Epidemiology and Psychiatric Sciences
◐ Cambridge University Press (CUP)
Preprints posted in the last 90 days, ranked by how well they match Epidemiology and Psychiatric Sciences's content profile, based on 10 papers previously published here. The average preprint has a 0.01% match score for this journal, so anything above that is already an above-average fit.
Reinecke-Tellefsen, C. J.; Orberg, A.; Ostergaard, S. D.
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The COVID-19 pandemic had substantial impact on healthcare systems across the globe, including psychiatric services. Use of electroconvulsive therapy (ECT), a lifesaving intervention for severe mental illness, was reported to have declined during the pandemic in several countries, but nationwide data remain scarce. Using nationwide data from the Danish National Patient Register, we examined all ECT treatments administered in Denmark from September 2019 to May 2025. Weekly treatment numbers were visualized across the three national COVID-19 lockdowns to descriptively assess changes in ECT use. A notable reduction in ECT treatments was observed in the weeks preceding and during the first lockdown (March 11 to May 18, 2020). A post-hoc estimation indicated approximately 1,366 "missed" treatments during the initial pandemic phase in 2020. When these were added to the 27,033 treatments delivered in 2020, the adjusted total approximated annual treatment volumes in 2019 and 2022, suggesting a temporary disruption rather than sustained decline. In contrast, ECT activity during the second and third lockdowns appeared largely unaffected. These findings suggest that ECT provision in Denmark was temporarily reduced during the initial phase of the pandemic but remained resilient thereafter. In the case of a future pandemic, safeguarding timely access to ECT--particularly in early phases-- should be prioritized given its critical role in the treatment of severe mental illness.
Galusca, B.; Germain, N.; Sarkar, M.; Gandit, B.; Milunov, D.; Urakpo, K.; Khaddour, M.; Saha, S.
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BackgroundAnorexia nervosa (AN) is a severe psychiatric disorder associated with profound malnutrition, multisystem medical complications, and one of the highest mortality rates among mental illnesses. Despite decades of research into its biological and neurocognitive mechanisms, effective pharmacological treatments remain limited. While systematic reviews synthesize results from published studies, clinical trial registries offer a complementary perspective by capturing ongoing research efforts, discontinued studies, and emerging therapeutic strategies that may not yet be reflected in the published literature. ObjectiveThis study aimed to characterize the landscape of clinical research in AN by systematically analyzing studies registered on ClinicalTrials.gov. MethodsWe conducted a structured analysis of studies registered on ClinicalTrials.gov related to AN. Trial characteristics, including study design, intervention type, phase classification, geographic distribution, and recruitment status, were extracted and analyzed using an automated text-based classification pipeline. ResultsNearly 400 studies investigating AN were identified over the past 25 years. Approximately 71% were classified as interventional studies; however, a large proportion were not associated with conventional clinical trial phases, suggesting that many registered trials correspond to mechanistic or exploratory investigations rather than therapeutic development programs. The geographic distribution of studies revealed a strong predominance of North America and Western Europe. A substantial proportion of trials were terminated or discontinued, highlighting the significant challenges associated with conducting interventional studies in this population. Observational studies generally included larger sample sizes than interventional trials. ConclusionsRegistry-based analyses provide valuable insights into the evolving landscape of clinical research in AN. Despite considerable scientific activity, important gaps remain between mechanistic knowledge and the development of therapeutic interventions. Understanding these gaps may help inform future translational research strategies aimed at improving treatment options for this severe disorder.
Badriku, K.; Dickens, A.; Paul, O.; Ronald, M.; Emmanuel, M.
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Background Complementary and Alternative Medicine (CAM) contributes significantly to the utilization of healthcare services in mental health care in sub-Saharan Africa. However, there is limited evidence on the utilization of CAM in the particular setting of post-conflict northern Uganda. This study sought to establish the prevalence, forms, and socio-demographic determinants of CAM use among patients attending the Mental Health Unit at Gulu Regional Referral Hospital (GRRH). Methods This is a cross-sectional study conducted in a hospital setting from June to August 2025. Convenience sampling was employed to recruit 407 participants. A structured questionnaire was employed for data collection. Data analysis was done using STATA software version 18.0. Descriptive statistics were calculated, and bivariate analysis with Prevalence Ratios (PR) with 95% confidence intervals was employed to determine factors that are significantly associated with the use of CAM. Results The lifetime prevalence of CAM use was 63.4% (258/407), with 41.3% (168/407) using CAM currently. The most frequent CAM practices used were herbal medicine (50.4%), spiritual practices (33.7%), and traditional medicine (19.8%). For current users, spiritual practices were most frequent (88.7%). The reasons for using CAM were recommendations from others (84.8%) and cultural or religious beliefs (63.4%). Predictors of CAM use were primary education (PR = 1.36, p = 0.017), living in an urban area (PR = 1.23, p = 0.007), separated (PR = 1.39, p = 0.050), and having a mental health disorder for six or more months (PR range = 1.55-1.72). Catholics (PR = 0.72, p = 0.0007) and Protestants (PR = 0.76, p = 0.011) were less likely to use CAM than Born Again Christians. Conclusion The level of CAM use among patients accessing mental health services in GRRH of northern Uganda is significantly high, while the reporting of CAM use to healthcare providers is remarkably low. This is a challenge that requires urgent attention. Recommendations include integrating the use of CAM into medical practice, developing national policy guidelines on CAM, working in collaboration with traditional/spiritual healers, and conducting public education campaigns.
WANG, X. X.
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BackgroundSuicide prevention has become a global public health priority, and Brief Contact Interventions (BCI) following suicide attempts (SA) are an important tool for preventing suicides. The VigilanS project was designed to generalize compounded BCIs at the entire population level., It involves resource cards, telephone calls, and mailings, following a predefined algorithm. It has been implemented progressively in France, on a region-by-region basis, since 2015. ObjectiveTo evaluate the effectiveness of VigilanS in reducing suicide attempts among patients aged 18 years and older, and to explore potential differences in effectiveness by sex, age, and geographical location. MethodsThe study used data from the French national hospitalization database, PMSI-MCO. It included all patients over age 18 who were admitted to general hospitals for suicide attempts, between 2012 and 2022. Time-to-event ("survival") analysis of a second SA after a first one was performed; patients whose first SA occurred before VigilanS implementation were compared with their after-VigilanS counterparts. Six regions, with implementation occurring between 2015 and 2017, are analyzed here. ResultsThe differences in distribution of time-to-new-SA among patients before and after VigilanS implementation were statistically significant in all six regions under scope (log-rank test: P<0.0001). The Cox regression analysis revealed that VigilanS was significantly associated with a reduced risk of reattempting suicide in all regions. Age consistently showed a negative association with reattempting suicide. ConclusionVigilanS is likely effective in reducing suicide attempts among patients aged 18 years and older in France. This suggests that implementing BCIs following SAs in general hospitals at a population-wide level can contribute to reducing suicide rates and provides real-world evidence (RWE).
Sevchik, B. L.; Singleton, S. P.; Lahey, A.; Cuijpers, P.; Harrer, M.; Jones, M. T.; Nayak, S. M.; Strain, E. C.; Vandekar, S. N.; Yaden, D. B.; Dworkin, R. H.; Scott, J. C.; Satterthwaite, T. D.
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3,4-methylenedioxymethamphetamine (MDMA) has emerged as a potential treatment for post-traumatic stress disorder (PTSD), generating considerable enthusiasm in the field. However, rapidly changing evidence in a fast-moving field can be challenging to integrate. Here, we present a living systematic review and open-data meta-analytic resource on MDMA treatment for PTSD. In this initial release, six randomized controlled trials comprising 286 participants are included in the database. Our primary model uses inverse-variance random-effects meta-analysis of standardized mean differences on primary outcomes of PTSD. Compared to control conditions, MDMA showed a greater reduction in PTSD symptoms (Hedges' g = -0.71). Meta-regression on both the number of dosing sessions and cumulative dose showed that a higher number of dosing sessions and a higher cumulative dose was related to larger effects of MDMA. Treatment with MDMA as compared to placebo also resulted in higher response (risk ratio (RR) = 1.35) and remission (RR = 2.25) rates. Most studies included in the database had a low risk of bias according to Cochrane guidelines, though these fail to capture pertinent challenges in the field such as expectancy, functional unblinding, potential issues with study conduct, and safety. The current findings were assigned an overall low certainty rating using the GRADE approach. Together, this systematic review and meta-analysis suggests that MDMA-assisted therapy results in short-term decreases in PTSD symptoms across studies to date, though more trials are needed. This living systematic review, meta-analysis, database, and online dashboard (sypres.io) will continue to be updated as evidence emerges, providing a valuable, open, and transparent resource for researchers in a rapidly evolving field.
Johnson, L. F.; Giovenco, D.; Eyal, K.; Craig, A.; Petersen, I.; Tlali, M.; Levitt, N. S.; Bachmann, M.; Haas, A. D.; Fairall, L.
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BackgroundDepression is estimated to be the leading cause of disability in South Africa, yet data on depression prevalence and antidepressant use are inconsistent and fragmentary. We present a system dynamics modelling approach to integrate these data and assess trends and inequalities in depression prevalence and treatment access. MethodsWe developed a deterministic model of the South African population aged 15 and older, stratified by age, sex, HIV status/stage and susceptibility to depression. Individual transitions between depressed/healthy and treated/untreated states were simulated over time, from 1985. The model was calibrated to depression prevalence data from nine nationally representative household surveys (2002-2024) and ten smaller studies reporting prevalence of antidepressant use, using a Bayesian approach. ResultsThe model estimated a slight decline in depression point prevalence over time, from 5.1% (95% CI: 4.5-5.6%) in 2002 to 4.5% (95% CI: 4.0-5.0%) in 2024, although with a transient rise in depression prevalence during the COVID-19 period. In 2024, depression prevalence was higher in women (5.3%, 95% CI: 4.7-5.9%) than men (3.6%, 95% CI: 3.2-4.0%), and highest at ages 60 and older. The lifetime prevalence of depression was 70.6% (95% CI: 67.8-73.6); alternative model settings with a more concentrated distribution of depression risk were inconsistent with longitudinal data. The proportion of adults using antidepressants increased from 1.0% (95% CI: 0.8-1.2%) in 2008 to 2.8% (95% CI: 2.2-3.4%) in 2024. In 2024, antidepressant use was 11.0% (95% CI: 8.8-13.5%) in the private sector, compared to only 0.9% (95% CI: 0.7-1.1%) in the rest of the population, and the ratio of new antidepressant initiations to new cases of depression was 0.12 nationally. ConclusionThe prevalence of depression in South Africa has been relatively stable over the last two decades. Although antidepressant use has increased, overall use remains low, and substantial inequality remains in access to treatment in the public and private health sectors.
Hossain, M. B.; Yan, R.; Morin, K. A.; Rotenberg, M.; Russolillo, A.; Solmi, M.; Lalva, T.; Marsh, D. C.; Nosyk, B.
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Introduction People with bipolar disorder (BD) and concurrent opioid use disorder (OUD) experience more severe clinical outcomes, including higher mortality, treatment complexity, and worse psychiatric symptoms, yet they are underserved due to a lack of tailored clinical guidelines and limited supporting research on competing treatment options. While pharmacological treatments for BD are well-established, their use varies widely across settings, and their effectiveness in individuals with co-occurring OUD is unclear. We propose parallel population-based studies to emulate randomized controlled trials to assess the comparative effectiveness of pharmacological treatment options for BD among people with OUD in British Columbia and Ontario, Canada, 2010-2023. Methods and analysis We propose emulating a series of parallel target trials using linked population-level health administrative data for all individuals aged 18 years or older diagnosed with both BD and OUD and who initiated treatments for BD between 1 January 2010 and 31 December 2023. All analyses will be conducted in parallel in British Columbia and Ontario. We propose a series of four successive target trial emulations, comparing (i) lithium versus non-antipsychotic mood stabilizers such as divalproex, lamotrigine, and valproic acid; (ii) lithium versus 2nd generation antipsychotics with mood stabilizing properties such as risperidone, olanzapine, aripiprazole, and quetiapine; (iii) lithium versus combination treatments such as lithium and divalproex, lithium and olanzapine, lithium and aripiprazole, lithium and quetiapine, divalproex and olanzapine, and olanzapine and quetiapine; (iv) lithium and valproate (LATVAL) versus lithium and olanzapine, lithium and aripiprazole, lithium and quetiapine, divalproex and olanzapine, and olanzapine and quetiapine. Incident user and prevalent new user analyses are planned for proposed target trials (i)-(iv), pending sufficient data. Stratified analyses will be conducted for BD-I, manic and depressive phases of BD illness. We propose an initiator analysis (intention-to-treat, conditional on medication dispensation) to determine the effectiveness of the treatments and per-protocol analyses to determine the efficacy of the treatments after dealing with treatment switching and recommended dose adjustment. The outcomes will include psychiatric acute-care visits (hospitalizations and emergency department visits), BD treatment discontinuation and all-cause mortality. Subgroup and sensitivity analyses, including cohort and study timeline restrictions, eligibility criteria modifications, and outcome reclassifications, are proposed to assess the robustness of our results. Executing analyses in parallel across settings using a co-developed protocol will allow us to evaluate the replicability of findings. Ethics and dissemination The protocol, cohort creation, and analysis plan have been classified and approved as a quality improvement initiative by the Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated to local advocacy groups, clinical groups and decision-makers, national and international clinical guideline developers, presented at international conferences, and published in peer-reviewed journals.
Gow, A.; Shih, E.; Reid, R.; Qian, J. J.; Mellor, C.; McInnes, L. A.; Carhart-Harris, R.; Davis, J. N.
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BackgroundIn 2020, Oregon became the first U.S. state to establish a regulated framework for adults to access psilocybin services using naturally-derived mushroom products. No studies have examined mental health outcomes among individuals receiving psilocybin in this context. AimsTo evaluate changes in self-reported symptoms of depression, anxiety, and well-being 30-days post-psilocybin session under the Oregon state-regulated model , and document session-related adverse events and doses consumed. MethodsThis was a naturalistic study (March 2024-April 2025) among adults [≥]21 years participating in a legal psilocybin services program. Online surveys were completed pre-session, 1-day, and 30-days post-session. Primary outcomes were change in depression, anxiety, and well-being symptoms pre-session to 30-days post-session evaluated using linear mixed-effects models (random effect: timepoint; fixed effects: sex, concurrent psychiatric medication use, age, session dose [total psilocybin equivalents, TPE, mg: psilocybin mg + 1.39 * psilocin mg]). Adverse events (e.g., hallucinogen persisting perception disorder [HPPD]) were assessed at 1-day and 30-days post-session. ResultsParticipants (n=88; median age 43 years; 52% male) were predominantly Oregon residents (53.4%), psychedelic-experienced (64.8%), and concurrently using psychiatric medication (46.6%). All outcomes improved significantly at 30-days post-session (p<0.001), including in sensitivity analyses stratified by concurrent psychiatric medication usage (p<0.001 all outcomes, both groups). Two participants (2.3%) reported symptoms consistent with HPPD at 1-day post-session, but none at 30-days. Mean dose was 27.8 mg (SD 8.2) TPE. ConclusionsPsilocybin sessions delivered under the Oregon regulatory model were associated with clinically meaningful improvements in depression, anxiety, and well-being 30-days post-session, supporting therapeutic effectiveness of legal psilocybin services.
Ngasa, S. N.; Nges, L.; Ngasa, N. C.; Dingana, T. N.; Nadeem, S.
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Armed conflict in Sub-Saharan Africa has exposed millions of civilians to repeated and severe traumatic events, yet the prevalence of posttraumatic stress disorder (PTSD) and its associated determinants across the region have not been comprehensively synthesised. This study aimed to estimate the prevalence of PTSD and examine its associated factors among conflict-affected adult populations in Sub-Saharan Africa. Methodological quality was assessed using the Joanna Briggs Institute (JBI) criteria for cross-sectional and epidemiological studies A systematic search of PubMed, MEDLINE, Embase, Scopus, CINAHL, APA PsycINFO, the Cochrane Library, and the WHO Global Index Medicus (including African Index Medicus) was conducted for studies published between January 1, 2000, and May 31, 2025. Observational studies reporting PTSD prevalence among adults aged 18 years or older exposed to armed conflict were included. Study selection followed PRISMA 2020 guidelines, with independent screening by two reviewers. Random-effects meta-analyses with logit transformation were used to pool prevalence estimates, and determinants were synthesised narratively with emphasis on adjusted effect estimates. Heterogeneity was assessed using the I{superscript 2} statistic. Sixty-eight studies comprising 82,021 participants from 13 countries met inclusion criteria. The pooled prevalence of PTSD was 43% (95% CI, 35.9%-50.0%), with substantial heterogeneity (I{superscript 2} = 99.9%). Prevalence was highest among refugees (79%), followed by internally displaced persons (48%) and residents of conflict-affected communities (34%). Female sex was consistently associated with increased odds of PTSD (pooled adjusted odds ratio approximately 2.0), as were comorbid depression or depressive symptoms (AOR range 4.2-9.5). Additional correlates included cumulative trauma exposure, displacement, poor social support, and substance use. Overall, PTSD is highly prevalent among conflict-affected adults in Sub-Saharan Africa, underscoring the need for integrated, context-sensitive mental health strategies to address the enduring psychological consequences of armed conflict in the region.
Rohde, C.; Ostergaard, S. D.
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ObjectivesElectroconvulsive Therapy (ECT) is an effective treatment for bipolar disorder, particularly in severe acute cases or for illness resistant to pharmacotherapy. However, the risk of relapse following ECT is high, necessitating intervention to reduce this risk. Based on findings from ECT studies in unipolar depression and its well-known mood-stabilizing properties, it is likely that lithium treatment may reduce the risk of relapse of bipolar disorder following ECT. Therefore, we conducted a target trial emulation using data from Danish nationwide registers to investigate whether lithium protects against relapse following ECT treatment of bipolar disorder. MethodsPatients discharged from their first psychiatric admission with a primary diagnosis of bipolar disorder between January 1, 2006, and June 1, 2024, who received at least six ECT treatments, were included. Follow-up began two weeks after discharge and continued until relapse, death, one year, or January 1, 2025. Patients were considered allocated to lithium treatment if they redeemed a prescription for lithium within the first two weeks after discharge from the index admission (ECT treatment). The outcome was time to relapse, defined by either psychiatric hospital admission or suicide. Cox proportional hazards regression, adjusted for potential confounders, was used to compare the outcome between patients allocated and not allocated to lithium treatment. ResultsAmong the 574 eligible patients (mean age 41.5 years, 61.3% women), 214 (37.3%) were allocated to lithium treatment and 360 (62.7%) were not allocated to lithium treatment. During follow-up, 56 patients (26.2%) in the lithium group and 135 patients (37.5%) in the non-lithium group experienced a relapse. Lithium treatment was associated with a substantially reduced risk of relapse (adjusted hazard rate ratio, 0.60, 95% CI=0.43-0.84). ConclusionLithium treatment after ECT may reduce the risk of relapse in patients with bipolar disorder. These findings should be followed up by a randomized controlled trial.
Connell, T.; Casella, C. B.; Esper, N. B.; Tottenham, N.; Tomlinson, M.; Ibanez, A.; Kousoulis, A. A.; Seedat, S.; Bantjes, J.; Kohrt, B. A.; Irarrazaval, M.; Ameis, S.; Rohde, L. A.; Stein, D. J.; Thompson, P.; Pan, P. M.; Merali, Z.; Valdes-Sosa, P. A.; Kieling, C.; Milham, M. P.; Mneimneh, Z.; Salum, G. A.
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BackgroundScientific research remains disproportionately grounded in data from high-income countries (HICs), yet efforts to map the distribution of neuroimaging findings by income levels remain limited. MethodsUsing data from the ENIGMA Consortium, we conducted a systematic quantitative synthesis of 83 publications across nine psychiatric and neurological conditions, analyzing T1-weighted structural MRI data from 16,086 cases in 27 countries. Representation was mapped using World Bank income classifications and World Health Organization (WHO) regions. ResultsHICs contributed 90.5% of cases; upper-middle-income countries 7.9%; lower-middle-income countries 1.6%; and low-income countries none. Geographically, 85% of cases originated from North America and Europe, while Africa, South-East Asia, and the Eastern Mediterranean were underrepresented. Supplemental analyses of other datasets (Brain Growth Charts; fMRI meta-analysis) revealed similar disparities. ConclusionsEquitable neuroimaging science is critical to inform practice and policy decision-making that is context specific. This requires targeted investment in infrastructure, data sharing, and participation from underrepresented regions.
Oliver, D.; Chesney, E.; Wallman, P.; Estrade, A.; Azis, M.; Provenzani, U.; Damiani, S.; Melillo, A.; Hunt, O.; Agarwala, S.; Minichino, A.; Uhlhaas, P. J.; McGuire, P.; Fusar-Poli, P.
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BackgroundAt present, there are no approved pharmacological treatments for people at clinical high risk for psychosis (CHR-P). We sought to assess the acceptability of cannabidiol (CBD): a promising candidate treatment for this population. MethodsCHR-P individuals completed a survey which assessed their views on the acceptability of CBD, its expected effectiveness and side effects, and on formulation preferences. ResultsThe sample comprised 55 CHR-P individuals (24.3 years and 69% female). Most (91%) were familiar with CBD, and had previously used cannabis (64%), and around half (42%) had tried over-the-counter CBD. 75% were willing to take CBD as an intervention for mental health problems. Most participants anticipated fewer side effects with CBD than with existing medications, and preferred tablet or capsule formulations over liquids. DiscussionCBD is perceived as a highly acceptable treatment among CHR-P individuals.
Carroll, H.; Guevara, T.; Gamarra, P.; Mukunta, C.; Dorsey, S.; Gelaye, B.; Bird, M. D.; Frier, L. F.
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Task-sharing approaches have shown promise in low-resource settings, yet few culturally adapted interventions have been systematically evaluated for forcibly displaced populations. Since 2016, over 1.7 million Venezuelans have migrated to Peru, facing significant barriers to healthcare and elevated risks of anxiety, depression, and post-traumatic stress disorder (PTSD). This protocol describes COMPASS (Cognitive-behavioral Open-source Mental-health Program Adapted for migrants, Sustainably delivered by lay providers and Supported by evidence). COMPASS is a transdiagnostic, open-source cognitive behavioral therapy program co-designed with forcibly displaced populations. This protocol describes the procedures for an ongoing randomized pilot trial with n = 90 forcibly displaced Venezuelan people (Clinicaltrials.gov: NCT06635486). COMPASS guides, or lay providers, trained through an intensive apprenticeship model, will deliver 6-12 weekly remote sessions. Primary outcomes include changes in anxiety, depression, and PTSD symptoms, assessed with validated Spanish-language measures. Secondary outcomes include feasibility (recruitment, retention, fidelity) and acceptability (therapist and participant ratings). Exploratory outcomes will examine integration, migration experiences, and demographic moderators of intervention effectiveness. Analyses will follow the intention-to-treat principle, using descriptive statistics and regression models to evaluate symptom trajectories across baseline, post-intervention, and 3- and 6-month follow-ups. This study represents the first effectiveness evaluation of an open-source, lay-delivered CBT program tailored for forcibly displaced people in Peru. Findings will inform feasibility, acceptability, and preliminary effectiveness of COMPASS, with potential to expand scalable, culturally relevant mental health services for forcibly displaced populations in resource-constrained settings worldwide.
Chau, L. W.; Yang, L.; Krebs, E.; Xie, H.; Nguyen, V. C.; Tran, H. N.; Nguyen, T. T. X.; Minas, H.; Lam, R. W.; Murphy, J. K.; Ho, J.; Hayashi, K.; Nguyen, V. H.; Duc, T.; O'Neil, J.
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Depression contributes substantially to the global burden of disease, with large treatment gaps, particularly in low- and middle-income countries (LMICs) like Vietnam. Digital mental health interventions (DMHIs) offer a promising solution, yet evidence for the efficacy and cost-effectiveness of digitally delivered adaptations of evidence-based interventions in LMICs remains limited. This trial evaluated the efficacy and cost-effectiveness of VMood, an app-based DMHI for depression adapted from an evidence-based in-person intervention, in Vietnam. We conducted a stepped-wedge cluster randomized controlled trial across 48 communes in eight Vietnamese provinces. A total of 480 adults screening positive for moderate depression (Patient Health Questionnaire-9 score 10-19), with a retention rate of 97.9%. Communes were randomized to immediate access to VMood or to enhanced usual care, consisting of a limited version of the app during the delay period. The primary outcome was depression caseness (PHQ-9 [≥] 10). Analyses followed an intention-to-treat approach using generalized estimating equations. A cost-effectiveness analysis estimated incremental costs per quality-adjusted life-year (QALY) gained. A total of 477 trial participants were included in the primary analysis. VMood was associated with a 59% reduction in the odds of depression at 6 months (adjusted odds ratio 0.41, 95% CI 0.19-0.89). Mean PHQ-9 scores decreased by 1.9 points (95% CI -3.6 to -0.3) at 6 months. Incremental costs were 1.205 million VND ($47 USD) (95% CI: 1.006 million VND, 1.297 million VND) with 0.008 incremental QALYs (95% CI: 0.006, 0.010), resulting in a 99.7% cost-effectiveness probability at a willingness-to-pay threshold of two times GDP/capita. VMood significantly reduced depressive symptoms and was highly likely to be cost-effective. As a scalable, low-cost intervention, VMood may help reduce the depression treatment gap in settings with limited specialist capacity, supporting investment in evidence-based DMHIs within community-based mental health systems. This trial was registered at ClinicalTrials.gov (NCT05783531) on March 8, 2023. Available from: https://clinicaltrials.gov/study/NCT05783531. Author SummaryDepression is a leading cause of disability worldwide, yet access to effective treatment remains limited, particularly in low- and middle-income countries (LMICs). Digital mental health interventions (DMHIs), such as mobile apps, can reduce depressive symptoms, especially when adapted from evidence-based treatments and delivered with human support. However, most evidence comes from high-income countries, with limited data on efficacy and cost-effectiveness in LMICs. VMood is a mobile app adapted from supported self-management, a modified approach to psychotherapy that is grounded in principles of Cognitive Behavioural Therapy and delivered in-person with support from non-specialist providers. The in-person intervention was shown to be effective in the Vietnamese context in a clinical trial. Here, we conducted a stepped-wedge cluster randomized controlled trial across eight provinces in Vietnam to evaluate the efficacy and cost-effectiveness of VMood. Participants received either the VMood app with supportive coaching provided by a social worker, or enhanced usual care, with subsequent access to the VMood app. Over six months, VMood significantly reduced depression caseness compared with the control group. Economic analysis showed that VMood represents good value for money and was feasible to deliver through existing community systems. Findings provide novel and policy-relevant evidence demonstrating that DMHIs can reduce depression and provide good value for money in LMICs.
Meinlschmidt, G.; Frick, A.; Baenteli, I.; Karpf, C.; Studer, A.; Bahmane, S.; Cicic, N.; Buechel, D.; Ebner, L.; Bachmann, M.; Doerner, A.; Tschudin, S.; Trost, S.; Wyss, K.; Fink, G.; Schwenkglenks, M.; Schaefert, R.; SomPsyNet Consortium,
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BackgroundUp to one-third of medical inpatients experience clinically relevant mental distress, yet many remain untreated. Stepped and collaborative care (SCC) models may improve access to mental health care, but predictors of service uptake are unclear. We examined patient- and ward-level predictors of psychosomatic-psychiatric consultation (PPC). MethodsWe analyzed data from SomPsyNet, a stepped-wedge cluster randomized trial targeting SOMatic inpatients across three Swiss tertiary hospitals, to prevent PSYchosocial distress by a care NETwork. Analyses focused on inpatients screening positive for mental distress. Multiple-imputed logistic regressions assessed predictors of four sequential service-use stages: PPC considered, offered, accepted, and received. ResultsAmong 589 distressed patients, 93.9% were offered PPC, 63.1% accepted, and 83.9% of acceptors received PPC, yielding a 50% overall receipt rate. Patients without Swiss citizenship showed higher odds of acceptance (odds ratio [OR]=1.82 [1.10, 3.00]) and eventual receipt (OR=1.62 [1.01, 2.62]). Being in a Geriatric ward facilitated PCC uptake, while patients from gynecology showed reduced progression through the care pathway. Age, gender, income, education, marital status, and living arrangement showed no statistically robust associations. ConclusionsAlmost two-thirds of mentally distressed medical hospital inpatients accepted an offered PPC, indicating high acceptability. About half ultimately received a consultation, highlighting substantial attrition along the SCC pathway. Ward specialty and nationality were key determinants of PPC uptake. These findings suggest that proactive, ward-oriented consultation-liaison models embedded in routine inpatient care may improve timely and equitable access to mental healthcare, including for migrant and minority patients who are otherwise less likely to access such care. HighlightsO_LIPsychosomatic-psychiatric consultation pathway of medically hospitalized inpatients C_LIO_LI63% accepted such a consultation when offered; overall 50% reached receipt. C_LIO_LINon-Swiss nationality increased odds of acceptance (OR 1.8) and receipt (OR 1.6). C_LIO_LIPatients at geriatrics wards showed higher, at gynecology wards lower transitions. C_LIO_LIResults support low-threshold, ward-oriented consultation-liaison models. C_LI
Mohr, G. H.; Agarwal, S. M.; Sorensen, V.; Lemvigh, C. K.; Sorensen, M. E.; Sanches, M.; Hartmann Hamilton, A. R.; Barcella, C. A.; Siskind, D.; Midtgaard, J.; Vilsboll, T.; Hahn, M. K.; Ebdrup, B. H.
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IntroductionSevere mental illness is associated with high mortality rates and cardiovascular disease. Obesity and dysmetabolism associated with antipsychotic treatment comprise modifiable risk factors, which remain undertreated. Interventions such as antipsychotic-switching, lifestyle-interventions and weight-reducing medication have shown varying results indicating a need for a more individualized approach. The Meta-Care Trial aims to assess the effectiveness of a pragmatic, individualized, evidence- and guideline-based cardiometabolic intervention. Methods and analysisMeta-Care is an open-label randomized controlled trial (RCT). Patients between 18-45 years with schizophrenia spectrum disorders or bipolar disorder will be recruited from in- and outpatient Mental Health Services in the Capital Region of Denmark. Inclusion criteria include treatment with antipsychotics and: either i) [≥]5% body weight gain or [≥]5cm waist circumference increase since initiation of antipsychotic therapy, or ii) a body mass index (BMI) [≥]30 kg/m2, or iii) BMI [≥]27 kg/m2 and related cardiovascular risk factors. Patients are randomized to a pragmatic, individualized metabolic clinic using evidence- and guideline-based care in a mental health center or standard care. Allocation-ratio is 1:1. The primary outcome is the proportion of patients achieving weight loss [≥]5% of initial body weight after 12 months. Secondary and exploratory outcomes cover cardiometabolic risk factors, cognition, personal recovery, and quality of life. Qualitative interviews will explore patient experience and contextual factors. Recruitment started in October 2023 and will include a total of 84 patients. Ethics and disseminationThe Meta-Care trial is funded by The Independent Research Fund Denmark and The Worzner Memorial Fund for Research in Mental Illness. The trial has been approved by the Regional Ethics Committee and Data Protection Agency in the Capital Region of Denmark. Positive, negative, and inconclusive results will be published in scientific peer-reviewed journals, presented at conferences, and dispersed to patient organisations and media. Strengths and limitations- The Meta-Care Trial is the first randomized control trial (RCT) to investigate the effectiveness and acceptability of a pragmatic, individualized metabolic clinic located in a mental health center using evidence- and guideline-based care to treat obesity and cardiometabolic risk factors in patients with severe mental illness - The pragmatic design with limited exclusion criteria and simple outcome measures will generate results that are generalizable to clinical practice - The complex Meta-Care multi-intervention limits inferences of effects explained by specific modifications of pharmacotherapy or lifestyle changes - Potential knowledge exchange from treating personnel in the Meta-Care Trial to caregivers in the standard care group may lead to contamination bias - Although the Meta-Care trial has an open label design, measurements of primary and secondary outcomes will be carried out by blinded assessors
Jin, J. W.; Winkler, C. J.; Blunt, H. B.; Riblet, N. B.
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Background and HypothesisClozapine is the only antipsychotic with protective effects against suicide in schizophrenia (SCZ). Newer third-generation antipsychotics (TGA) have better tolerability and modulate serotonin, dopamine, and N-methyl-d-aspartate neurotransmission pathways implicated in suicide. We aimed to investigate the effects of TGAs on suicide in SCZ. MethodsWe searched seven databases up to December 2023 for SCZ studies that reported suicide data. The primary outcome was suicide deaths and attempts; suicidal ideation was added as a secondary outcome. Random effects meta-analyses quantified suicide risk in randomized controlled trials (RCT) while single proportion meta-analyses assessed longitudinal suicide risk in open label extension trials (OLE). For RCTs, sensitivity analyses were conducted and subgroup analyses explored the impact of dose, drug type, and comparator arm. Study ResultsTwenty articles were included; thirteen excluded higher suicide risk participants. Compared to placebo control, TGAs did not significantly change the risk of primary [RR = 0.65, p = 0.38] or secondary [RR = 0.63, p = 0.15] suicide outcomes. Subgroup and sensitivity analyses were not statistically significant. For OLEs, there was a significant increase in the incidence of primary [Ip = 0.004, p = 0.048] and secondary [Ip = 0.024, p = 0.0013] suicide outcomes, but there was marked study heterogeneity. ConclusionThere is no current trial evidence to show that TGAs significantly impact suicide outcomes in SCZ. The signal from OLEs should be interpreted cautiously due to heterogeneity and requires replication. An effective clozapine alternative is needed for suicide prevention in SCZ.
Foo, C. Y. S.; Leonard, C. J.; McLaughlin, M. M.; Johnson, K. A.; Ongur, D.; Mueser, K. T.; Cather, C.
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BackgroundPoor patient retention and family engagement compromise the effectiveness of coordinated specialty care (CSC) for first-episode psychosis (FEP). This mixed methods study aimed to identify program-level characteristics (CSC fidelity and engagement strategies) associated with patient retention and family engagement in Massachusetts CSC programs. MethodsPrimary outcomes were rates of patient retention and family engagement ([≥]1 evidence-based family intervention session), based on CSC program census (October 2022 - September 2023). Quantitative analyses explored program characteristics (EPINET Program-Level Core Assessment Battery) and fidelity ratings (Massachusetts Psychosis Fidelity Scale) as predictors using t-tests or univariate linear regressions. Thematic analysis of program interviews compared patient and family engagement strategies employed by high versus low performing programs. ResultsAcross nine programs, mean patient retention was 86% (range: 58-97%) and family engagement was 40% (range: 12-100%). Higher fidelity to evidence-based services (e.g., individual therapy, family intervention, and supported education/employment) was significantly associated with both outcomes (p<.05; R2 range: .51-.72). Mixed-methods analysis showed that high performing programs used case management-related supports to meet service users practical needs. Factors associated with higher patient retention included having comprehensive intake assessments, provider visits during hospitalization, and periodic treatment reviews. Programs that conducted benefits counseling and proactively recommended family services as standard care had higher family engagement. ConclusionsHigher fidelity CSC programs had better patient retention and family engagement. Case management-related supports addressed treatment barriers. Strategies designed to strengthen therapeutic alliance and goal alignment may promote patient engagement, while family engagement may benefit from proactive recommendation of family intervention.
Bunk, H.; Ayoubkhani, D.; Nafilyan, V.; Becares, L.; Curcin, V.; Khanolkar, A. R.; Sharland, E.
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BackgroundSexual minority (SM) individuals have worse mental health than heterosexual peers. However, there is no total population-based and national-level evidence on differences in risk of self-harm and suicide by sexual orientation. This study provides the first national population-based estimates in England and Wales. MethodsUsing 2021 Census data linked with hospital records and death registrations, we analysed sexual orientation (SO) differences in: (i) at least one hospital inpatient admission/emergency attendance for intentional self-harm, and (ii) death by suicide. We calculated age-standardised rates per 100,000 people by SO between March 2021 and December 2023, and stratified by sociodemographic, geographical, socioeconomic and health-related variables. We calculated rate ratios for lesbian/gay/bisexual/other SO (LGB+) groups compared with heterosexuals to estimate sexual identity disparities. FindingsOur study population included 28.7 million people (mean age 48.1 years, 53.7% female, 84.2% White) aged [≥]16 years who self-reported their SO in Census 2021 and linked to an NHS number. LGB+ individuals had 2.52 (95% CI 2.48-2.56) times higher risk for self-harm and 2.17 (95% CI 1.98-2.37) times higher risk for suicide than heterosexual people. Relative risk of self-harm was highest for LGB+ females, younger adults, and Black individuals. Relative risk of suicide was highest for LGB+ females, older adults, and Black individuals. InterpretationThis study demonstrates stark inequalities in risk of self-harm and suicide by sexual orientation, consistent across multiple sociodemographic factors. These findings are important for informing government prevention programs and further mental health research. FundingThere was no external funding for this study. Research in contextO_ST_ABSEvidence before the studyC_ST_ABSThe substantial evidence on higher risk for self-harm and suicide in sexual minority groups in the UK (and wider Europe) is impacted by regional samples, younger populations, or surveys limited by smaller numbers precluding analyses by key sociodemographic factors (like sex, ethnic group, socioeconomic indicators, faith, housing situations and geographical indicators) or combining all sexual minority groups together. To date, no study has used total population-based data to examine sexual orientation inequalities in self-harm and suicide and in relation to a range of sociodemographic factors. Added value of this studyTo our knowledge, this is the first study in the UK to provide national population-based estimates of intentional self-harm and suicide by sexual orientation, including intersectional analyses across age, sex, ethnic group, and socioeconomic position. This study used a unique linkage between the census, hospital inpatient data, emergency care records and death registrations from across England and Wales, with a study population of 28.7 million people aged [≥]16 years who self-reported their sexual orientation in Census 2021 and linked to a National Health Service (NHS) number. Implications of all the available evidenceThis research provides national population-level evidence of substantial increased risk for self-harm and suicide among sexual minority individuals, compared with heterosexual individuals. This study also identified key groups of individuals at an increased risk of self-harm and suicide. These findings are important for informing government prevention programs and further research supporting the mental health of sexual minority groups.
Bailey, M.; Hammerton, G.; Fairchild, G.; Tsunga, L.; Hoffman, N.; Burd, T.; Shadwell, R.; Danese, A.; Armour, C.; Zar, H. J.; Stein, D. J.; Donald, K. A.; Halligan, S. L.
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ObjectiveThere is little longitudinal research investigating links between violence exposure and mental disorders among children in low- and middle-income countries (LMICs), despite high rates of violence. We examined cross-sectional and longitudinal violence-mental health associations among children in a large South African birth cohort, the Drakenstein Child Health Study, including direct clinical interviews capturing childrens mental disorders. MethodIn this birth cohort (N=974), we assessed lifetime violence exposure and four subtypes (witnessed community, community victimization, witnessed domestic, domestic victimization) at ages 4.5 and 8-years via caregiver reports. At 8-years, caregivers completed the Child Behaviour Checklist; and psychiatric disorders were assessed using the Mini-International Neuropsychiatric Interview for Children and Adolescents, a self-report measure. We tested for associations using linear/logistic regressions, adjusted for confounders. ResultsMost children (91%) had experienced violence by 8-years. Cross-sectionally, total violence exposure was associated with total (B =0.49 [95% CI 0.32, 0.66]), internalizing (0.32 [0.17, 0.47]), and externalizing problems (0.46 [0.31, 0.61]), and with increased odds of disorder at 8 years (aOR=1.09 [1.05, 1.13]). Longitudinally, total violence exposure up to 4.5-years was associated with total (B=0.27 [0.03, 0.52]), internalizing (0.24 [0.04. 0.44]), and externalizing scores (0.23 [0.008, 0.45]) at 8-years, but not with increased risk of psychiatric disorders. The strongest and most consistent associations were observed for domestic versus community violence subtypes. ConclusionOur strong cross-sectional but weaker longitudinal findings suggest that recent violence exposures may be more critical than early exposures for childrens mental health. Longitudinal exploration of other violence-affected LMIC populations is urgently needed.