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BackgroundRecruitment processes for clinical trials of digital interventions for psychosis are seldom described in detail in the literature. Although trial staff have expertise in describing barriers to and facilitators of recruitment, a specific focus on understanding recruitment from the point of view of trial staff is rare, and because trial staff are responsible for meeting recruitment targets, a lack of research on their point of view is a key limitation. ObjectiveThe primary aim of this study was to understand recruitment from the point of view of trial staff and discover what they consider important. MethodsWe applied pluralistic ethnographic methods, including analysis of trial documents, observation, and focus groups, and explored the recruitment processes of the EMPOWER (Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-being, Engagement, and Recovery) feasibility trial, which is a digital app–based intervention for people diagnosed with schizophrenia. ResultsRecruitment barriers were categorized into 2 main themes: service characteristics (lack of time available for mental health staff to support recruitment, staff turnover, patient turnover [within Australia only], management styles of community mental health teams, and physical environment) and clinician expectations (filtering effects and resistance to research participation). Trial staff negotiated these barriers through strategies such as emotional labor (trial staff managing feelings and expressions to successfully recruit participants) and trying to build relationships with clinical staff working within community mental health teams. ConclusionsResearchers in clinical trials for digital psychosis interventions face numerous recruitment barriers and do their best to work flexibly and to negotiate these barriers and meet recruitment targets. The recruitment process appeared to be enhanced by trial staff supporting each other throughout the recruitment stage of the trial.

BackgroundDeveloping a digital health innovation can require a substantial amount of financial and human resource investment before it can be scaled for implementation across geographical, cultural, and health care contexts. As such, there is an increased interest in leveraging eHealth innovations developed and tested in one country or jurisdiction and using these innovations in local settings. However, limited knowledge exists on the processes needed to appropriately adapt digital health innovations to optimize their transferability across geographical, cultural, and contextual settings. ObjectiveWe report on the results of an adaptation study of Horyzons, a digital health innovation originally developed and tested in Australia. Horyzons is designed to prevent relapses and support recovery in young people receiving services for first-episode psychosis (FEP). The aim of this study is to assess the initial acceptability of Horyzons and adapt it in preparation for pilot testing in Canada. MethodsThis research took place in 2 specialized early intervention clinics for FEP, located in 1 urban and 1 urban-rural setting, in 2 Canadian provinces. A total of 26 participants were recruited: 15 clinicians (age range 26-56 years) and 11 patients (age range 19-37 years). Following the digital health adaptation framework developed by our team, we used a mixed methods approach, combining descriptive quantitative and qualitative methods across 3 stages of data collection (focus groups, interviews, and consultations), analysis, and adaptations. ResultsOverall, patients and clinicians appreciated the strengths-based approach and social media features of Horyzons. However, participants expressed concerns related to implementation, especially in relation to capacity (eg, site moderation, crisis management, internet speed in rural locations). They also provided suggestions for adapting content and features, for example, in relation to community resources, volume of text, universal accessibility (eg, for individuals with limitations in vision), and optimization of platform accessibility through mobile devices. Additional aspects of the innovation were flagged for adaptation during the final stages of preparing it for live implementation. These included terms of use, time zone configuration to reflect local time and date, safety and moderation protocols, the need help now feature, and the list of trigger words to flag posts indicative of potential risk. ConclusionsIn the context of the COVID-19 pandemic and public health guidelines for social distancing, there is an increasing interest and need to leverage the internet and mobile technologies for delivering youth mental health services. As countries look to one another for guidance on how to navigate changing social dynamics, knowledge on how to utilize and adapt existing innovations across contexts is now more important than ever. Using a systematic approach, this study illustrates the methods, processes, results, and lessons learned on adapting a digital health innovation to enhance its local acceptability. International Registered Report Identifier (IRRID)RR2-10.2196/resprot.8810

BackgroundMental ill-health is the leading cause of disability worldwide. Moreover, 75% of mental health conditions emerge between the ages of 12 and 25 years. Unfortunately, due to lack of resources and limited engagement with services, a majority of young people affected by mental ill-health do not access evidence-based support. To address this gap, our team has developed a multimodal, scalable digital mental health service (Enhanced Moderated Online Social Therapy [MOST+]) merging real-time, clinician-delivered web chat counseling; interactive user-directed online therapy; expert and peer moderation; and peer-to-peer social networking. ObjectiveThe primary aim of this study is to ascertain the feasibility, acceptability, and safety of MOST+. The secondary aims are to assess pre-post changes in clinical, psychosocial, and well-being outcomes and to explore the correlations between system use, perceived helpfulness, and secondary outcome variables. MethodsOverall, 157 young people seeking help from a national youth e-mental health service were recruited over 5 weeks. MOST+ was active for 9 weeks. All participants had access to interactive online therapy and integrated web chat counseling. Additional access to peer-to-peer social networking was granted to 73 participants (46.5%) for whom it was deemed safe. The intervention was evaluated via an uncontrolled single-group study. ResultsOverall, 93 participants completed the follow-up assessment. Most participants had moderate (52/157, 33%) to severe (96/157, 61%) mental health conditions. All a priori feasibility, acceptability, and safety criteria were met. Participants provided mean scores of ≥3.5 (out of 5) on ease of use (mean 3.7, SD 1.1), relevancy (mean 3.9, SD 1.0), helpfulness (mean 3.5, SD 0.9), and overall experience (mean 3.9, SD 0.8). Moreover, 98% (91/93) of participants reported a positive experience using MOST+, 82% (70/93) reported that using MOST+ helped them feel better, 86% (76/93) felt more socially connected using it, and 92% (86/93) said they would recommend it to others. No serious adverse events or inappropriate use were detected, and 97% (90/93) of participants reported feeling safe. There were statistically significant improvements in 8 of the 11 secondary outcomes assessed: psychological distress (d=−0.39; P

BackgroundA small number of studies have found that digital mental health interventions can be feasible and acceptable for young people experiencing first-episode psychosis; however, little research has examined how they might be blended with face-to-face approaches in order to enhance care. Blended treatment refers to the integration of digital and face-to-face mental health care. It has the potential to capitalize on the evidence-based features of both individual modalities, while also exceeding the sum of its parts. This integration could bridge the online–offline treatment divide and better reflect the interconnected, and often complementary, ways young people navigate their everyday digital and physical lives. ObjectiveThis study aimed to gain young people’s perspectives on the design and implementation of a blended model of care in first-episode psychosis treatment. MethodsThis qualitative study was underpinned by an end-user development framework and was based on semistructured interviews with 10 participants aged 19 to 28 (mean 23.4, SD 2.62). A thematic analysis was used to analyze the data. ResultsThree superordinate themes emerged relating to young people’s perspectives on the design and implementation of a blended model of care in first-episode psychosis treatment: (1) blended features, (2) cautions, and (3) therapeutic alliance. ConclusionsWe found that young people were very enthusiastic about the prospect of blended models of mental health care, in so far as it was used to enhance their experience of traditional face-to-face treatment but not to replace it overall. Aspects of blended treatment that could enhance clinical care were readily identified by young people as increasing accessibility, continuity, and consolidation; accessing posttherapy support; strengthening the relationship between young person and clinician; and tracking personal data that could be used to better inform clinical decision making. Future research is needed to investigate the efficacy of blended models of care by evaluating its impact on the therapeutic alliance, clinical and social outcomes, cost-effectiveness, and engagement.

BackgroundDigital mental health interventions present a unique opportunity to address the lack of social connection and loneliness experienced by young people with first-episode psychosis (FEP). The first generation of digital interventions, however, is associated with high attrition rates. Social media presents an opportunity to target this issue. A new generation of digital intervention has harnessed the popularity of social media to both promote engagement and foster social connectedness in youth mental health interventions. Despite their potential, little is known about how young people engage with, and experience, social media–based interventions as well as the optimal design, implementation, and management needed to ensure young people with psychosis receive benefit. ObjectiveThis study aimed to explore how young people engage with, and experience, a long-term social media–based mental health intervention designed to address social functioning in individuals with FEP. MethodsThis qualitative study was based on 12 interviews with young people who used Horyzons, a long-term social media–based mental health intervention, as part of a previous randomized controlled trial. A semistructured phenomenological interview guide with open-ended questions was used to explore young people’s subjective experience of the intervention. All interviews were recorded and transcribed verbatim. Data were analyzed using interpretative phenomenological analysis. ResultsA total of 4 superordinate themes emerged during the analysis including (1) shared experience as the catalyst for a cocreated social space, (2) the power of peer support, (3) an upbeat environment, and (4) experiences that interrupt being in Horyzons. ConclusionsWe found that Horyzon’s therapeutic social network fostered a connection and an understanding among young people. It also aided in the creation of an embodied experience that afforded young people with FEP a sense of self-recognition and belonging over the long term. However, although we found that most young people had strong positive experiences of a social connection on Horyzons, we also found that they experienced significant barriers that could substantively interrupt their ability to use the platform. We found that social anxiety, paranoia, internalized stigma, lack of autonomy, and social protocol confusion interfered with young people’s usage of the platform. From a design perspective, digital interventions are flexible and thus equipped to begin addressing these implications by providing customizable and personalized treatment options that account for varying levels of social connection and psychological need that could otherwise interrupt young people’s usage of social media–based interventions.

BackgroundRelapse 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. ObjectiveThis 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. MethodsWe 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. ResultsRecruitment 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. ConclusionsThe 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 RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262 International Registered Report Identifier (IRRID)DERR1-10.2196/15058

BackgroundRelapse is common in people who experience psychosis and is associated with many negative consequences, both societal and personal. People who relapse often exhibit changes (early warning signs [EWS]) in the period before relapse. Successful identification of EWS offers an opportunity for relapse prevention. However, several known barriers impede the use of EWS monitoring approaches. Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being. This is currently being tested in a pilot cluster randomized controlled trial. As digital interventions have not been widely used in relapse prevention, little is known about their implementation. Process evaluation studies run in parallel to clinical trials can provide valuable data on intervention feasibility. ObjectiveThis study aims to transparently describe the protocol for the process evaluation element of the EMPOWER trial. We will focus on the development of a process evaluation framework sensitive to the worldview of service users, mental health staff, and carers; the aims of the process evaluation itself; the proposed studies to address these aims; and a plan for integration of results from separate process evaluation studies into one overall report. MethodsThe overall process evaluation will utilize mixed methods across 6 substudies. Among them, 4 will use qualitative methodologies, 1 will use a mixed methods approach, and 1 will use quantitative methodologies. ResultsThe results of all studies will be triangulated into an overall analysis and interpretation of key implementation lessons. EMPOWER was funded in 2016, recruitment finished in January 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in December 2019. ConclusionsThe findings from this study will help identify implementation facilitators and barriers to EMPOWER. These insights will inform both upscaling decisions and optimization of a definitive trial. Trial RegistrationISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262 International Registered Report Identifier (IRRID)DERR1-10.2196/15634

BackgroundMajor depression accounts for the greatest burden of all diseases globally. The peak onset of depression occurs between adolescence and young adulthood, and for many individuals, depression displays a relapse-remitting and increasingly severe course. Given this, the development of cost-effective, acceptable, and population-focused interventions for depression is critical. A number of online interventions (both prevention and acute phase) have been tested in young people with promising results. As these interventions differ in content, clinician input, and modality, it is important to identify key features (or unhelpful functions) associated with treatment outcomes. ObjectiveA systematic review of the research literature was undertaken. The review was designed to focus on two aspects of online intervention: (1) standard approaches evaluating online intervention content in randomized controlled designs (Section 1), and (2) second-generation online interventions and services using social networking (eg, social networking sites and online support groups) in any type of research design (Section 2). MethodsTwo specific literature searches were undertaken. There was no date range specified. The Section 1 search, which focused on randomized controlled trials, included only young people (12-25 years) and yielded 101 study abstracts, of which 15 met the review inclusion criteria. The Section 2 search, which included all study design types and was not restricted in terms of age, yielded 358 abstracts, of which 22 studies met the inclusion criteria. Information about the studies and their findings were extracted and tabulated for review. ResultsThe 15 studies identified in Section 1 described 10 trials testing eight different online interventions, all of which were based on a cognitive behavioral framework. All but one of the eight identified studies reported positive results; however, only five of the 15 studies used blinded interviewer administered outcomes with most trials using self-report data. Studies varied significantly in presentation of intervention content, treatment dose, and dropout. Only two studies included moderator or clinician input. Results for Section 2 were less consistent. None of the Section 2 studies reported controlled or randomized designs. With the exception of four studies, all included participants were younger than 25 years of age. Eight of the 16 social networking studies reported positive results for depression-related outcomes. The remaining studies were either mixed or negative. Findings for online support groups tended to be more positive; however, noteworthy risks were identified. ConclusionsOnline interventions with a broad cognitive behavioral focus appear to be promising in reducing depression symptomology in young people. Further research is required into the effectiveness of online interventions delivering cognitive behavioral subcomponents, such as problem-solving therapy. Evidence for the use of social networking is less compelling, although limited by a lack of well-designed studies and social networking interventions. A range of future social networking therapeutic opportunities are highlighted.

Traditionally, behavioral, social, and health science researchers have relied on global/retrospective survey methods administered cross-sectionally (i.e., on a single occasion) or longitudinally (i.e., on several occasions separated by weeks, months, or years). More recently, social and health scientists have added daily life survey methods (also known as intensive longitudinal methods or ambulatory assessment) to their toolkit. These methods (e.g., daily diaries, experience sampling, ecological momentary assessment) involve dense repeated assessments in everyday settings. To facilitate research using daily life survey methods, we present SEMA3 (http://www.SEMA3.com), a platform for designing and administering intensive longitudinal daily life surveys via Android and iOS smartphones. SEMA3 fills an important gap by providing researchers with a free, intuitive, and flexible platform with basic and advanced functionality. In this article, we describe SEMA3's development history and system architecture, provide an overview of how to design a study using SEMA3 and outline its key features, and discuss the platform's limitations and propose directions for future development of SEMA3. [ABSTRACT FROM AUTHOR]

Fear of relapse into psychosis is an independent risk factor for future relapse events, indicating its importance as a novel intervention target. Twenty-five participants responded to daily ecological momentary assessment prompts assessing common early warning signs of relapse and self-reported positive experiences like feeling supported by others. We conducted multilevel vector auto-regression using common symptoms assessed in early warning signs monitoring relapse prevention while controlling for positive self-reported experiences like feeling supported by others to estimate three networks (to explore concurrent, temporal and overall relationships). Reporting fear of relapse was positively associated (within the same cross-sectional time window) with hearing voices, alongside anxiety, negative affect and sleep change. Fear of relapse appeared to predict anxiety, negative affect and greater fear of relapse on the next consecutive day. However, none of the typical early warning signs predicted fear of relapse within the temporal window, and the observed relationships were small. Early warning signs appeared to be poor predictors of experiencing fear of relapse in this study. Fear of relapse predicts later anxiety and negative affect and may be a valuable intervention target within the daily life of people diagnosed with schizophrenia. [ABSTRACT FROM AUTHOR]

Gaining awareness of psychosis (i.e., insight) is linked to depression, particularly in the post‐acute phase of psychosis. Informed by social rank theory, we examined whether the insight–depression relationship is explained by reduced social rank related to psychosis and whether self‐compassion (including uncompassionate self‐responding [UCS] and compassionate self‐responding [CSR]) and mindfulness buffered the relationship between social rank and depression in individuals with first episode psychosis during the post‐acute phase. Participants were 145 young people (Mage = 20.81; female = 66) with first episode psychosis approaching discharge from an early psychosis intervention centre. Questionnaires and interviews assessed insight, depressive symptoms, perceived social rank, self‐compassion, mindfulness and illness severity. Results showed that insight was not significantly associated to depression and thus no mediation analysis was conducted. However, lower perceived social rank was related to higher depression, and this relationship was moderated by self‐compassion and, more specifically, UCS. Mindfulness was related to depression but had no moderating effect on social rank and depression. Results supported previous findings that depressive symptoms are common during the post‐acute phase. The role of insight in depression for this sample is unclear and may be less important during the post‐acute phase than previously considered. Supporting social rank theory, the results suggest that low perceived social rank contributes to depression, and reducing UCS may ameliorate this effect. UCS, social rank and possibly mindfulness may be valuable intervention targets for depression intervention and prevention efforts in the recovery of psychosis. [ABSTRACT FROM AUTHOR]