Dataset Information

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.

ABSTRACT:

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.

SUBMITTER: Gumley A

PROVIDER: S-EPMC6996736 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Gumley Andrew A Bradstreet Simon S Ainsworth John J Allan Stephanie S Alvarez-Jimenez Mario M Beattie Louise L Bell Imogen I Birchwood Max M Briggs Andrew A Bucci Sandra S Castagnini Emily E Clark Andrea A Cotton Sue M SM Engel Lidia L French Paul P Lederman Reeva R Lewis Shon S Machin Matthew M MacLennan Graeme G Matrunola Claire C McLeod Hamish H McMeekin Nicola N Mihalopoulos Cathrine C Morton Emma E Norrie John J Reilly Frank F Schwannauer Matthias M Singh Swaran P SP Smith Lesley L Sundram Suresh S Thomson David D Thompson Andrew A Whitehill Helen H Wilson-Kay Alison A Williams Christopher C Yung Alison A Farhall John J Gleeson John J

JMIR research protocols 20200109 1

<h4>Background</h4>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.<h4>Objective</h4>This study was designed to establish the feasibility of conducting a definitive cluster randomized controll ...[more]

PMID: 31917372

Similar Datasets

Project description:BACKGROUND:Schizophrenia relapses are common, have profound, adverse consequences for patients and are costly to health services. Early signs interventions aim to use warning signs of deterioration to prevent full relapse. Such interventions show promise but could be further developed. This study addresses 2 developments: adding basic symptoms to checklists of conventional early signs and using a mobile phone app ExPRESS to aid early signs monitoring. OBJECTIVE:This study aimed to (1) design a pool of self-report items assessing basic symptoms (Basic Symptoms Checklist, BSC); (2) develop and beta test a mobile phone app (ExPRESS) for monitoring early signs, basic symptoms, and psychotic symptoms; and (3) evaluate the long-term acceptability of ExPRESS via qualitative feedback from participants in a 6-month feasibility study. METHODS:The BSC items and ExPRESS were developed and then adjusted following feedback from beta testers (n=5) with a schizophrenia diagnosis. Individuals (n=18) experiencing a relapse of schizophrenia within the past year were asked to use ExPRESS for 6 months to answer weekly questions about experiences of early signs, basic symptoms, and psychotic symptoms. At the end of follow-up, face-to-face qualitative interviews (n=16; 2 were uncontactable) explored experiences of using ExPRESS. The topic guide sought participants' views on the following a priori themes regarding app acceptability: item content, layout, and wording; app appearance; length and frequency of assessments; worries about app use; how app use fitted with participants' routines; and the app's extra features. Interview transcripts were analyzed using the framework method, which allows examination of both a priori and a posteriori themes, enabling unanticipated aspects of app use experiences to be explored. RESULTS:Participants' mean age was 38 years (range 22-57 years). Responses to a priori topics indicated that long-term use of ExPRESS was acceptable; small changes for future versions of ExPRESS were suggested. A posteriori themes gave further insight into individuals' experiences of using ExPRESS. Some reported finding it more accessible than visits from a clinician, as assessments were more frequent, more anonymous, and did not require the individual to explain their feelings in their own words. Nevertheless, barriers to app use (eg, unfamiliarity with smartphones) were also reported. Despite ExPRESS containing no overtly therapeutic components, some participants found that answering the weekly questions prompted self-reflection, which had therapeutic value for them. CONCLUSIONS:This study suggests that apps are acceptable for long-term symptom monitoring by individuals with a schizophrenia diagnosis across a wide age range. If the potential benefits are understood, patients are generally willing and motivated to use a weekly symptom-monitoring app; most participants in this study were prepared to do so for more than 6 months. TRIAL REGISTRATION:ClinicalTrials.gov NCT03558529; https://clinicaltrials.gov/ct2/show/NCT03558529 (Archived by WebCite at http://www.webcitation.org/70qvtRmZY).

Project description:BackgroundRelapse 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.ObjectiveSeeking 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.MethodsTo 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.ResultsAll 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.ConclusionsA 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 registrationISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262.

Dataset Information

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

Objective

Methods

Results

Conclusions

Trial registration

International registered report identifier (irrid)

Publications

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.

Similar Datasets

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