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BackgroundMobile health (mHealth) apps offer a scalable option for treating sleep disturbances at a population level. However, there is a lack of clarity about the development and evaluation of evidence-based mHealth apps. ObjectiveThe aim of this systematic review was to provide evidence for the design engineering and clinical implementation and evaluation of mHealth apps for sleep disturbance. MethodsA systematic search of studies published from the inception of databases through February 2020 was conducted using 5 databases (MEDLINE, Embase, Cochrane Library, PsycINFO, and CINAHL). ResultsA total of 6015 papers were identified using the search strategy. After screening, 15 papers were identified that examined the design engineering and clinical implementation and evaluation of 8 different mHealth apps for sleep disturbance. Most of these apps delivered cognitive behavioral therapy for insomnia (CBT-I, n=4) or modified CBT-I (n=2). Half of the apps (n=4) identified adopting user-centered design or multidisciplinary teams in their design approach. Only 3 papers described user and data privacy. End-user acceptability and engagement were the most frequently assessed implementation metrics. Only 1 app had available evidence assessing all 4 implementation metrics (ie, acceptability, engagement, usability, and adherence). Most apps were prototype versions (n=5), with few matured apps. A total of 6 apps had supporting papers that provided a quantitative evaluation of clinical outcomes, but only 1 app had a supporting, adequately powered randomized controlled trial. ConclusionsThis is the first systematic review to synthesize and examine evidence for the design engineering and clinical implementation and evaluation of mHealth apps for sleep disturbance. The minimal number of apps with published evidence for design engineering and clinical implementation and evaluation contrasts starkly with the number of commercial sleep apps available. Moreover, there appears to be no standardization and consistency in the use of best practice design approaches and implementation assessments, along with very few rigorous efficacy evaluations. To facilitate the development of successful and evidence-based apps for sleep disturbance, we developed a high-level framework to guide researchers and app developers in the end-to-end process of app development and evaluation.

BackgroundThe workplace represents a unique setting for mental health interventions. Due to range of job-related factors, employees in male-dominated industries are at an elevated risk. However, these at-risk groups are often overlooked. HeadGear is a smartphone app–based intervention designed to reduce depressive symptoms and increase well-being in these populations. ObjectiveThis paper presents the development and pilot testing of the app’s usability, acceptability, feasibility, and preliminary effectiveness. MethodsThe development process took place from January 2016 to August 2017. Participants for prototype testing (n=21; stage 1) were recruited from industry partner organizations to assess acceptability and utility. A 5-week effectiveness and feasibility pilot study (n=84; stage 2) was then undertaken, utilizing social media recruitment. Demographic data, acceptability and utility questionnaires, depression (Patient Health Questionnaire-9), and other mental health measures were collected. ResultsThe majority of respondents felt HeadGear was easy to use (92%), easily understood (92%), were satisfied with the app (67%), and would recommend it to a friend (75%; stage 1). Stage 2 found that compared with baseline, depression and anxiety symptoms were significantly lower at follow-up (t30=2.53; P=.02 and t30=2.18; P=.04, respectively), days of sick leave in past month (t28=2.38; P=.02), and higher self-reported job performance (t28=−2.09; P=.046; stage 2). Over 90% of respondents claimed it helped improve their mental fitness, and user feedback was again positive. Attrition was high across the stages. ConclusionsOverall, HeadGear was well received, and preliminary findings indicate it may provide an innovative new platform for improving mental health outcomes. Unfortunately, attrition was a significant issue, and findings should be interpreted with caution. The next stage of evaluation will be a randomized controlled trial. If found to be efficacious, the app has the potential to reduce disease burden and improve health in this at-risk group.

BackgroundThere 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. ObjectiveThe objective of this study was to determine which usage metrics, if any, are associated with outcome in an online depression treatment trial. MethodsCardiovascular 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. ResultsIn 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. ConclusionsOnly 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. Trial RegistrationAustralian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12610000085077; http://www.anzctr.org.au/ACTRN12610000085077.aspx (Archived by WebCite at http://www.webcitation.org/6K9FQtKBn).

BackgroundMany users of Internet interventions do not persist with the full treatment program. As persistence may influence outcomes of such interventions, being able to maximize persistence is vital. However, while studies have begun to explore the predictors of dropout in Internet interventions, few have explored reasons why users persist with the programs, which may not just be the converse of the reasons for dropout. ObjectiveTo answer the question of what influences persistence with online interventions. MethodsWe interviewed participants in the Cardiovascular Risk E-couch Depression Outcome (CREDO), a trial evaluating the efficacy of an eHealth intervention (e-couch) in treating depressive symptoms in those with comorbid depression and cardiovascular risk factors. Interviews were semistructured in nature and were analyzed using a grounded theory approach. Interview numbers were curtailed (n = 12) after theoretical saturation. ResultsAll participants reported substantial barriers to completing the program including time constraints, competing priorities, anxiety about spending time on the computer, and perception of limited worth of the intervention. Participants who persisted with the trial reported intrinsic motivations such as personal values about task completion and sense of control, and recognized external motivators that aided the development of habits and identified personal benefits attributable to the program. ConclusionsOnline interventions may benefit from content that enhances the intrinsic motivations such as a having sense of control and being able to identify with the program, and by increasing the relative value of the program in order to enhance persistence. Persistence within a trial setting appears modifiable through explicit messages regarding supporting others. In terms of motivators, the use of a hook to engage participants who are starting the intervention due to curiosity and the use of reminder systems to prompt participants may also improve persistence. The worth of such additions should be evaluated using adherence and outcomes metrics. Trial RegistrationAustralian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12610000085077; http://www.anzctr.org.au/ACTRN12610000085077.aspx (Archived by WebCite at http://www.webcitation.org/68MtyPO3w)

BackgroundAs the popularity of e-therapies grows, so too has the body of literature supporting their effectiveness. However, these interventions are often plagued by high attrition rates and varying levels of user adherence. Understanding the role of adherence may be crucial to understanding how program usage influences the effectiveness of e-therapy interventions. ObjectiveThe aim of this study was to systematically review the e-therapy literature to (1) describe the methods used to assess adherence and (2) evaluate the association of adherence with outcome of these interventions. MethodsA systematic review of e-therapy interventions was conducted across disease states and behavioral targets. Data were collected on adherence measures, outcomes, and analyses exploring the relationship between adherence measures and outcomes. ResultsOf 69 studies that reported an adherence measure, only 33 (48%) examined the relationship between adherence and outcomes. The number of logins was the most commonly reported measure of adherence, followed by the number of modules completed. The heterogeneity of adherence and outcome measures limited analysis. However, logins appeared to be the measure of adherence most consistently related to outcomes in physical health interventions, while module completion was found to be most related to outcomes in psychological health interventions. ConclusionsThere is large variation in the reporting of adherence and the association of adherence with outcomes. A lack of agreement about how best to measure adherence is likely to contribute to the variation in findings. Physical and psychological outcomes seem influenced by different types of adherence. A composite measure encompassing time online, activity completion, and active engagements with the intervention may be the best measure of adherence. Further research is required to establish a consensus for measuring adherence and to understand the role of adherence in influencing outcomes.

Autistic adults report concerns with social skills and unemployment. Despite anxiety and difficulty with executive cognitive skills being associated with autism, no studies to date have investigated relationships between anxiety or executive cognition with social and work functioning. This study aimed to investigate the associations between perceived social anxiety, perceived and objective executive function, and perceived social and work functioning in a sample of autistic people. A total of 62 participants completed self-report questionnaires of social anxiety (via the Liebowitz Social Anxiety Scale), mental health (via the Depression Anxiety Stress Scale), executive cognition (via the Behaviour Rating Inventory of Executive Function) and perceived social and work functioning (the Work and Social Adjustment Scale), and a smaller subset (n = 36-40) completed performance-based executive function tasks (Trail Making Task and Rapid Visual Processing Task). Participants who reported having more social anxiety and more difficulty with executive cognition also perceived themselves as having poorer social and work functioning. Performance-based executive function was not related to social or work functioning. Our results suggest that perceived social anxiety and executive cognition are both areas that have potential to be targeted to investigate whether they improve social and vocational outcomes for autistic people.

Background: There is scant research examining evidence-based processes and practices that delineate how to include the voices of children in service design and delivery in school age care environments such as Outside of School Hours Care (OSHC). A possible structure to support children to share leadership in design of their OSHC program and have a meaningful voice in decision-making is co-production, whereby children and their OSHC communities have the opportunity to co-plan, co-design, co-deliver, and co-evaluate OSHC program activities. The Connect Promote and Protect Program (CP3), a social connection and wellbeing program that provides a structured method of co-producing with children, educators, and their OSHC communities, is examined. Objectives: This study aimed to explore the response to a co-production approach in OSHC settings as part of participation in the CP3. Methods: Qualitative interviews and focus groups were conducted with 12 OSHC staff (educators, coordinators, managers, and volunteers) and 12 children attending OSHC as part of a wider mixed-methods implementation-effectiveness stepped-wedge trial of CP3 in 12 OSHC services located in urban and regional areas of New South Wales, Australia. Participants undertook semi-structured interviews/focus groups via multiple communication platforms (face-to-face, phone, and video-conferencing platforms). A representative research team (including researchers, OSHC educators/coordinators, OSHC administrators, clinicians, and parents of children in OSHC) used an inductive thematic analysis process. Two researchers undertook iterative coding using NVivo12 software, with themes developed and refined in ongoing team discussion. Results: The analysis identified nine sub-themes that related to child co-production and voice in CP3, which were organised into two super-ordinate themes: (1) processes that enable child agency and voice and (2) the impact of child agency and voice. Process related sub-themes included the following: co-production (ko-production) as a key driver ; high-quality programming practice in a demanding environment ; structure balanced with flexibility ; the importance of being agile and having a willingness to adjust ; and implementation factors supporting child voice. The impact related sub-themes included the following: empowerment of children through meaningful engagement ; we all have a role in the team (a space for growing leadership skills) ; a spark through engagement and enjoyment ; and being and belonging (the impact on children's social and emotional wellbeing). Conclusion: This is the first known qualitative study to examine the use and impact of co-production processes in OSHC—where children not only co-design but also co-plan, co-deliver, and co-evaluate the activity programming alongside OSHC educators and their communities. The findings indicate that the co-production process provides a structured, yet flexible, way of supporting children's voice and leadership even when delivered in diverse types of OSHC settings. [ABSTRACT FROM AUTHOR]

In this study, we consecutively recruited treatment-seeking young autistic adults without intellectual impairment aged 16-30 years who presented to a mental health service and evaluated general health (distress, quality of life, and disability), functioning (work loss days and social functioning), and mood symptoms (depression, anxiety, and stress) in those diagnosed with autism spectrum disorder (n = 96). This group was compared to young adults presenting to the same service with primary mental health disorders (depression, n = 343; bipolar, n = 132; psychosis, n = 166; and anxiety, n = 303). This study also investigated the influence of mood symptoms on general health and functioning in the autism spectrum disorder group. Young autistic adults reported significant general health and functioning impairments that were of similar degree to those presenting with primary mental health disorders. Interestingly, the autistic group also reported similarly high levels of mood symptoms to those with primary depressive and anxiety disorders. In the autistic group, depressive symptoms were strongly associated with distress, quality of life, and work loss days, while stress symptoms were strongly associated with disability. This study highlights further research, and mental health services are required specifically targeting young autistic adults to address their significant unmet needs.

Previously published analyses of suicide case investigations suggest that work or working conditions contribute to 10%–13% of suicide deaths. Yet, the way in which work may increase suicide risk is an underdeveloped area of epidemiologic research. In this Commentary, we propose a definition of work‐related suicide from an occupational health and safety perspective, and review the case investigation‐based and epidemiologic evidence on work‐related causes of suicide. We identified six broad categories of potential work‐related causes of suicide, which are: (1) workplace chemical, physical, and psychosocial exposures; (2) exposure to trauma on the job; (3) access to means of suicide through work; (4) exposure to high‐stigma work environments; (5) exposure to normative environments promoting extreme orientation to work; and (6) adverse experiences arising from work‐related injury or illness. We summarise current evidence in a schema of potential work‐related causes that can also be applied in workplace risk assessment and suicide case investigations. There are numerous implications of these findings for policy and practice. Various principle‐ and evidence‐based workplace intervention strategies for suicide prevention exist, some of which have been shown to improve suicide‐prevention literacy, reduce stigma, enhance helping behaviours, and in some instances maybe even reduce suicide rates. Prevailing practice in workplace suicide prevention, however, overly emphasises individual‐ and illness‐directed interventions, with little attention directed to addressing the working conditions that may increase suicide risk. We conclude that a stronger emphasis on improving working conditions will be required for workplace suicide prevention to reach its full preventive potential. [ABSTRACT FROM AUTHOR]

Background: Whilst both mental illness comorbidity and the delivery of emergency surgery are commonplace in Australia, there is little evidence investigating any link between them. As such, this study examines the emergency surgical outcomes for patients with mental illness compared to other surgical patients within the Australian public surgical system. Methods: Retrospective cohort study involving adult emergency and elective surgical patients treated at three public hospitals in Sydney, Australia between 2018 and 2019. Patients were identified using ICD‐10 diagnosis codes, and grouped by those with decompensated mental illness, chronic depression, or those without mental illness. Outcome measures included those within the emergency department (ED), along with in‐hospital mortality and surgical outcomes. Results: Of 48 338 total patients, 31 890 (66.0%) had elective and 16 448 (34.0%) had emergency surgery. For patients with decompensated mental illness, only 228 (0.7%) had elective whilst 425 (2.6%) had emergency surgery. Their outcomes for this surgery type included being triaged significantly higher (Cat 1 or 2, 34% vs. 15%) and longer ED stays (8.3 vs. 6.6 h). They also had significantly more post‐operative complications (26% vs. 8%) and total days in hospital (33.8 vs. 8.5 days). There was no significant difference for in‐hospital mortality. Conclusion: Patients with mental illness are significantly more likely to have emergency surgery including presenting to the ED with more acute physical illness and to experience worse surgical outcomes compared to other surgical patients for every measure analyzed except mortality. There is considerable opportunity to further investigate how these differences might be improved. [ABSTRACT FROM AUTHOR]

Objectives: The Australian government recently rescheduled psilocybin and 3,4-methylenedioxymethamphetamine for limited clinical uses. This change has raised various regulatory concerns and challenges for the field of psychedelic-assisted therapy. To provide clarity, we aimed to comprehensively catalogue the matters relating to psychedelic-assisted therapy that are or could be regulated. Methods: We conducted a desktop review of the literature and current regulatory sources, semi-structured interviews with professionals who had expertise in fields relating to psychedelic-assisted therapy and a framework analysis to generate a taxonomy of relevant regulatory matters. In relation to each matter, we further identified what type of regulation (if any) currently applies to that matter, any uncertainty as to how the matter should be addressed in clinical practice in the context of current regulation and whether there are conflicting views as to how the matter could or should be further regulated. Results: The taxonomy is structured into six main regulatory domains, three of which have a substantial proportion of matters with uncertainty or conflicting views: Service Establishment, Practitioner, and Treatment Delivery. Key examples of such matters include the location of services and facilities required, which professionals are eligible to become psychedelic therapists, and with what qualifications and experience. Matters in the remaining three domains, Patient Evaluation, Drug Supply and Service Oversight, appear by comparison relatively settled, with regulation either well-established or thought unnecessary. Conclusions: The taxonomy provides a roadmap for health services establishing and implementing a psychedelic-assisted therapy program, or for government and other policymakers when determining areas that may require further regulation. [ABSTRACT FROM AUTHOR]

One could argue that we are living through a period of innovation and change in psychiatry unlike that seen before, with repurposed medications emerging as novel treatments. However, despite evidence of enhanced clinical outcomes and potential medium-term savings, delivering these promising interventions is resource-intensive and perceived as difficult in the public sector. Consequently, they are generally only available in the private sector, often at great cost, effectively making them inaccessible to the 'Have Nots'. The arrival of these paradigm-shifting treatments has inadvertently highlighted a growing mental health inequity. The Royal Prince Alfred Hospital's Ketamine Treatment Clinic was the first public-sector ketamine treatment clinic for complex mood disorders in Australia. Based on 3 years' experience establishing, developing and running a public-sector ketamine treatment service, we review the progress, perils and pitfalls for clinicians and health services contemplating establishing a public-sector ketamine treatment service of their own. [ABSTRACT FROM AUTHOR]

Making decisions about disclosing mental health conditions in the workplace is complicated. A previous randomized controlled trial showed that web-based decision aid tool (READY?) helped employees make decisions and improved mental health. We aimed to evaluate the implementation of this tool and its outcomes when scaled up by a governmental health and safety agency. We used website analytics and event data of those using the decision aid tool, and self-report stage of decision-making, distress, engagement, and usability data from consenting users of READY? over the first year of it being made publicly available. Over the year 2021, 100 adults opted in to be involved in the research evaluation of the program. This study replicated the previous Randomised Controlled Trial (RCT) that showed at post-intervention; a later stage of decision-making (t 1,99 = 6.308, P <.001) with a large effect size (d = 0.87), and psychological distress was significantly reduced (t 1,99 = 3.088, P <.001) with a moderate effect size (d = 0.41). READY? facilitated disclosure with 36.3% deciding to disclose after use. Disclosure was associated with a greater reduction in mental ill-health symptoms than non-disclosure [ F (2,31) = 18.67, P <.001] with a moderate effect size (d = 0.64). Engagement, usage, and attrition rates were favourable when compared with other digital mental health approaches in community samples. This study shows that READY? is successfully implemented in a real-world sample. Aligning with the RCT results, for many, disclosure can be positive, research should continue to focus on developing organization-wide tools to create better supported and safe workplaces that promote disclosure. [ABSTRACT FROM AUTHOR]

Objective: Heterogeneous brief non-pharmacological interventions and guidelines exist to treat the burgeoning presentations to both emergency department and inpatient settings, for those in a crisis of mental ill-health. We systematically reviewed the literature to create a taxonomy of these brief non-pharmacological interventions, and review their evaluation methods and effectiveness. Method: We conducted a systematic review across Cochrane, CINAHL, DARE, Embase, MEDLINE, PsycINFO databases. Studies meeting quality criteria, using Joanna Briggs Institute tools, were eligible. Interventions were categorised, and outcomes synthesised. Results: Thirty-nine studies were included: 8 randomised controlled trials, 17 quasi-experimental, 11 qualitative studies, and 3 file audits. Taxonomy produced six coherent intervention types: Skills-focussed, Environment-focussed, Special Observation, Psychoeducation, Multicomponent Group and Multicomponent Individual. Despite this, a broad and inconsistent range of outcome measures reflected different outcome priorities and prevented systematic comparison of different types of intervention or meta-analysis. Few brief non-pharmacological interventions had consistent evidential support: sensory modulation rooms consistently improved distress in inpatient settings. Short admissions may reduce suicide attempts and readmission, if accompanied by psychotherapy. Suicide-specific interventions in emergency departments may improve depressive symptoms, but not suicide attempt rates. There was evidence that brief non-pharmacological interventions did not reduce incidence of self-harm on inpatient wards. We found no evidence for frequently used interventions such as no-suicide contracting, special observation or inpatient self-harm interventions. Conclusion: Categorising brief non-pharmacological interventions is feasible, but an evidence base for many is severely limited if not missing. Even when there is evidence, the inconsistency in outcomes often precludes clinicians from making inferences, although some interventions show promise. [ABSTRACT FROM AUTHOR]

In this paper, the case study of ketamine as a new treatment for severe depression is used to outline the challenges of repurposing established medicines and we suggest potential solutions. The antidepressant effects of generic racemic ketamine were identified over 20 years ago, but there were insufficient incentives for commercial entities to pursue its registration, or support for non-commercial entities to fill this gap. As a result, the evaluation of generic ketamine was delayed, piecemeal, uncoordinated, and insufficient to gain approval. Meanwhile, substantial commercial investment enabled the widespread registration of a patented, intranasal s-enantiomeric ketamine formulation (Spravato®) for depression. However, Spravato is priced at $600–$900/dose compared to ~$5/dose for generic ketamine, and the ~AUD$100 million annual government investment requested in Australia (to cover drug costs alone) has been rejected twice, leaving this treatment largely inaccessible for Australian patients 2 years after Therapeutic Goods Administration approval. Moreover, emerging evidence indicates that generic racemic ketamine is at least as effective as Spravato, but no comparative trials were required for regulatory approval and have not been conducted. Without action, this story will repeat regularly in the next decade with a new wave of psychedelic-assisted psychotherapy treatments, for which the original off-patent molecules could be available at low-cost and reduce the overall cost of treatment. Several systemic reforms are required to ensure that affordable, effective options become accessible; these include commercial incentives, public and public–private funding schemes, reduced regulatory barriers and more coordinated international public funding schemes to support translational research. [ABSTRACT FROM AUTHOR]

The prevalence of autism spectrum disorder (ASD) in adults is estimated to be at least 1% (Brugha et al., 2011), yet almost all ASD research focuses on children. Adult intervention studies, in particular, are few in number and poor in quality (Bishop-Fitzpatrick, Minshew, & Eack, 2013), and support networks for adults with ASD are much more limited and of a far lower standard than for children (Taylor & Seltzer, 2012). Around half of all adults are rated as having a poor or very poor outcome (Howlin & Moss, 2012), with social independence and integration remaining very limited, even when compared with other groups of individuals with disability (Roux et al., 2013). It is within this context that a 1-day meeting was convened at The University of Sydney to discuss the current state of research on adults with ASD and to identify priorities for future research. Participants were clinicians and/or researchers in the fields of ASD or intellectual disability, from a range of disciplines, including occupational therapy, social work psychology (cognitive, developmental, clinical, and social), child and adult psychiatry, psycholinguistics, disability research and policy, and providers of specialist services for children and adults with ASD. The article summarizes the principal issues raised, identifies gaps in current knowledge, and highlights potential research priorities.