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BackgroundShift (Black Dog Institute) is the first mobile health smartphone app created to support the mental health of junior physicians. Junior physicians experience demanding work conditions, leading to high levels of psychological distress and burnout. However, they are often concerned about the potential career impacts of seeking mental health support. The confidentiality and ease of access of digital interventions may be particularly suited to address these concerns. The Shift app provides therapeutic and psychoeducational content and strategies contextualized for the specific needs of physicians in training. App content includes information on mental health, help seeking, mindfulness, and common workplace-related concerns of junior physicians. ObjectiveThis study aims to test, at scale, the effectiveness of Shift among junior physicians working in Australia using a randomized controlled trial design. The primary aim is to examine whether junior physicians using Shift experience a reduction in depressive symptoms compared with a waitlist control group. The secondary aim is to examine whether the app intervention group experiences improvements in anxiety, work and social functioning, help seeking, quality of life, and burnout compared with the control group. MethodsA total of 778 junior physicians were recruited over the internet through government and nongovernment medical organizations across Australia, as well as through paid social media advertisements. They were randomly allocated to one of 2 groups: (1) the intervention group, who were asked to use the Shift app for a period of 30 days, or (2) the waitlist control group, who were placed on a waitlist and were asked to use the app after 3 months. Participants completed psychometric measures for self-assessing mental health and wellbeing outcomes, with assessments occurring at baseline, 1 month after completing the baseline period, and 3 months after completing the baseline period. Participants in the waitlist control group were asked to complete an additional web-based questionnaire 1 month after receiving access to the app or 4 months after completing the baseline survey. Participants took part in the study on the internet; the study was completely automated. ResultsThe study was funded from November 2022 to December 2024 by the New South Wales Ministry of Health. Data collection for the study occurred between January and August 2024, with 780 participants enrolling in the study during this time. Data analysis is underway; the effectiveness of the intervention will be estimated on an intention-to-treat basis using a mixed-model, repeated measures analysis. Results are expected to be submitted for publication in 2025. ConclusionsTo the best of our knowledge, this is the first randomized controlled trial to examine the effectiveness of a mobile health smartphone app specifically designed to support the mental health of junior physicians. Trial RegistrationAustralia and New Zealand Clinical Trials Registry ACTRN12623000664640; https://tinyurl.com/7xt24dhk International Registered Report Identifier (IRRID)DERR1-10.2196/58288

Abstract Background Anxiety and depressive disorders typically emerge in adolescence and can be chronic and disabling if not identified and treated early. School-based universal mental health screening may identify young people in need of mental health support and facilitate access to treatment. However, few studies have assessed the potential harms of this approach. This paper examines some of the potential mental health-related harms associated with the universal screening of anxiety and depression administered in Australian secondary schools. Methods A total of 1802 adolescent students from 22 secondary schools in New South Wales, Australia, were cluster randomised (at the school level) to receive either an intensive screening procedure (intervention) or a light touch screening procedure (control). Participants in the intensive screening condition received supervised self-report web-based screening questionnaires for anxiety, depression and suicidality with the follow-up care matched to their symptom severity. Participants in the light touch condition received unsupervised web-based screening for anxiety and depression only, followed by generalised advice on help-seeking. No other care was provided in this condition. Study outcomes included the increased risk of anxiety, depression, psychological distress, decreased risk of help-seeking, increased risk of mental health stigma, determined from measures assessed at baseline, 6 weeks post-baseline, and 12 weeks post-baseline. Differences between groups were analysed using mixed effect models. Results Participants in the intensive screening group were not adversely affected when compared to the light touch screening condition across a range of potential harms. Rather, participants in the intensive screening group were found to have a decreased risk of inhibited help-seeking behaviour compared to the light touch screening condition. Conclusions The intensive screening procedure did not appear to adversely impact adolescents’ mental health relative to the light touch procedure. Future studies should examine other school-based approaches that may be more effective and efficient than universal screening for reducing mental health burden among students. Trial registration Australian and New Zealand Clinical Trials Registry (ACTRN12618001539224) https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375821 .

ABSTRACTObjective Complex post-traumatic stress disorder (complex trauma) describes a cluster of symptoms frequently associated with prolonged exposure to inescapable threats or abuse. For Aboriginal and Torres Strait Islander peoples in Australia impacted by complex trauma, there may be compounding factors, such as experiences of historical trauma, loss and socio-economic deprivation stemming from colonisation. However, there is no culturally appropriate tool to assess complex trauma. This paper presents the psychometric evaluation of a preliminary version Aboriginal and Torres Strait Islander Complex Trauma and Strengths Questionnaire (ACTSQ).Methods Following 2 years of rigorous Aboriginal-led co-design, participants were recruited through community networks and partner health services in South Australia, Victoria, and Northern Territory (October 2020–May 2022). A trained interviewer contacted Aboriginal (n = 109) and Torres Strait Islander (n = 1) parents aged >16 years by phone to complete the ACTSQ. Underlying domain structures were investigated with exploratory factor analysis and reviewed by experts to refine. Reliability and inter-rater reliability were assessed using McDonald’s Omega and Intraclass Correlation Coefficient (ICC).Results Forty-four items on five factors were retained. Factors were labelled complex trauma symptoms (16 items), grief, loss and disconnection (6 items), support and relationships (9 items), sense of self and strengths (7 items), and Cultural connections and resources (6 items). There were moderate correlations between factors, with the exception of factor 5. Omega was >0.75 for all factors. The inter-rater reliability for each factor was fair to good (ICC 0.5–0.7).Conclusions This study conducted a comprehensive psychometric validation that provides initial evidence towards the cultural validity of the ACTSQ to support assessment of complex trauma and strengths among Aboriginal and Torres Strait Islander peoples. Future studies are required to replicate and further evaluate the psychometric properties of the ACTSQ using larger samples.

Abstract Background The use of electronic informed consent (eIC) in decentralized trials offers a pragmatic approach to enrolling participants across multiple geographic areas. Methods Using a randomized, cross-over study design, we conducted a qualitative descriptive evaluation of two eIC approaches—text-only eIC and enhanced eIC—in a mock hypertension Phase III clinical trial. We assessed participant comprehension and acceptability (usability, satisfaction, and eIC preference). Results A total of 24 individuals with hypertension participated in the study: 12 reviewed the text-only eIC first, followed by the enhanced eIC, and 12 reviewed the enhanced eIC first, followed by the text-only eIC. The study population was diverse in gender, age, race, and geographic location. We found no descriptive differences in participant comprehension and satisfaction between the two eIC approaches. However, more participants preferred the enhanced eIC, and participants indicated that the digital elements were personable and made them feel more informed, engaged, comfortable, and prepared to participate in clinical research. Conclusions Our findings suggest that enhancing the eIC process with digital elements may have beneficial outcomes among potential participants beyond comprehension and satisfaction.

Introduction Previous research has shown that cognitive bias modification of interpretations (CBM-I) may be a promising intervention for anxiety in youth; however, results are mixed. Given the high comorbidity between anxiety and depression in youth, it is surprising that no child studies have targeted biases associated with both. This study aims to evaluate the effectiveness and acceptability of an online CBM-I intervention (Mindmaster) for children with symptom scores of anxiety or depression above a borderline or clinical threshold. The intervention has been codesigned with children, parents and mental health professionals to promote user engagement.Methods and analysis The study is a randomised controlled trial, with two parallel arms. Participants are 143 children aged 8–10 years with scores of anxiety and/or depressive symptoms above a borderline or clinical threshold. They will be allocated to either the intervention group or the waitlist control group. The intervention consists of 2 weeks of online CBM-I training, with four sessions (10–15 min) per week. Outcome assessments will be conducted at baseline, 4 weeks after baseline (post-training/post-waitlist) and 8 weeks after baseline (follow-up) for the intervention group only. The primary outcome is interpretation bias. Secondary outcomes are anxiety and depressive symptoms and life interference. Analyses will be conducted within an intention-to-treat framework using mixed models for repeated measures.Ethics and dissemination The study was approved by the University of New South Wales Human Research Ethics Committee (HC220758). Findings will be reported to (1) participating families; (2) presented at scientific conferences and (3) disseminated to peer-review publications. Data will be available from the corresponding author on request.Trial registration number ACTRN12622001493730.

Abstract Background Cerebral palsy (CP) is one of the most common childhood disabilities, impacting many areas of a child’s life. Increasingly, quality of life (QOL) measures are used to capture holistic wellbeing of children with CP. However most validated QOL measures for children are based on adult perspective only, with limited focus on child perspective. Conceptual differences between children’s and adults’ definitions of QOL may reflect different underlying QOL models which contribute to measurement score divergence. This qualitative study investigated the conceptual meaning of QOL for children with CP, comparing child and parent perspectives. Eighteen families completed 8 child interviews and 18 parent interviews. Children (11 boys, 7 girls) represented the spectrum of motor functioning, with comorbidities including epilepsy, intellectual disability, and communication impairments. Child and parent interviews were analysed separately using constructivist grounded theory methods and then findings were integrated to examine similarities and differences. Results All participants sought child inclusion in social activities, education, and recreation, requiring negotiation, adaptations, and advocacy. Five conceptual categories emerged from child interviews: socialising, play, negotiating limitations, self-identity, and developing agency. This reflected an individual model of QOL supporting child development goals. Parent interview findings revealed concepts related to child-specific QOL (day-to-day functioning and enabling child goals), as well as parent and family functioning concepts aligned to models of “family QOL”, embracing impacts of family relationships and the interdependence of QOL among family members. Conclusions This study identified similarities and differences in child and parent perceptions of QOL for the child with CP. Children provided insights into the importance of play and peer support, and their developing self-identity and sense of agency. Self-directed free play, especially, was identified by children but not parents as a central everyday activity promoting wellbeing and social inclusion. Parents discussed family functioning and aspects outside of child sight, such as managing time and financial resources. Relying on parents’ perspective alone to model child QOL misses valuable information that children contribute. Equally, child report alone misses parent experiences that directly influence child QOL. There is value in incorporating family QOL into parent reports while developing a conceptually separate child self-report QOL instrument.

Abstract Background When COVID-19 spread to Australia in January 2020, many communities were already in a state of emergency from the Black Summer bushfires. Studies of adolescent mental health have typically focused on the effects of COVID-19 in isolation. Few studies have examined the impact of COVID-19 and other co-occurring disasters, such as the Black Summer bushfires in Australia, on adolescent mental health. Methods We conducted a cross-sectional survey to examine the impact of COVID-19 and the Black Summer bushfires on the mental health of Australian adolescents. Participants (N = 5866; mean age 13.61 years) answered self-report questionnaires about COVID-19 diagnosis/quarantine (being diagnosed with and/or quarantined because of COVID-19) and personal exposure to bushfire harm (being physically injured, evacuated from home and/or having possessions destroyed). Validated standardised scales were used to assess depression, psychological distress, anxiety, insomnia, and suicidal ideation. Trauma related to COVID-19 and the bushfires was also assessed. The survey was completed in two large school-based cohorts between October 2020 and November 2021. Results Exposure to COVID-19 diagnosis/quarantine was associated with increased probability of elevated trauma. Exposure to personal harm by the bushfires was associated with increased probability of elevated insomnia, suicidal ideation, and trauma. There were no interactive effects between disasters on adolescent mental health. Effects between personal risk factors and disasters were generally additive or sub-additive. Conclusions Adolescent mental health responses to community-level disasters are multi-faceted. Complex psychosocial factors associated with mental ill health may be relevant irrespective of disaster. Future research is needed to investigate synergistic effects of disasters on young mental health.

Abstract Objectives The Future Proofing Study (FPS) was established to examine factors associated with the onset and course of mental health conditions during adolescence. This paper describes the design, methods, and baseline characteristics of the FPS cohort. Methods The FPS is an Australian school‐based prospective cohort study with an embedded cluster‐randomized controlled trial examining the effects of digital prevention programs on mental health. Data sources include self‐report questionnaires, cognitive functioning, linkage to health and education records, and smartphone sensor data. Participants are assessed annually for 5 years. Results The baseline cohort (N = 6388, M = 13.9 years) is broadly representative of the Australian adolescent population. The clinical profile of participants is comparable to other population estimates. Overall, 15.1% of the cohort met the clinical threshold for depression, 18.6% for anxiety, 31.6% for psychological distress, and 4.9% for suicidal ideation. These rates were significantly higher in adolescents who identified as female, gender diverse, sexuality diverse, or Aboriginal and/or Torres Strait Islander (all ps

BackgroundThere is increasing evidence that depression can be prevented; however, universal approaches have had limited success. Appropriate targeting of interventions to at-risk populations has been shown to have potential, but how to selectively determine at-risk individuals remains unclear. Workplace stress is a risk factor for depression and a target for intervention, but few interventions exist to prevent depression among workers at risk due to heightened stress. ObjectiveThis trial aimed to evaluate the efficacy of a smartphone-based intervention in reducing the onset of depression and improving related outcomes in workers experiencing at least moderate levels of stress. MethodsA randomized controlled trial was conducted with participants who were currently employed and reported no clinically significant depression and at least moderate stress. The intervention group (n=1053) were assigned Anchored, a 30-day self-directed smartphone app-based cognitive behavioral- and mindfulness-based intervention. The attention-control group (n=1031) were assigned a psychoeducation website. Assessment was performed via web-based self-report questionnaires at baseline and at 1-, 3-, and 6-month postbaseline time points. The primary outcome was new depression caseness aggregated over the follow-up period. The secondary outcomes included depressive and anxiety symptoms, stress, well-being, resilience, work performance, work-related burnout, and quality of life. Analyses were conducted within an intention-to-treat framework using mixed modeling. ResultsThere was no significant between-group difference in new depression caseness (z score=0.69; P=.49); however, those in the Anchored arm had significantly greater depressive symptom reduction at 1 month (Cohen d=0.02; P=.049) and 6 months (Cohen d=0.08; P=.03). Anchored participants also showed significantly greater reduction in anxiety symptoms at 1 month (Cohen d=0.07; P=.04) and increased work performance at 1 month (Cohen d=0.07; P=.008) and 6 months (Cohen d=0.13; P=.01), compared with controls. Notably, for Anchored participants completing at least two-thirds of the intervention, there was a significantly lower rate of depression onset (1.1%, 95% CI 0.0%-3.7%) compared with controls (9.0%, 95% CI 6.8%-12.3%) at 1 month (z score=4.50; P

Abstract Background Although the proportion of men seeking professional mental health care has risen over the past two decades, on average, men continue to attend fewer sessions of psychotherapy and are more likely to drop out of treatment prematurely compared to women. Men account for three-quarters of suicide deaths; furthermore, over half of the males who die by suicide have engaged with mental health care in the 12 months prior to their death. These findings highlight a need to equip mental health practitioners with skills to improve male clients’ engagement and mental health outcomes. This article reports the protocol for a randomized controlled trial of Men in Mind, a self-paced online training program purpose-built to advance the clinical competencies of practitioners who provide psychotherapy to male clients. Methods A randomized controlled trial with two parallel groups will be conducted. Participating practitioners will be randomly allocated, on a 1:1 basis, to the intervention group (Men in Mind training) or a waitlist control group. The primary outcome, efficacy of the training, will be evaluated by pre- to post-training (T1 to T2) changes in scores on the Engaging Men in Therapy Scale (EMITS) in the intervention group, relative to the control group. Discussion This trial will provide evidence of the efficacy of Men in Mind training, as an interim step towards adjusting content and delivery of the intervention to maximize the potential for sustaining and scaling. Trial registration: The trial was registered prospectively with the Australian New Zealand Clinical Trials Registry on 3rd December 2021 (ACTRN12621001669886).

Introduction Meta-analytical evidence confirms a range of interventions, including mindfulness, physical activity and sleep hygiene, can reduce psychological distress in university students. However, it is unclear which intervention is most effective. Artificial intelligence (AI)-driven adaptive trials may be an efficient method to determine what works best and for whom. The primary purpose of the study is to rank the effectiveness of mindfulness, physical activity, sleep hygiene and an active control on reducing distress, using a multiarm contextual bandit-based AI-adaptive trial method. Furthermore, the study will explore which interventions have the largest effect for students with different levels of baseline distress severity.Methods and analysis The Vibe Up study is a pragmatically oriented, decentralised AI-adaptive group sequential randomised controlled trial comparing the effectiveness of one of three brief, 2-week digital self-guided interventions (mindfulness, physical activity or sleep hygiene) or active control (ecological momentary assessment) in reducing self-reported psychological distress in Australian university students. The adaptive trial methodology involves up to 12 sequential mini-trials that allow for the optimisation of allocation ratios. The primary outcome is change in psychological distress (Depression, Anxiety and Stress Scale, 21-item version, DASS-21 total score) from preintervention to postintervention. Secondary outcomes include change in physical activity, sleep quality and mindfulness from preintervention to postintervention. Planned contrasts will compare the four groups (ie, the three intervention and control) using self-reported psychological distress at prespecified time points for interim analyses. The study aims to determine the best performing intervention, as well as ranking of other interventions.Ethics and dissemination Ethical approval was sought and obtained from the UNSW Sydney Human Research Ethics Committee (HREC A, HC200466). A trial protocol adhering to the requirements of the Guideline for Good Clinical Practice was prepared for and approved by the Sponsor, UNSW Sydney (Protocol number: HC200466_CTP).Trial registration number ACTRN12621001223820.

Abstract Background Approximately one fifth of Australian males aged 16+ experience mood, anxiety or substance use disorders in a given year, and suicide by males accounts for three quarters of all suicides annually. However, males with mental health problems are less likely to seek and receive help than their female counterparts. Media campaigns with videos at their core are gaining popularity as a means of promoting help-seeking for mental health difficulties, but few studies have rigorously tested the impact of such videos. This randomised controlled trial tests the effectiveness of a short video promoting help-seeking by Australian men. Methods This study is an online randomised controlled trial (RCT). Participants will attend an online group orientation session, where they will provide consent to participate and complete a baseline questionnaire (T1). After completion of the T1 questionnaire, participants will be randomised to watch either the intervention or control video on a 1:1 basis. After randomisation, participants will be able to access their allocated video for 1 week. Seven days after T1, participants will again be sent links to the video and to the post-exposure questionnaire (T2). One month after T2, participants will be emailed the follow-up questionnaire (T3). The primary outcome will be change in help-seeking intentions from T1 to T2. Secondary outcomes will be changes in help-seeking intentions from T1 to T3, changes in intentions to encourage other males to seek help, self-reliance, and male depression symptoms from T1 to T2 and from T1 to T3. The cost-effectiveness of the intervention will be evaluated. Participants will also complete questions about their opinions of the video and its effects at T2 and T3. Discussion Our video-based intervention is designed to promote help-seeking for mental health difficulties among Australian men. If a lack of net harm is shown to be associated with viewing the intervention video, the video will be publicly released and could have broad impacts on individual and community attitudes towards help-seeking for mental health difficulties, and ultimately enhance men’s mental health and wellbeing. An evaluation of the effectiveness of the intervention is essential to ensure the intervention is achieving its objectives. Trial registration anzctr.org.au 12621001008819

BackgroundShift is a novel smartphone app for providing a digital-first mental health resource to junior doctors. It contains psychoeducational material, cognitive behavioral modules, guided mediations, information on common work stressors, and a section on help-seeking options for psychological problems through workplace and private avenues. ObjectiveThis study aimed to conduct a preliminary investigation of the use and potential effectiveness of Shift on depressive and anxiety symptoms (primary outcomes) and work and social functioning, COVID-19 safety concerns, and help seeking (secondary outcomes). This study also sought feedback on whether Shift was seen as an acceptable tool. MethodsJunior doctors in New South Wales, Australia, were approached through promotional activities from the Ministry of Health, specialist medical colleges, and social media advertisements between June and August 2020. Consenting participants provided web-based baseline data, used the Shift app for 30 days, and were asked to complete a poststudy web-based questionnaire. Outcomes were analyzed under the intention-to-treat principle. ResultsA total of 222 (n=156 female, 70.3%; mean age 29.2, SD 4.61 years) junior doctors provided full baseline data. Of these, 89.2% (198/222) downloaded the app, logged into the app approximately 6 times (mean 5.68, SD 7.51), completed 4 in-app activities (mean 3.77, SD 4.36), and spent a total of 1 hour on in-app activities (mean 52:23, SD 6:00:18) over 30 days. Postintervention and app use data were provided by 24.3% (54/222) of participants. Depressive and anxiety symptoms significantly decreased between the pre- and postassessment points as expected; however, physicians’ COVID-19 safety concerns significantly increased. Work and social functioning, COVID-19 concerns for family and friends, and help seeking did not change significantly. There was no significant relationship between symptom changes and app use (number of log-ins, days between first and last log-in, and total activity time). Most poststudy completers (31/54, 57%) rated Shift highly or very highly. ConclusionsDespite high levels of nonresponse to the poststudy assessment and increases in COVID-19 safety concerns, junior doctors who used the app reported some improvements in depression and anxiety, which warrant further exploration in a robust manner.

Abstract Background Suicide is a significant concern in Australia and globally. There is a strong argument for training community gatekeepers in how to recognise and support suicidal people in their social network. One such training course is the Mental Health First Aid for the Suicidal Person course. This course was developed using suicide prevention best practice guidelines based on expert opinion (determined using the Delphi Method). Methods We evaluated the impact of attending the Mental Health First Aid for the Suicidal Person course on suicide literacy and stigma, confidence in and quality of intended and actual helping behaviours towards a person who is suicidal, and course satisfaction. Surveys were administered before and immediately after the course, and at 6-month follow-up. Data were analysed to yield descriptive statistics (percentages, means, standard deviations), with linear mixed models and generalized linear mixed models being used to test the statistical significance of changes over occasions of measurement. Results We recruited 284 participants from workplaces and general community networks. The mean age was 41 years and 74% were female. 85% of people undertook the course as part of professional development, and almost half (44%) did the course because they had contact with a suicidal person. The majority (59%) of participants had previous mental health and suicide prevention training. The majority of participants held knowledge (suicide literacy) before undertaking the course. The major effect of training was to strengthen this knowledge. There was a significant improvement from pre-course (M = 1.79, SD 0.56) to post-course (M = 1.48, SD 0.82, p

Abstract Background Despite increasing investment in suicide prevention, Australian suicide rates have increased steadily in the past decade. In response to growing evidence for multicomponent intervention models for reducing suicide, the LifeSpan model has been developed as the first multicomponent, evidence-based, system-wide approach to suicide prevention in Australia. The LifeSpan model consists of nine evidence-based strategies. These include indicated, selective and universal interventions which are delivered simultaneously to community and healthcare systems over a 2-year implementation period. This study will evaluate the effectiveness of the LifeSpan model in reducing suicide attempts and suicide deaths in four geographically defined regions in New South Wales, Australia. Methods We outline the protocol for a stepped-wedge, cluster randomized controlled trial. Following a 6-month transition phase, the trial sites will move to the 2-year active implementation phase in 4-monthly intervals with evaluation extending a minimum of 24 months after establishment of the full active period. Analysis will be undertaken of the change attributable to the invention across the four sites. The primary outcome for the study is the rate of attempted suicide in the regions involved. Rate of suicide deaths within each site is a secondary outcome. Discussion If proven effective, the LifeSpan model for suicide prevention could be more widely delivered in Australian communities, providing a valuable new approach to tackle rising suicide rates. LifeSpan has the potential to significantly contribute to the mental health of Australians by improving help-seeking for suicide, facilitating early detection, and improving aftercare to reduce re-attempts. The findings from this research should also contribute to the evidence base for multilevel suicide prevention programs internationally. Trial registration Australia New Zealand Clinical Trials Register, ID: ACTRN12617000457347 . Prospectively registered on 28 March 2017. https://www.anzctr.org.au/TrialSearch.aspx#&&conditionCode=&dateOfRegistrationFrom=&interventionDescription=&interventionCodeOperator=OR&primarySponsorType=&gender=&distance=&postcode=&pageSize=20&ageGroup=&recruitmentCountryOperator=OR Protocol Version: 1.0, 31 May 2019.

Abstract Background Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programmes. However, barriers to implementing and accessing these programmes remain, typically reflecting a requirement for delivery by clinical experts and high associated delivery costs. Digital technologies, specifically smartphones, are now considered a key strategy to overcome the barriers inhibiting access to mental health programmes. The Future Proofing Study is a large-scale school-based trial investigating whether cognitive behaviour therapies (CBT) delivered by smartphone application can prevent depression. Methods A randomised controlled trial targeting up to 10,000 Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomised at the cluster level either to receive the CBT intervention app (SPARX) or to a non-active control group comparator. The primary outcome will be symptoms of depression, and secondary outcomes include psychological distress, anxiety and insomnia. At the 12-month follow-up, participants in the intervention arm with elevated depressive symptoms will participate in an individual-level randomised controlled trial (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur post intervention (both trial stages) and at 6, 12, 24, 36, 48 and 60 months post baseline. Primary analyses will use an intention-to-treat approach and compare changes in symptoms from baseline to follow-up relative to the control group using mixed-effect models. Discussion This is the first trial testing the effectiveness of smartphone apps delivered to school students to prevent depression at scale. Results from this trial will provide much-needed insight into the feasibility of this approach. They stand to inform policy and commission decisions concerning if and how such programmes should be deployed in school-based settings in Australia and beyond. Trial registration Australian and New Zealand Clinical Trial Registry, ACTRN12619000855123. Registered on 31 May 2019. Clinical Trial Notification Scheme (CTN), CT-2019-CTN-02110-1-v1. Registered on 30 June 2019.

Abstract Background Inflammation contributes to the pathophysiology of major depressive disorder (MDD), and anti-inflammatory strategies might therefore have therapeutic potential. This trial aimed to determine whether adjunctive aspirin or rosuvastatin, compared with placebo, reduced depressive symptoms in young people (15–25 years). Methods YoDA-A, Youth Depression Alleviation with Anti-inflammatory Agents, was a 12-week triple-blind, randomised, controlled trial. Participants were young people (aged 15–25 years) with moderate to severe MDD (MADRS mean at baseline 32.5 ± 6.0; N = 130; age 20.2 ± 2.6; 60% female), recruited between June 2013 and June 2017 across six sites in Victoria, Australia. In addition to treatment as usual, participants were randomised to receive aspirin (n = 40), rosuvastatin (n = 48), or placebo (n = 42), with assessments at baseline and weeks 4, 8, 12, and 26. The primary outcome was change in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to week 12. Results At the a priori primary endpoint of MADRS differential change from baseline at week 12, there was no significant difference between aspirin and placebo (1.9, 95% CI (− 2.8, 6.6), p = 0.433), or rosuvastatin and placebo (− 4.2, 95% CI (− 9.1, 0.6), p = 0.089). For rosuvastatin, secondary outcomes on self-rated depression and global impression, quality of life, functioning, and mania were not significantly different from placebo. Aspirin was inferior to placebo on the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) at week 12. Statins were superior to aspirin on the MADRS, the Clinical Global Impressions Severity Scale (CGI-S), and the Negative Problem Orientation Questionnaire scale (NPOQ) at week 12. Conclusions The addition of either aspirin or rosuvastatin did not to confer any beneficial effect over and above routine treatment for depression in young people. Exploratory comparisons of secondary outcomes provide limited support for a potential therapeutic role for adjunctive rosuvastatin, but not for aspirin, in youth depression. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12613000112763. Registered on 30/01/2013.

BackgroundDigital mental health interventions stand to play a critical role in managing the mental health impact of the COVID-19 pandemic. Thus, enhancing their uptake is a key priority. General practitioners (GPs) are well positioned to facilitate access to digital interventions, but tools that assist GPs in identifying suitable patients are lacking. ObjectiveThis study aims to evaluate the suitability of a web-based mental health screening and treatment recommendation tool (StepCare) for improving the identification of anxiety and depression in general practice and, subsequently, uptake of digital mental health interventions. MethodsStepCare screens patients for symptoms of depression (9-item Patient Health Questionnaire) and anxiety (7-item Generalized Anxiety Disorder scale) in the GP waiting room. It provides GPs with stepped treatment recommendations that include digital mental health interventions for patients with mild to moderate symptoms. Patients (N=5138) from 85 general practices across Australia were invited to participate in screening. ResultsScreening identified depressive or anxious symptoms in 43.09% (1428/3314) of patients (one-quarter were previously unidentified or untreated). The majority (300/335, 89.6%) of previously unidentified or untreated patients had mild to moderate symptoms and were candidates for digital mental health interventions. Although less than half were prescribed a digital intervention by their GP, when a digital intervention was prescribed, more than two-thirds of patients reported using it. ConclusionsImplementing web-based mental health screening in general practices can provide important opportunities for GPs to improve the identification of symptoms of mental illness and increase patient access to digital mental health interventions. Although GPs prescribed digital interventions less frequently than in-person psychotherapy or medication, the promising rates of uptake by GP-referred patients suggest that GPs can play a critical role in championing digital interventions and maximizing the associated benefits.

Abstract Background Suicide amongst Australian Aboriginal and Torres Strait Islander communities occurs at twice the rate of the general population and, with significant barriers to treatment, help-seeking prior to a suicide attempt is low. This trial aims to test the effectiveness of an app (iBobbly) designed with Aboriginal and Torres Strait Islander people for reducing suicidal ideation. Methods/design This is a two-arm randomised controlled trial that will compare iBobbly to a wait-list control condition. The trial aims to recruit Aboriginal and Torres Strait Islander participants aged 16 years and over to test iBobbly, which is a self-help app delivering content based on acceptance and commitment therapy. The primary outcome for the study is suicidal ideation, and secondary outcomes include depression, hopelessness, distress tolerance, perceived burdensomeness and thwarted belonging, and help-seeking intentions. Data will be collected for both groups at baseline, post-intervention (after 6 weeks of app use), and at 6 months post-baseline (with a final 12-month follow-up for the iBobbly group). Primary analysis will compare changes in suicidal ideation for the intervention condition relative to the wait-list control condition using mixed models. An examination of the cost-effectiveness of the intervention compared to the control condition will be conducted. Discussion If effective, iBobbly could overcome many barriers to help-seeking amongst a group of people who are at increased risk of suicide. It may provide a low-cost, accessible intervention that can reach more people. This trial will add to a sparse literature on indigenous suicide prevention and will increase our knowledge about the effectiveness of e-health interventions for suicide prevention. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12614000686606. Registered on 30 June 2014.

Dysregulated metabolism is a hallmark of cancer that manifests through alterations in bioenergetic and biosynthetic pathways to enable tumor cell proliferation and survival. Tumor cells exhibit high rates of glycolysis, a phenomenon known as the Warburg effect, and an increase in glutamine consumption to support the tricarboxylic acid (TCA) cycle. Renal cell carcinoma (RCC) tumors express high levels of glutaminase (GLS), the enzyme required for the first step in metabolic conversion of glutamine to glutamate and the entry of glutamine into the TCA cycle. We found that RCC cells are highly dependent on glutamine for proliferation, and this dependence strongly correlated with sensitivity to telaglenstat (CB-839), an investigational, first-in-class, selective, orally bioavailable GLS inhibitor. Metabolic profiling of RCC cell lines treated with telaglenastat revealed a decrease in glutamine consumption, which was concomitant with a decrease in the production of glutamate and other glutamine-derived metabolites, consistent with GLS inhibition. Treatment of RCC cells with signal transduction inhibitors everolimus (mTOR inhibitor) or cabozantinib (VEGFR/MET/AXL inhibitor) in combination with telaglenastat resulted in decreased consumption of both glucose and glutamine and synergistic anti-proliferative effects. Treatment of mice bearing Caki-1 RCC xenograft tumors with cabozantinib plus telaglenastat resulted in reduced tumor growth compared to either agent alone. Enhanced anti-tumor activity was also observed with the combination of everolimus plus telaglenastat. Collectively, our results demonstrate potent, synergistic, anti-tumor activity of telaglenastat plus signal transduction inhibitors cabozantinib or everolimus via a mechanism involving dual inhibition of glucose and glutamine consumption.

An understanding of land and sea surface backscatter coefficients at high frequencies (HF) is required to accurately assess ionospheric propagation conditions for over-the-horizon radar. In this paper, two methods of calculating sea surface backscatter coefficients are compared. The first method is a theoretical method developed by Barrick in 1972, which treats the sea as a slightly rough surface defined by a wave height spectrum and uses a perturbation approach. The second method compares the difference between observed and modelled backscatter ionograms in which all other losses are accounted for to obtain a measurement of the sea surface backscatter coefficient. Similar trends and values for the sea surface backscatter coefficients from each method were found despite the many models and assumptions required for both these methods. However, it was noted that there was a larger range of values for the sea surface backscatter coefficients when the Barrick method was used.

BackgroundPrevious research on public stigma towards people with mental disorders has mostly targeted adult samples and focused on depression, schizophrenia or mental disorders in general. Hence, the present study aimed to investigate predictors of stigmatizing attitudes towards different mental disorders (including less researched ones) in a representative sample of adolescents and young adults.MethodsData from the Swiss Youth Mental Health Literacy and Stigma Survey were used (analytical sample: n = 4,932). Each participant was randomly presented with one of five vignettes (depression; alcohol abuse; depression and alcohol abuse combined; schizophrenia; social anxiety). The structure of stigmatizing attitudes was assessed using confirmatory factor analysis. Regression models, implemented within a structural equation framework, were used to study predictors for the identified latent variables.ResultsA three-factor model for stigmatizing attitudes-consisting of 'dangerous/unpredictable', 'weak-no-sick', and 'social distance' factors-best fitted the data. Female gender was associated with less stigmatizing attitudes. Associations in opposite directions with different latent factors were found for educational and migration background. Exposure to mental disorders (being personally affected, personally having received professional help or knowing someone close who has received treatment for a mental disorder) was either not or was negatively associated with stigmatizing attitudes. In contrast, current mental health symptoms (heightened levels of psychological distress, problematic alcohol use) were generally not or were positively associated with stigmatizing attitudes. Even though the included predictors had some predictive value, the variance explained by the models was rather small (the adjusted R2 varied between 0.03 and 0.26).ConclusionsThe current study indicates that contact with someone who has received treatment for a mental disorder might be an important component of programs aiming to decrease stigmatizing attitudes towards people with mental disorders, since this exposure variable predicted lower levels of stigmatizing attitudes. Furthermore, the findings suggest that target-group interventions for specific subgroups need to be considered, as the process leading to stigmatizing attitudes towards people with mental disorders appears to differ between specific sociodemographic subgroups.

ObjectiveSuicide is a leading cause of death among Aboriginal and Torres Strait Islander people. Friends, family and frontline workers (for example, teachers, youth workers) are often best positioned to provide initial assistance if someone is at risk of suicide. We developed culturally appropriate expert consensus guidelines on how to provide mental health first aid to Australian Aboriginal and Torres Strait Islander people experiencing suicidal thoughts or behaviour and used this as the basis for a 5-hour suicide gatekeeper training course called Talking About Suicide. This paper describes the outcomes for participants in an uncontrolled trial of this training course.MethodsWe undertook an uncontrolled trial of the Talking About Suicide course, delivered by Aboriginal and Torres Strait Islander Mental Health First Aid instructors to 192 adult (i.e. 18 years of age or older) Aboriginal and Torres Strait Islander (n = 110) and non-Indigenous (n = 82) participants. Questionnaires capturing self-report outcomes were self-administered immediately before (n = 192) and after attending the training course (n = 188), and at four-months follow-up (n = 98). Outcome measures were beliefs about suicide, stigmatising attitudes, confidence in ability to assist, and intended and actual actions to assist a suicidal person.ResultsDespite a high level of suicide literacy among participants at pre-course measurement, improvements at post-course were observed in beliefs about suicide, stigmatising attitudes, confidence in ability to assist and intended assisting actions. While attrition at follow-up decreased statistical power, some improvements in beliefs about suicide, stigmatising attitudes and intended assisting actions remained statistically significant at follow-up. Importantly, actual assisting actions taken showed dramatic improvements between pre-course and follow-up. Participants reported feeling more confident to assist a suicidal person after the course and this was maintained at follow-up. The course was judged to be culturally appropriate by those participants who identified as Aboriginal and/or Torres Strait Islanders.ImplicationsThe results of this uncontrolled trial were encouraging, suggesting that the Talking About Suicide course was able to improve participants' knowledge, attitudes, and intended assisting actions as well as actual actions taken.

Abstract Background Within high income countries, mental health is now the leading cause of long term sickness absence in the workplace. Managers are in a position to make changes and decisions that have a positive effect on the wellbeing of staff, the recovery of employees with mental ill health, and potentially prevent future mental health problems. However, managers report addressing workplace mental health issues as challenging. The aim of the HeadCoach trial is to evaluate the effectiveness of a newly developed online training intervention to determine whether it is able to build managers’ confidence to better support individuals within their teams who are experiencing mental ill health, and the confidence to promote manager behaviour likely to result in a more mentally healthy workplace. Methods/Design We will conduct a cluster randomised control trial (RCT) to evaluate the effect of HeadCoach, an online training intervention for managers with a focus on the mental health of their employees, compared to a waitlist control. The target sample is 168 managers, and their direct employees. Managers and employees will be assessed at baseline and at 4-month follow up. Managers will have an additional, intermediate assessment 6-weeks post-baseline. The primary outcome is change from baseline in managers’ self-reported confidence when dealing with mental health issues within their team and promoting a mentally healthy workplace. The difference between the intervention and waitlist control groups will be assessed using linear mixed effects repeated measures (MMRM) analysis of variance (ANOVA). Secondary managerial outcomes include mental health literacy, attitudes towards mental health issues in the workplace and managerial behaviour in dealing with mental health matters with their staff. Employee outcomes will be perceived level of manager support, engagement, psychological distress, and rates of sickness absence and presenteeism. Discussion To our knowledge this will be the first RCT of a purely online training intervention developed specifically for managers that promotes confidence to both support staff experiencing mental ill health and create a mentally healthy work environment. If successful, this intervention has the potential to provide an effective and efficient method of training managers in workplace mental health and to enhance employee wellbeing. Trial Registration Australian and New Zealand Clinical Trials Registry ACTRN12617000279325

Joint modelling has emerged to be a potential tool to analyse data with a time-to-event outcome and longitudinal measurements collected over a series of time points. Joint modelling involves the simultaneous modelling of the two components, namely the time-to-event component and the longitudinal component. The main challenges of joint modelling are the mathematical and computational complexity. Recent advances in joint modelling have seen the emergence of several software packages which have implemented some of the computational requirements to run joint models. These packages have opened the door for more routine use of joint modelling. Through simulations and real data based on transition to psychosis research, we compared joint model analysis of time-to-event outcome with the conventional Cox regression analysis. We also compared a number of packages for fitting joint models. Our results suggest that joint modelling do have advantages over conventional analysis despite its potential complexity. Our results also suggest that the results of analyses may depend on how the methodology is implemented.

Background: Obstructive sleep apnoea (OSA) in the general community is associated with obesity, smoking, alcohol and sedative medication use; and contributes to depressed mood, daytime sedation, and sudden cardiovascular deaths. Poor cardiovascular health, impaired social functioning, negative and cognitive symptoms are also among the common clinical features of psychotic disorders. People with psychosis have higher rates of sleep disturbance, however, OSA has not been extensively investigated in this population. Aims: This study aimed to determine the prevalence of OSA and general sleep disruption symptoms in a representative Australian sample of people with psychosis. We investigated the prevalence of potential risk factors for OSA including obesity, psychotropic medications, and substance abuse in this population. Finally, we evaluated associations between symptoms of OSA, symptoms of general sleep disruption, and various clinical features in people with psychosis. Methods: Participants took part in the Second National Australian Survey of Psychosis, a population-based survey of Australians with a psychotic disorder aged 18-64 years. Symptoms associated with OSA (snoring and breathing pauses during sleep) in the past year were assessed using questions from the University of Maryland Medical Centre Questionnaire, and symptoms associated with general sleep disruption in the past week using the Assessment of Quality of Life Questionnaire (AQoL). Data collected included psychiatric diagnosis and symptoms, education, employment, medications, smoking status, physical activity, drug and alcohol use, and cognitive function. Physical health measures included body mass index, waist circumference, blood pressure, fasting blood glucose and lipids.Results: Snoring was reported by 41.9%; 7% stating they frequently stopped breathing (pauses) during sleep. Univariate logistic regressions show OSA symptoms (pauses and snoring) were associated with older age, female gender, lower levels of social participation or employment, cardiovascular risk factors, sedentary lifestyle and poorer quality of life, whilst symptoms of general sleep disruption were more likely in people with depressive symptoms.Conclusions: Australians with psychosis have high levels of sleep disturbance including OSA. OSA symptoms were associated with cardiovascular disease risk factors, reduced social participation and employment, and poorer quality of life. Whether correction of OSA can improve these factors in people with psychosis remains to be determined.

Background and aimMild to moderate depression is common in those with cardiovascular disease and undertreated. We aimed to evaluate the effectiveness of internet-delivered Cognitive Behaviour Therapy (iCBT) on depressive symptom severity and adherence to medical advice and lifestyle interventions in adults with mild to moderate depression and high cardiovascular disease (CVD) risks.MethodsRandomised double-blind, 12 week attention-controlled trial comparing an iCBT programme (E-couch) with an internet-delivered attention control health information package (HealthWatch, n = 282). The primary outcome was depression symptom level on the nine-item Patient Health Questionnaire (PHQ-9) (trial registration: ACTRN12610000085077).Results487/562 (88%) participants completed the endpoint assessment. 383/562 (70%) were currently treated for cardiovascular disease and 314/562 (56%) had at least one other comorbid condition. In ITT analysis of 562 participants iCBT produced a greater decline in the mean PHQ-9 score compared to the attention control of 1.06 (95% CI: 0.23-1.89) points, with differences between the two arms increasing over the intervention period (time by treatment effect interaction p = .012). There were also larger improvements in adherence (2.16 points; 95% CI: 0.33-3.99), reductions in anxiety (0.96 points; 95% CI: 0.19-1.73), and a greater proportion engaging in beneficial physical activity (Odds Ratio 1.91, 95%CI: 1.01-3.61) in the iCBT participants but no effect upon disability, or walking time/day. There were no withdrawals due to study related adverse events.ConclusionsIn people with mild to moderate depression and high levels of CVD risk factors, a freely accessible iCBT programme (http://www.ecouch.anu.edu.au) produced a small, but robust, improvement in depressive symptoms, adherence and some health behaviours.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12610000085077.

Individuals with psychosis are more likely than the general community to develop obesity and to die prematurely from heart disease. Interventions to improve cardiovascular outcomes are best targeted at the earliest indicators of risk, at the age they first emerge. We investigated which cardiometabolic risk indicators distinguished those with psychosis from the general population, by age by gender, and whether obesity explained the pattern of observed differences. Data was analyzed from an epidemiologically representative sample of 1,642 Australians with psychosis aged 18-64 years and a national comparator sample of 8,866 controls aged 25-64 years from the general population. Cubic b-splines were used to compare cross sectional age trends by gender for mean waist circumference, body mass index [BMI], blood pressure, fasting blood glucose, triglycerides, LDL, HDL, and total cholesterol in our psychosis and control samples. At age 25 individuals with psychosis had a significantly higher mean BMI, waist circumference, triglycerides, glucose [women only], and diastolic blood pressure and significantly lower HDL-cholesterol than controls. With the exception of triglycerides at age 60+ in men, and glucose in women at various ages, these differences were present at every age. Differences in BMI and waist circumference between samples, although dramatic, could not explain all differences in diastolic blood pressure, HDL-cholesterol or triglycerides but did explain differences in glucose. Psychosis has the hallmarks of insulin resistance by at least age 25. The entire syndrome, not just weight, should be a focus of intervention to reduce mortality from cardiovascular disease.

BACKGROUND: Telephone helplines are frequently and repeatedly used by individuals with chronic mental health problems and web interventions may be an effective tool for reducing depression in this population. AIM: To evaluate the effectiveness of a 6 week, web-based cognitive behaviour therapy (CBT) intervention with and without proactive weekly telephone tracking in the reduction of depression in callers to a helpline service. METHOD: 155 callers to a national helpline service with moderate to high psychological distress were recruited and randomised to receive either Internet CBT plus weekly telephone follow-up; Internet CBT only; weekly telephone follow-up only; or treatment as usual. RESULTS: Depression was lower in participants in the web intervention conditions both with and without telephone tracking compared to the treatment as usual condition both at post intervention and at 6 month follow-up. Telephone tracking provided by a lay telephone counsellor did not confer any additional advantage in terms of symptom reduction or adherence. CONCLUSIONS: A web-based CBT program is effective both with and without telephone tracking for reducing depression in callers to a national helpline. TRIAL REGISTRATION: Controlled-Trials.comISRCTN93903959.