Search

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.)

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.)

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.)

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.)

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.)

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.

Background: Prior trials suggest that intravenous racemic ketamine is a highly effective for treatment-resistant depression (TRD), but phase 3 trials of racemic ketamine are needed., Aims: To assess the acute efficacy and safety of a 4-week course of subcutaneous racemic ketamine in participants with TRD. Trial registration: ACTRN12616001096448 at www.anzctr.org.au., Method: This phase 3, double-blind, randomised, active-controlled multicentre trial was conducted at seven mood disorders centres in Australia and New Zealand. Participants received twice-weekly subcutaneous racemic ketamine or midazolam for 4 weeks. Initially, the trial tested fixed-dose ketamine 0.5 mg/kg versus midazolam 0.025 mg/kg (cohort 1). Dosing was revised, after a Data Safety Monitoring Board recommendation, to flexible-dose ketamine 0.5-0.9 mg/kg or midazolam 0.025-0.045 mg/kg, with response-guided dosing increments (cohort 2). The primary outcome was remission (Montgomery-Åsberg Rating Scale for Depression score ≤10) at the end of week 4., Results: The final analysis (those who received at least one treatment) comprised 68 in cohort 1 (fixed-dose), 106 in cohort 2 (flexible-dose). Ketamine was more efficacious than midazolam in cohort 2 (remission rate 19.6% v . 2.0%; OR = 12.1, 95% CI 2.1-69.2, P = 0.005), but not different in cohort 1 (remission rate 6.3% v . 8.8%; OR = 1.3, 95% CI 0.2-8.2, P = 0.76). Ketamine was well tolerated. Acute adverse effects (psychotomimetic, blood pressure increases) resolved within 2 h., Conclusions: Adequately dosed subcutaneous racemic ketamine was efficacious and safe in treating TRD over a 4-week treatment period. The subcutaneous route is practical and feasible.

Background: Mental health problems are common among people with diabetes. However, evidence-based strategies for the prevention and early intervention of emotional problems in people with diabetes are lacking. Our aim is to assess the real-world effectiveness, cost-effectiveness, and implementation of a Low-Intensity mental health Support via a Telehealth Enabled Network (LISTEN), facilitated by diabetes health professionals (HPs)., Methods: A hybrid type I effectiveness-implementation trial, including a two-arm parallel randomised controlled trial, alongside mixed methods process evaluation. Recruited primarily via the National Diabetes Services Scheme, Australian adults with diabetes (N = 454) will be eligible if they are experiencing elevated diabetes distress. Participants are randomised (1:1 ratio) to LISTEN-a brief, low-intensity mental health support program based on a problem-solving therapy framework and delivered via telehealth (intervention) or usual care (web-based resources about diabetes and emotional health). Data are collected via online assessments at baseline (T0), 8 weeks (T1) and 6 months (T2, primary endpoint) follow-up. The primary outcome is between-group differences in diabetes distress at T2. Secondary outcomes include the immediate (T1) and longer-term (T2) effect of the intervention on psychological distress, general emotional well-being, and coping self-efficacy. A within-trial economic evaluation will be conducted. Implementation outcomes will be assessed using mixed methods, according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Data collection will include qualitative interviews and field notes., Discussion: It is anticipated that LISTEN will reduce diabetes distress among adults with diabetes. The pragmatic trial results will determine whether LISTEN is effective, cost-effective, and should be implemented at scale. Qualitative findings will be used to refine the intervention and implementation strategies as required., Trial Registration: This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN: ACTRN12622000168752) on 1 February, 2022., (© 2023. The Author(s).)

Background: The evidence for the clinical utility of pharmacogenomic (PGx) testing is growing, and guidelines exist for the use of PGx testing to inform prescribing of 13 antidepressants. Although previous randomised controlled trials of PGx testing for antidepressant prescribing have shown an association with remission of depression in clinical psychiatric settings, few trials have focused on the primary care setting, where most antidepressant prescribing occurs., Methods: The PRESIDE Trial is a stratified double-blinded randomised controlled superiority trial that aims to evaluate the impact of a PGx-informed antidepressant prescribing report (compared with standard prescribing using the Australian Therapeutic Guidelines) on depressive symptoms after 12 weeks, when delivered in primary care. Six hundred seventy-two patients aged 18-65 years of general practitioners (GPs) in Victoria with moderate to severe depressive symptoms, measured using the Patient Health Questionnaire-9 (PHQ-9), will be randomly allocated 1:1 to each arm using a computer-generated sequence. Participants and GPs will be blinded to the study arm. The primary outcome is a difference between arms in the change of depressive symptoms, measured using the PHQ-9 after 12 weeks. Secondary outcomes include a difference between the arms in change in PHQ-9 score at 4, 8 and 26 weeks, proportion in remission at 12 weeks, a change in side effect profile of antidepressant medications, adherence to antidepressant medications, change in quality of life and cost-effectiveness of the intervention., Discussion: This trial will provide evidence as to whether PGx-informed antidepressant prescribing is clinically efficacious and cost-effective. It will inform national and international policy and guidelines about the use of PGx to select antidepressants for people with moderate to severe depressive symptoms presenting in primary care., Trial Registration: Australian and New Zealand Clinical Trial Registry ACTRN12621000181808. Registered on 22 February 2021., (© 2023. The Author(s).)

The objectives of this study are to assess the association between childhood bullying and preference-based health-related quality of life (QoL) in Australian school children and their parents and estimate quality-adjusted life years (QALYs) associated with bullying chronicity. Children aged 8-10 years completed the child health utilities (CHU-9D), while parents completed the Australian quality of life (AQoL-8D). Children were grouped into four categories of bullying involvement (no bullying, victim, perpetrator, or both perpetrator and victim) based on the Revised Olweus Bully/Victim Questionnaire. Parental data were compared across two bullying involvement groups (bullying vs. no bullying). QALYs were calculated for children over two years and comparisons made based on the number of assessments where bullying was reported (baseline, 1- and 2-year follow up). Children who were involved in bullying (victims and/or perpetrators) reported statistically significantly lower mean utility scores compared to children who were not involved in bullying. Parents whose child was involved in bullying had significantly lower mean utility scores compared to parents of children not involved with bullying. There appeared to be a dose-response relationship, with higher QALY losses associated with increasing frequency of reported bullying. Bullying among Australian school children was associated with significantly lower preference-based QoL for themselves and their parents. This study also confirmed the significant burden of disease for bullying among children measured by an incremental decrease in QALY with an increasing chronicity of bullying over time., (© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: This paper reports on the cost-effectiveness evaluation of Link-me - a digitally supported, systematic approach to triaging care for depression and anxiety in primary care that uses a patient-completed Decision Support Tool (DST)., Methods: The economic evaluation was conducted alongside a parallel, stratified individually randomised controlled trial (RCT) comparing prognosis-matched care to usual care at six- and 12-month follow-up. Twenty-three general practices in three Australian Primary Health Networks recruited 1,671 adults (aged 18 - 75 years), predicted by the DST to have minimal/mild or severe depressive or anxiety symptoms in three months. The minimal/mild prognostic group was referred to low intensity services. Participants screened in the severe prognostic group were offered high intensity care navigation, a model of care coordination. The outcome measures included in this evaluation were health sector costs (including development and delivery of the DST, care navigation and other healthcare services used) and societal costs (health sector costs plus lost productivity), psychological distress [Kessler Psychological Distress Scale (K10)] and quality adjusted life years (QALYs) derived from the EuroQol 5-dimension quality of life questionnaire with Australian general population preference weights applied. Costs were valued in 2018-19 Australian dollars (A$)., Results: Across all participants, the health sector incremental cost-effectiveness ratio (ICER) of Link-me per point decrease in K10 at six months was estimated at $1,082 (95% CI $391 to $6,204) increasing to $2,371 (95% CI $191 to Dominated) at 12 months. From a societal perspective, the ICER was estimated at $1,257/K10 point decrease (95% CI Dominant to Dominated) at six months, decreasing to $1,217 (95% CI Dominant to Dominated) at 12 months. No significant differences in QALYs were detected between trial arms and the intervention was dominated (less effective, more costly) based on the cost/QALY ICER., Conclusions: The Link-me approach to stepped mental health care would not be considered cost-effective utilising a cost/QALY outcome metric commonly adopted by health technology assessment agencies. Rather, Link-me showed a trend toward cost-effectiveness by providing improvement in mental health symptoms, measured by the K10, at an additional cost., Trial Registration: Australian and New Zealand Clinical Trials Registry, ANZCTRN 12617001333303., (© 2022. The Author(s).)

Background: Target-D, a new person-centred e-health platform matching depression care to symptom severity prognosis (minimal/mild, moderate or severe) has demonstrated greater improvement in depressive symptoms than usual care plus attention control. The aim of this study was to evaluate the cost-effectiveness of Target-D compared to usual care from a health sector and partial societal perspective across 3-month and 12-month follow-up., Methods and Findings: A cost-utility analysis was conducted alongside the Target-D randomised controlled trial; which involved 1,868 participants attending 14 general practices in metropolitan Melbourne, Australia. Data on costs were collected using a resource use questionnaire administered concurrently with all other outcome measures at baseline, 3-month and 12-month follow-up. Intervention costs were assessed using financial records compiled during the trial. All costs were expressed in Australian dollars (A$) for the 2018-19 financial year. QALY outcomes were derived using the Assessment of Quality of Life-8D (AQoL-8D) questionnaire. On a per person basis, the Target-D intervention cost between $14 (minimal/mild prognostic group) and $676 (severe group). Health sector and societal costs were not significantly different between trial arms at both 3 and 12 months. Relative to a A$50,000 per QALY willingness-to-pay threshold, the probability of Target-D being cost-effective under a health sector perspective was 81% at 3 months and 96% at 12 months. From a societal perspective, the probability of cost-effectiveness was 30% at 3 months and 80% at 12 months., Conclusions: Target-D is likely to represent good value for money for health care decision makers. Further evaluation of QALY outcomes should accompany any routine roll-out to assess comparability of results to those observed in the trial. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616000537459)., Competing Interests: The authors have declared that no competing interests exist.

Objective: To identify and describe the available literature quantifying the economic burden associated with the negative symptoms of schizophrenia., Methods: A search of five electronic databases (Medline, PsycINFO, EconLit, CINAHL, EMBASE) and hand searches of bibliographies was conducted to identify all relevant articles written in English and published from date of database inception to January 2021. Search strategies included terms for schizophrenia, negative symptoms, direct and indirect costs and health-care resource utilisation. Quality assessment of included articles was undertaken using a standardised checklist for the evaluation of cost of illness studies. Annual costs were converted to 2022 Australian dollars (A$)., Results: Four hundred and thirty-six abstracts were identified for inclusion. Following screening, six unique studies utilizing data from 6293 participants with an average age of 40 were identified to inform the review. Study quality was high for four studies. All studies concluded there was a positive relationship between negative symptoms and costs or resource utilisation. Four studies providing cost data show an increase in direct costs per annum associated with negative symptoms (range A$ 4046 to 171,564). The wide range in costs was attributable to between study differences in patient characteristics and cohorts, included costs, and country of study., Conclusion: Health care costs and resource utilisation are associated with negative symptoms in people with schizophrenia. Heterogeneity prevented calculation of an overall dollar value per point increase in negative symptoms. Future research is warranted to further quantify the relationship between negative symptoms and costs, including health sector and societal., (Copyright © 2022 Elsevier B.V. All rights reserved.)

Purpose: The early postnatal period is a time of increased risk for psychiatric admission. However, there is scope to further examine if this increase in risk extends to the entire perinatal period (pregnancy and first postnatal year), and how it compares to admission outside of the perinatal period., Methods: Data were linked across birth and hospital admission registers from July 2000 to December 2009. The study cohort, consisting of all pregnant and childbearing women with a psychiatric history, was divided into two groups: case women (at least one perinatal principal psychiatric admission in the study period) (38%) and comparison women (no perinatal principal psychiatric admissions) (62%). Outcomes were admission rate and length of stay adjusted for diagnosis, socio-demographic factors and timing of admission., Results: Antenatal and postnatal admissions rates were both higher than non-perinatal admission rates for case women for all diagnoses. There was little evidence that women with perinatal admissions were at an increased risk of admissions at other times. Socially disadvantaged women had significantly fewer and shorter admissions than their respective counterparts., Conclusions: The entire perinatal period is a time of increased risk for admission across the range of psychiatric disorders, compared to other times in a woman's childbearing years. Reduced admission rate and length of stay for socially disadvantaged women suggest lack of equity of access highlighting the importance of national perinatal mental health policy initiatives inclusive of disadvantaged groups., (© 2021. Crown.)

Objective: Patient-reported outcomes of health-related quality-of-life (HRQoL) are important descriptors of population health. A recent Australian adolescent population survey provided a unique opportunity to derive preference-based HRQoL., Methods: Data from 2967 adolescents aged 11-17 years were analysed. An interviewer-led parent/carer questionnaire was administered for demographic variables and mental disorders of adolescents during previous 12 months using the Diagnostic Interview Schedule for Children. A self-report survey was administered to derive HRQoL using the child health utility nine-dimensions instrument (CHU-9D). Weighted HRQoL was derived for several demographic groups, mental disorder diagnosis, and youth risk behaviours., Results: The total population had a mean utility of 0.78 [standard deviation (SD): 0.20]. Males had a significantly higher mean utility (0.81, SD 0.18) than females (0.76, SD: 0.21) (Cohen's d = 0.23, p < 0.001), and utility decreased with age for both males and females (p < 0.001). Family type and some parent/carer variables were associated with significant lower HRQoL scores with small effect size. Youth risk behaviours were associated with reduced HRQoL with moderate effect sizes. Adolescents who self-harmed, had suicidal ideation, or had a mental disorder had significantly lower utilities scores with moderate to large effect sizes compared to those who did not have such conditions., Conclusions: This study has provided contemporary Australian population norms for HRQoL in adolescents that may be used as cross comparison between studies as well as indicators allowing estimation of population health (e.g. estimation of the burden of disease) and can be used to populate future economic models., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Objective: To examine the health care costs associated with mental disorders and subthreshold mental disorders within a nationally representative sample of children and adolescents in Australia., Method: Data were derived from the Young Minds Matter Survey (N = 6,310). Mental disorders were classified using the Diagnostic Interview Schedule for Children Version IV. Participant data were linked to administrative data on health care costs. Adjusted generalized linear regression models and two-part models were used to estimate mean differences in costs between those with a mental disorder or subthreshold disorder and those without., Results: Costs associated with health care attendances and medications were higher for children and adolescents with mental disorders and subthreshold mental disorders compared to those without a mental disorder. The additional population health care costs due to mental disorders amounted to AUD$234 million annually in children and adolescents, of which approximately 16% was attributed to out-of-pocket costs. Findings showed that those with subthreshold mental disorders or comorbid mental disorders have substantial additional costs of Medicare-funded medical and pharmaceutical services., Conclusion and Implication: Mental disorders in children and adolescents are associated with significant health care costs. Further research is needed to ensure that this population is receiving effective and efficient care., Competing Interests: The authors have declared that no competing interests exist.

Background: The volume and heterogeneity of mental health problems that primary care patients present with is a substantial challenge for health systems, and both undertreatment and overtreatment are common. We developed Link-me, a patient-completed Decision Support Tool, to predict severity of depression or anxiety, identify priorities, and recommend interventions. In this study, we aimed to examine if Link-me reduces psychological distress among individuals predicted to have minimal/mild or severe symptoms of anxiety or depression., Methods: In this pragmatic stratified randomised controlled trial, adults aged 18-75 years reporting depressive or anxiety symptoms or use of mental health medication were recruited from 23 general practices in Australia. Participants completed the Decision Support Tool and were classified into three prognostic groups (minimal/mild, moderate, severe), and those in the minimal/mild and severe groups were eligible for inclusion. Participants were individually and randomly assigned (1:1) by a computer-generated allocation sequence to receive either prognosis-matched care (intervention group) or usual care plus attention control (control group). Participants were not blinded but intervention providers were only notified of those allocated to the intervention group. Outcome assessment was blinded. The primary outcome was the difference in the change in scores between the intervention and control group, and within prognostic groups, on the 10-item Kessler Psychological Distress Scale at 6 months post randomisation. The trial was registered on the Australian and New Zealand Clinical Trials Registry, ACTRN12617001333303., Outcomes: Between Nov 21, 2017, and Oct 31, 2018, 24 616 patients were invited to complete the eligibility screening survey. 1671 of these patients were included and randomly assigned to either the intervention group (n=834) or the control group (n=837). Prognosis-matched care was associated with greater reductions in psychological distress than usual care plus attention control at 6 months (p=0·03), with a standardised mean difference (SMD) of -0·09 (95% CI -0·17 to -0·01). This reduction was also seen in the severe prognostic group (p=0·003), with a SMD of -0·26 (-0·43 to -0·09), but not in the minimal/mild group (p=0·73), with a SMD of 0·04 (-0·17 to 0·24). In the complier average causal effect analysis in the severe prognostic group, differences were larger among those who received some or all aspects of the intervention (SMD range -0·58 to -1·15). No serious adverse effects were recorded., Interpretation: Prognosis-based matching of interventions reduces psychological distress in patients with anxiety or depressive symptoms, particularly in those with severe symptoms, and is associated with better outcomes when patients access the recommended treatment. Optimisation of the Link-me approach and implementation into routine practice could help reduce the burden of disease associated with common mental health conditions such as anxiety and depression., Funding: Australian Government Department of Health., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: Mental health treatment rates are increasing, but the burden of disease has not reduced. Tools to support efficient resource distribution are required., Aim: To investigate whether a person-centred e-health (Target-D) platform matching depression care to symptom severity prognosis can improve depressive symptoms relative to usual care., Design and Setting: Stratified individually randomised controlled trial in 14 general practices in Melbourne, Australia, from April 2016 to February 2019. In total, 1868 participants aged 18-65 years who had current depressive symptoms; internet access; no recent change to antidepressant; no current antipsychotic medication; and no current psychological therapy were randomised (1:1) via computer-generated allocation to intervention or usual care., Method: The intervention was an e-health platform accessed in the GP waiting room, comprising symptom feedback, priority-setting, and prognosis-matched management options (online self-help, online guided psychological therapy, or nurse-led collaborative care). Management options were flexible, neither participants nor staff were blinded, and there were no substantive protocol deviations. The primary outcome was depressive symptom severity (9-item Patient Health Questionnaire [PHQ-9]) at 3 months., Results: In intention to treat analysis, estimated between- arm difference in mean PHQ-9 scores at 3 months was -0.88 (95% confidence interval [CI] = -1.45 to -0.31) favouring the intervention, and -0.59 at 12 months (95% CI = -1.18 to 0.01); standardised effect sizes of -0.16 (95% CI = -0.26 to -0.05) and -0.10 (95% CI = -0.21 to 0.002), respectively. No serious adverse events were reported., Conclusion: Matching management to prognosis using a person-centred e-health platform improves depressive symptoms at 3 months compared to usual care and could feasibly be implemented at scale. Scope exists to enhance the uptake of management options., (© The Authors.)

COVID-19 has resulted in broad impacts on the economy and aspects of daily life including our collective mental health and well-being. The Australian health care system already faces limitations in its ability to treat people with mental health diagnoses. Australia has responded to the COVID-19 outbreak by, among other initiatives, providing reimbursement for telehealth services. However, it is unclear if these measures will be enough to manage the psychological distress, depression, anxiety and post-traumatic distress shown to accompany infectious disease outbreaks and economic shocks. Decision making has focused on the physical health ramifications of COVID-19, the avoidance of over-burdening the health care system and saving lives. We propose an alternative framework for decision making that combines life years saved with impacts on quality of life. A framework that simultaneously includes mental health and broader economic impacts into a single decision-making process would facilitate transparent and accountable decision making that can improve the overall welfare of Australian society as we continue to address the considerable challenges that the COVID-19 pandemic is creating.

Objective: A translational trial evaluated the effectiveness of screening for inhibited childhood temperament, followed by a preventive parenting program -Cool Little Kids. This study determined the cost-effectiveness from societal and health sector perspectives using trial data., Method: Resources to deliver the screening and parenting sessions were determined from study records. Parents completed a questionnaire reporting resources used at one-year follow-up. Standard Australian unit costs were applied. Clinical outcomes for children and parental quality adjusted life-years (QALYs) were used to calculate incremental cost-effectiveness ratios (ICERs)., Results: Total societal costs were lower, but non-significant for the intervention compared to the control group (mean difference -$500 p = 0.937). Total health sector costs were significantly greater (mean difference $1,956; p = 0.015). The intervention led to significantly fewer internalising symptoms (Strengths and Difficulties Questionnaire (SDQ)-emotional difficulties adjusted mean difference -0.5; p = 0.006), fewer children with SDQ-emotional symptoms in the abnormal range (24.2 % vs. 33.0 % p = .014) and fewer with diagnosed anxiety (44.2 % vs. 50.2 % p = 0.427). From the societal perspective, the intervention would likely be cost-effective. Health sector ICERs were $1,171/SDQ-emotional symptom decrease, $51/abnormal SDQ avoided and $77/anxiety case avoided., Conclusions: This economic analysis alongside an implementation study provides an early indication that Cool Little Kids may be cost-effective., Competing Interests: Declaration of Competing Interest Rapee developed and distributes the Cool Little Kids program, but receives no financial benefit. There are no other conflicts of interest., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Objective: To evaluate the cost-effectiveness of stepped care compared to care as usual (CAU) for the treatment of adults with mild-to-moderate anxiety disorders from a health sector perspective in the Australian setting., Method: A decision tree model was constructed to estimate the cost per disability adjusted life year (DALY) averted over a 12-month time horizon. The model compared a three-step stepped care intervention to CAU. Stepped care included an initial phase of guided self-help, followed by face-to-face cognitive behavioural therapy, and pharmacotherapy as the final step. The model adopted a health sector perspective, used epidemiological parameters and disability weights obtained from the Global Burden of Disease Study 2013. Effect sizes were derived from a randomized trial of stepped care and a longitudinal cohort study. Costs were expressed in 2013 Australian dollars (A$). Multivariate probabilistic and univariate sensitivity analyses were performed., Results: Stepped care was found to be cost-effective compared to CAU with an incremental cost-effective ratio of A$3093 per DALY averted. One-hundred percent of the uncertainty iterations fell below the A$50,000 per DALY averted willingness-to-pay threshold commonly used in Australia. The evaluation was most sensitive to changes in diagnosis rates and effect sizes., Conclusion: A three-step model of stepped care appears to be cost-effective for the treatment of adults with mild to moderate anxiety disorders from the Australian health sector perspective. These results can provide some assurance to decision-makers that stepped care represents an efficient use of health care resources., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: Bipolar depression is characterized by neurobiological features including perturbed oxidative biology, reduction in antioxidant levels, and a concomitant rise in oxidative stress markers. Bipolar depression manifests systemic inflammation, mitochondrial dysfunction, and changes in brain growth factors. The depressive phase of the disorder is the most common and responds the least to conventional treatments. Garcinia mangostana Linn, commonly known as mangosteen, is a tropical fruit. The pericarp's properties may reduce oxidative stress and inflammation and improve neurogenesis, making mangosteen pericarp a promising add-on therapy for bipolar depression., Methods: Participants will receive 24 weeks of either 1,000 mg mangosteen pericarp or placebo per day, in addition to their usual treatment. The primary outcome is change in severity of mood symptoms, measured using the Montgomery-Åsberg Depression Rating Scale (MADRS), over the treatment phase. Secondary outcomes include global psychopathology, quality of life, functioning, substance use, cognition, safety, biological data, and cost-effectiveness. A follow-up interview will be conducted 4 weeks post-treatment., Conclusion: The findings of this study may have implications for improving treatment outcomes for those with bipolar disorder and may contribute to our understanding of the pathophysiology of bipolar depression., Clinical Trial Registration: Australian and New Zealand Clinical Trial Registry, ACTRN12616000028404.

This paper helps to quantify the impact of the Australian National Perinatal Depression Initiative (NPDI) on postnatal inpatient psychiatric hospitalisation. Based on individual hospital admissions data from New South Wales and Western Australia, we found that the NPDI reduced inpatient psychiatric hospital admission by up to 50% [0.9% point reduction (95% CI 0.70-1.22)] in the first postnatal year. The greatest reduction was observed for adjustment disorders. The NPDI appears to be associated with fewer post-birth psychiatric disorders hospital admissions; this suggests earlier detection of psychiatric disorders resulting in early care of women at risk during their perinatal period.

Primary care in Australia is undergoing significant reform, with a particular focus on cost-effective tailoring of mental health care to individual needs. Link-me is testing whether a patient-completed Decision Support Tool (DST), which predicts future severity of depression and anxiety symptoms and triages individuals into care accordingly, is clinically effective and cost-effective relative to usual care. The trial is set in general practices, with English-speaking patients invited to complete eligibility screening in their general practitioner's waiting room. Eligible and consenting patients will then complete the DST assessment and are randomised and stratified according to predicted symptom severity. Participants allocated to the intervention arm will receive feedback on DST responses, select treatment priorities, assess motivation to change, and receive a severity-matched treatment recommendation (information about and links to low intensity services for those with mild symptoms, or assistance from a specially trained health professional (care navigator) for those with severe symptoms). All patients allocated to the comparison arm will receive usual GP care plus attention control. Primary (psychological distress) and secondary (depression, anxiety, quality of life, days out of role) outcomes will be assessed at 6 and 12 months. Differences in outcome means between trial arms both across and within symptom severity group will be examined using intention-to-treat analyses. Within trial and modelled economic evaluations will be conducted to determine the value for money of credentials of Link-me. Findings will be reported to the Federal Government to inform how mental health services across Australia are funded and delivered in the future., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective To quantify total provider fees, benefits paid by the Australian Government and out-of-pocket patients' costs of mental health Medicare Benefits Schedule (MBS) consultations provided to women in the perinatal period (pregnancy to end of the first postnatal year). Method A retrospective study of MBS utilisation and costs (in 2011-12 A$) for women giving birth between 2006 and 2010 by state, provider-type, and geographic remoteness was undertaken. Results The cost of mental health consultations during the perinatal period was A$17.5million for women giving birth in 2007, rising to A$29million in 2010. Almost 9% of women giving birth in 2007 had a mental health consultation compared with more than 14% in 2010. An increase in women accessing consultations, along with an increase in the average number of consultations received, were the main drivers of the increased cost, with costs per service remaining stable. There was a shift to non-specialist care and bulk billing rates increased from 44% to 52% over the study period. In 2010, the average total cost (provider fees) per woman accessing mental health consultations during the perinatal period was A$689, and the average cost per service was A$133. Compared with women residing in regional and remote areas, women residing in major cities where more likely to access consultations, and these were more likely to be with a psychiatrist rather than an allied health professional or general practitioner. Conclusion Increased access to mental health consultations has coincided with the introduction of recent mental health initiatives, however disparities exist based on geographic location. This detailed cost analysis identifies inequities of access to perinatal mental health services in regional and remote areas and provides important data for economic and policy analysis of future mental health initiatives. What is known about the topic? The mental healthcare landscape in Australia has changed significantly over the last decade, with the introduction of numerous policies aimed at prevention, screening and improving access to treatment. Several of these policies have been aimed at perinatal depression, which affects 15% of women giving birth. What does this paper add? This is the first population-based, cost analysis of mental health consultations during the perinatal period (pregnancy to end of the first postnatal year) in Australia. Almost 9% of women giving birth in 2007 had a mental health consultation funded though the MBS, compared with more than 14% in 2010. Over the same period there was a shift from psychiatric consultations to allied health and primary care consultations. In 2010, the total cost (provider fee) of these consultations was A$29million, equating to an average cost per woman of A$689 and A$133 per service. Despite the changing policy environment, significant disparities exist in access to care according to geographic remoteness. What are the implications for practitioners? Recent policy initiatives have resulted in increasing access to mental health consultations for women around the time of childbirth. However, policies are needed that target women outside of major cities. Furthermore, evidence is needed on whether the increase in access has resulted in improved mental health outcomes for women at this vulnerable time. The cost data provided by this study are unique and will inform future mental health policy development and health economic evaluations.

Purpose: High prevalence mental disorders including depression, anxiety and substance use disorders are associated with high economic and disease burden. However, there is little information regarding the health state utility values of such disorders according to their clinical severity using comparable instruments across all disorders. This study reports utility values for high prevalence mental disorders using data from the 2007 Australian National Survey of Mental Health and Wellbeing (NSMHWB)., Methods: Utility values were derived from the AQoL-4D and analysed by disorder classification (affective only (AD), anxiety-related only (ANX), substance use only (SUB) plus four comorbidity groups), severity level (mild, moderate, severe), symptom recency (reported in the past 30 days), and comorbidity (combination of disorders). The adjusted Wald test was applied to detect statistically significant differences of weighted means and the magnitude of difference between groups was presented as a modified Cohen's d., Results: In total, 1526 individuals met criteria for a 12-month mental disorder. The mean utility value was 0.67 (SD = 0.27), with lower utility values associated with higher severity levels and some comorbidities. Utility values for AD, ANX and SUB were 0.64 (SD = 0.25), 0.71 (SD = 0.25) and 0.81 (SD = 0.19), respectively. No differences in utility values were observed between disorders within disorder groups. Utility values were significantly lower among people with recent symptoms (within past 30 days) than those without; when examined by diagnostic group, this pattern held for people with SUB, but not for people with ANX or AD., Conclusions: Health state utility values of people with high prevalence mental disorders differ significantly by severity level, number of mental health comorbidities and the recency of symptoms, which provide new insights on the burden associated with high prevalence mental disorders in Australia. The derived utility values can be used to populate future economic models.

Background: Recently, the efficacy of dietary improvement as a therapeutic intervention for moderate to severe depression was evaluated in a randomised controlled trial. The SMILES trial demonstrated a significant improvement in Montgomery-Åsberg Depression Rating Scale scores favouring the dietary support group compared with a control group over 12 weeks. We used data collected within the trial to evaluate the cost-effectiveness of this novel intervention., Methods: In this prospective economic evaluation, sixty-seven adults meeting DSM-IV criteria for a major depressive episode and reporting poor dietary quality were randomised to either seven sessions with a dietitian for dietary support or to an intensity matched social support (befriending) control condition. The primary outcome was Quality Adjusted Life Years (QALYs) as measured by the AQoL-8D, completed at baseline and 12 week follow-up (endpoint) assessment. Costs were evaluated from health sector and societal perspectives. The time required for intervention delivery was costed using hourly wage rates applied to the time in counselling sessions. Food and travel costs were also included in the societal perspective. Data on medications, medical services, workplace absenteeism and presenteesim (paid and unpaid) were collected from study participants using a resource-use questionnaire. Standard Australian unit costs for 2013/2014 were applied. Incremental cost-effectiveness ratios (ICERs) were calculated as the difference in average costs between groups divided by the difference in average QALYs. Confidence intervals were calculated using a non-parametric bootstrap procedure., Results: Compared with the social support condition, average total health sector costs were $856 lower (95% CI -1247 to - 160) and average societal costs were $2591 lower (95% CI -3591 to - 198) for those receiving dietary support. These differences were driven by lower costs arising from fewer allied and other health professional visits and lower costs of unpaid productivity. Significant differences in mean QALYs were not found between groups. However, 68 and 69% of bootstrap iterations showed the dietary support intervention was dominant (additional QALYs at less cost) from the health sector and societal perspectives., Conclusions: This novel dietary support intervention was found to be likely cost-effective as an adjunctive treatment for depression from both health sector and societal perspectives., Trial Registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000251820 . Registered on 29 February 2012.

Background: Despite increased investment in its recognition and treatment, depression remains a substantial health and economic burden worldwide. Current treatment strategies generally focus on biological and psychological pathways, largely neglecting the role of lifestyle. There is emerging evidence to suggest that diet and nutrition play an important role in the risk, and the genesis, of depression. However, there are limited data regarding the therapeutic impact of dietary changes on existing mental illness. Using a randomised controlled trial design, we aim to investigate the efficacy and cost-efficacy of a dietary program for the treatment of Major Depressive Episodes (MDE)., Methods/design: One hundred and seventy six eligible participants suffering from current MDE are being randomised into a dietary intervention group or a social support group. Depression status is assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS) and Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (Non Patient Edition) (SCID-I/NP). The intervention consists of 7 individual nutrition consulting sessions (of approximately 60 minutes), delivered by an Accredited Practising Dietitian (APD). Sessions commence within one week of baseline assessment. The intervention focuses on advocating a healthy diet based on the Australian Dietary Guidelines and the Dietary Guidelines for Adults in Greece. The control condition comprises a befriending protocol using the same visit schedule and length as the diet intervention. The study is being conducted at two locations in Victoria, Australia (a metropolitan and regional centre). Data collection occurs at baseline (pre-intervention), 3-months (post-intervention) and 6- months. The primary endpoint is MADRS scores at 3 months. A cost consequences analysis will determine the economic value of the intervention., Discussion: If efficacious, this program could provide an alternative or adjunct treatment strategy for the management of this highly prevalent mental disorder; the benefits of which could extend to the management of common co-morbidities including cardiovascular disease (CVD), obesity, and type 2 diabetes., Trial Registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000251820.