica Holistica Engiadina and represents the role of the investigator at site. Clinica Holistica Engiadina employed Dr MP (until 30 June 2023) and KM (until 1 January 2024). Clinica Holistica Engiadina also employs Dr TR (since 1 July 2023) and Dr RLM. Professor AS-T, Professor HB and Dr BS are members of the scientific advisory board of the Clinica Holistica Engiadina. Other conflicts of interest are not declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Depression is a major global health problem, with high prevalence rates of depressive symptoms observed among the elderly population in China, particularly exacerbating in rural areas. Due to a lack of professional mental health training and inadequate psychotherapy capacity within primary medical staff, rural elderly individuals grappling with depressive symptoms often encounter challenges in receiving timely diagnosis and treatment. In this landscape, the modified behavioural activation treatment (MBAT) emerges as a promising approach due to its practicality, ease of therapist training and application, patient acceptability, and broad applicability. However, existing evidence for MBAT mainly hails from developed countries, leaving a gap in its adaptation and implementation within rural China. This study aims to develop an MBAT training programme for primary medical staff to manage depressive symptoms among rural elderly and evaluate its effectiveness., Methods and Analysis: A cluster randomised controlled trial will be conducted in 10 randomly selected township hospitals in Lengshuijiang and Lianyuan, Hunan Province. We aim to recruit 150 participants, with 5 township hospitals selected for each group, each consisting of 15 participants. The intervention group will implement the MBAT training programme, while the control group will receive usual care training programme. Depressive symptoms, psychosocial functioning, quality of life and satisfaction will be measured at baseline, immediately post-intervention, and at 3 and 6 months post-intervention. Effectiveness will be assessed using linear or generalised linear mixed models., Ethics and Dissemination: This study has obtained approval from the Institutional Review Board of the Third Xiangya Hospital, Centre South University (No.: 2022-S261). Results will be disseminated through publication in international peer-reviewed journals and presentations at national and international conferences., Trial Registration Number: ChiCTR2300074544., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Clinical practice guidelines (CPGs) are essential for standardising patient care based on evidence-based medicine. However, the presence of financial conflicts of interest (COIs) among CPG authors can undermine their credibility. This study aimed to examine the extent and size of COIs among authors of psychiatry CPGs in Japan., Methods: This cross-sectional analysis of disclosed payments from pharmaceutical companies assesses the prevalence and magnitude of personal payments for lecturing, consulting and writing to CPGs for bipolar disorder and major depressive disorder in Japan between 2016 and 2020., Results: This study found that 93.3% of authors received payments over a 5-year period, with total payments exceeding US$4 million. The median payment per author was US$51 403 (IQR: US$9982-US$111 567), with a notable concentration of payments among a small number of authors, including the CPG chairperson. Despite these extensive financial relationships, only a fraction of authors disclosed their COIs in the CPGs. These large amounts of personal payments were made by pharmaceutical companies manufacturing new antidepressants and sleeping aids listed in the CPGs., Conclusions: This study found that more than 93% of authors of CPGs for major depressive disorder and bipolar disorder in Japan received considerable amounts of personal payments from the pharmaceutical industry. The findings highlight deviations from international COI management standards and suggest a need for more stringent COI policies for psychiatry CPGs in Japan., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Workplace stigmatisation and discrimination are significant barriers to accessing employment opportunities, reintegration and promotion in the workforce for people with mental illnesses in comparison to other disabilities. This paper presents qualitative evidence of anticipated and experienced workplace stigma and discrimination among individuals with major depressive disorder (MDD) in 35 countries, and how these experiences differ across countries based on their Human Development Index (HDI) level., Design: Mixed-method cross-sectional survey., Participants, Setting and Measures: The qualitative data were gathered as part of the combined European Union Anti-Stigma Programme European Network and global International Study of Discrimination and Stigma Outcomes for Depression studies examining stigma and discrimination among individuals with MDD across 35 countries. Anticipated and experienced stigma and discrimination were assessed using the Discrimination and Stigma Scale version 12 (DISC-12). This study used responses to the open-ended DISC-12 questions related to employment. Data were analysed using the framework analysis method., Results: The framework analysis of qualitative data of 141 participants identified 6 key 'frames' exploring (1) participants reported experiences of workplace stigma and discrimination; (2) impact of experienced workplace stigma and discrimination; (3) anticipated workplace stigma and discrimination; (4) ways of coping; (5) positive work experiences and (6) contextualisation of workplace stigma and discrimination. In general, participants from very high HDI countries reported higher levels of anticipated and experienced discrimination than other HDI groups (eg, less understanding and support, being more avoided/shunned, stopping themselves from looking for work because of expectation and fear of discrimination). Furthermore, participants from medium/low HDI countries were more likely to report positive workplace experiences., Conclusions: This study makes a significant contribution towards workplace stigma and discrimination among individuals with MDD, still an under-researched mental health diagnosis. These findings illuminate important relationships that may exist between countries/contexts and stigma and discrimination, identifying that individuals from very high HDI countries were more likely to report anticipated and experienced workplace discrimination., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction and Objectives: There is an unmet need to develop high-quality evidence addressing tuberculosis (TB)-related mental health comorbidity, particularly in the context of lower-middle-income countries. This study aims to examine the effectiveness and cost-effectiveness of cognitive behavioural therapy (CBT) versus enhanced treatment as usual (ETAU) in improving depressive symptoms in people with TB and comorbid depression, enhancing adherence with anti-TB treatment (ATT) and its implementation in the real-world setting of Pakistan., Methods: We will conduct a pragmatic parallel arm randomised control trial with an internal pilot. A brief psychological intervention based on CBT has been developed using a combination of qualitative and ethnographic studies. The inbuilt pilot trial will have a sample size of 80, while we plan to recruit 560 (280 per arm) participants in the definitive trial. Participants who started on ATT within 1 month of diagnosis for pulmonary and extrapulmonary TB or multidrug resistant TB (MDR-TB) and meeting the criteria for depression on Patient Health Questionnaire-9 (PHQ-9) will be randomised with 1:1 allocation to receive six sessions of CBT (delivered by TB healthcare workers) or ETAU. Data on the feasibility outcomes of the pilot will be considered to proceed with the definitive trial. Participants will be assessed (by a blinded assessor) for the following main trial primary outcomes: (1) severity of depression using PHQ-9 scale (interviewer-administered questionnaire) at baseline, weeks 8, 24 and 32 postrandomisation and (2) ATT at baseline and week 24 at the end of ATT therapy., Ethics and Dissemination: Ethical approval has been obtained from Keele University Research Ethics Committee (ref: 2023-0599-792), Khyber Medical University Ethical Review Board (ref: DIR/KMU-EB/CT/000990) and National Bioethics Committee Pakistan (ref: No.4-87/NBC-998/23/587). The results of this study will be reported in peer-reviewed journals and academic conferences and disseminated to stakeholders and policymakers., Trial Registration Number: ISRCTN10761003., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Despite the high prevalence of major depressive disorder (MDD) among the elderly population, the rate of treatment is low due to stigmas and barriers to medical access. Wearable devices such as smartphones and smartwatches can help to screen MDD symptoms earlier in a natural setting while forgoing these concerns. However, previous research using wearable devices has mostly targeted the younger population. By collecting longitudinal data using wearable devices from the elderly population, this research aims to produce prediction algorithms for late-life depression and to develop strategies that strengthen medical access in community care systems., Methods and Analysis: The current cohort study recruited a subsample of 685 elderly people from the Korean Genome and Epidemiology Study-Cardiovascular Disease Association Study, a national large cohort established in 2004. The current study has been conducted over a 3-year period to explore the development patterns of late-life depression. Participants have completed three annual face-to-face interviews (baseline, the first follow-up and the second follow-up) and 2 years of app-based surveys and passive sensing data collection. All the data collection will end at the second follow-up interview. The collected self-report, observational and passive sensing data will be primarily analysed by machine learning., Ethics and Dissemination: This study protocol has been reviewed and approved by the Yonsei University Mirae Campus Institutional Review Board (1041849-2 02 111 SB-180-06) in South Korea. All participants provided written informed consent. The findings of this research will be disseminated by academic publications and conference presentations., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The objective of this study is to estimate the overall pooled prevalence of depression and its associated factors among high school, college and university students in Ethiopia., Design: Systematic review and meta-analysis., Data Sources: PubMed/MEDLINE, EMBASE, Science Direct, African Journal Online and Google Scholar. The primary articles were searched from 2 April 2023 to 11 May 2023., Eligibility Criteria: Observational studies such as cross-sectional, case-control and cohort studies that reported the prevalence and associated factors of depression among students in Ethiopia were included. Both published and unpublished primary studies were included in this review., Data Extraction and Synthesis: Two authors independently extracted all the important data using a Microsoft Excel spreadsheet and exported it to Stata V.14 for analysis. The statistical heterogeneity among the included articles was assessed by the I 2 statistics test. Publication bias was checked using the funnel plot and Egger's regression test., Results: A total of 17 primary studies with 8798 study participants were included in the current study to estimate the combined prevalence of depression. The pooled prevalence of depression among Ethiopian students was 35.52% with a 95% CI (30.54% to 40.51%). Subgroup analysis showed that the pooled prevalence of depression was higher in Addis Ababa, which was 40.43%, with a 95% CI (28.02% to 52.83%). Female sex, first-year educational level, family history of mental illness, alcohol drinking and parental neglect were significantly associated with depression in this study., Conclusion: In this review, the overall pooled prevalence of depression among students in Ethiopia was high compared with the general population. Therefore, it is necessary to make more efforts to provide mental healthcare and psychosocial support to students to improve their mental health and decrease the overall burden of depression., Prospero Registration Number: CRD42023424301., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Diabetes and depression are among the 10 biggest health burdens globally. They often coexist and exhibit a strong bidirectional relationship. Depression leads to decreased adherence to self-care activities. This impacts glycaemic control and worsens type 2 diabetes mellitus (T2D). Both conditions have a synergistic effect and lead to greater complications, hospitalisations, healthcare expenditure and a worse quality of life. There is no consensus on managing people with comorbid T2D and depression. Bupropion is an efficacious antidepressant with many properties suitable for T2D with depression, including a favourable metabolic profile, persistent weight loss and improvement in sexual dysfunction. We will assess the efficacy and safety of add-on bupropion compared with standard care in people with T2D and mild depression. This study can give valuable insights into managing the multimorbidity of T2D and depression. This can help mitigate the health, social and economic burden of both these diseases., Research Design and Methods: This cross-over randomised controlled trial will recruit people with T2D (for 5 years or more) with mild depression. They will be randomised to add-on bupropion and standard care. After 3 months of treatment, there will be a washout period of 1 month (without add-on bupropion while standard treatment will continue). Following this, the two arms will be swapped. Participants will be assessed for glycosylated haemoglobin, adherence to diabetes self-care activities, lipid profile, urine albumin-to-creatinine ratio, autonomic function, sexual function, quality of life and adverse events., Ethics and Dissemination: The Institutional Ethics Committee at All India Institute of Medical Sciences, Jodhpur has approved this study (AIIMS/IEC/2022/4172, 19 September 2022). We plan to disseminate the research findings via closed group discussions at the site of study, scientific conferences, peer-reviewed published manuscripts and social media., Trial Registration Number: CTRI/2022/10/046411., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Patients with breast cancer often suffer from depressive symptoms throughout various stages of cancer, significantly impacting their quality of life and treatment outcomes. Non-pharmaceutical interventions such as psychotherapy, mind-body therapies and physical exercise have shown effectiveness in addressing cancer-related depression. However, the efficacy and safety of different non-pharmacological interventions remain a topic of debate. Therefore, to provide an objective assessment and comparison of the impact of different non-pharmaceutical interventions on depression, we will conduct a network meta-analysis (NMA) to explore the effects of different non-pharmaceutical interventions on reducing depressive symptoms among patients with breast cancer., Methods and Analysis: We will search nine Chinese and English-language databases, from database inception to 31 July 2023, for randomised controlled trials published in Chinese or English. The English-language databases are PubMed, Medline, Embase, Web of Science and Cochrane Central Register of Controlled Trials, and the Chinese databases are CBM, CNKI, VIP and Wanfang. Two independent researchers will perform information extraction from eligible articles. The primary outcome will be the changes in depressive symptoms, while the secondary outcome will include adverse events. STATA V.15.0 will be used to conduct paired meta-analysis and NMA. Grading of Recommendations Assessment, Development and Evaluation will be used to assess the quality of evidence, and the Cochrane tool for assessing the risks of bias in randomised trials V.2 will be used for risk of bias assessment., Ethics and Dissemination: The study does not require ethical approval as it will analyse data from existing studies. It is expected that the results of the study will be published in peer-reviewed journals and presented at relevant conferences., Prospero Registration Number: CRD42023450494., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: This study investigated the correlation between uncertainty stress (US) and depression among healthcare professionals (HCPs) in China., Design, Settings and Participants: A cross-sectional online survey was conducted by recruiting HCPs from three provinces in China (central, eastern and western) through purposive sampling between 29 September 2022 and 18 January 2023. US was measured using the Life Stress Questionnaire and depression was measured using the Patient Health Questionnaire-9. In total, 2976 questionnaires were deemed valid., Primary and Secondary Outcome: This study examined the prevalence of US and depression among HCPs in China; the correlating sociodemographic traits; and the correlation between US and depression., Results: The prevalence of US and depression among HCPs in China was 26.54% (790 out of 2976) and 71.63% (2132 out of 2976). Binary logistic analysis revealed that individuals with graduate degrees (OR: 1.83; 95% CI 1.07 to 3.11; p<0.05), central China (OR: 1.75; 95% CI 1.36 to 2.24; p<0.01), primary medical institutes (OR: 1.33; 95% CI 1.03 to 1.72; p<0.05), secondary medical institutes (OR: 1.30; 95% CI 1.01 to 1.68; p<0.05), an annual income of less than ¥50 000 (OR: 1.85; 95% CI 1.26 to 2.73; p<0.01) and an income range of ¥50 000-¥99 999 (OR: 1.49; 95% CI 1.10 to 2.03; p<0.05) were associated with a higher likelihood of US. The adjusted logistic regression model demonstrated that HCPs with higher US had a greater likelihood of depression (adjusted OR: 5.02; 95% CI 3.88 to 6.50; p<0.01). The increase in the US score was paralleled by an increased depression score (beta (B): 1.32; 95% CI 1.25 to 1.39; p<0.01)., Conclusion: These findings reveal a significant correlation between US and depression among HCPs and suggest that improving the management of US may help reduce the prevalence of depression among HCPs., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Depressed mood is a psychological state characterised by sadness or loss of interest in activities. Depressed mood is a highly prevalent symptom across major mental disorders. However, there is limited understanding of the burden and management of comorbid depressed mood across major mental disorders. Therefore, this scoping review aims to summarise knowledge on depressed mood among persons with anxiety and/or psychosis. The specific aims are to describe the epidemiology and risk factors of depressed mood as a transdiagnostic target among persons with anxiety and/or psychosis, to identify commonly used outcome measures for depressed mood and to outline initial evidence of psychometric robustness and to identify and summarise the effectiveness of commonly applied depressed mood modification interventions. Our hope is that the proposed review will provide insights into the burden of depressed mood in persons with anxiety and psychosis and help to identify evidence gaps and recommendations for future research., Methods and Analysis: This scoping review will be conducted per Arksey and O'Malley's framework. We will first search for peer-reviewed articles and grey literature published from 2004 to 2023 in PubMed, Scopus, Web of Science, Africa-Wide Information, CINAHL, PsycINFO, Academic Search Premier, Humanities International Complete, Sabinet, SocINDEX, Open Grey and Google Scholar. We will include articles reporting depressed mood (subthreshold depression) among persons with anxiety and/or psychosis. Studies recruiting participants meeting depression diagnostic criteria and those published in non-English languages will be excluded. Two independent researchers will extract the data. We will analyse and chart data collaboratively with researchers with lived experiences of depressed mood., Ethics and Dissemination: This study does not require ethical approval as it is a literature review. The results will be submitted for publication in a peer-reviewed journal., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Late-life treatment-resistant depression (LL-TRD) is common and increases risk for accelerated ageing and cognitive decline. Impaired sleep is common in LL-TRD and is a risk factor for cognitive decline. Slow wave sleep (SWS) has been implicated in key processes including synaptic plasticity and memory. A deficiency in SWS may be a core component of depression pathophysiology. The anaesthetic propofol can induce electroencephalographic (EEG) slow waves that resemble SWS. Propofol may enhance SWS and oral antidepressant therapy, but relationships are unclear. We hypothesise that propofol infusions will enhance SWS and improve depression in older adults with LL-TRD. This hypothesis has been supported by a recent small case series., Methods and Analysis: SWIPED (Slow Wave Induction by Propofol to Eliminate Depression) phase I is an ongoing open-label, single-arm trial that assesses the safety and feasibility of using propofol to enhance SWS in older adults with LL-TRD. The study is enrolling 15 English-speaking adults over age 60 with LL-TRD. Participants will receive two propofol infusions 2-6 days apart. Propofol infusions are individually titrated to maximise the expression of EEG slow waves. Preinfusion and postinfusion sleep architecture are evaluated through at-home overnight EEG recordings acquired using a wireless headband equipped with dry electrodes. Sleep EEG recordings are scored manually. Key EEG measures include sleep slow wave activity, SWS duration and delta sleep ratio. Longitudinal changes in depression, suicidality and anhedonia are assessed. Assessments are performed prior to the first infusion and up to 10 weeks after the second infusion. Cognitive ability is assessed at enrolment and approximately 3 weeks after the second infusion., Ethics and Dissemination: The study was approved by the Washington University Human Research Protection Office. Recruitment began in November 2022. Dissemination plans include presentations at scientific conferences, peer-reviewed publications and mass media. Positive results will lead to a larger phase II randomised placebo-controlled trial., Trial Registration Number: NCT04680910., Competing Interests: Competing interests: BJAP has a patent on control of anaesthetic state modulation and an agreement with Elemind on the use of non-pharmacological potentiation of EEG slow waves. EL reports consulting fees from Merck, Boehringer-Ingelheim, Pritikin ICR, IngenioRx and Prodeo, grant funding from Janssen, the COVID Early Treatment Fund and FastGrants, and a patent pending on sigma-1 receptor agonists for COVID-19. BPL reports consulting fees from Eisai, Eli Lilly, OrbiMed and the GLG Group. He has also received research funding from Eisai and serves on the Scientific Advisory Board for Beacon Biosignals and a Data Safety Monitoring Board for Eli Lilly. RLR and MK have no conflicts to disclose concerning any product mentioned or concept discussed in this article. MK, BPL, EL and BJAP have received funding from the National Institutes of Health., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: People living in less urban areas in the UK may have reduced access to mental healthcare compared with people in urban areas. Although this was not reported in the 2000 Adult Psychiatric Morbidity Survey (APMS) data, subsequent changes to mental health provision and economic recession may have impacted care inequalities. We re-examined this, hypothesising that those living in less urban areas of England received less antidepressant medication and psychological interventions, compared with those living in urban areas, after adjusting for covariates including common mental disorders (CMDs) and socioeconomic status., Design: National cross-sectional study., Setting: Households in England., Participants: We analysed data from 7455 participants aged 16 and above from the 2014 English APMS., Exposures: Residence in an urban or less urban area., Primary Outcome: Current receipt of any antidepressant medication or any psychological intervention., Results: Participants living in less urban areas were half as likely to be in receipt of any psychological intervention relative to those living in urban areas (adjusted OR (aOR) 0.49; 95% CI 0.30 to 0.79; p=0.004). There was no association between urbanisation and antidepressant receipt (aOR 1.01; 95% CI 0.81 to 1.25; p=0.944)., Conclusion: People living in less urban areas have a lower likelihood of being in receipt of psychological treatment for CMDs, which may indicate barriers to care access. Our findings differ from the results of a study using a comparable sample conducted 14 years previously. While Improving Access to Psychological Therapies services have increased therapy access nationwide, this may have had more impact in urban areas, potentially widening urban/rural inequalities. Further research is needed to understand how to address such geographical inequalities in access to mental healthcare., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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 aOR 2-12months 0.66-0.67, range 99% CI 0.60 to 0.73) and with lower adverse events over 6 months (range aOR 2-6months 0.90-0.96, range 99% CI 0.91 to 0.99), but not at 1 year (aOR 12months 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., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/disclosure-of-interest/ and declare the following: RDG is supported by the Wellcome Trust (award 102176/Z/13/Z, grant 216452/Z/19/Z, title 'The effects of anti-inflammatory drugs on emotional and reward processing'). FDC is supported by the National Institute for Health Research (NIHR) Research Professorship to AC (grant RP-2017-08-ST2-006) and by the NIHR Oxford Health Biomedical Research Centre (grant BRC-1215-20005). EGO is supported by the NIHR Research Professorship to AC (grant RP-2017-08-ST2-006). PC is supported by the Medical Research Council (MRC) (grant MR/S003037/1, title 'Clinical Psychopharmacology of Depression'). CJH is supported by the NIHR Oxford Health Biomedical Research Centre. SF is supported by the NIHR Oxford Health Biomedical Research Centre. AC is supported by the NIHR Oxford Cognitive Health Clinical Research Facility, by an NIHR Research Professorship (grant RP-2017-08-ST2-006), by the NIHR Oxford and Thames Valley Applied Research Collaboration, by the NIHR Oxford Health Biomedical Research Centre (grant BRC-1215-20005) and by Wellcome Trust (GALENOS Project). CJH has received consultancy fees from P1vital, Lundbeck, Servier, UCB, Zogenix, J&J and Syndesi outside of the current work. AC has received research and consultancy fees from INCiPiT (Italian Network for Paediatric Trials), CARIPLO, Lundbeck and Angelini Pharma outside of the current work. The other authors declare that they have no conflict of interest., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: There are around 250 million adolescents (10-19 years) in India. The prevalence of mental health-related morbidity among adolescents in India is approximately 7.3%. Vulnerable subpopulations among adolescents such as those living in slum communities are particularly at risk due to poor living conditions, financial difficulty and limited access to support services. Adolescents' Resilience and Treatment nEeds for Mental Health in Indian Slums (ARTEMIS) is a cluster randomised controlled trial of an intervention that intends to improve the mental health of adolescents living in slum communities in India. The aim of this paper is to describe the process evaluation protocol for ARTEMIS trial. The process evaluation will help to explain the intervention outcomes and understand how and why the intervention worked or did not work. It will identify contextual factors, intervention barriers and facilitators and the adaptations required for optimising implementation., Methods: Case study method will be used and the data will include a mix of quantitative metrics and qualitative data. The UK Medical Research Council's guidance on evaluating complex interventions, the Reach, Efficacy, Adoption, Implementation and Maintenance Framework and the Affordability, Practicability, Effectiveness and cost-effectiveness, Acceptability, Safety/Side Effects and, Equity criteria will be used to develop a conceptual framework and a priori codes for qualitative data analysis. Quantitative data will be analysed using descriptive statistics. Implementation fidelity will also be measured., Discussion: The process evaluation will provide an understanding of outcomes and causal mechanisms that influenced any change in trial outcomes., Ethics and Dissemination: Ethics Committee of the George Institute for Global Health India (project number 17/2020) and the Research Governance and Integrity Team, Imperial College, London (ICREC reference number: 22IC7718) have provided ethics approval. The Health Ministry's Screening Committee has approved to the study (ID 2020-9770)., Trial Registration Number: CTRI/2022/02/040307., Competing Interests: Competing interests: We declare that the George Institute for Global Health has a part-owned social enterprise, George Health Enterprises, which has commercial relationships involving digital health innovations., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Postnatal depression affects up to one in six new mothers in Australia each year, with significant impacts on the woman and her family. Prevention strategies can be complicated by a woman's reluctance to seek professional help. Peer support is a promising but inadequately tested early intervention. Very few trials have reported on the efficacy of peer support in the perinatal period and no study has been undertaken in Australia. We will explore if proactive telephone-based peer (mother-to-mother) support, provided to women identified as being at high risk of postnatal depression, impacts on clinically significant depressive symptomatology at 6 months postpartum., Methods and Analysis: This is a protocol for a single-blinded, multi-centre, randomised controlled trial conducted in Melbourne, Australia. Eligible women will be recruited from either the postnatal units of two maternity hospitals, or around 4 weeks postpartum at maternal and child health centres within two metropolitan council areas. A total of 1060 (530/group) women will be recruited and randomly allocated (1:1 ratio) to either-usual care, to receive the standard community postpartum services available to them, or the intervention group, to receive proactive telephone-based support from a peer volunteer for 6 months, in addition to standard community services., Primary Outcome: clinically significant depressive symptomatology at 6 months postpartum as measured using the Edinburgh Postnatal Depression Scale., Secondary Outcomes: symptoms of anxiety and/or stress, health-related quality of life, loneliness, perception of partner support, self-rated parenting, child health and development, infant feeding and health service use. The cost-effectiveness of the intervention relative to standard care will also be assessed., Ethics and Dissemination: Ethics approval has been obtained from La Trobe University, St. Vincent's Hospital, the Royal Women's Hospital, Northern Health, Victorian Department of Health and Human Services and Victorian Department of Education and Training. Written informed consent will be obtained from all participants before randomisation. Trial results will be disseminated through peer-reviewed publications, conference presentations and a higher degree thesis., Trial Registration Number: ACTRN12619000684123; Australian New Zealand Clinical Trials Registry., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: This study aimed to examine the mediation role of perceived social support in the relationship between functional limitations, depressive symptoms and quality of life among older people in Malaysia., Setting: The Malaysian National Health Morbidity Survey 2018: Elderly Health was a cross-sectional health community survey among adults aged 50 and above., Participants: 3977 community-dwelling older Malaysians aged 60 and above., Outcome Measures: Functional limitations were defined as personal activities of daily living (PADL) and instrumental activities of daily living (IADL), tested in separate paths in all analyses. PADL was measured using the Barthel Index, while IADL was measured using the Lawton and Brody scale. Perceived social support, depressive symptoms and quality of life were measured using the Duke Social Support Index, Geriatric Depression Scale-14 and Control, Autonomy, Self-Realisation and Pleasure-19 tools. We used mediation analysis through structural equation modelling to explore the role of perceived social support., Results: Perceived social support mediated the relationship between PADL and IADL with depressive symptoms, with the indirect effects at -0.079 and -0.103, respectively (p<0.001). Similarly, perceived social support mediated the relationship between PADL and IADL with quality of life, with the indirect effects at 0.238 and 0.301, respectively (p<0.001). We performed serial multiple mediation analysis and found that perceived social support and depressive symptoms mediated the path between PADL and IADL with quality of life, with the indirect effects at 0.598 and 0.747, respectively (p<0.001). The relationship between functional limitations and all outcomes remained significant in all mediation analyses., Conclusion: The present study provides evidence that perceived social support relieves the influence of functional limitations on depressive symptoms and declining quality of life among older people. Therefore, it is imperative to establish a social support system to improve the overall well-being of older people., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Incomplete combustion of solid fuel and exposure to secondhand smoke (SHS) are the primary causes of indoor air pollution (IAP), potentially leading to detrimental effects on individual mental health. However, current evidence regarding the association between IAP and depression remains inconclusive. This study aims to systematically investigate the evidence regarding the association between IAP and the risk of depression., Design: Systematic review and meta-analysis of cohort studies., Data Sources: Two independent reviewers searched PubMed, the Cochrane Library, Web of Science and EMBASE for available studies published up to 13 January 2024., Eligibility Criteria: We included all cohort studies published in English that aimed to explore the relationship between IAP from solid fuel use and SHS exposure and the risk of depression., Data Extraction and Synthesis: Two independent reviewers extracted data and assessed the risk of bias. The association between IAP and depression was calculated using pooled relative risk (RR) with 95% CIs. Heterogeneity was assessed using the I 2 value, and the effect estimates were pooled using fixed-effects or random-effects models depending on the results of homogeneity analysis., Results: We included 12 articles with data from 61 217 participants. The overall findings demonstrated a significant association between IAP exposure and depression (RR=1.22, 95% CI: 1.13 to 1.31), although with substantial heterogeneity (I 2 =75%). Subgroup analyses based on pollutant type revealed that IAP from solid fuel use was associated with a higher risk of depression (RR=1.20, 95% CI: 1.13 to 1.26; I 2 =62%; 5 studies, 36 768 participants) than that from SHS exposure (RR = 1.11, 95% CI: 0.87 to 1.41; I 2 =80%; 7 studies, 24 449 participants). In terms of fuel use, the use of solid fuel for cooking (RR: 1.23, 95% CI: 1.16 to 1.31; I 2 =58%; 4 studies, 34 044 participants) and heating (RR 1.15, 95% CI: 1.04 to 1.27; I 2 =65%; 3 studies, 24 874 participants) was associated with increased depression risk., Conclusions: The findings from this systematic review and meta-analysis of cohort studies indicated an association between exposure to IAP and depression., Prospero Registration Number: CRD42022383285., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., Competing Interests: Competing interests: KD and RP use software for research at no cost from Scientific Brain Training Pro. RP has received support for travel to educational meetings from Servier and Lundbeck. PG has a research contract with Douglas Pharmaceuticals to develop novel oral ketamine formulations. He has also attended advisory boards for Janssen Pharmaceuticals., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)