The Cost-Effectiveness of a Novel Online Social Therapy to Maintain Treatment Effects From First-Episode Psychosis Services: Results From the Horyzons Randomized Controlled Trial.

BACKGROUND: Digital interventions have potential applications in promoting long-term recovery and improving outcomes in first-episode psychosis (FEP). This study aimed to evaluate the cost-effectiveness of Horyzons, a novel online social therapy to support young people aged 16-27 years following discharge from FEP services, compared with treatment as usual (TAU) from a healthcare sector and a societal perspective. STUDY DESIGN: A cost-effectiveness analysis (CEA), based on the change in social functioning, and a cost-utility analysis (CUA) using quality-adjusted life years were undertaken alongside a randomized controlled trial. Intervention costs were determined from study records; resources used by patients were collected from a resource-use questionnaire and administrative data. Mean costs and outcomes were compared at 18 months and incremental cost-effectiveness ratios were calculated. Uncertainty analysis using bootstrapping and sensitivity analyses was conducted. STUDY RESULTS: The sample included 170 participants: Horyzons intervention group (n = 86) and TAU (n = 84). Total costs were significantly lower in the Horyzons group compared with TAU from both the healthcare sector (-AU$4789.59; P < .001) and the societal perspective (-AU$5131.14; P < .001). In the CEA, Horyzons was dominant, meaning it was less costly and resulted in better social functioning. In the CUA, the Horyzons intervention resulted in fewer costs but also yielded fewer QALYs. However, group differences in outcomes were not statistically significant. When young people engaged more with the platform, costs were shown to decrease and outcomes improved. CONCLUSIONS: The Horyzons intervention offers a cost-effective approach for improving social functioning in young people with FEP after discharge from early intervention services.

Moderated Online Social Therapy for Carers of Early Psychosis Clients in Real-World Settings: Cluster Randomized Controlled Trial.

BACKGROUND: Family carers of youth recovering from early psychosis experience significant stress; however, access to effective family interventions is poor. Digital interventions provide a promising solution. OBJECTIVE: Our objective was to evaluate across multiple Australian early psychosis services the effectiveness of a novel, web-based early psychosis intervention for carers. METHODS: In this cluster randomized controlled trial conducted across multiple Australian early psychosis services, our digital moderated online social therapy for carers (Altitudes) plus enhanced family treatment as usual (TAU) was compared with TAU alone on the primary outcome of perceived stress and secondary outcomes including mental health symptoms and family variables at the 6-month follow-up. RESULTS: Eighty-six caregivers were randomized and data were available for 74 young people in their care. Our primary hypothesis that carers randomized to Altitudes+TAU would report greater improvements in perceived stress at follow-up compared with carers randomized to TAU alone was not supported, with the TAU alone group showing more improvement. For secondary outcomes, the TAU alone group showed improved mindfulness over time. Regardless of group assignment, we observed improvements in satisfaction with life, quality of life, emotional overinvolvement, and burden of care. In contrast, hair cortisol concentration increased. Post hoc analyses revealed more contact with early psychosis services in the intervention group compared to TAU alone and that improvements in perceived stress and social support were associated with use of the intervention in the Altitudes+TAU group. In this study, 80% (12/15) reported a positive experience with Altitudes and 93% (14/15) would recommend it to others. CONCLUSIONS: Our trial did not show a treatment effect for Altitudes in perceived stress. However, our post hoc analysis indicated that the amount of use of Altitudes related to improvements in stress and social support. Additional design work is indicated to continue users' engagement and to significantly improve outcomes in problem-solving, communication, and self-care. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12617000942358; https://trialsearch.who.int/Trial2.aspx?TrialID=ACTRN12617000942358.

Conceptualizing the digital therapeutic alliance in the context of fully automated mental health apps: A thematic analysis.

Fully automated mental health apps provide a promising opportunity for increasing access to mental health care and resources. Given this opportunity, continued research into the utility and effectiveness of mental health apps is crucial. Therapeutic alliance (TA) refers to the relationship between a client and a healthcare professional, and has been shown to be an important predictor of clinical outcomes in face-to-face therapy. Given the significance of TA in traditional therapy, it is important to explore whether the notion of a digital therapeutic alliance (DTA) in the context of fully automated mental health apps also plays an important role in clinical outcomes. Current evidence shows that the conceptualization of DTA in the context of fully automated mental health apps can be potentially different to TA in face-to-face therapy. Thus, a new DTA conceptual model is necessary for comprehensively understanding the mechanisms underpinning DTA for fully automated mental health apps. To the best of our knowledge, this is the first study that qualitatively explored the dimensions of a DTA in the context of fully automated mental health apps. We conducted interviews with 20 users of mental health apps to explore the key dimensions comprising DTA in the context of fully automated mental health apps. We found that although conceptualizations of DTA and TA have shared dimensions, flexibility and emotional experiences are unique domains in DTA. On the other hand, although agreement on goals between a therapist and a client is important in face to face therapy, we found that users can have an alliance with an app without a goal. The importance of goal needs further investigations.

A randomized controlled trial of moderated online social therapy for family carers of first-episode psychosis patients in a specialist treatment setting.

BACKGROUND: Family members, who provide the majority of informal care during the recovery period from first-episode psychosis (FEP), experience high levels of psychological distress. However, there is a lack of effective and accessible interventions for FEP carers. OBJECTIVE: To determine the effectiveness of an online intervention ("Altitudes") in relation to the primary outcome of FEP-carer stress at 6 months follow-up. METHODS: We conducted a cluster randomized controlled trial in which FEP carers were randomized to Altitudes combined with specialized treatment as usual (STAU) or STAU alone. In addition to questionnaires, we included multiple waves of intensive ecological momentary assessment (EMA) to measure carer stress and family outcomes in 164 carers of young (15-27 years) FEP patients. RESULTS: Both groups improved over time on stress and a range of secondary outcomes, including mental health symptoms, self-efficacy, and expressed emotion with no group by time interactions. At 12 months there were significantly fewer visits to emergency departments by FEP patients in the Altitudes group (p = 0.022). Modelling of multiple EMA waves revealed that more time spent by carers with FEP patients predicted greater worry, expressed emotion, and adaptive coping. CONCLUSIONS: Engagement and usability findings for Altitudes were positive. Further refinements to our online carer interventions may be needed to engage carers in purposeful skill development for improved management of stress and communication with the young person compared with existing specialist family interventions. TRIAL REGISTRATION: ACTRN12616000968471.

Tasks as needs: reframing the paradigm of clinical natural language processing research for real-world decision support.

Electronic medical records are increasingly used to store patient information in hospitals and other clinical settings. There has been a corresponding proliferation of clinical natural language processing (cNLP) systems aimed at using text data in these records to improve clinical decision-making, in comparison to manual clinician search and clinical judgment alone. However, these systems have delivered marginal practical utility and are rarely deployed into healthcare settings, leading to proposals for technical and structural improvements. In this paper, we argue that this reflects a violation of Friedman's "Fundamental Theorem of Biomedical Informatics," and that a deeper epistemological change must occur in the cNLP field, as a parallel step alongside any technical or structural improvements. We propose that researchers shift away from designing cNLP systems independent of clinical needs, in which cNLP tasks are ends in themselves-"tasks as decisions"-and toward systems that are directly guided by the needs of clinicians in realistic decision-making contexts-"tasks as needs." A case study example illustrates the potential benefits of developing cNLP systems that are designed to more directly support clinical needs.

Digital Therapeutic Alliance With Fully Automated Mental Health Smartphone Apps: A Narrative Review.

Fully automated mental health smartphone apps show strong promise in increasing access to psychological support. Therefore, it is crucial to understand how to make these apps effective. The therapeutic alliance (TA), or the relationship between healthcare professionals and clients, is considered fundamental to successful treatment outcomes in face-to-face therapy. Thus, understanding the TA in the context of fully automated apps would bring us insights into building effective smartphone apps which engage users. However, the concept of a digital therapeutic alliance (DTA) in the context of fully automated mental health smartphone apps is nascent and under-researched, and only a handful of studies have been published in this area. In particular, no published review paper examined the DTA in the context of fully automated apps. The objective of this review was to integrate the extant literature to identify research gaps and future directions in the investigation of DTA in relation to fully automated mental health smartphone apps. Our findings suggest that the DTA in relation to fully automated smartphone apps needs to be conceptualized differently to traditional face-to-face TA. First, the role of bond in the context of fully automated apps is unclear. Second, human components of face-to-face TA, such as empathy, are hard to achieve in the digital context. Third, some users may perceive apps as more non-judgmental and flexible, which may further influence DTA formation. Subdisciplines of computer science, such as affective computing and positive computing, and some human-computer interaction (HCI) theories, such as those of persuasive technology and human-app attachment, can potentially help to foster a sense of empathy, build tasks and goals and develop bond or an attachment between users and apps, which may further contribute to DTA formation in fully automated smartphone apps. Whilst the review produced a relatively limited quantity of literature, this reflects the novelty of the topic and the need for further research.

Digital smartphone intervention to recognise and manage early warning signs in schizophrenia to prevent relapse: the EMPOWER feasibility cluster RCT.

BACKGROUND: Relapse is a major determinant of outcome for people with a diagnosis of schizophrenia. Early warning signs frequently precede relapse. A recent Cochrane Review found low-quality evidence to suggest a positive effect of early warning signs interventions on hospitalisation and relapse. OBJECTIVE: How feasible is a study to investigate the clinical effectiveness and cost-effectiveness of a digital intervention to recognise and promptly manage early warning signs of relapse in schizophrenia with the aim of preventing relapse? DESIGN: A multicentre, two-arm, parallel-group cluster randomised controlled trial involving eight community mental health services, with 12-month follow-up. SETTINGS: Glasgow, UK, and Melbourne, Australia. PARTICIPANTS: Service users were aged > 16 years and had a schizophrenia spectrum disorder with evidence of a relapse within the previous 2 years. Carers were eligible for inclusion if they were nominated by an eligible service user. INTERVENTIONS: The Early signs Monitoring to Prevent relapse in psychosis and prOmote Wellbeing, Engagement, and Recovery (EMPOWER) intervention was designed to enable participants to monitor changes in their well-being daily using a mobile phone, blended with peer support. Clinical triage of changes in well-being that were suggestive of early signs of relapse was enabled through an algorithm that triggered a check-in prompt that informed a relapse prevention pathway, if warranted. MAIN OUTCOME MEASURES: The main outcomes were feasibility of the trial and feasibility, acceptability and usability of the intervention, as well as safety and performance. Candidate co-primary outcomes were relapse and fear of relapse. RESULTS: We recruited 86 service users, of whom 73 were randomised (42 to EMPOWER and 31 to treatment as usual). Primary outcome data were collected for 84% of participants at 12 months. Feasibility data for people using the smartphone application (app) suggested that the app was easy to use and had a positive impact on motivations and intentions in relation to mental health. Actual app usage was high, with 91% of users who completed the baseline period meeting our a priori criterion of acceptable engagement (> 33%). The median time to discontinuation of > 33% app usage was 32 weeks (95% confidence interval 14 weeks to ∞). There were 8 out of 33 (24%) relapses in the EMPOWER arm and 13 out of 28 (46%) in the treatment-as-usual arm. Fewer participants in the EMPOWER arm had a relapse (relative risk 0.50, 95% confidence interval 0.26 to 0.98), and time to first relapse (hazard ratio 0.32, 95% confidence interval 0.14 to 0.74) was longer in the EMPOWER arm than in the treatment-as-usual group. At 12 months, EMPOWER participants were less fearful of having a relapse than those in the treatment-as-usual arm (mean difference -4.29, 95% confidence interval -7.29 to -1.28). EMPOWER was more costly and more effective, resulting in an incremental cost-effectiveness ratio of £3041. This incremental cost-effectiveness ratio would be considered cost-effective when using the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year gained. LIMITATIONS: This was a feasibility study and the outcomes detected cannot be taken as evidence of efficacy or effectiveness. CONCLUSIONS: A trial of digital technology to monitor early warning signs that blended with peer support and clinical triage to detect and prevent relapse is feasible. FUTURE WORK: A main trial with a sample size of 500 (assuming 90% power and 20% dropout) would detect a clinically meaningful reduction in relapse (relative risk 0.7) and improvement in other variables (effect sizes 0.3-0.4). TRIAL REGISTRATION: This trial is registered as ISRCTN99559262. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 27. See the NIHR Journals Library website for further project information. Funding in Australia was provided by the National Health and Medical Research Council (APP1095879).

WHAT WAS THE PROBLEM?: Relapse is a considerable problem for people with a diagnosis of schizophrenia. Relapse can be predicted by early warning signs that are unique to the person. They include withdrawal, fear and paranoia. WHAT WAS THE QUESTION?: Is it possible to investigate the effectiveness of an intervention to recognise and promptly manage early warning signs of relapse in schizophrenia with the aim of preventing relapse? WHAT DID WE DO?: We spoke with 88 mental health staff, 40 carers and 21 service users before we designed a system that used a mobile phone to help people monitor early warning signs. We included peer support to help people using the system reflect on their experiences. We hoped the overall system, called EMPOWER, would help people to be more in charge of their mental health. After consenting 86 people to the study, we were able to randomly assign 73 people either to use the EMPOWER system (42 people) or to receive their normal treatment alone (31 people). We used research measures over 1 year to help us better understand people's experiences. We also involved carers (for example family or friends) and mental health service providers in the research. WHAT DID WE FIND?: We found that it was possible to recruit people to the study and to gather research data. We also found that people used the EMPOWER system and found it acceptable. We found that those who used EMPOWER had a lower rate of relapse over 12 months than people who did not. They were also less likely to be fearful of relapse. We found that EMPOWER was likely to be cost-effective. WHAT DOES THIS MEAN?: This means that a study to investigate the effectiveness of a system to recognise and respond to early warning signs of relapse in schizophrenia is possible.

The EMPOWER blended digital intervention for relapse prevention in schizophrenia: a feasibility cluster randomised controlled trial in Scotland and Australia.

BACKGROUND: Early warning signs monitoring by service users with schizophrenia has shown promise in preventing relapse but the quality of evidence is low. We aimed to establish the feasibility of undertaking a definitive randomised controlled trial to determine the effectiveness of a blended digital intervention for relapse prevention in schizophrenia. METHODS: This multicentre, feasibility, cluster randomised controlled trial aimed to compare Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) with treatment as usual in community mental health services (CMHS) in Glasgow and Melbourne. CMHS were the unit of randomisation, selected on the basis of those that probably had five or more care coordinators willing to participate. Participants were eligible if they were older than 16 years, had a schizophrenia or related diagnosis confirmed via case records, were able to provide informed consent, had contact with CMHS, and had had a relapse within the previous 2 years. Participants were randomised within stratified clusters to EMPOWER or to continue their usual approach to care. EMPOWER blended a smartphone for active monitoring of early warning signs with peer support to promote self-management and clinical triage to promote access to relapse prevention. Main outcomes were feasibility, acceptability, usability, and safety, which was assessed through face-to-face interviews. App usage was assessed via the smartphone and self-report. Primary end point was 12 months. Participants, research assistants and other team members involved in delivering the intervention were not masked to treatment conditions. Assessment of relapse was done by an independent adjudication panel masked to randomisation group. The study is registered at ISRCTN (99559262). FINDINGS: We identified and randomised eight CMHS (six in Glasgow and two in Melbourne) comprising 47 care coordinators. We recruited 86 service users between Jan 19 and Aug 8, 2018; 73 were randomised (42 [58%] to EMPOWER and 31 [42%] to treatment as usual). There were 37 (51%) men and 36 (49%) women. At 12 months, main outcomes were collected for 32 (76%) of service users in the EMPOWER group and 30 (97%) of service users in the treatment as usual group. Of those randomised to EMPOWER, 30 (71%) met our a priori criterion of more than 33% adherence to daily monitoring that assumed feasibility. Median time to discontinuation of these participants was 31·5 weeks (SD 14·5). There were 29 adverse events in the EMPOWER group and 25 adverse events in the treatment as usual group. There were 13 app-related adverse events, affecting 11 people, one of which was serious. Fear of relapse was lower in the EMPOWER group than in the treatment as usual group at 12 months (mean difference -7·53 (95% CI -14·45 to 0·60; Cohen's d -0·53). INTERPRETATION: A trial of digital technology to monitor early warning signs blended with peer support and clinical triage to detect and prevent relapse appears to be feasible, safe, and acceptable. A further main trial is merited. FUNDING: UK National Institute for Health Research Health Technology Assessment programme and the Australian National Health and Medical Research Council.

Recommender systems for mental health apps: advantages and ethical challenges.

Recommender systems assist users in receiving preferred or relevant services and information. Using such technology could be instrumental in addressing the lack of relevance digital mental health apps have to the user, a leading cause of low engagement. However, the use of recommender systems for digital mental health apps, particularly those driven by personal data and artificial intelligence, presents a range of ethical considerations. This paper focuses on considerations particular to the juncture of recommender systems and digital mental health technologies. While separate bodies of work have focused on these two areas, to our knowledge, the intersection presented in this paper has not yet been examined. This paper identifies and discusses a set of advantages and ethical concerns related to incorporating recommender systems into the digital mental health (DMH) ecosystem. Advantages of incorporating recommender systems into DMH apps are identified as (1) a reduction in choice overload, (2) improvement to the digital therapeutic alliance, and (3) increased access to personal data & self-management. Ethical challenges identified are (1) lack of explainability, (2) complexities pertaining to the privacy/personalization trade-off and recommendation quality, and (3) the control of app usage history data. These novel considerations will provide a greater understanding of how DMH apps can effectively and ethically implement recommender systems.

The Digital Therapeutic Alliance: Prospects and Considerations.

The growing prevalence of digital approaches to mental health care raises a range of questions and considerations. A notion that has recently emerged is that of the digital therapeutic alliance, prompting consideration of whether and how the concept of therapeutic alliance, which has proven to be a central ingredient of successful traditional psychotherapy, could translate to mental health care via digital technologies. This special issue editorial article outlines the topic of digital therapeutic alliance and introduces the five articles that comprise the special issue.

The Horyzons project: a randomized controlled trial of a novel online social therapy to maintain treatment effects from specialist first-episode psychosis services.

This study aimed to determine whether, following two years of specialized support for first-episode psychosis, the addition of a new digital intervention (Horyzons) to treatment as usual (TAU) for 18 months was more effective than 18 months of TAU alone. We conducted a single-blind randomized controlled trial. Participants were people with first-episode psychosis (N=170), aged 16-27 years, in clinical remission and nearing discharge from a specialized service. They were randomly assigned (1:1) to receive Horyzons plus TAU (N=86) or TAU alone (N=84) between October 2013 and January 2017. Horyzons is a novel, comprehensive digital platform merging: peer-to-peer social networking; theory-driven and evidence-informed therapeutic interventions targeting social functioning, vocational recovery and relapse prevention; expert clinician and vocational support; and peer support and moderation. TAU involved transfer to primary or tertiary community mental health services. The primary outcome was social functioning at 18 months as measured by the Personal and Social Performance Scale (PSP). Forty-seven participants (55.5%) in the Horyzons plus TAU group logged on for at least 6 months, and 40 (47.0%) for at least 9 months. Social functioning remained high and stable in both groups from baseline to 18-month follow-up, with no evidence of significant between-group differences (PSP mean difference: -0.29, 95% CI: -4.20 to 3.63, p=0.77). Participants in the Horyzons group had a 5.5 times greater increase in their odds to find employment or enroll in education compared with those in TAU (odds ratio, OR=5.55, 95% CI: 1.09-28.23, p=0.04), with evidence of a dose-response effect. Moreover, participants in TAU were twice as likely to visit emergency services compared to those in the Horyzons group (39% vs. 19%; OR=0.31, 95% CI: 0.11-0.86, p=0.03, number needed to treat, NNT=5). There was a non-significant trend for lower hospitalizations due to psychosis in the Horyzons group vs. TAU (13% vs. 27%; OR=0.36, 95% CI: 0.11-1.08, p=0.07, NNT=7). So, although we did not find a significant effect of Horyzons on social functioning compared with TAU, the intervention was effective in improving vocational or educational attainment, a core component of social recovery, and in reducing usage of hospital emergency services, a key aim of specialized first-episode psychosis services. Horyzons holds significant promise as an engaging and sustainable intervention to provide effective vocational and relapse prevention support for young people with first-episode psychosis beyond specialist services.

A pilot trial of moderated online social therapy for family and friends of young people with borderline personality disorder features.

AIM: We evaluated the acceptability, usability and safety of Kindred, a novel online intervention for carers of young people with borderline personality disorder (BPD) using a pre-post pilot trial design. The secondary aim explored whether Kindred use was associated with clinical improvements for caregivers on measures of burden of caregiving, stress, expressed emotion, family communication, disability, coping and knowledge of BPD and for patients on measures of severity of BPD symptoms and level of functional impairment. METHODS: The trial site was the Helping Young People Early program for young people with BPD at Orygen in Melbourne, Australia. Informed consent was obtained from 20 adult carers (i.e., relatives or friends) and 10 young people aged 15-25 with BPD. Kindred, which was available for 3 months, incorporated online psychoeducation, carer-to-carer social networking and guidance from expert and peer moderators. Assessments were completed at baseline and 3 months follow-up. Multiple indicators of acceptability, usability and safety were utilized. RESULTS: Seventeen carers were enrolled in Kindred and eight young people completed baseline measures. A priori acceptability, usability and safety criteria were met. Carer burden, stress, expressed emotion, family communication, quality of life, functioning, coping and perceived knowledge of BPD improved at follow-up. Sixty-six percent of the young people (4/6) reported that they believed Kindred had improved their carers' understanding of BPD. CONCLUSION: Kindred was shown to be acceptable, usable and safe, with encouraging improvements in both carer and young person outcomes. Kindred warrants evaluation of its efficacy via an randomized controlled trial.

The Digital Therapeutic Alliance and Human-Computer Interaction.

The therapeutic alliance (TA), the relationship that develops between a therapist and a client/patient, is a critical factor in the outcome of psychological therapy. As mental health care is increasingly adopting digital technologies and offering therapeutic interventions that may not involve human therapists, the notion of a TA in digital mental health care requires exploration. To date, there has been some incipient work on developing measures to assess the conceptualization of a digital TA for mental health apps. However, the few measures that have been proposed have more or less been derivatives of measures from psychology used to assess the TA in traditional face-to-face therapy. This conceptual paper explores one such instrument that has been proposed in the literature, the Mobile Agnew Relationship Measure, and examines it through a human-computer interaction (HCI) lens. Through this process, we show how theories from HCI can play a role in shaping or generating a more suitable, purpose-built measure of the digital therapeutic alliance (DTA), and we contribute suggestions on how HCI methods and knowledge can be used to foster the DTA in mental health apps.

Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-Being, Engagement, and Recovery: Protocol for a Feasibility Cluster Randomized Controlled Trial Harnessing Mobile Phone Technology Blended With Peer Support.

BACKGROUND: Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. OBJECTIVE: This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. METHODS: We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants' own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. RESULTS: Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. CONCLUSIONS: The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15058.

Quantifying Use of a Health Virtual Community of Practice for General Practitioners' Continuing Professional Development: A Novel Methodology and Pilot Evaluation.

BACKGROUND: Health care practitioners (HPs), in particular general practitioners (GPs), are increasingly adopting Web-based social media platforms for continuing professional development (CPD). As GPs are restricted by time, distance, and demanding workloads, a health virtual community of practice (HVCoP) is an ideal solution to replace face-to-face CPD with Web-based CPD. However, barriers such as time and work schedules may limit participation in an HVCoP. Furthermore, it is difficult to gauge whether GPs engage actively or passively in HVCoP knowledge-acquisition for Web-based CPD, as GPs' competencies are usually measured with pre- and posttests. OBJECTIVE: This study investigated a method for measuring the engagement features needed for an HVCoP (the Community Fracture Capture [CFC] Learning Hub) for learning and knowledge sharing among GPs for their CPD activity. METHODS: A prototype CFC Learning Hub was developed using an Igloo Web-based social media software platform and involved a convenience sample of GPs interested in bone health topics. This Hub, a secure Web-based community site, included 2 key components: an online discussion forum and a knowledge repository (the Knowledge Hub). The discussion forum contained anonymized case studies (contributed by GP participants) and topical discussions (topics that were not case studies). Using 2 complementary tools (Google Analytics and Igloo Statistical Tool), we characterized individual participating GPs' engagement with the Hub. We measured the GP participants' behavior by quantifying the number of online sessions of the participants, activities undertaken within these online sessions, written posts made per learning topic, and their time spent per topic. We calculated time spent in both active and passive engagement for each topic. RESULTS: Seven GPs participated in the CFC Learning Hub HVCoP from September to November 2017. The complementary tools successfully captured the GP participants' engagement in the Hub. GPs were more active in topics in the discussion forum that had direct clinical application as opposed to didactic, evidence-based discussion topics (ie, topical discussions). From our knowledge hub, About Osteoporosis and Prevention were the most engaging topics, whereas shared decision making was the least active topic. CONCLUSIONS: We showcased a novel complementary analysis method that allowed us to quantify the CFC Learning Hub's usage data into (1) sessions, (2) activities, (3) active or passive time spent, and (4) posts made to evaluate the potential engagement features needed for an HVCoP focused on GP participants' CPD process. Our design and evaluation methods for ongoing use and engagement in this Hub may be useful to evaluate future learning and knowledge-sharing projects for GPs and may allow for extension to other HPs' environments. However, owing to the limited number of GP participants in this study, we suggest that further research with a larger cohort should be performed to validate and extend these findings.

The Impact of Information Systems Use on Work Tasks and Work Practices in an Emergency Department.

This paper describes the plan for the third stage of a longitudinal assessment of the progressive implementation of IS in an emergency department. The assessment adopts a case study approach with nested mixed methods where quantitative data will be collected through observations and qualitative data will be collected through focus group interviews. The findings from the study can inform the design of IS that is well aligned with the intended strategic outcomes of IS implementation in emergency medicine.

HORYZONS trial: protocol for a randomised controlled trial of a moderated online social therapy to maintain treatment effects from first-episode psychosis services.

INTRODUCTION: Specialised early intervention services have demonstrated improved outcomes in first-episode psychosis (FEP); however, clinical gains may not be sustained after patients are transferred to regular care. Moreover, many patients with FEP remain socially isolated with poor functional outcomes. To address this, our multidisciplinary team has developed a moderated online social media therapy (HORYZONS) designed to enhance social functioning and maintain clinical gains from specialist FEP services. HORYZONS merges: (1) peer-to-peer social networking; (2) tailored therapeutic interventions; (3) expert and peer-moderation; and (4) new models of psychological therapy (strengths and mindfulness-based interventions) targeting social functioning. The aim of this trial is to determine whether following 2 years of specialised support and 18-month online social media-based intervention (HORYZONS) is superior to 18 months of regular care. METHODS AND ANALYSIS: This study is a single-blind randomised controlled trial. The treatment conditions include HORYZONS plus treatment as usual (TAU) or TAU alone. We recruited 170 young people with FEP, aged 16-27 years, in clinical remission and nearing discharge from Early Psychosis Prevention and Intervention Centre, Melbourne. The study includes four assessment time points, namely, baseline, 6-month, 12-month and 18-month follow-up. The study is due for completion in July 2018 and included a 40-month recruitment period and an 18-month treatment phase. The primary outcome is social functioning at 18 months. Secondary outcome measures include rate of hospital admissions, cost-effectiveness, vocational status, depression, social support, loneliness, self-esteem, self-efficacy, anxiety, psychological well-being, satisfaction with life, quality of life, positive and negative psychotic symptoms and substance use. Social functioning will be also assessed in real time through our Smartphone Ecological Momentary Assessment tool. ETHICS AND DISSEMINATION: Melbourne Health Human Research Ethics Committee (2013.146) provided ethics approval for this study. Findings will be made available through scientific journals and forums and to the public via social media and the Orygen website. TRIAL REGISTRATION NUMBER: ACTRN12614000009617; Pre-results.

Implementation of the Enhanced Moderated Online Social Therapy (MOST+) Model Within a National Youth E-Mental Health Service (eheadspace): Protocol for a Single Group Pilot Study for Help-Seeking Young People.

BACKGROUND: There is a substantial need for youth electronic mental health (e-mental health) services. In addressing this need, our team has developed a novel moderated online social therapy intervention called enhanced moderated online social therapy (MOST+). MOST+ integrates real-time, clinician-delivered Web chat counseling, interactive user-directed online therapy, expert and peer moderation, and private and secure peer-to-peer social networking. MOST+ has been designed to give young people immediate, 24-hour access to anonymous, evidence-based, and short-term mental health care. OBJECTIVE: The primary aims of this pilot study were to determine the feasibility, acceptability, and safety of the intervention. Secondary aims were to assess prepost changes in key psychosocial outcomes and collect qualitative data for future intervention refinement. METHODS: MOST+ will be embedded within eheadspace, an Australian youth e-mental health service, and will be evaluated via an uncontrolled single-group study. Approximately 250 help-seeking young people (16-25 years) will be progressively recruited to the intervention from the eheadspace home page over the first 4 weeks of an 8-week intervention period. All participants will have access to evidence-based therapeutic content and integrated Web chat counseling. Additional access to moderated peer-to-peer social networking will be granted to individuals for whom it is deemed safe and appropriate, through a three-tiered screening process. Participants will be enrolled in the MOST+ intervention for 1 week, with the option to renew their enrollment across the duration of the pilot. Participants will complete a survey at enrollment to assess psychological well-being and other mental health outcomes. Additional assessment will occur following account deactivation (ie, after participant has opted not to renew their enrollment, or at trial conclusion) and will include an online survey and telephone interview assessing psychological well-being and experience of using MOST+. RESULTS: Recruitment for the study commenced in October 2017. We expect to have initial results in March 2018, with more detailed qualitative and quantitative analyses to follow. CONCLUSIONS: This is the first Australia-wide research trial to pilot an online social media platform merging real-time clinical support, expert and peer moderation, interactive online therapy, and peer-to-peer social networking. The importance of the project stems from the need to develop innovative new models for the efficient delivery of responsive evidence-based online support to help-seeking young people. If successful, this research stands to complement and enhance e-mental health services in Australia.

Moderated online social therapy for depression relapse prevention in young people: pilot study of a 'next generation' online intervention.

AIM: Implementation of targeted e-mental health interventions offers a promising solution to reducing the burden of disease associated with youth depression. A single-group pilot study was conducted to evaluate the acceptability, feasibility, usability and safety of a novel, moderated online social therapy intervention (entitled Rebound) for depression relapse prevention in young people. METHODS: Participants were 42 young people (15-25 years) (50% men; mean age = 18.5 years) in partial or full remission. Participants had access to the Rebound platform for at least 12 weeks, including the social networking, peer and clinical moderator and therapy components. RESULTS: Follow-up data were available for 39 (92.9%) participants. There was high system usage, with 3034 user logins (mean = 72.2 per user) and 2146 posts (mean = 51.1). Almost 70% of users had ≥10 logins over the 12 weeks, with 78.5% logging in over at least 2 months of the pilot. A total of 32 (84%) participants rated the intervention as helpful. There was significant improvement between the number of participants in full remission at baseline (n = 5; none of whom relapsed) relative to n = 19 at 12-week follow-up (P < 0.001). Six (14.3%) participants relapsed to full threshold symptoms at 12 weeks. There was a significant improvement to interviewer-rated depression scores (Montgomery-Asberg Depression Rating Scale (MADRS); P = 0.014, d = 0.45) and a trend for improved strength use (P = 0.088, d = 0.29). The single-group design and 12-week treatment phase preclude a full understanding of the clinical benefits of the Rebound intervention. CONCLUSIONS: The Rebound intervention was shown to be acceptable, feasible, highly usable and safe in young people with major depression.

Enhancing General Practitioners Participation in a Virtual Community of Practice for Continuing Medical Education: An Exploratory Study.

As sources of medical information grow online, Virtual Communities of Practice (VCoPs) have evolved into a potential tool that allows General Practitioners (GPs) to interact through the sharing of their experience and knowledge. However, literature reports that GPs are reluctant to participate in VCoPs especially for their continuing medical education (CME). Currently, no study has explored the design and structural aspects of VCoPs that may lead to enhancing GPs' participation in such online communities. Hence, this paper explores how GPs envisage the use of a VCoP for their CME and how to enhance their participation by conducting an exploratory qualitative study of two focus groups with 10 GPs in each group, accompanied by a specialist and a nurse. Our empirical findings identified two key contributions: i) seven themes that need to be incorporated in the VCoP to enable and support GP's CME through the use of a VCoP; ii) three recommendations to take into consideration for researchers when evaluating VCoPs for CME.