Using EMPOWER in daily life: a qualitative investigation of implementation experiences.

BACKGROUND: Digital self-management tools blended with clinical triage and peer support have the potential to improve access to early warning signs (EWS) based relapse prevention in schizophrenia care. However, the implementation of digital interventions in psychosis can be poor. Traditionally, research focused on understanding how people implement interventions has focused on the perspectives of mental health staff. Digital interventions are becoming more commonly used by patients within the context of daily life, which means there is a need to understand implementation from the perspectives of patients and carers. METHODS: Semi-structured one-on-one interviews with 16 patients who had access to the EMPOWER digital self-management intervention during their participation in a feasibility trial, six mental health staff members who supported the patients and were enrolled in the trial, and one carer participant. Interviews focused on understanding implementation, including barriers and facilitators. Data were coded using thematic analysis. RESULTS: The intervention was well implemented, and EMPOWER was typically perceived positively by patients, mental health staff and the carer we spoke to. However, some patients reported negative views and reported ideas for intervention improvement. Patients reported valuing that the app afforded them access to things like information or increased social contact from peer support workers that went above and beyond that offered in routine care. Patients seemed motivated to continue implementing EMPOWER in daily life when they perceived it was creating positive change to their wellbeing, but seemed less motivated if this did not occur. Mental health staff and carer views suggest they developed increased confidence patients could self-manage and valued using the fact that people they support were using the EMPOWER intervention to open up conversations about self-management and wellbeing. CONCLUSIONS: The findings from this study suggest peer worker supported digital self-management like EMPOWER has the potential to be implemented. Further evaluations of these interventions are warranted, and conducting qualitative research on the feasibility gives insight into implementation barriers and facilitators, improving the likelihood of interventions being usable. In particular, the views of patients who demonstrated low usage levels would be valuable.

Not the story you want? Assessing the fit of a conceptual framework characterising mental health recovery narratives.

PURPOSE: Narratives of recovery have been central to the development of the recovery approach in mental health. However, there has been a lack of clarity around definitions. A recent conceptual framework characterised recovery narratives based on a systematic review and narrative synthesis of existing literature, but was based on a limited sample. The aims of this study were to assess the relevance of the framework to the narratives of more diverse populations, and to develop a refined typology intended to inform narrative-based research, practice and intervention development. METHOD: 77 narrative interviews were conducted with respondents from four under-researched mental health sub-populations across England. Deductive and inductive analysis was used to assess the relevance of the dimensions and types of the preliminary typology to the interview narratives. RESULTS: Five or more dimensions were identifiable within 97% of narratives. The preliminary typology was refined to include new definitions and types. The typology was found not to be relevant to two narratives, whose narrators expressed a preference for non-verbal communication. These are presented as case studies to define the limits of the typology. CONCLUSION: The refined typology, based on the largest study to date of recovery narratives, provides a defensible theoretical base for clinical and research use with a range of clinical populations. Implications for practice include ensuring a heterogeneous selection of narratives as resources to support recovery, and developing new approaches to supporting non-verbal narrative construction.

Mental Health Recovery Narratives and Their Impact on Recipients: Systematic Review and Narrative Synthesis.

OBJECTIVE: Mental health recovery narratives are often shared in peer support work and antistigma campaigns. Internet technology provides access to an almost unlimited number of narratives, and yet little is known about how they affect recipients. The aim of this study was to develop a conceptual framework characterizing the impact of recovery narratives on recipients. METHOD: A systematic review of evidence about the impact of mental health recovery narratives was conducted. Searches used electronic databases (n = 9), reference tracking, hand-searching of selected journals (n = 2), grey literature searching, and expert consultation (n = 7). A conceptual framework was generated through a thematic analysis of included articles, augmented by consultation with a Lived Experience Advisory Panel. RESULTS: In total, 8137 articles were screened. Five articles were included. Forms of impact were connectedness, understanding of recovery, reduction in stigma, validation of personal experience, affective responses, and behavioural responses. Impact was moderated by characteristics of the recipient, context, and narrative. Increases in eating disorder behaviours were identified as a harmful response specific to recipients with eating disorders. CONCLUSIONS: Mental health recovery narratives can promote recovery. Recovery narratives might be useful for clients with limited access to peers and in online interventions targeted at reducing social isolation in rural or remote locations, but support is needed for the processing of the strong emotions that can arise. Caution is needed for use with specific clinical populations. Protocol registration: Prospero-CRD42018090923.

Developing a Hypothetical Implementation Framework of Expectations for Monitoring Early Signs of Psychosis Relapse Using a Mobile App: Qualitative Study.

BACKGROUND: Relapse is a common experience for people diagnosed with psychosis, which is associated with increased service costs and profound personal and familial distress. EMPOWER (Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery) is a peer worker-supported digital intervention that aims to enable service users to self-monitor their mental health with the aim of encouraging self-management and the shared use of personal data to promote relapse prevention. Digital interventions have not been widely used in relapse prevention and, therefore, little is currently known about their likely implementation-both within trials and beyond. OBJECTIVE: Seeking the perspectives of all relevant stakeholder groups is recommended in developing theories about implementation because this can reveal important group differences in understandings and assumptions about whether and for whom the intervention is expected to work. However, the majority of intervention implementation research has been retrospective. This study aimed to discover and theoretically frame implementation expectations in advance of testing and synthesize these data into a framework. METHODS: To develop a hypothetical implementation framework, 149 mental health professionals, carers, and people diagnosed with psychosis participated in 25 focus groups in both Australia and the United Kingdom. An interview schedule informed by the normalization process theory was used to explore stakeholders' expectations about the implementation of the EMPOWER intervention. Data were analyzed using thematic analysis and then theoretically framed using the Medical Research Council guidelines for understanding the implementation of complex interventions. RESULTS: All groups expected that EMPOWER could be successfully implemented if the intervention generated data that were meaningful to mental health staff, carers, and service users within their unique roles. However, there were key differences between staff, carers, and service users about what facilitators and barriers that stakeholders believe exist for intervention implementation in both the cluster randomized controlled trial stage and beyond. For example, service user expectations mostly clustered around subjective user experiences, whereas staff and carers spoke more about the impact upon staff interactions with service users. CONCLUSIONS: A hypothetical implementation framework synthesized from stakeholder implementation expectations provides an opportunity to compare actual implementation data gathered during an ongoing clinical trial, giving valuable insights into the accuracy of these stakeholders' previous expectations. This is among the first studies to assess and record implementation expectations for a newly developed digital intervention for psychosis in advance of testing in a clinical trial. TRIAL REGISTRATION: ISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262.

Evaluating the feasibility of complex interventions in mental health services: standardised measure and reporting guidelines.

BACKGROUND: The feasibility of implementation is insufficiently considered in clinical guideline development, leading to human and financial resource wastage. AIMS: To develop (a) an empirically based standardised measure of the feasibility of complex interventions for use within mental health services and (b) reporting guidelines to facilitate feasibility assessment. METHOD: A focused narrative review of studies assessing implementation blocks and enablers was conducted with thematic analysis and vote counting used to determine candidate items for the measure. Twenty purposively sampled studies (15 trial reports, 5 protocols) were included in the psychometric evaluation, spanning different interventions types. Cohen's kappa (κ) was calculated for interrater reliability and test-retest reliability. RESULTS: In total, 95 influences on implementation were identified from 299 references. The final measure - Structured Assessment of FEasibility (SAFE) - comprises 16 items rated on a Likert scale. There was excellent interrater (κ = 0.84, 95% CI 0.79-0.89) and test-retest reliability (κ = 0.89, 95% CI 0.85-0.93). Cost information and training time were the two influences least likely to be reported in intervention papers. The SAFE reporting guidelines include 16 items organised into three categories (intervention, resource consequences, evaluation). CONCLUSIONS: A novel approach to evaluating interventions, SAFE, supplements efficacy and health economic evidence. The SAFE reporting guidelines will allow feasibility of an intervention to be systematically assessed.

Effectiveness and cost-effectiveness of online recorded recovery narratives in improving quality of life for people with non-psychotic mental health problems: a pragmatic randomized controlled trial.

Narratives describing first-hand experiences of recovery from mental health problems are widely available. Emerging evidence suggests that engaging with mental health recovery narratives can benefit people experiencing mental health problems, but no randomized controlled trial has been conducted as yet. We developed the Narrative Experiences Online (NEON) Intervention, a web application providing self-guided and recommender systems access to a collection of recorded mental health recovery narratives (n=659). We investigated whether NEON Intervention access benefited adults experiencing non-psychotic mental health problems by conducting a pragmatic parallel-group randomized trial, with usual care as control condition. The primary endpoint was quality of life at week 52 assessed by the Manchester Short Assessment (MANSA). Secondary outcomes were psychological distress, hope, self-efficacy, and meaning in life at week 52. Between March 9, 2020 and March 26, 2021, we recruited 1,023 participants from across England (the target based on power analysis was 994), of whom 827 (80.8%) identified as White British, 811 (79.3%) were female, 586 (57.3%) were employed, and 272 (26.6%) were unemployed. Their mean age was 38.4±13.6 years. Mood and/or anxiety disorders (N=626, 61.2%) and stress-related disorders (N=152, 14.9%) were the most common mental health problems. At week 52, our intention-to-treat analysis found a significant baseline-adjusted difference of 0.13 (95% CI: 0.01-0.26, p=0.041) in the MANSA score between the intervention and control groups, corresponding to a mean change of 1.56 scale points per participant, which indicates that the intervention increased quality of life. We also detected a significant baseline-adjusted difference of 0.22 (95% CI: 0.05-0.40, p=0.014) between the groups in the score on the "presence of meaning" subscale of the Meaning in Life Questionnaire, corresponding to a mean change of 1.1 scale points per participant. We found an incremental gain of 0.0142 quality-adjusted life years (QALYs) (95% credible interval: 0.0059 to 0.0226) and a £178 incremental increase in cost (95% credible interval: -£154 to £455) per participant, generating an incremental cost-effectiveness ratio of £12,526 per QALY compared with usual care. This was lower than the £20,000 per QALY threshold used by the National Health Service in England, indicating that the intervention would be a cost-effective use of health service resources. In the subgroup analysis including participants who had used specialist mental health services at baseline, the intervention both reduced cost (-£98, 95% credible interval: -£606 to £309) and improved QALYs (0.0165, 95% credible interval: 0.0057 to 0.0273) per participant as compared to usual care. We conclude that the NEON Intervention is an effective and cost-effective new intervention for people experiencing non-psychotic mental health problems.

Assessing Diversity and Inclusivity is the Next Frontier in Mental Health Recovery Narrative Research and Practice.

Demand for digital health interventions is increasing in many countries. The use of recorded mental health recovery narratives in digital health interventions is becoming more widespread in clinical practice. Mental health recovery narratives are first-person lived experience accounts of recovery from mental health problems, including struggles and successes over time. Helpful impacts of recorded mental health recovery narratives include connectedness with the narrative and validation of experiences. Possible harms include feeling disconnected and excluded from others. Diverse narrative collections from many types of narrators and describing multiple ways to recover are important to maximize the opportunity for service users to benefit through connection and to minimize the likelihood of harm. Mental health clinicians need to know whether narrative collections are sufficiently diverse to recommend to service users. However, no method exists for assessing the diversity and inclusivity of existing or new narrative collections. We argue that assessing diversity and inclusivity is the next frontier in mental health recovery narrative research and practice. This is important, but methodologically and ethically complex. In this viewpoint, we propose and evaluate one diversity and two inclusivity assessment methods. The diversity assessment method involves use of the Simpson Diversity Index. The two inclusivity assessment methods are based on comparator demographic rates and arbitrary thresholds, respectively. These methods were applied to four narrative collections as a case study. Refinements are needed regarding a narrative assessment tool in terms of its practicality and cultural adaptation.

Recovery in Scotland: beyond service development.

Over the last ten years there has been significant activity related to the promotion and support of recovery in Scotland, much of it linked to the work of the Scottish Recovery Network. A range of government policies have consistently identified recovery as a guiding principle of both service design and mental health improvement efforts. New learning has been developed and shared, workforce competencies reviewed and training developed, and a range of national initiatives put in place. In Scotland, as elsewhere, these efforts have tended to focus primarily on ensuring that mental health services offer environments and practices that support personal recovery. While service improvement is crucial, a wider challenge is ensuring that opportunities and support for self-directed recovery are enhanced outside statutory services. Providing examples, this paper will look at the development of recovery in Scotland - including the work of the Scottish Recovery Network - and consider the potential for building on progress made by rebalancing efforts to support personal recovery, highlighting the importance of public attitudes and community-based learning approaches. We will also touch on the role of identity in personal recovery and consider cultural issues related to the promotion of recovery in Scotland.

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.

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.

Perspectives of Trial Staff on the Barriers to Recruitment in a Digital Intervention for Psychosis and How to Work Around Them: Qualitative Study Within a Trial.

BACKGROUND: Recruitment 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. OBJECTIVE: The primary aim of this study was to understand recruitment from the point of view of trial staff and discover what they consider important. METHODS: We 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. RESULTS: Recruitment 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. CONCLUSIONS: Researchers 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.

The VOICES Typology of Curatorial Decisions in Narrative Collections of the Lived Experiences of Mental Health Service Use, Recovery, or Madness: Qualitative Study.

BACKGROUND: Collections of lived experience narratives are increasingly used in health research and medical practice. However, there is limited research with respect to the decision-making processes involved in curating narrative collections and the work that curators do as they build and publish collections. OBJECTIVE: This study aims to develop a typology of curatorial decisions involved in curating narrative collections presenting lived experiences of mental health service use, recovery, or madness and to document approaches selected by curators in relation to identified curatorial decisions. METHODS: A preliminary typology was developed by synthesizing the results of a systematic review with insights gained through an iterative consultation with an experienced curator of multiple recovery narrative collections. The preliminary typology informed the topic guide for semistructured interviews with a maximum variation sample of 30 curators from 7 different countries. All participants had the experience of curating narrative collections of the lived experiences of mental health service use, recovery, or madness. A multidisciplinary team conducted thematic analysis through constant comparison. RESULTS: The final typology identified 6 themes, collectively referred to as VOICES, which stands for values and motivations, organization, inclusion and exclusion, control and collaboration, ethics and legal, and safety and well-being. A total of 26 subthemes related to curation decisions were identified. CONCLUSIONS: The VOICES typology identifies the key decisions to consider when curating narrative collections about the lived experiences of mental health service use, recovery, or madness. It might be used as a theoretical basis for a good practice resource to support curators in their efforts to balance the challenges and sometimes conflicting imperatives involved in collecting, organizing, and sharing narratives. Future research might seek to document the use of such a tool by curators and hence examine how best to use VOICES to support decision making.

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.

Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation.

BACKGROUND: Relapse 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. OBJECTIVE: This 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. METHODS: The 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. RESULTS: The 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. CONCLUSIONS: The 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 REGISTRATION: ISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15634.

Perspectives of patients, carers and mental health staff on early warning signs of relapse in psychosis: a qualitative investigation.

BACKGROUND: Relapse prevention strategies based on monitoring of early warning signs (EWS) are advocated for the management of psychosis. However, there has been a lack of research exploring how staff, carers and patients make sense of the utility of EWS, or how these are implemented in context. AIMS: To develop a multiperspective theory of how EWS are understood and used, which is grounded in the experiences of mental health staff, carers and patients. METHOD: Twenty-five focus groups were held across Glasgow and Melbourne (EMPOWER Trial, ISRCTN: 99559262). Participants comprised 88 mental health staff, 21 patients and 40 carers from UK and Australia (total n = 149). Data were analysed using constructivist grounded theory. RESULTS: All participants appeared to recognise EWS and acknowledged the importance of responding to EWS to support relapse prevention. However, recognition of and acting on EWS were constructed in a context of uncertainty, which appeared linked to risk appraisals that were dependent on distinct stakeholder roles and experiences. Within current relapse management, a process of weighted decision-making (where one factor was seen as more important than others) described how stakeholders weighed up the risks and consequences of relapse alongside the risks and consequences of intervention and help-seeking. CONCLUSIONS: Mental health staff, carers and patients speak about using EWS within a weighted decision-making process, which is acted out in the context of relationships that exist in current relapse management, rather than an objective response to specific signs and symptoms.

Curation of Mental Health Recovery Narrative Collections: Systematic Review and Qualitative Synthesis.

BACKGROUND: Mental health recovery narratives are first-person lived experience accounts of recovery from mental health problems, which refer to events or actions over a period. They are readily available either individually or in collections of recovery narratives published in books, health service booklets, or on the Web. Collections of recovery narratives have been used in a range of mental health interventions, and organizations or individuals who curate collections can therefore influence how mental health problems are seen and understood. No systematic review has been conducted of research into curatorial decision making. OBJECTIVE: This study aimed to produce a conceptual framework identifying and categorizing decisions made in the curation of mental health recovery narrative collections. METHODS: A conceptual framework was produced through a systematic review and qualitative evidence synthesis. Research articles were identified through searching bibliographic databases (n=13), indexes of specific journals (n=3), and gray literature repositories (n=4). Informal documents presenting knowledge about curation were identified from editorial chapters of electronically available books (n=50), public documents provided by Web-based collections (n=50), and prefaces of health service booklets identified through expert consultation (n=3). Narrative summaries of included research articles were produced. A qualitative evidence synthesis was conducted on all included documents through an inductive thematic analysis. Subgroup analyses were conducted to identify differences in curatorial concerns between Web-based and printed collections. RESULTS: A total of 5410 documents were screened, and 23 documents were included. These comprised 1 research publication and 22 informal documents. Moreover, 9 higher level themes were identified, which considered: the intended purpose and audience of the collection; how to support safety of narrators, recipients, and third parties; the processes of collecting, selecting, organizing, and presenting recovery narratives; ethical and legal issues around collections; and the societal positioning of the collection. Web-based collections placed more emphasis on providing benefits for narrators and providing safety for recipients. Printed collections placed more emphasis on the ordering of narrative within printed material and the political context. CONCLUSIONS: Only 1 research article was identified despite extensive searches, and hence this review has revealed a lack of peer-reviewed empirical research regarding the curation of recovery narrative collections. The conceptual framework can be used as a preliminary version of reporting guidelines for use when reporting on health care interventions that make use of narrative collections. It provides a theory base to inform the development of new narrative collections for use in complex mental health interventions. Collections can serve as a mechanism for supporting collective rather than individual discourses around mental health.

Internalised stigma in mental health: An investigation of the role of attachment style.

Internalised stigma is associated with a range of negative outcomes, yet little is known about what determines the internalisation of stigma. In this study we examined the potential role of adult attachment style in the internalisation process in a transdiagnostic sample of adults with experience of recent mental health service use (n = 122), using an online survey. Associations between internalised stigma and perceived public stigma were tested. We also examined whether anxious and avoidant (insecure) attachment styles were positively associated with a significant amount of variance in internalised stigma when controlling for other variables, and whether the relationship between perceived public stigma and internalised stigma was moderated by anxious and avoidant attachment. We found that internalised stigma, perceived public stigma and insecure attachment were commonly reported and that internalised stigma was positively associated with perceived public stigma. However, neither anxious or avoidant attachment were associated with a significant amount of variance in internalised stigma and we found no moderating effect on the relationship between perceived public stigma and internalised stigma for insecure attachment. Despite mixed results, the strength of association between anxious attachment and internalised stigma suggests further research, which addresses some limitations of the current study, is warranted.

So if we like the idea of peer workers, why aren't we seeing more?

The employment of peer support workers is widely encouraged in recovery-oriented mental health systems and services, providing a tangible example of how to translate recovery values and principles into actions. In Scotland, despite a long-term policy commitment to recovery approaches, the creation of peer worker roles has been slow and patchy. This paper describes findings from a study on the levers and barriers to the development of peer worker roles in two Scottish health board areas. Findings suggest that new evidence on effective implementation and cost effectiveness should be prioritised to support potentially complex role development in times of reduced resources. We argue that additional evidence on effectiveness is unlikely, by itself, to lead to country-wide employment of peer workers. We therefore suggest that a policy commitment to peer working would be reinforced by not only a strengthened evidence base but also strengthened accountability mechanisms. In the absence of such accountability, decision-makers and planners might reasonably continue to ask "why bother"?

Dyad conversations about self-stigma in two Scottish communities.

OBJECTIVE: This study explored self-stigma in 2 Scottish communities and strategies for challenging stigma and discrimination. METHODS: A mixed-methods approach was used encompassing a survey including the Internalized Stigma of Mental Illness Inventory (ISMI) and facilitated dyad conversations with people with lived experience of mental illness. RESULTS: Self-reported experience of self-stigma across 2 communities was most closely associated with the ISMI Alienation cluster, accompanied by a high level of agreement with the Stigma Resistance cluster. Some 44% agreed that stereotypes about people with mental health problems applied to them, and almost 2/3 felt that having a mental health problem had spoiled their lives. Many participants reported reduced confidence, loss of hope, a sense of failure, and protecting oneself through social withdrawal. The findings also offer hope through narratives from people who have "pushed back" and are striving to reduce their own self-stigma by engaging with others and managing their own recovery journey. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: The journey through self-stigma and beyond has to be informed by what we know works with recovery from a mental health problem. At a policy and practice level, we recommend emphasis on 4 priorities: (a) refocusing antistigma and discrimination efforts more on the experiences of people who report stigma, (b) rights-based approaches, (c) identity-based work, and (d) information sharing and educational strategies.