Early signs monitoring to prevent relapse and promote wellbeing: CRCT
Research type
Research Study
Full title
EMPOWER: Early signs Monitoring to Prevent relapse in psychosis and prOmote Wellbeing, Engagement and Recovery - a pilot Cluster Randomised Controlled Trial
IRAS ID
212143
Contact name
Andrew I Gumley
Contact email
Sponsor organisation
NHS Greater Glasgow & Clyde
ISRCTN Number
ISRCTN99559262
Duration of Study in the UK
1 years, 8 months, 30 days
Research summary
BACKGROUND: Relapse in schizophrenia is a major cause of distress and disability amongst patients and their families. Relapse is predicted by changes in symptoms such as anxiety, depression and suspiciousness (early warning signs, EWS) and can be used as the basis for timely interventions to prevent relapse and hospitalization. Research shows that interventions focused on EWS can reduce these negative outcomes and enhance recovery. The quality of research evidence is poor so that it is not possible to estimate whether these can be applied in routine practice.
AIMS: We aim to build a practitioner led and peer informed intervention (EMPOWER) that utilizes digital smartphone technology for the monitoring of EWS; that promotes autonomy, self-management and timely help seeking whilst minimizing the risk of false alarms. Therefore, we will seek to embed our digital technology into a Stepped-Care model that aims to enhance self-management and facilitate timely support from mental health services.
PARTICIPANTS: Eligible service users will be (i) adults (age 16+) (ii) in contact with a local community based services; (iii) who 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 of psychosis; (iv) a DSM-5 diagnosis of a Schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate.
SETTINGS: The study will take place in Glasgow (UK) and Melbourne (Australia).
DESIGN AND PROCEDURES: We will undertake a pilot cluster randomised controlled trial (CRCT) where we will randomise Community Mental Health Services (CMHS) to EMPOWER or to ‘Treatment as Usual’ (TAU). We aim to recruit 120 service user participants from 8 Community Mental Health Services and follow them up for 12-months. This pilot will enable us to investigate the feasibility of a larger scale (definitive) trial and the acceptability and safety of the EMPOWER intervention. We will conduct a Health Economic study and we will also undertake wider engagement of service user, carer and NHS stakeholders to facilitate transition to the main study.
INTERVENTION: The EMPOWER intervention involves three levels of stepped care: (i) smartphone based early signs monitoring, (ii) individualised self-management support delivered through smartphone, and (iii) activation of a relapse prevention pathway into secondary care. Service user participants will have access to the EMPOWER App for the full 12-months of the study. EMPOWER will enable service users, their nominated carer and their care coordinator to agree and personalize additional individual EWS items. Wellbeing messages tailored to enhance self-management and autonomy will be delivered and thresholds for activating a team-based relapse prevention pathway will be set.
OUTCOMES: 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. We will assess relapse, symptom recovery, emotional recovery, empowerment and engagement. We will determine (a) any changes or enhancements to the smartphone app, and (b) any changes or enhancements to the implementation of the intervention required for optimal operation in the main trial We will manualise the intervention and establish the methods to deliver the main (definitive) trial.REC name
West of Scotland REC 4
REC reference
16/WS/0225
Date of REC Opinion
22 Dec 2016
REC opinion
Further Information Favourable Opinion