Title: EMPOWER: Early Signs Monitoring to Prevent Relapse and PrOmote Wellbeing, Engagement and Recovery
Funder: Chief Scientist Office, Scotland

Abstract: DESIGN: Study using mixed methodologies including a single (rater) blind pilot cluster randomized controlled trial (C-RCT) of a novel intervention (EMPOWER) to detect and prevent relapse in people with schizophrenia. SETTINGS: United Kingdom (Glasgow) and Australia (Melbourne). STRATEGY FOR REVIEWING THE LITERATURE: A recent Cochrane Review of monitoring Early Warning Signs (EWS) (2013) to prevent relapse identified that: (i) there were significant differences in favour of EWS interventions in outcomes of relapse and rehospitalisation. However, the quality of evidence was poor and there was a substantial gap in the cost evaluation of these interventions. TARGET POPULATION: Adults with Schizophrenia, their carers, and their mental health teams. INCLUSION/EXCLUSION CRITERIA: Eligible service users will be (i) adults (age 16+) (ii) in contact with a local community based services; (iii) who have been admitted to a psychiatric in-patient service at least once in the previous two years for a relapse of psychosis or received crisis intervention (e.g. via a crisis intervention service; re-engaged with a CMHS) in the previous two years for a relapse of psychosis; (iv) a DSM-V diagnosis of Schizophrenia. Service users will also be invited to nominate a carer to participate. HEALTH TECHNOLOGIES TO BE ASSESSED: We will explore service users’, carers’ and staff perspectives on early signs monitoring, their preferences for using mobile technology, opportunities and barriers to help-seeking and preferences for pathways and responses to help-seeking. We will refine digital technology to deliver EMPOWER on Smartphone devices with peer support and embed delivery of this technology in a Stepped Care Relapse Prevention Pathway. MEASUREMENT OF COSTS AND OUTCOMES AND PLANNED HEALTH ECONOMIC ANALYSIS: In order to confirm the design and methods of the definitive trial we will demonstrate feasibility of the trial, acceptability and safety of our proposed intervention. We will explore adverse events including increased fear of relapse, disengagement from EWS, relapse, rehospitalisation, suicide and attempted suicide. We will measure adherence to early signs monitoring, number of early signs episodes, number of help seeking attempts, and changes in relapse management. We will measure relapse, symptoms, service engagement, coercion, empowerment, adverse events, emotional adjustment, and carer burden. We will focus on the development of economic measures as part of the trial including how to capture resource use and quality of life. We will work between different service systems in the UK and Australia to build comparability and utilise the pilot to refine the measurement and capture of economic data. This will lead into the development of an analytic framework (model) for the health economic analysis in the definitive study. SAMPLE SIZE: As a pilot study, no formal sample size calculation is appropriate or meaningful as it is not the intention of the study to detect a specific magnitude of treatment effect. We have chosen two sites (one in each region, the UK and Australia), and within these two sites we will involve around 8 mental health teams (which form the clusters), with each team supporting around 15 participants each. This will provide information to assess the feasibility of the main study and inform the assumptions around the important design parameters for the full trial, including the sample size. PROJECT TIMELINES: Months 13-17 C-RCT setup and approvals; Months 3-16 software development and evaluation; Months 21-39 C-RCT ; Months 36-41 Health Economics; Months 40-41 Analysis and Write-up.

Lay abstract: BACKGROUND For people with a diagnosis of schizophrenia or related conditions a relapse of illness can lead to considerable distress and life disruption. Early warning signs of relapse are the first indicators of a worsening in mental health. These may relate to changes in thoughts, feelings or behaviours. Early warning signs can appear weeks or even months before a period of illness. Evidence suggests that monitoring early warning signs can allow people to intervene early to minimise or even prevent a relapse of psychosis. However, because our thoughts and feeling change a great deal from day to day this type of monitoring can lead to false alarms. This is something which we are trying to address with EMPOWER. Early warning signs vary between people but common signs include feeling more anxious, withdrawing from others, changes to sleep patterns, feeling confused or becoming suspicious of people. One of the things which can prevent early intervention when warning signs first appear is fear of what might happen. This can be based on previous negative experiences during periods of illness, a sense of shame or worrying about letting people down. This in turn can lead to avoidance of the problem or heightened anxiety. Sometimes mental health services response to early warning signs can also discourage help seeking. We hope that through the routine monitoring of early warning signs people using the APP and those supporting them will feel more able to respond helpfully and to intervene effectively. Too often people with experiences of psychosis get help when things are at crisis point causing distress for everyone involved. This is something we believe can be improved through the careful use of digital technology. OUR AIMS AND APPROACH Our aim is to build and test a smartphone application (App). The EMPOWER App is intended to allow self-monitoring of a variety of different experiences. These include psychosis experiences (e.g. hearing voices, experiencing suspicious thoughts), anxiety, mood and self-esteem. Ultimately our goal with EMPOWER is to enhance control for people with experiences of psychosis and to support early intervention. Each time people put information into the App they will receive ‘EMPOWER messages.’ These messages include practical advice and suggestions related to questions asked in the App. Many include links to further information. Messages are intended to help people have a greater sense of control over their mental health and to support self-management. Information entered into the App will also be monitored by health professionals in our research team. Where it looks like someone may be starting to experience problems then further action can be taken to support that person. For example, they may be contacted by the research team to see whether there is any need for additional help. We will also interact with service providers to support and encourage early intervention. Our team also includes Peer Support Workers who will support people to use and benefit from the App. Peer Support Workers have their own lived experiences of psychosis and are familiar with how the App works. Another function of the App is the facility for people to view charts that show how things have been changing for people using the App over time. We believe this sort of information can help people identify their own individual patterns and identify areas to focus on. People using the App choose whether or not to share these charts with other people. An optional diary function also allows people to record how things have been for them and what they have been up to. WHO IS TAKING PART IN THE STUDY? People are eligible to participate if they are over sixteen and are in contact with certain community mental health services in or around Glasgow in Scotland and Melbourne in Australia. People also need to have a psychiatric diagnosis of schizophrenia or a similar condition. We also look for evidence that people taking part have had a relapse of psychosis within the previous two years. People taking part in the study can also nominate a friend or family to be involved if they want. HOW WILL THE RESEARCH WORK EMPOWER is a two phase mixed methods study. This means we will use qualitative and quantitative methods over two parts. Phase one involves examining different perspectives on early signs monitoring, preferences for using mobile technology and current opportunities and barriers to help-seeking. In this phase we will run focus groups with people in receipt of services, people providing services and informal carers. Information gathered at this stage will inform how the App is developed and the approach to testing in phase two. Phase two involves a cluster randomized controlled trial (C-RCT) in community based mental health services operated within the NHS Greater Glasgow and Clyde and NorthWestern Mental Health areas. This will involve selecting six teams in Scotland and two in Australia. From those eight teams four will be randomly selected to use the App over one year and four will provided with their normal treatment and support. Up to one hundred and twenty people with experiences of psychosis will be involved in the study. We will ask everyone involved in the study research questions at set time points and then compare how people using the App get on compared to people receiving their normal care and treatment (but no App). We will also assess how the App performs and how safe the approach is. Information we collect will also be used to inform the design of a larger study that we hope to run in the future. You can read more about the EMPOWER study at our website: www.empowerstudy.net

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH