Title: Building Resilience and Recovery through Enhancing Cognition and quality of LIfe in the early PSychosEs (ECLIPSE)
Funder: Department of Health and Social Care

Abstract: PATIENT and PUBLIC INVOLVEMENT We have already consulted service users and carers on treatment development and study design and will build on this to ensure active involvement in all aspects of the study. Most interventions rarely take account of either the views of patients or health care staff but this programme is different. We designed the studies to ensure continued involvement and will use their views in balancing recommendations on delivery. BACKGROUND Systematic reviews demonstrate cognitive remediation therapy (CRT) benefits1 with larger gains in younger than older patients with psychosis8. These benefits are in a diagnostic group with associated high levels of disability and NHS support throughout their lives. Interventions that improve recovery trajectories have the biggest impact if provided at the earliest opportunity within services offering other recovery opportunities. NHS benefit is not only based solely on intervention efficacy but also on the acceptability to those who provide and receive it. This is a key issue if treatment is to be cost-effective in practice. AIMS and OBJECTIVES The proposal investigates, in a novel framework of studies, the optimal method of providing CRT in EIS by assessing cost-effectiveness of alternative intervention methods by combining costs with monetary values of outcome using the net benefit approach. This will be considered alongside the views of services users and staff regarding the different modes of treatment implementation. Our objectives are: to measure feasibility; evaluate therapist training protocols; and assess preferences of staff and service users. We will evaluate factors that might impact implementation success such as organizational climate as well as explore treatment moderators that might help in tailoring individual treatments. CRT will be provided together with other services and we will explore the potential for boosting recovery outcomes with novel social cognition treatment. Finally, we will investigate how many people might benefit from such treatment and further explore factors that may affect benefits. RESEARCH PLAN WP1 &ndash; is a developmental phase which will devise satisfaction measures and preference domains using participatory methods and is service user led. Finally, we will investigate the organisational factors likely to affect implementation WP2 &ndash; develops a web-supported training programme for cognitive remediation therapists WP3 &ndash; investigates three different methods of providing CRT across ten EIS teams and will compare their outcomes with treatment as usual using a net benefit approach. The trial will stop an implementation arm at 12 months if it provides significantly poorer outcomes at greater cost than the other arms. WP4 &ndash; assesses the effects of different potential moderators of outcome to provide advice on tailoring treatment. DISSEMINATION and PROJECTED OUTPUTS We are proposing at least 20 publications throughout the programme (see Appendix p43) which disseminate information through peer review and to all relevant groups. We will provide a manual and multimedia web-available training for delivering therapy. Finally, we provide a guide to implementation of cognitive remediation for NHS managers. Many of these resources will aid other therapy implementation in NHS mental health services. Successful implementation has the potential to change the recovery trajectory of individuals with a first episode of psychosis but also provides guidance on large scale roll out to all mental health services where cognitive difficulties impact recovery and resilience. TEAM EXPERTISE The team has extensive expertise in developing, evaluating and translating therapy into practice. We have world class statistical and health economic support and, uniquely, expertise in service user involvement and implementation science. The team has managed applied programmes, large scale trials as well as observational studies and will bring their experience to ensure this programme is a success. We have included clinicians who have been influential in the development of early intervention services and currently manage those services across different geographical boundaries including rural and urban areas in order that the outputs will have most NHS relevance. MANAGEMENT and GOVERNANCE We propose a Steering committee (6 monthly), Data Monitoring and Ethics Committee (as needed), Service User Advisory Committee (4 monthly) and a Management team (monthly). Weekly site management meetings will be overseen by the programme coordinator. JUSTIFICATION of COSTS All applicants are costed for their time on the project. Research workers are allocated to specific work packages although we expect a sharing of roles as recruitment waxes and wanes. They are specified only for the time when the work package is operating. Non-pay costs include essential equipment and travel needed to see participants in teams within one trust.

Lay abstract: Cognitive problems in people with schizophrenia predict functional recovery even with the best possible rehabilitation opportunities and optimal medication. However, one new psychological treatment known as cognitive remediation (CRT) can improve cognitive and functional recovery &ndash; such as social relationships and the opportunity to go to work or take part in further education. The ideal time to provide CRT is in Early Intervention Services (EIS) as we know that it is more effective for younger people and may have larger effects on functioning if we intervene at the earliest opportunity. Our plan is to incorporate service user views of therapy implementation, develop a training programme and investigating different methods of CRT implementation to guide the UK-wide implementation. Different implementation models varying therapist input will be evaluated from different perspectives as suggested by the best practice in implementation science. We will investigate: (i) the service user perspective through effects on service user defined personal goals as well as direct cognitive and functioning gains. We will detect therapy satisfaction and the method of provision and the most sustainable therapy; (ii) the staff perspectives on the different implementation methods defined as the level of training, commitment and resource required from staff as well as organisational facilitators and barriers, and finally (iii) the provider perspective in terms of the costs and cost-effectiveness of the different methods of providing therapy. This will allow us to balance staff and service user perspectives on different intervention methods. Our research team has experts in all the different perspectives &ndash; service user researchers, staff researchers as well as health economists, statisticians, service managers, organisational behaviour specialists and practitioners. We also have the experience of implementing treatments in the NHS particularly in Early Intervention Services. In order to produce a comprehensive plan for the best implementation method we will also need to know about a number of different factors. For specific individual tailoring of therapy we need to understand which of several factors known to affect outcome are important for first episode patients. For introduction into routine practice organisational factors, such as staff resources and background treatments, might affect successful CRT implementation. All this information will allow: (i) policy makers to plan for this treatment; (ii) individual teams to understand what is required before and during implementation; and (iii) service users to receive the best individualised care to improve their recovery potential.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH