Search

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.

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

Background: Disrupted metacognition is implicated in development and maintenance of negative symptoms, but more fine‐grained analyses would inform precise treatment targeting for individual negative symptoms. Aims: This systematic review identifies and examines datasets that test whether specific metacognitive capacities distinctly influence negative symptoms. Materials & Methods: PsycINFO, EMBASE, Medline and Cochrane Library databases plus hand searching of relevant articles, journals and grey literature identified quantitative research investigating negative symptoms and metacognition in adults aged 16+ with psychosis. Authors of included articles were contacted to identify unique datasets and missing information. Data were extracted for a risk of bias assessment using the Quality in Prognostic Studies tool. Results: 85 published reports met criteria and are estimated to reflect 32 distinct datasets and 1623 unique participants. The data indicated uncertainty about the relationship between summed scores of negative symptoms and domains of metacognition, with significant findings indicating correlation coefficients from 0.88 to −0.23. Only eight studies investigated the relationship between metacognition and individual negative symptoms, with mixed findings. Studies were mostly moderate‐to‐low risk of bias. Discussion: The relationship between negative symptoms and metacognition is rarely the focus of studies reviewed here, and negative symptom scores are often summed. This approach may obscure relationships between metacognitive domains and individual negative symptoms which may be important for understanding how negative symptoms are developed and maintained. Conlclusion: Methodological challenges around overlapping participants, variation in aggregation of negative symptom items and types of analyses used, make a strong case for use of Individual Participant Data Meta‐Analysis to further elucidate these relationships. [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]