JMIR Publications

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, EWS). 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 Randomised Controlled Trial (cRCT) comparing EMPOWER against Treatment As Usual (TAU). Our primary outcomes are establishing the parameters of the 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 (NHS) and Australian community mental health service settings. We will also assess the feasibility of candidate primary, secondary outcomes and mechanistic outcomes for a definitive trial.

Methods:

We will randomise Community Mental Health Services (CMHS) to EMPOWER or to TAU. We aim to recruit up to 120 service user participants from eight CMHS and follow them for up to 12-months. Eligible service users will be: (i) aged 16+; (ii) in contact with local CMHS; (iii) have either been admitted to a psychiatric in-patient service or received crisis intervention at least once in the previous two years for a relapse; (iv) have an ICD10 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.

Results:

Recruitment to the trial began in January 2018 and follow-up of participants will be completed in July 2019. Data collection is continuing. The database lock is anticipated in July 2019, followed by analysis and disclosing of group allocation. The database has not been locked and trial allocation concealment remains intact.

Conclusions:

The knowledge gained from the study will inform the design of a definitive trial including finalising the delivery of our Digital Health Intervention, sample size estimation, methods to ensure successful identification, consent, randomisation 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. Clinical Trial: ISRCTN99559262