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Background: Early identification and intervention for mental health (MH) problems in childhood offers lifelong benefits. Many children with MH problems do not receive appropriate help. To address this need, an online universal MH screening tool, the Growing Minds Check-In for parents/caregivers (GMCI-P), was developed to provide feedback to parents on their children's MH, identify children at risk of MH problems, and link parents to evidence-based online programs/information, with the goal of facilitating parent help-seeking, and ultimately reducing the prevalence of child MH problems., Methods/design: A randomised controlled trial (RCT) with 440 parents/caregivers will be conducted to 1) examine the efficacy of GMCI-P for increasing parent help-seeking; 2) explore acceptability; and 3) cost-effectiveness. Participants will be Australian parents/caregivers with a child aged from birth to 17 years, 6 months, who will be randomly allocated to GMCI-P (intervention) or waitlist control (WLC) group, and complete baseline measures. The intervention group will complete the GMCI-P immediately, the post-GMCI-P intervention questions, a three-month and six-month follow-up. The WLC group will receive access to GMCI-P after their three-month follow-up but will not be followed up further. The primary outcome is parent help-seeking behaviour for child MH, and secondary outcomes include child MH, parenting, parent wellbeing, acceptability, cost-effectiveness, and unintended negative effects., Discussion: The results from this study will provide efficacy, acceptability and cost-effectiveness data on a universal online, parent-report child MH Check-In. These results can be used to inform public policy on universal screening for child MH., Trial Registration: ACTRN12624000098538., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Anxiety disorders and treatment-resistant major depressive disorder (TRD) are often comorbid. Studies suggest ketamine has anxiolytic and antidepressant properties., Aims: To investigate if subcutaneous racemic ketamine, delivered twice weekly for 4 weeks, reduces anxiety in people with TRD., Method: The Ketamine for Adult Depression Study was a multisite 4-week randomised, double-blind, active (midazolam)-controlled trial. The study initially used fixed low dose ketamine (0.5 mg/kg, cohort 1), before protocol revision to flexible, response-guided dosing (0.5-0.9 mg/kg, cohort 2). This secondary analysis assessed anxiety using the Hamilton Anxiety (HAM-A) scale (primary measure) and 'inner tension' item 3 of the Montgomery-Åsberg Depression Rating Scale (MADRS), at baseline, 4 weeks (end treatment) and 4 weeks after treatment end. Analyses of change in anxiety between ketamine and midazolam groups included all participants who received at least one treatment ( n = 174), with a mixed effects repeated measures model used to assess the primary anxiety measure. The trial was registered at www.anzctr.org.au (ACTRN12616001096448)., Results: In cohort 1 ( n = 68) the reduction in HAM-A score was not statistically significant: -1.4 (95% CI [-8.6, 3.2], P = 0.37), whereas a significant reduction was seen for cohort 2 ( n = 106) of -4.0 (95% CI [-10.6, -1.9], P = 0.0058), favouring ketamine over midazolam. These effects were mediated by total MADRS and were not maintained at 4 weeks after treatment end. MADRS item 3 was also significantly reduced in cohort 2 ( P = 0.026) but not cohort 1 ( P = 0.96)., Conclusion: Ketamine reduces anxiety in people with TRD when administered subcutaneously in adequate doses.

Objective: To quantify the costs of hypertension diagnosis and treatment in Australia, particularly in primary care, including general practices and pharmacies., Study Design: Economic analysis; analysis of Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) data., Setting: Australia, 2012-22., Main Outcome Measure: Estimated expenditure on hypertension care (adjusted to 2022 Australian dollars), overall and by expenditure type (general practice consultations, medications), cost bearer (PBS, MBS, patient out-of-pocket costs), and broad expenditure category (medication costs, pharmacy costs, general practice consultations, ambulatory blood pressure monitoring)., Results: During 2012-22, estimated total expenditure for the diagnosis and treatment of hypertension in Australia was $12.2 billion: $7.3 billion (60%) was borne by the MBS and PBS, $4.9 billion (40%) by patients as out-of-pocket costs. During 2021-22, an estimated $1.2 billion was spent on the management of hypertension; the three main cost components were pharmacy-related costs (administration and handling fees, dispensing fees, electronic prescription fees: $611.1 million, 50.8%), general practice consultations ($342.7 million, 28.5%), and blood pressure-lowering medications (manufacturer and wholesale costs: $244.3 million, 20.3%)., Conclusions: During 2012-22, about 40% of the cost of managing hypertension in Australia was borne directly by patients (about $494 million per year). Important changes to pharmacy supply and payment policies were introduced in 2023, but further efforts may be needed to reduce treatment costs for patients. These changes are particularly important if the hypertension control rate is to be substantially improved in Australia, given the large numbers of undertreated and untreated people with hypertension., (© 2024 AMPCo Pty Ltd.)

Competing Interests: Conflict of interest: C.L. and D.M. have received institutional NHMRC grant funding for the CARE Network. The authors have no conflicts of interest or financial disclosures to report.

Background: Suicide is the fourth leading cause of death among young people aged 15-29 worldwide. Young people often present to emergency departments (EDs) with self-harm and suicide-related behaviors. The period following discharge from the ED is recognized as one of elevated risk for both repeated self-harm and suicide. During this critical time, suicide prevention aftercare services are recommended. Despite their increased popularity, evidence demonstrating the effectiveness of these models is very limited., Methods: Using a hybrid effectiveness-implementation type I design, this evaluation will assess the effectiveness and implementation of a suicide prevention aftercare (Hospital Outreach Post-suicidal Engagement; HOPE) service designed to reduce risk of self-harm and suicide in young people aged 12-25 who are referred to the service following an ED presentation for self-harm or suicide attempt. Two complementing theoretical frameworks will guide this evaluation, specifically the design, data collection, analysis, and interpretation of results. The RE-AIM evaluation framework will be used to assess Reach, Effectiveness (including cost-effectiveness), Adoption, Implementation and Maintenance of the HOPE aftercare service. The PRISM implementation framework will be used to assess multi-level contextual factors hypothesized to affect the RE-AIM outcomes. Several data sources will be used to assess the changes in primary and secondary outcomes from baseline to post-intervention, and at follow-up, including user and provider self-report surveys, semi-structured interviews, and routinely collected hospital data. An historical control study will also be conducted using data from the Self-Harm Monitoring System for Victoria to examine the impact of the service on rates of self-harm and suicide-related presentations to ED, and compare trends prior to and following commencement of the HOPE aftercare service. In addition, dynamic systems modelling will be used to assess the future scalability of the service., Discussion: Findings from this evaluation will determine the effectiveness, including cost-effectiveness, of the HOPE aftercare service and describe the implementation context. They will inform the future development and sustainability of this and other similar services across Australia and internationally., Trial Registration: This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) on the 19th December 2023 (Registration number ACTRN12623001332617). We do not foresee any amendments to this protocol however, if any unforeseen modifications are required, they will be submitted to ANZCTR., Trial Sponsor: Orygen, 35 Poplar Road, Parkville, VIC, 3052, Australia., Competing Interests: Declarations Ethics approval and consent to participate This project was approved by the Melbourne Health Human Ethics Committee under HREC/81583/MH-2021 and REC/91556/MH-2022. Informed consent to participate will be obtained from all participants in the study. Parental consent will be provided for all participants under the age of 18. Consent for publication Not applicable, as this manuscript does not contain any individual person’ data. Competing interests Several co-authors (DZ, TJ, ML, HR, KW, AC, PM, IZ, AT, CH, MW, EM, BK, JR) are based within the Centre for Youth Mental Health which is the research department of Orygen and part of the University of Melbourne. This is distinct from the clinical services. Clinical staff working in the HOPE aftercare service are funded by Melbourne Health. The authors do not have any financial competing interests to declare., (© 2024. The Author(s).)

Background: Management of type 1 diabetes (T1D) requires the use of insulin, which can cause hypoglycaemia (low blood glucose levels). While most hypoglycaemic episodes can be self-treated, all episodes can be sudden, inconvenient, challenging to prevent or manage, unpleasant and/or cause unwanted attention or embarrassment. Severe hypoglycaemic episodes, requiring assistance from others for recovery, are rare but potentially dangerous. Repeated exposure to hypoglycaemia can reduce classic warning symptoms ('awareness'), thereby increasing risk of severe episodes. Thus, fear of hypoglycaemia is common among adults with T1D and can have a negative impact on how they manage their diabetes, as well as on daily functioning, well-being and quality of life. While advances in glycaemic technologies and group-based psycho-educational programmes can reduce fear, frequency and impact of hypoglycaemia, they are not universally or freely available, nor do they fully resolve problematic hypoglycaemia or associated worries. This study aims to determine the effectiveness of a fully online, self-directed, scalable, psycho-educational intervention for reducing fear of hypoglycaemia: the Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment (HypoPAST) programme., Methods: A 24-week, two-arm, parallel-group, hybrid type 1 randomised controlled trial, conducted remotely (online and telephone). Australian adults (≥ 18 years) with self-reported T1D and fear of hypoglycaemia will be recruited, and allocated at random (1:1) to HypoPAST or control (usual care). The primary outcome is the between-group difference in fear of hypoglycaemia (assessed using HFS-II Worry score) at 24 weeks. A sample size of N = 196 is required to detect a 9-point difference, with 90% power and allowing for 30% attrition. Multiple secondary outcomes include self-reported psychological, behavioural, biomedical, health economic, and process evaluation data. Data will be collected at baseline, 12 and 24 weeks using online surveys, 2-week ecological momentary assessments, website analytics and semi-structured interviews., Discussion: This study will provide evidence regarding the effectiveness, cost-effectiveness and acceptability of a novel, online psycho-educational programme: HypoPAST. Due to the fully online format, HypoPAST is expected to provide an inexpensive, convenient, accessible and scalable solution for reducing fear of hypoglycaemia among adults with T1D., Trial Registration: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623000894695 (21 August 2023)., (© 2024. The Author(s).)

Background: Mood disorders, including unipolar and bipolar depression, contribute significantly to the global burden of disease. Psychological therapy is considered a gold standard non-pharmacological treatment for managing these conditions; however, a growing body of evidence also supports the use of lifestyle therapies for these conditions. Despite some clinical guidelines endorsing the application of lifestyle therapies as a first-line treatment for individuals with mood disorders, there is limited evidence that this recommendation has been widely adopted into routine practice. A key obstacle is the insufficient evidence on whether lifestyle therapies match the clinical and cost effectiveness of psychological therapy, particularly for treating those with moderate to severe symptoms. The HARMON-E Trial seeks to address this gap by conducting a non-inferiority trial evaluating whether a multi-component lifestyle therapy program is non-inferior to psychological therapy on clinical and cost-effectiveness outcomes over 8-weeks for adults with major depressive disorder and bipolar affective disorder., Methods: This trial uses an individually randomised group treatment design with computer generated block randomisation (1:1). Three hundred and seventy-eight adults with clinical depression or bipolar affective disorder, a recent major depressive episode, and moderate-to-severe depressive symptoms are randomised to receive either lifestyle therapy or psychological therapy (adjunctive to any existing treatments, including pharmacotherapies). Both therapy programs are delivered remotely, via a secure online video conferencing platform. The programs comprise an individual session and six subsequent group-based sessions over 8-weeks. All program aspects (e.g. session duration, time of day, and communications between participants and facilitators) are matched except for the content and program facilitators. Lifestyle therapy is provided by a dietitian and exercise physiologist focusing on four pillars of lifestyle (diet, physical activity, sleep, and substance use), and the psychological therapy program is provided by two psychologists using a cognitive behavioural therapy approach. Data collection occurs at baseline, 8-weeks, 16-weeks, and 6 months with research assistants blinded to allocation. The primary outcome is depressive symptoms at 8 weeks, measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) (minimal clinically important difference = 1.6). A pre-specified within-trial economic evaluation will also be conducted., Discussion: Should lifestyle therapy be found to be as clinically and cost effective as psychological therapy for managing mood disorders, this approach has potential to be considered as an adjunctive treatment for those with moderate to severe depressive symptoms., Trial Registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12622001026718, registered 22nd July 2022., Protocol Version:  4.14, 26/06/2024., (© 2024. The Author(s).)

Background and Aims: Alcohol use and anxiety often co-occur, causing increased severity impairment. This protocol describes a randomized controlled trial (RCT) that aims to test the efficacy and cost-effectiveness of a web-based, self-guided alcohol and anxiety-focused program, compared with a web-based brief alcohol-focused program, for young adults who drink at hazardous levels and experience anxiety. It will also test moderators and mechanisms of change underlying the intervention effects., Design: This RCT will be conducted with a 1:1 parallel group., Setting: The study will be a web-based trial in Australia., Participants: Individuals aged 17-30 years who drink alcohol at hazardous or greater levels and experience at least mild anxiety (n = 500) will be recruited through social media, media (TV, print) and community networks., Intervention and Comparator: Participants will be randomly allocated to receive a web-based, integrated alcohol-anxiety program plus technical and motivational telephone/e-mail support (intervention) or a web-based brief alcohol-feedback program (control)., Measurements: Clinical measures will be assessed at baseline, post-intervention (2 months), 6 months (primary end-point), 12 months and 18 months. Co-primary outcomes are hazardous alcohol consumption and anxiety symptom severity. Secondary outcomes are binge-drinking frequency; alcohol-related consequences; depression symptoms; clinical diagnoses of alcohol use or anxiety disorder (at 6 months post-intervention), health-care service use, educational and employment outcomes; and quality of life. Mediators and moderators will also be assessed. Efficacy will be tested using mixed models for repeated measures within an intention-to-treat framework. The economic evaluation will analyze individual-level health and societal costs and outcomes of participants between each trial arm, while mediation models will test for mechanisms of change., Comments: This will be the first trial to test whether a developmentally targeted, web-based, integrated alcohol-anxiety intervention is effective in reducing hazardous alcohol use and anxiety severity among young adults. If successful, the integrated alcohol-anxiety program will provide an accessible intervention that can be widely disseminated to improve wellbeing of young adults, at minimal cost., (© 2024 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.)

Background: We conducted the first non-inferiority, randomised controlled trial to determine whether lifestyle therapy is non-inferior to psychotherapy with respect to mental health outcomes and costs when delivered via online videoconferencing., Methods: An individually randomised, group treatment design with computer-generated block randomisation was used. Between May 2021-April 2022, 182 adults with a Distress Questionnaire-5 score = ≥8 (indicative depression) were recruited from a tertiary mental health service in regional Victoria, Australia and surrounds. Participants were assigned to six 90-min sessions over 8-weeks using group-based, online videoconferencing comprising: (1) lifestyle therapy (targeting nutrition, physical activity) with a dietitian and exercise physiologist (n = 91) or (2) psychotherapy (Cognitive Behavioural Therapy) with psychologists (n = 91). The primary outcome was Patient Health Questionnaire-9 (PHQ-9) depression at 8-weeks (non-inferiority margin ≤2) using Generalised Estimating Equations (GEE). Cost-minimisation analysis estimated the mean difference in total costs from health sector and societal perspectives. Outcomes were assessed by blinded research assistants using Computer Assisted Telephone Interviews. Results are presented per-protocol (PP) and Intention to Treat (ITT) using beta coefficients with 95% Confidence Intervals (CIs)., Findings: The sample was 80% women (mean: 45-years [SD:13.4], mean PHQ-9:10.5 [SD:5.7]. An average 4.2 of 6 sessions were completed, with complete data for n = 132. Over 8-weeks, depression reduced in both arms (PP: Lifestyle (n = 70) mean difference:-3.97, 95% CIs:-5.10, -2.84; and Psychotherapy (n = 62): mean difference:-3.74, 95% CIs:-5.12, -2.37; ITT: Lifestyle (n = 91) mean difference:-4.42, 95% CIs: -4.59, -4.25; Psychotherapy (n = 91) mean difference:-3.82, 95% CIs:-4.05, -3.69) with evidence of non-inferiority (PP GEE β:-0.59; 95% CIs:-1.87, 0.70, n = 132; ITT GEE β:-0.49, 95% CIs:-1.73, 0.75, n = 182). Three serious adverse events were recorded. While lifestyle therapy was delivered at lower cost, there were no differences in total costs (health sector adjusted mean difference: PP AUD$156 [95% CIs -$182, $611, ITT AUD$190 [95% CIs -$155, $651] ]; societal adjusted mean difference: PP AUD$350 [95% CIs:-$222, $1152] ITT AUD$ 408 [95% CIs -$139, $1157]., Interpretation: Remote-delivered lifestyle therapy was non-inferior to psychotherapy with respect to clinical and cost outcomes. If replicated in a fully powered RCT, this approach could increase access to allied health professionals who, with adequate training and guidelines, can deliver mental healthcare at comparable cost to psychologists., Funding: This trial was funded by the Australian Medical Research Future Fund (GA133346) under its Covid-19 Mental Health Research Grant Scheme., Competing Interests: This trial was funded by the National Health and Medical Research Council’s (NHMRC) Medical Research Future Fund–COVID-19 Mental Health Research Australian Government Department of Health (GA133346). AO is supported by a NHMRC Emerging Leader 2 Fellowship (2009295). FNJ is supported by an NHMRC Investigator Grant (#1194982). FNJ has received fellowship funding support from the National Health and Medical Research Council (#1194982) and payment or honorariums for lectures, presentations, speakers bureaus, manuscript writing, or educational events from the Malaysian Society of Gastroenterology and Hepatology, JNPN Congress, American Nutrition Association, Personalised Nutrition Summit, and American Academy of Craniofacial Pain, is a Scientific Advisory Board member of Dauten Family Centre for Bipolar Treatment Innovation (unpaid) and Zoe Nutrition (unpaid), has written two books for commercial publication on the topic of nutritional psychiatry and gut health, and is the principal investigator for the MicroFit Study. She is Director of the Food & Mood Centre, Deakin University, which has received research funding support from Be Fit Food, Bega Dairy and Drinks, and the a2 Milk Company and philanthropic research funding support from the Waterloo Foundation, Wilson Foundation, the JTM Foundation, the Serp Hills Foundation, the Roberts Family Foundation, and the Fernwood Foundation. SR is supported by an NHMRC Investigator Grant (2017506). MB is supported by a NHMRC Senior Principal Research Fellowship and Leadership 3 Investigator grant (1156072 and 2017131). MTey is supported by a NHMRC Emerging Leadership Fellowship (APP1195335). JS is supported by core funding to the Australian Centre for Behavioural Research in Diabetes provided by the collaboration between Diabetes Victoria and Deakin University. VV is supported by the Rural Health Multidisciplinary Training program. SMah has received funding from Education in Nutrition to provide a professional development presentation and Red Island Olive Oil for social media promotion. MMor has received research grants related to antimicrobial stewardship, discharge medication, consulting fees from Primary Health Networks of Gold Coast and Western Australia related to Primary Sense software. Australian Health Policy Collaboration, RACGP, Australian Department of Health and Aged Care (DoHAC), conference support from RACGP various as chair of Expert Committee for Quality Care, participation in DSMBs for Primary Sense and DoHAC and is a member of Arthritis Australia and Bond University Boards. The contents of the published material are solely the responsibility of the individual authors and do not reflect the views of the funding bodies. The authors have no interests to declare., (© 2024 The Authors.)

Objective: To evaluate the cost-effectiveness of repetitive transcranial magnetic stimulation (rTMS) as an adjunct to standard care from an Australian health sector perspective, compared to standard care alone for adults with treatment-resistant bipolar depression (TRBD)., Methods: An economic model was developed to estimate the cost per disability-adjusted life-year (DALY) averted and quality-adjusted life-year (QALY) gained for rTMS added to standard care compared to standard care alone, for adults with TRBD. The model simulated the time in three health states (mania, depression, residual) over one year. Response to rTMS was sourced from a meta-analysis, converted to a relative risk and used to modify the time in the depressed state. Uncertainty and sensitivity tested the robustness of results., Results: Base-case incremental cost-effectiveness ratios (ICERs) were $72,299 per DALY averted (95 % Uncertainty Interval (UI): $60,915 to $86,668) and $46,623 per QALY gained (95 % UI: $39,676 - $55,161). At a willingness to pay (WTP) threshold of $96,000 per DALY averted, the base-case had a 100 % probability of being marginally cost-effective. At a WTP threshold of $64,000 per QALY gained, the base-case had a 100 % probability of being cost-effective. Sensitivity analyses decreasing the number of sessions provided, increasing the disability weight or the time spent in the depression state for standard care improved the ICERs for rTMS., Conclusions: Dependent on the outcome measure utilised and assumptions, rTMS would be considered a very cost-effective or marginally cost-effective adjunct to standard care for TRBD compared to standard care alone., Competing Interests: Declaration of competing interest None., (Copyright © 2024. Published by Elsevier B.V.)

Background: Most people with mental health problems do not seek help, with delays of even decades in seeking professional help. Lack of engagement with professional mental health services can lead to poor outcomes and functional impairment. However, few effective interventions have been identified to improve help-seeking in adults, and those that exist are not widely implemented to deliver public health impact. Co-designing interventions with people with lived experience of mental ill-health and other relevant stakeholders is critical to increase the likelihood of uptake and engagement with these programs., Objective: This study aims to (1) test the effectiveness of a co-designed help-seeking program on increasing professional help-seeking intentions in employees in a workplace setting; (2) determine whether the program reduces mental illness stigma and improves help-seeking intentions and behavior, mental health literacy, mental health symptoms, and work and activity functioning relative to the control condition; (3) explore factors that facilitate broader implementation of the co-designed program; and (4) explore the cost-effectiveness of the co-designed program compared to the control condition over 6 months., Methods: A 2-arm cluster randomized controlled trial will be conducted (target sample: N=900 from 30 to 36 workplaces, with n=25 to 35 participants per workplace). The trial will compare the relative effectiveness of an enhanced interactive program (intervention condition) with a standard psychoeducation-alone program (active control condition) on the primary outcome of professional help-seeking intentions as measured by the General Help-Seeking Questionnaire. Secondary outcomes include the impact on mental illness stigma; mental health literacy; help-seeking attitudes and behavior; work and activity functioning; quality of life; and symptoms of mental ill-health including depression, anxiety, and general psychological distress., Results: Facilitators of and risks to the trial are identified and addressed in this protocol. Recruitment of workplaces is scheduled to commence in the first quarter of 2024., Conclusions: If effective, the program has the potential to be ready for rapid dissemination throughout Australia, with the potential to increase appropriate and efficient service use across the spectrum of evidence-based services., Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12623000270617p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385376., International Registered Report Identifier (irrid): PRR1-10.2196/55529., (©Philip J Batterham, Amelia Gulliver, Cassandra Heffernan, Alison L Calear, Aliza Werner-Seidler, Alyna Turner, Louise M Farrer, Mary Lou Chatterton, Cathrine Mihalopoulos, Michael Berk. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 24.05.2024.)

Objective: This analysis estimated 2013 annual healthcare costs associated with the common mental disorders of mood and anxiety disorders and psychological symptoms within a representative sample of Australian women., Methods: Data from the 15-year follow-up of women in the Geelong Osteoporosis Study were linked to 12-month Medicare Benefits Schedule and Pharmaceutical Benefits Scheme data. A Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Non-patient edition identified common mental disorders and the General Health Questionnaire 12 assessed psychological symptoms. Participants were categorised into mutually exclusive groups: (1) common mental disorder (past 12 months), (2) subthreshold (no common mental disorder and General Health Questionnaire 12 score ⩾4) or (3) no common mental disorder and General Health Questionnaire 12 score <4. Two-part and hurdle models estimated differences in service use, and adjusted generalised linear models estimated mean differences in costs between groups., Results: Compared to no common mental disorder, women with common mental disorders utilised more Medicare Benefits Schedule services (mean 26.9 vs 20.0, p  < 0.001), had higher total Medicare Benefits Schedule cost ($1889 vs $1305, p  < 0.01), received more Pharmaceutical Benefits Scheme prescriptions (35.8 vs 20.6, p  < 0.001), had higher total Pharmaceutical Benefits Scheme cost ($1226 vs $740, p  < 0.05) and had significantly higher annual out-of-pocket costs for Pharmaceutical Benefits Scheme prescriptions ($249 vs $162, p  < 0.001). Compared to no common mental disorder, subthreshold women were less likely to use any Medicare Benefits Schedule service (89.6% vs 97.0%, p  < 0.01), but more likely to use mental health services (11.4% vs 2.9%, p  < 0.01). The subthreshold group received more Pharmaceutical Benefits Scheme prescriptions (mean 43.3 vs 20.6, p  < 0.001) and incurred higher total Pharmaceutical Benefits Scheme cost ($1268 vs $740, p  < .05) compared to no common mental disorder., Conclusions: Common mental disorders and subthreshold psychological symptoms place a substantial economic burden on Australian healthcare services and consumers., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.

Background: The CSC study found that the universal delivery of a school-based, online programme for the prevention of mental health and substance use disorders among adolescents resulted in improvements in mental health and substance use outcomes at 30-month follow-up. We aimed to compare the long-term effects of four interventions-Climate Schools Combined (CSC) mental health and substance use, Climate Schools Substance Use (CSSU) alone, Climate Schools Mental Health (CSMH) alone, and standard health education-on mental health and substance use outcomes among adolescents at 72-month follow-up into early adulthood., Methods: This long-term study followed up adolescents from a multicentre, cluster-randomised trial conducted across three states in Australia (New South Wales, Queensland, and Western Australia) enrolled between Sept 1, 2013, and Feb 28, 2014, for up to 72 months after baseline assessment. Adolescents (aged 18-20 years) from the original CSC study who accepted contact at 30-month follow-up and provided informed consent at 60-month follow-up were eligible. The interventions were delivered in school classrooms through an online delivery format and used a mixture of peer cartoon storyboards and classroom activities that were focused on alcohol, cannabis, anxiety, and depression. Participants took part in two web-based assessments at 60-month and 72-month follow-up. Primary outcomes were alcohol use, cannabis use, anxiety, and depression, measured by self-reported surveys and analysed by intention to treat (ie, in all students who were eligible at baseline). This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613000723785), including the extended follow-up study., Findings: Of 6386 students enrolled from 71 schools, 1556 (24·4%) were randomly assigned to education as usual, 1739 (27·2%) to CSSU, 1594 (25·0%) to CSMH, and 1497 (23·4%) to CSC. 311 (22·2%) of 1401 participants in the control group, 394 (26·4%) of 1495 in the CSSU group, 477 (37·%) of 1289 in the CSMH group, and 400 (32·5%) of 1232 in the CSC group completed follow-up at 72 months. Adolescents in the CSC group reported slower year-by-year increases in weekly alcohol use (odds ratio 0·78 [95% CI 0·66-0·92]; p=0·0028) and heavy episodic drinking (0·69 [0·58-0·81]; p<0·0001) than did the control group. However, significant baseline differences between groups for drinking outcomes, and no difference in the predicted probability of weekly or heavy episodic drinking between groups were observed at 72 months. Sensitivity analyses increased uncertainty around estimates. No significant long-term differences were observed in relation to alcohol use disorder, cannabis use, cannabis use disorder, anxiety, or depression. No adverse events were reported during the trial., Interpretation: We found some evidence that a universal online programme for the prevention of anxiety, depression, and substance use delivered in early adolescence is effective in reducing the use and harmful use of alcohol into early adulthood. However, confidence in these findings is reduced due to baseline differences, and we did not see a difference in the predicted probability of drinking between groups at 72-month follow-up. These findings suggest that a universal prevention programme in adolescence is not sufficient to have lasting effects on mental health and substance use disorders in the long term. In addition to baseline differences, substantial attrition warrants caution in interpretation and the latter factor highlights the need for future long-term follow-up studies to invest in strategies to increase engagement., Funding: Australian National Health and Medical Research Council., Competing Interests: Declaration of interests MT and NCN are two of the developers of the OurFutures programmes (formerly Climate Schools) and are members of the OurFutures Institute, a not-for-profit charity that distributes the OurFutures programmes to maximise social wellbeing. All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Competing Interests: We declare no competing interests.

Background: Public health guidelines recommend delaying the initiation age for alcohol. However, the causal link between age-at-first-drink (AFD) and future alcohol use in young adulthood is uncertain. This study examined the association between AFD and alcohol-related outcomes at age 20 years using an Australian sample., Methods: Data were obtained from Waves 1-19 (years 2001-2019) of the Household, Income and Labour Dynamics in Australia Survey on 20-year-olds with responses across ≥3 consecutive waves (n = 2278). The AFD for each respondent (between 15 and 20 years) was analysed relative to Australian legal drinking age (18 years). Inverse probability treatment weighting was used to evaluate associations between AFD and four outcomes at age 20 years: risk of current alcohol use; quantity of weekly alcohol consumption; risk of binge drinking; and frequency of binge drinking. Adjustments were made for confounders (e.g., heavy drinking by parents). Robustness of study findings was evaluated using several diagnostic tests/sensitivity analyses., Results: Among 20-year-olds, those with an AFD of 15-16 years consumed significantly more alcohol per week compared to an AFD of 18 years. Additionally, 20-year-old drinkers with an AFD of 16 years were significantly more likely to binge drink (though this association was likely confounded). An inverse dose-response relationship was observed between AFD and weekly alcohol consumption at 20 years, where a higher AFD led to lower alcohol consumption., Conclusion: Study findings indicate an association between a higher AFD and consuming less alcohol in young adulthood, which could potentially support the scale-up of prevention programs to delay AFD among Australian adolescents., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier Inc.)

Background: Self-reported service use informs resource utilisation and cost estimates, though its validity for use within economic evaluations is uncertain., Objective: The aim of this study is to assess agreement in health resource-use measurement between self-reported and administrative data across different resource categories, over time and between different recall periods by subgroups among Australians living with psychosis., Methods: Data were obtained for 104 participants with psychotic disorders from a randomised controlled trial. Agreement between self-reported resource-use questionnaires and administrative data on community-based services and medication use was assessed through estimating differences of group mean number of visits and medications used and intraclass correlation coefficients (ICC) over multiple time periods., Results: ICC showed moderate agreement across most time periods for general practitioners, psychiatrists and mental health medications. No clear trends were discernible over time, between varying lengths of recall periods nor across participant subgroups., Conclusion: Despite poor agreement, when measuring visits to psychologists and other health professionals, small overall differences in group mean number of visits indicate that self-reported data may still be valid for use in economic evaluations in people living with psychosis., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

In this paper, the case study of ketamine as a new treatment for severe depression is used to outline the challenges of repurposing established medicines and we suggest potential solutions. The antidepressant effects of generic racemic ketamine were identified over 20 years ago, but there were insufficient incentives for commercial entities to pursue its registration, or support for non-commercial entities to fill this gap. As a result, the evaluation of generic ketamine was delayed, piecemeal, uncoordinated, and insufficient to gain approval. Meanwhile, substantial commercial investment enabled the widespread registration of a patented, intranasal s-enantiomeric ketamine formulation (Spravato ® ) for depression. However, Spravato is priced at $600-$900/dose compared to ~$5/dose for generic ketamine, and the ~AUD$100 million annual government investment requested in Australia (to cover drug costs alone) has been rejected twice, leaving this treatment largely inaccessible for Australian patients 2 years after Therapeutic Goods Administration approval. Moreover, emerging evidence indicates that generic racemic ketamine is at least as effective as Spravato, but no comparative trials were required for regulatory approval and have not been conducted. Without action, this story will repeat regularly in the next decade with a new wave of psychedelic-assisted psychotherapy treatments, for which the original off-patent molecules could be available at low-cost and reduce the overall cost of treatment. Several systemic reforms are required to ensure that affordable, effective options become accessible; these include commercial incentives, public and public-private funding schemes, reduced regulatory barriers and more coordinated international public funding schemes to support translational research., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: A.R., C.G.D., M.L.C., N.G., M.H. and C.L. have all received competitive research grants from NHMRC and MRFF for clinical trials evaluating ketamine in depression. C.L. and M.H. have served on advisory boards for Janssen and C.L. has served on advisory boards for Douglas Pharmaceuticals. NG has received a panel honorarium from Janssen and served on Advisory Boards for Servier and Lundbeck. D.B. is an employee of Psylo. The remaining authors have no conflicts of interest to declare.

Objective: Alcohol use disorders confer a significant burden of disease and economic cost worldwide. However, the utilisation of pharmacotherapies to manage alcohol use disorder is poor. We aimed to conduct a systematic review of economic evaluation studies of alcohol use disorder pharmacotherapies., Methods: A search was conducted in Embase, Medline, CINAHL, PsychINFO and EconLit (August 2019, updated September 2022). Full economic evaluations using pharmacotherapy to treat alcohol use disorders were included. Included studies were stratified by medication and summarised descriptively. The Consensus on Health Economic Criteria list was used to assess the methodological quality., Results: A total of 1139 studies were retrieved, of which 15 met the inclusion criteria. All studies were conducted in high-income countries. Four studies analysed nalmefene, four studies assessed acamprosate, three for naltrexone and four for stand-alone and/or combinations of naltrexone and acamprosate. There were 21 interventions synthesised from 15 studies as some studies evaluated multiple interventions and comparators. More than half of the included studies (73%) reported pharmacotherapy as dominant (less costly and more effective than comparators). From healthcare payer perspectives, five studies found that pharmacotherapy added to psychosocial support was dominant or cost-effective, accruing additional benefits at a higher cost but under accepted willingness to pay thresholds. Three analyses from a societal perspective found pharmacotherapy added to psychosocial support was a dominant or cost-effective strategy. Quality scores ranged from 63% to 95%., Conclusion: Pharmacotherapy added to psychosocial support was cost-effective from both healthcare and societal perspectives, emphasising an increased role for pharmacotherapy to reduce the burden of alcohol use disorders., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article.

Objective: This systematic review updates an existing review examining the cost-effectiveness of interventions to prevent and treat eating disorders (EDs)., Method: Literature search was conducted in Academic Search Complete, MEDLINE, CINAHL, PsycINFO, EconLit, Global Health, ERIC, Health Business Elite, and Health Policy Reference Center electronic databases, capturing studies published between March 2017 to April 2023. Hand-searching was conducted as supplementary including gray literature search. Included articles were (1) full economic evaluations or return-on-investment studies, (2) in English and (3) aimed at prevention and treatment of any ED. Included studies were added and synthesized with previously reviewed studies. Screening and extraction followed PRISMA guidelines. Quality assessment was conducted using the Drummond checklist. PROSPERO registration CRD42021287464., Results: A total of 28 studies were identified, including 15 published after the previous review. There were nine prevention, seven anorexia nervosa (AN) treatment, five bulimia nervosa (BN) treatment, four binge-eating disorder (BED), and three non-specific ED treatment studies. Findings indicate value-for-money evidence supporting all interventions. Quality assessment showed studies were fair-to-good quality., Discussion: There has been significant growth in cost-effectiveness studies over the last 5 years. Findings suggest that interventions to prevent and treat ED offer value for money. Interventions such as Featback (ED prevention and non-specific ED treatment); focal psychodynamic therapy, enhanced cognitive behavioral therapy, and high-calorie refeeding (AN treatment); stepped-care with assisted self-help and internet-based cognitive behavioral therapy (BN treatment); and cognitive behavioral therapy guided self-help intervention (BED treatment) have good quality economic evidence. Further research in implementation of interventions is required., Public Significance Statement: The increasing prevalence of ED globally has significant impact on healthcare systems, families, and society. This review is showcasing the value for money of interventions of eating disorders prevention and treatment. This review found that existing interventions offers positive economic benefit for the healthcare system., (© 2023 The Authors. International Journal of Eating Disorders published by Wiley Periodicals LLC.)

Background: Anorexia nervosa (AN) has amongst the highest mortality rates and the highest treatment costs of any psychiatric disorder. Recently, interest in non-invasive brain stimulation as a novel treatment for AN has grown. These include repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS)., Methods: This double-blind, randomised sham-controlled trial will compare the relative acceptability and efficacy of tDCS and rTMS in people with AN. 70 participants will be randomised to active or sham tDCS, or active or sham rTMS treatment (2:1:2:1 ratio) over an 8-week treatment period. Participants will receive treatment as usual across the study duration. The primary outcomes are change on the Eating Disorder Examination Questionnaire and treatment acceptability. Secondary outcomes will include change in weight, cognition, mood, interpersonal functioning, and quality of life. Following the 8-week assessment, all participants will have the option of receiving an additional 12 weeks of at-home tDCS. A follow-up assessment will be conducted at 20 weeks post treatment., Discussion: Research into non-invasive brain stimulation as treatments for AN has potential to improve clinical outcomes for patients by comparing the relative efficacy and acceptability of both treatment modalities in the inpatient and at-home setting (i.e., for at-home tDCS) results from this study will provide important information for informing future larger clinical trials of these treatments for AN., Trial Registration: ClinicalTrials.gov Identifier: NCT05788042., (© 2023. The Author(s).)