Mental Health Screening in General Practices as a Means for Enhancing Uptake of Digital Mental Health Interventions: Observational Cohort Study.

BACKGROUND: Digital 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. OBJECTIVE: This 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. METHODS: StepCare 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. RESULTS: Screening 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. CONCLUSIONS: Implementing 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.

Best strategies for reducing the suicide rate in Australia.

OBJECTIVES: There is accumulating evidence about effectiveness of a number of suicide prevention interventions, and a multilevel systems approach seems promising in reducing suicide risk. This approach requires that components ranging from individual-level to public health interventions are implemented simultaneously in a localised region. This paper presents estimated reductive effects on suicide attempts and deaths that might be expected in Australia if active components of the systems approach were to be implemented. METHOD: The study estimated population preventable fractions which indicate the extent to which suicide attempts and deaths might be decreased if the each of the proposed interventions was fully implemented. The population preventable fractions were based on the best available evidence available in the literature for the risk ratio for each intervention. Prevalence estimates were assessed for each component of the proposed systems approach: reducing access to suicide means, media guidelines, public health campaigns, gatekeeper programmes, school programmes, general practitioner training, psychotherapy and co-ordinated/assertive aftercare. RESULTS: There was insufficient evidence available for the impact of a number of strategies, including frontline staff gatekeeper training, on either suicide attempts or deaths. Taking prevalence of exposure to the intervention into consideration, the strategies likely to bring about the strongest reduction in suicide attempts were psychosocial treatments and co-ordinated/assertive aftercare. The greatest impact on reductions in suicide deaths was found for psychosocial treatment, general practitioner training, gatekeeper training and reducing access to means of suicide. CONCLUSION: The evidence regarding the overall efficacy of the systems approach is important in identifying what strategies should be prioritized to achieve the biggest impact. The findings of the population preventable fraction calculations indicate that the systems approach could lead to significant reduction in suicide attempts and suicide deaths in Australia. Potential synergistic effects between strategies included in the approach could further increase the impact of implemented strategies.

The Sleep Or Mood Novel Adjunctive therapy (SOMNA) trial: a study protocol for a randomised controlled trial evaluating an internet-delivered cognitive behavioural therapy program for insomnia on outcomes of standard treatment for depression in men.

BACKGROUND: Insomnia is a significant risk factor for depression onset, can result in more disabling depressive illness, and is a common residual symptom following treatment cessation that can increase the risk of relapse. Internet-based cognitive behavioural therapy for insomnia has demonstrated efficacy and acceptability to men who are less likely than women to seek help in standard care. We aim to evaluate whether internet delivered cognitive behavioural therapy for insomnia as an adjunct to a standard depression therapeutic plan can lead to improved mood outcomes. METHODS/DESIGN: Male participants aged 50 years or more, meeting Diagnostic and Statistical Manual of Mental Disorders criteria for current Major Depressive Episode and/or Dysthymia and self-reported insomnia symptoms, will be screened to participate in a single-centre double-blind randomised controlled trial with two parallel groups involving adjunctive internet-delivered cognitive behavioural therapy for insomnia and an internet-based control program. The trial will consist of a nine-week insomnia intervention period with a six-month follow-up period. During the insomnia intervention period participants will have their depression management coordinated by a psychiatrist using standard guideline-based depression treatments. The study will be conducted in urban New South Wales, Australia, where 80 participants from primary and secondary care and direct from the local community will be recruited. The primary outcome is change in the severity of depressive symptoms from baseline to week 12. DISCUSSION: This study will provide evidence on whether a widely accessible, evidence-based, internet-delivered cognitive behavioural therapy for insomnia intervention can lead to greater improvements than standard treatment for depression alone, in a group who traditionally do not readily access psychotherapy. The study is designed to establish effect size, feasibility and processes associated with implementing e-health solutions alongside standard clinical care, to warrant undertaking a larger more definitive clinical trial. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12612000985886 .

Efficacy of BrighterSide, a Self-Guided App for Suicidal Ideation: Randomized Controlled Trial.

Background: Self-guided digital interventions can reduce the severity of suicidal ideation, although there remain relatively few rigorously evaluated smartphone apps targeting suicidality. Objective: This trial evaluated whether the BrighterSide smartphone app intervention was superior to a waitlist control group at reducing the severity of suicidal ideation. Methods: A total of 550 adults aged 18 to 65 years with recent suicidal ideation were recruited from the Australian community. In this randomized controlled trial, participants were randomly assigned to receive either the BrighterSide app or to a waitlist control group that received treatment as usual. The app was self-guided, and participants could use the app at their own pace for the duration of the study period. Self-report measures were collected at baseline, 6 weeks, and 12 weeks. The primary outcome was severity and frequency of suicidal ideation, and secondary outcomes included psychological distress and functioning and recovery. Additional data were collected on app engagement and participant feedback. Results: Suicidal ideation reduced over time for all participants, but there was no significant interaction between group and time. Similar improvements were observed for self-harm, functioning and recovery, days out of role, and coping. Psychological distress was significantly lower in the intervention group at the 6-week follow-up, but this was not maintained at 12 weeks. Conclusions: The BrighterSide app did not lead to a significant improvement in suicidal ideation relative to a waitlist control group. Possible reasons for this null finding are discussed.

Study protocol for an adaptive, multi-arm, multi-stage (MAMS) randomised controlled trial of brief remotely delivered psychosocial interventions for people with serious mental health problems who have experienced a recent suicidal crisis: Remote Approaches to Psychosocial Intervention Delivery (RAPID).

BACKGROUND: People with serious mental health problems (SMHP) are more likely to be admitted to psychiatric hospital following contact with crisis services. Admissions can have significant personal costs, be traumatic and are the most expensive form of mental health care. There is an urgent need for treatments to reduce suicidal thoughts and behaviours and reduce avoidable psychiatric admissions. METHODS: A multi-stage, multi-arm (MAMS) randomised controlled trial (RCT) with four arms conducted over two stages to determine the clinical and cost effectiveness of three psychosocial treatments, compared to treatment as usual (TAU), for people with SMHP who have had recent suicidal crisis. Primary outcome is any psychiatric hospital admissions over a 6-month period. We will assess the impact on suicidal thoughts and behaviour, hope, recovery, anxiety and depression. The remote treatments delivered over 3 months are structured peer support (PREVAIL); a safety planning approach (SAFETEL) delivered by assistant psychologists; and a CBT-based suicide prevention app accessed via a smartphone (BrighterSide). Recruitment is at five UK sites. Stage 1 includes an internal pilot with a priori progression criteria. In stage 1, the randomisation ratio was 1:1:1:2 in favour of TAU. This has been amended to 2:2:3 in favour of TAU following an unplanned change to remove the BrighterSide arm following the release of efficacy data from an independent RCT. Randomisation is via an independent remote web-based randomisation system using randomly permuted blocks, stratified by site. An interim analysis will be performed using data from the first 385 participants from PREVAIL, SAFETEL and TAU with outcome data at 6 months. If one arm is dropped for lack of benefit in stage 2, the allocation ratio of future participants will be 1:1. The expected total sample size is 1064 participants (1118 inclusive of BrighterSide participants). DISCUSSION: There is a need for evidence-based interventions to reduce psychiatric admissions, via reduction of suicidality. Our focus on remote delivery of established brief psychosocial interventions, utilisation of different modalities of delivery that can provide sustainable and scalable solutions, which are also suitable for a pandemic or national crisis context, will significantly advance treatment options. TRIAL REGISTRATION: ISRCTN33079589. Registered on June 20, 2022.

Rethinking the dose-response relationship between usage and outcome in an online intervention for depression: randomized controlled trial.

BACKGROUND: There is now substantial evidence that Web-based interventions can be effective at changing behavior and successfully treating psychological disorders. However, interest in the impact of usage on intervention outcomes has only been developed recently. To date, persistence with or completion of the intervention has been the most commonly reported metric of use, but this does not adequately describe user behavior online. Analysis of alternative measures of usage and their relationship to outcome may help to understand how much of the intervention users may need to obtain a clinically significant benefit from the program. OBJECTIVE: The objective of this study was to determine which usage metrics, if any, are associated with outcome in an online depression treatment trial. METHODS: Cardiovascular Risk E-couch Depression Outcome (CREDO) is a randomized controlled trial evaluating an unguided Web-based program (E-couch) based on cognitive behavioral therapy and interpersonal therapy for people with depression and cardiovascular disease. In all, 280 participants in the active arm of the trial commenced the program, delivered in 12 modules containing pages of text and activities. Usage data (eg, number of log-ins, modules completed, time spent online, and activities completed) were captured automatically by the program interface. We estimated the association of these and composite metrics with the outcome of a clinically significant improvement in depression score on the Patient Health Questionnaire (PHQ-9) of ≥ 5 points. RESULTS: In all, 214/280 (76.4%) participants provided outcome data at the end of the 12-week period and were included in the analysis. Of these, 94 (43.9%) participants obtained clinically significant improvement. Participants logged into the program an average of 18.7 times (SD 8.3) with most (62.1%, 133/214) completing all 12 modules. Average time spent online per log-in was 17.3 minutes (SD 10.5). Participants completed an average of 9 of 18 activities available within the program. In a multivariate regression model, only the number of activities completed per log-in was associated with a clinically significant outcome (OR 2.82, 95% CI 1.05-7.59). The final model predicted 7.4% of variance in outcome. Curve estimates indicated that significant logarithmic (P=.009) and linear (P=.002) relationships existed between activities completed per log-in and clinically significant change. CONCLUSIONS: Only one objective measure of usage was independently associated with better outcome of a Web-based intervention of known effectiveness. The 4 usage metrics retained in the final step of the regression accounted for little outcome variance. Medium level users appeared to have little additional benefit compared to low users indicating that assumptions of a linear relationship between use and outcome may be too simplistic and further models and variables need to be explored to adequately understand the relationship.

The Essential Network (TEN): Protocol for an Implementation Study of a Digital-First Mental Health Solution for Australian Health Care Workers During COVID-19.

BACKGROUND: The COVID-19 pandemic has placed health care workers (HCWs) under severe stress, compounded by barriers to seeking mental health support among HCWs. The Essential Network (TEN) is a blend of digital and person-to-person (blended care) mental health support services for HCWs, funded by the Australian Federal Department of Health as part of their national COVID-19 response strategy. TEN is designed as both a preventative measure and treatment for common mental health problems faced by HCWs. New blended services need to demonstrate improvements in mental health symptoms and test acceptability in their target audience, as well as review implementation strategies to improve engagement. OBJECTIVE: The primary objective of this implementation study is to design and test an implementation strategy to improve uptake of TEN. The secondary objectives are examining the acceptability of TEN among HCWs, changes in mental health outcomes associated with the use of TEN, and reductions in mental health stigma among HCWs following the use of TEN. METHODS: The implementation study contains 3 components: (1) a consultation study with up to 39 stakeholders or researchers with implementation experience to design an implementation strategy, (1) a longitudinal observational study of at least 105 HCWs to examine the acceptability of TEN and the effectiveness of TEN at 1 and 6 months in improving mental health (as assessed by the Distress Questionnaire [DQ-5], Patient Health Questionnaire [PHQ-9], Generalized Anxiety Disorder [GAD-7], Oldenburg Burnout Inventory [OBI-16], and Work and Social Adjustment Scale [WSAS]) and reducing mental health stigma (the Endorsed and Anticipated Stigma Inventory [EASI]), and (3) an implementation study where TEN service uptake analytics will be examined for 3 months before and after the introduction of the implementation strategy. RESULTS: The implementation strategy, designed with input from the consultation and observational studies, is expected to lead to an increased number of unique visits to the TEN website in the 3 months following the introduction of the implementation strategy. The observational study is expected to observe high service acceptability. Moderate improvements to general mental health (DQ-5, WSAS) and a reduction in workplace- and treatment-related mental health stigma (EASI) between the baseline and 1-month time points are expected. CONCLUSIONS: TEN is a first-of-a-kind blended mental health service available to Australian HCWs. The results of this project have the potential to inform the implementation and development of blended care mental health services, as well as how such services can be effectively implemented during a crisis. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/34601.

Internet-based treatment for older adults with depression and co-morbid cardiovascular disease: protocol for a randomised, double-blind, placebo controlled trial.

BACKGROUND: Depression, cardiovascular disease (CVD) risk factors and cognitive impairment are important causes of disability and poor health outcomes. In combination they lead to an even worse prognosis. Internet or web-based interventions have been shown to deliver efficacious psychological intervention programs for depression on a large scale, yet no published studies have evaluated their impact among patients with co-existing physical conditions. The aims of this randomised controlled trial are to determine the effects of an evidence-based internet intervention program for depression on depressive mood symptoms, cognitive function and treatment adherence in patients at risk of CVD. METHODS/DESIGN: This study is an internet-based, double-blind, parallel group randomised controlled trial. The trial will compare the effectiveness of online cognitive behavioural therapy with an online attention control placebo. The trial will consist of a 12-week intervention phase with a 40-week follow-up. It will be conducted in urban and rural New South Wales, Australia and will recruit a community-based sample of adults aged 45 to 75 years. Recruitment, intervention, cognitive testing and follow-up data collection will all be internet-based and automated. The primary outcome is a change in severity of depressive symptoms from baseline to three-months. Secondary outcomes are changes in cognitive function and adherence to treatment for CVD from baseline to three, six and 12-months. DISCUSSION: Prior studies of depression amongst patients with CVD have targeted those with previous vascular events and major depression. The potential for intervening earlier in these disease states appears to have significant potential and has yet to be tested. Scalable psychological programs using web-based interventions could deliver care to large numbers in a cost effective way if efficacy were proved. This study will determine the effects of a web-based intervention on depressive symptoms and adherence to treatment among patients at risk of CVD. In addition it will also precisely and reliably define the effects of the intervention upon aspects of cognitive function that are likely to be affected early in at risk individuals, using sensitive and responsive measures. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12610000085077.

The Building Educators' Skills in Adolescent Mental Health Training Program for Secondary School Educators: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: In Australia, secondary school educators are well positioned to recognize mental illness among students and provide support. However, many report that they lack the knowledge and confidence to do so, and few mental health training programs available for educators are evidence based. To address this gap, the Black Dog Institute (BDI) developed a web-based training program (Building Educators' Skills in Adolescent Mental Health [BEAM]) that aims to improve mental health knowledge, confidence, and helping behaviors among secondary school educators in leadership positions. A pilot study of the training program found it to be positively associated with increased confidence and helping behaviors among educators and reduced personal psychological distress. An adequately powered randomized controlled trial (RCT) is needed. OBJECTIVE: The primary objective of this cluster RCT is to evaluate the effectiveness of the BEAM program for improving educators' confidence in managing student mental health. The trial will also evaluate the effect of the BEAM program in increasing educators' frequency of providing help to students and improving their mental health knowledge and reducing educators' psychological distress and stigma toward students with mental health issues. METHODS: The target sample size is 234 educators from 47 secondary schools across New South Wales, Australia. Four waves of recruitment and enrollment into the trial are planned. Schools will participate in one wave only and will be randomized to the intervention or waitlist control conditions. Participants from the same school will be assigned to the same condition. Assessments will be conducted at baseline, posttest (10 weeks after baseline), and follow-up (22 weeks after baseline) using the BDI eHealth research platform. Intervention participants will receive access to the BEAM program for 10 weeks upon completion of baseline, and the control condition will receive access for 10 weeks upon completion of the follow-up assessment. RESULTS: Recruitment for this trial began on July 21, 2020, with the first baseline assessments occurring on August 17, 2020. To date, 295 participants from 71 schools have completed baseline. Due to the unexpected success of recruitment in the first 3 waves, the final fourth wave has been abandoned. Intervention participants are currently receiving the program, with follow-up due for completion in March 2021. CONCLUSIONS: This is one of the first RCTs to examine the effectiveness of a web-based adolescent mental health training program for Australian secondary school educators in leadership positions. If found to be effective, this training program will offer a sustainable and scalable delivery method for upskilling educators in caring for students' mental health. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12620000876998; https://covid-19.cochrane.org/studies/crs-14669208. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25870.

A cluster randomised controlled trial of a web-based youth mental health service in Australian schools.

BACKGROUND: Secondary schools have attempted to address gaps in help-seeking for mental health problems with little success. This trial evaluated the effectiveness of a universal web-based service (Smooth Sailing) for improving help-seeking intentions for mental health problems and other related outcomes among students. METHODS: A cluster randomised controlled trial was conducted to evaluate the 12-week outcomes of the Smooth Sailing service among 1841 students from 22 secondary schools in New South Wales, Australia. Assignment was conducted at the school level. The control condition received school-as-usual. The primary outcome was help-seeking intentions for general mental health problems at 12-weeks post-baseline. Secondary outcomes included help-seeking behaviour, anxiety and depressive symptoms, psychological distress, psychological barriers to help-seeking, and mental health literacy. Data were analysed using mixed linear models. This trial was registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12618001539224). FINDINGS: At 12-weeks post-baseline, there was a marginal statistical difference in the relative means of help-seeking intentions (effect size=0•10, 95%CI: -0•02-0•21) that favoured the intervention condition. Help-seeking from adults declined in both conditions. There was a greater reduction in the number of students who "needed support for their mental health but were not seeking help" in the intervention condition (OR: 2•08, 95%CI: 1•72-2.27, P<•0001). No other universal effects were found. Participants found the service easy to use and understand; However, low motivation, time, forgetfulness, and lack of perceived need were barriers to use. INTERPRETATION: Smooth Sailing led to small improvements in help-seeking intentions. Refinements are needed to improve its effectiveness on other mental health outcomes and to increase student uptake and engagement. FUNDING: HSBC and Graf Foundation.

Protocol for a stepped-wedge, cluster randomized controlled trial of the LifeSpan suicide prevention trial in four communities in New South Wales, Australia.

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.

A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study.

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.

Smooth Sailing: A Pilot Study of an Online, School-Based, Mental Health Service for Depression and Anxiety.

Background: Schools play an important role in supporting young people's mental health, but face challenges identifying and responding to students in need of care. To assist secondary schools, the Black Dog Institute has developed an online, school-based, mental health service (Smooth Sailing). Delivered in the classroom, Smooth Sailing uses a website to screen, assess, allocate, and deliver care for depression and anxiety. The service is based on the principles of stepped care, offering treatments with varied intensity and follow-up by a school counselor when necessary. The current study aimed to evaluate the feasibility, acceptability, and safety of this new type of service among secondary school students. Methods: Between February and June 2017, a single-arm, pre-post, pilot study was conducted among students from four NSW secondary schools. Schools were given access to the service for 6 weeks. Feasibility measures (consent rates and step allocations), acceptability measures (service use and satisfaction) and safety measures (deterioration in help-seeking intention scores and mental health symptoms) were assessed at baseline and completion of the 6-week trial period. Results: A total of 59 students took part in the service pilot (mean age, 14.57 years; SD, 0.89 years; range, 13-16 years). At baseline, 18.64% of students were found to require follow-up from the school counselor, and 80% of these were new cases. Although completion of the online modules was low, service satisfaction was high. At 6 weeks, the mean scores for help-seeking, depression, and anxiety remained relatively stable or improved. Conclusions: The current study presents important findings for the development and implementation of an online mental health service that screens students' mental health and allocates care accordingly, all within the school setting. Although the findings provide some support for the feasibility, acceptability, and safety, service improvements are needed. The modifications outlined are likely to improve the quality of the service and its effectiveness. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12617000977370.

Evaluating a Web-Based Mental Health Service for Secondary School Students in Australia: Protocol for a Cluster Randomized Controlled Trial.

BACKGROUND: Mental health problems are prevalent among Australian secondary school youth; however, help-seeking is low. Schools offer an ideal setting to address these concerns. The Black Dog Institute has developed a Web-based mental health service for secondary schools that is modeled on the principles of stepped care. The Smooth Sailing service aims to improve help-seeking and reduce anxiety and depressive symptoms in secondary school students. The acceptability of this service has been demonstrated in a pilot study. A full trial is now warranted. OBJECTIVE: This study protocol for a cluster randomized controlled trial (RCT) aims to evaluate the effectiveness of the Smooth Sailing Web-based service for improving help-seeking intentions and behavior, and reducing depressive and anxiety symptoms, alongside other mental health outcomes, when compared with a school-as-usual control condition in secondary school youth. METHODS: This RCT aims to recruit 1600 students from 16 secondary schools in regional and urban locations throughout New South Wales, Australia. Schools are randomly assigned to the intervention or school-as-usual control condition at the school level. Approximately 100 students from 1 or multiple grades are recruited from each participating school. Participants complete measures at 3 timepoints: baseline, 6 weeks post, and 12 weeks post, with the primary outcome assessed at 12 weeks posttest. Participants assigned to the intervention condition register to the Web-based service at baseline and receive care in accordance with the service model. Participants in the control condition receive school-as-usual. RESULTS: The first baseline assessment occurred on February 22, 2018, with the 12-week endpoint assessments completed on Friday, June 29, 2018. Control schools are currently receiving the service, due for completion by June 30, 2019. The trial results are expected to demonstrate improved help-seeking intentions and behavior among students assigned to the intervention condition, alongside improvements in symptoms of depression, anxiety, distress, and other mental health outcomes when compared with students assigned to the control condition. CONCLUSIONS: To our knowledge, this is the first time that a Web-based mental health service based on the principles of stepped care will have been integrated into, and evaluated in, the Australian school context. The findings of this trial will have implications for the suitability of this type of service model in Australian schools and for the delivery of school-based mental health services more broadly. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618001539224 https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375821&isReview=true (Archived by WebCite at http://www.webcitation.org/77N3MDGS6). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12892.

Oxidative stress and depressive symptoms in older adults: A magnetic resonance spectroscopy study.

Major depression is common in older adults and associated with greater health care utilisation and increased risk of poor health outcomes. Oxidative stress may be implicated in the pathophysiology of depression and can be measured via the neurometabolite glutathione using proton magnetic resonance spectroscopy ((1)H-MRS). This study aimed to examine the relationship between glutathione concentration and depressive symptom severity in older adults 'at-risk' of depression. In total, fifty-eight older adults considered 'at-risk' of depression (DEP) and 12 controls underwent (1)H-MRS, medical and neuropsychological assessments. Glutathione was measured in the anterior cingulate cortex (ACC), and calculated as a ratio to creatine. Depressive and anxiety symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS). Compared to controls, DEP patients had increased glutathione/creatine ratios in the ACC (t=2.7, p=0.012). In turn, these increased ratios were associated with greater depressive symptoms (r=0.28, p=0.038), and poorer performance on a verbal learning task (r=-0.28, p=0.040). In conclusion, depressive symptoms in older people are associated with increased glutathione in the ACC. Oxidative stress may be pathophysiologically linked to illness development and may represent an early compensatory response. Further research examining the utility of glutathione as a marker for depressive symptoms and cognitive decline is now required.

The effect of 12-wk ω-3 fatty acid supplementation on in vivo thalamus glutathione concentration in patients "at risk" for major depression.

OBJECTIVES: As life expectancy increases, the need to prevent major health disorders is clear. Depressive symptoms are common in older adults and are associated with cognitive decline and greater risk for transitioning to major depression. Oxidative stress may be implicated in the pathophysiology of major depression and can be measured in vivo using proton magnetic resonance spectroscopy via the neurometabolite glutathione (GSH). Evidence suggests ω-3 fatty acid (FA) supplementation may prevent depression and directly affect GSH concentration. The aim of this study was to examine the effect of ω-3 FA supplementation on in vivo GSH concentration in older adults at risk for depression. METHODS: Fifty-one older adults at risk for depression were randomized to receive either four 1000-mg ω-3 FA supplements daily (containing eicosapentaenoic acid 1200 mg plus docosahexaenoic acid 800 mg) or placebo (four 1000-mg paraffin oil placebo capsules daily) for 12 wk. Participants underwent magnetic resonance spectroscopy, as well as medical, neuropsychological, and self-report assessments at baseline and after 12 wk of supplementation. GSH was measured in the thalamus and calculated as a ratio to creatine. Depressive symptoms were measured using the Patient Health Questionnaire. RESULTS: Compared with the group given the ω-3 FA supplements, the placebo group had greater change in the GSH-to-creatine ratio in the thalamus (t = 2.00; P = 0.049) after the 12 wk intervention. This increase was in turn associated with a worsening of depressive symptoms (r = 0.43; P = 0.043). CONCLUSIONS: Depressive symptom severity in older adults appears to be associated with increased brain levels of GSH, a key marker of oxidative stress. Importantly, ω-3 FA supplementation may attenuate oxidative stress mechanisms, thereby offering benefits for depression prevention.

Randomized controlled trial of a healthy brain ageing cognitive training program: effects on memory, mood, and sleep.

BACKGROUND: With the rise in the ageing population and absence of a cure for dementia, cost-effective prevention strategies for those 'at risk' of dementia including those with depression and/or mild cognitive impairment are urgently required. OBJECTIVE: This study evaluated the efficacy of a multifaceted Healthy Brain Ageing Cognitive Training (HBA-CT) program for older adults 'at risk' of dementia. METHODS: Using a single-blinded design, 64 participants (mean age = 66.5 years, SD = 8.6) were randomized to an immediate treatment (HBA-CT) or treatment-as-usual control arm. The HBA-CT intervention was conducted twice-weekly for seven weeks and comprised group-based psychoeducation about cognitive strategies and modifiable lifestyle factors pertaining to healthy brain ageing, and computerized cognitive training. RESULTS: In comparison to the treatment-as-usual control arm, the HBA-CT program was associated with improvements in verbal memory (p = 0.03), self-reported memory (p = 0.03), mood (p = 0.01), and sleep (p = 0.01). While the improvements in memory (p = 0.03) and sleep (p = 0.02) remained after controlling for improvements in mood, only a trend in verbal memory improvement was apparent after controlling for sleep. CONCLUSION: The HBA-CT program improves cognitive, mood, and sleep functions in older adults 'at risk' of dementia, and therefore offers promise as a secondary prevention strategy.

The Beyond Ageing Project Phase 2--a double-blind, selective prevention, randomised, placebo-controlled trial of omega-3 fatty acids and sertraline in an older age cohort at risk for depression: study protocol for a randomized controlled trial.

BACKGROUND: Late-life depression is associated with high rates of morbidity, premature mortality, disability, functional decline, caregiver burden and increased health care costs. While clinical and public health approaches are focused on prevention or early intervention strategies, the ideal method of intervention remains unclear. No study has set out to evaluate the role of neurobiological agents in preventing depressive symptoms in older populations at risk of depression. METHODS/DESIGN: Subjects with previously reported sub-threshold depressive symptoms, aged 60 to 74 years, will be screened to participate in a single-centre, double-blind, randomised controlled trial with three parallel groups involving omega-3 fatty acid supplementation or sertraline hydrochloride, compared with matching placebo. Subjects will be excluded if they have current depression or suicide ideation; are taking antidepressants or any supplement containing omega-3 fatty acid; or have a prior history of stroke or other serious cerebrovascular or cardiovascular disease, neurological disease, significant psychiatric disease (other than depression) or neurodegenerative disease. The trial will consist of a 12 month treatment phase with follow-up at three months and 12 months to assess outcome events. At three months, subjects will undergo structural neuroimaging to assess whether treatment effects on depressive symptoms correlate with brain changes. Additionally, proton spectroscopy techniques will be used to capture brain-imaging markers of the biological effects of the interventions. The trial will be conducted in urban New South Wales, Australia, and will recruit a community-based sample of 450 adults. Using intention-to-treat methods, the primary endpoint is an absence of clinically relevant depression scores at 12 months between the omega-3 fatty acid and sertraline interventions and the placebo condition. DISCUSSION: The current health, social and economic costs of late-life depression make prevention imperative from a public health perspective. This innovative trial aims to address the long-neglected area of prevention of depression in older adults. The interventions are targeted to the pathophysiology of disease, and regardless of the effect size of treatment, the outcomes will offer major scientific advances regarding the neurobiological action of these agents. The main results are expected to be available in 2017. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12610000032055 (12 January 2010).

Cognitive training enhances pre-attentive neurophysiological responses in older adults 'at risk' of dementia.

BACKGROUND: With predicted increases in dementia incidence, interventions targeting neuroplasticity and neuroprotection are required. Cognitive Training (CT) is an intervention which has been shown to improve aspects of cognition, but the pathophysiological mechanisms contributing to its efficacy are unknown. OBJECTIVE: We aimed to explore the neurobiological correlates of CT using Mismatch Negativity (MMN), a neurophysiological marker of pre-attentive information processing, which in turn, is postulated to underpin higher-order cognitive processes. METHODS: As part of a larger randomized controlled trial, forty 'at risk' (i.e., mild cognitive impairment or late-life depression) participants aged 51-79 years underwent neurophysiological, neuropsychological, and psychiatric assessments before and after a multi-faceted seven-week CT program or a 'treatment-as-usual' seven-week waitlist period. RESULTS: The treatment group demonstrated significantly increased fronto-central MMN responses (p < 0.05), as well as improved phonemic verbal fluency (p < 0.05) and decreased self-rated memory difficulties (p < 0.05) following CT, in comparison to the waitlist control group. However, there were no significant correlations between enhanced MMN and cognitive/psychosocial outcomes. CONCLUSIONS: Results from this preliminary investigation indicate that CT is associated with enhanced neurophysiological mechanisms suggestive of improved pre-attentive processing, which may reflect alterations in underlying neurobiology. Further research is warranted to confirm these findings, to explicate whether CT is associated with restorative or compensatory neuroplastic processes and to determine whether MMN is a useful biomarker for treatment response.