Kathryn Greenwood1,2, Rebecca Webb3, Jenny Gu3, David Fowler4,3,5, Richard de Visser3, Stephen Bremner6, Iga Abramowicz6, Nicky Perry7, Stuart Clark8, Anastacia O'Donnell8, Dan Charlton8, Rebecca Jarvis8, Philippa Garety9,10, Sunil Nandha10, Belinda Lennox11,12, Louise Johns11,12, Shanaya Rathod13, Peter Phiri13, Paul French14,15, Heather Law16, Jo Hodgekins5, Michelle Painter17, Cate Treise17, James Plaistow18, Francis Irwin18, Rose Thompson19, Tanya Mackay19, Carl R May20, Andy Healey9, Richard Hooper21, Emmanuelle Peters9,10. 1. R&D, Sussex Partnership NHS Foundation Trust, Hove, UK. k.e.greenwood@sussex.ac.uk. 2. School of Psychology, University of Sussex, Falmer, UK. k.e.greenwood@sussex.ac.uk. 3. School of Psychology, University of Sussex, Falmer, UK. 4. R&D, Sussex Partnership NHS Foundation Trust, Hove, UK. 5. University of East Anglia, Norwich, UK. 6. Brighton and Sussex Medical School, University of Sussex, Falmer, UK. 7. Brighton and Sussex University Hospitals NHS Trust, Brighton, UK. 8. Sussex Partnership NHS Foundation Trust, Hove, UK. 9. King's College London, Institute of Psychiatry Psychology and Neuroscience, London, UK. 10. South London and Maudsley NHS Foundation Trust, London, UK. 11. Department of Psychiatry, University of Oxford, Oxford, UK. 12. Oxford Health NHS Foundation Trust, Oxford, UK. 13. Southern Health NHS Foundation Trust, Southampton, UK. 14. Pennine Care NHS Foundation Trust, Ashton-under-Lyne, UK. 15. Manchester Metropolitan University, Manchester, UK. 16. Greater Manchester Mental Health NHS Foundation Trust, Greater Manchester, UK. 17. Cambridge and Peterborough NHS Foundation Trust, Cambridge, UK. 18. Norfolk and Suffolk NHS Foundation Trust, Norwich, UK. 19. McPin Foundation, London, UK. 20. Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK. 21. Institute of Population Health Sciences, Queen Mary University of London, London, UK.
Abstract
BACKGROUND:Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium-long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and the NHS. This study will evaluate the effectiveness, cost-effectiveness and implementation of a team-based motivational Early Youth Engagement (EYE-2) intervention. METHOD: The study design is a cluster randomised controlled trial (RCT) with economic evaluation, comparing the EYE-2 intervention + standardised EIP service to standardised EIP service alone, with randomisation at the team level. A process evaluation will evaluate the delivery of the intervention qualitatively and quantitatively across contexts. The setting is 20 EIP teams in 5 sites: Manchester, South London, East Anglia, Thames Valley and Hampshire. Participants are young people (14-35 years) with first episode psychosis, and EIP staff. The intervention is the team-based motivational engagement (EYE-2) intervention, delivered alongside standardised EIP services, and supported by additional training, website, booklets and social groups. The comparator is the standardised EIP service. Both interventions are delivered by EIP clinicians. The primary outcome is time to disengagement (time in days from date of allocation to care coordinator to date of last contact following refusal to engage with EIP service, or lack of response to EIP contact for a consecutive 3-month period). Secondary outcomes include mental and physical health, deaths, social and occupational function, recovery, satisfaction and service use at 6, 12, 18 and 24 months. A 12-month within-trial economic evaluation will investigate cost-effectiveness from a societal perspective and from an NHS perspective. DISCUSSION: The trial will provide the first test of an engagement intervention in standardised care, with the potential for significant impact on the mental health and wellbeing of young people and their families, and economic benefits for services. The intervention will be highly scalable, supported by the toolkit including manuals, commissioning guide, training and resources, adapted to meet the needs of the diverse EIP population, and based on an in-depth process evaluation. TRIAL REGISTRATION: ISRCTN 51629746 prospectively registered 7th May 2019. Date assigned 10th May 2019.
RCT Entities:
BACKGROUND: Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium-long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and the NHS. This study will evaluate the effectiveness, cost-effectiveness and implementation of a team-based motivational Early Youth Engagement (EYE-2) intervention. METHOD: The study design is a cluster randomised controlled trial (RCT) with economic evaluation, comparing the EYE-2 intervention + standardised EIP service to standardised EIP service alone, with randomisation at the team level. A process evaluation will evaluate the delivery of the intervention qualitatively and quantitatively across contexts. The setting is 20 EIP teams in 5 sites: Manchester, South London, East Anglia, Thames Valley and Hampshire. Participants are young people (14-35 years) with first episode psychosis, and EIP staff. The intervention is the team-based motivational engagement (EYE-2) intervention, delivered alongside standardised EIP services, and supported by additional training, website, booklets and social groups. The comparator is the standardised EIP service. Both interventions are delivered by EIP clinicians. The primary outcome is time to disengagement (time in days from date of allocation to care coordinator to date of last contact following refusal to engage with EIP service, or lack of response to EIP contact for a consecutive 3-month period). Secondary outcomes include mental and physical health, deaths, social and occupational function, recovery, satisfaction and service use at 6, 12, 18 and 24 months. A 12-month within-trial economic evaluation will investigate cost-effectiveness from a societal perspective and from an NHS perspective. DISCUSSION: The trial will provide the first test of an engagement intervention in standardised care, with the potential for significant impact on the mental health and wellbeing of young people and their families, and economic benefits for services. The intervention will be highly scalable, supported by the toolkit including manuals, commissioning guide, training and resources, adapted to meet the needs of the diverse EIP population, and based on an in-depth process evaluation. TRIAL REGISTRATION: ISRCTN 51629746 prospectively registered 7th May 2019. Date assigned 10th May 2019.
Entities:
Keywords:
Early intervention; Economic evaluation; Engagement; Intervention; Process evaluation; Psychosis; RCT
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