TY - JOUR AU - M. Slade AU - S. Rennick-Egglestone AU - C. Robinson AU - C. Newby AU - R. A. Elliott AU - Y. Ali AU - C. Yeo AU - T. Glover AU - S. P. Gavan AU - L. Paterson AU - K. Pollock AU - S. Priebe AU - G. Thornicroft AU - J. Keppens AU - M. Smuk AU - D. Franklin AU - R. Walcott AU - J. Harrison AU - D. Robotham AU - S. Bradstreet AU - S. Gillard AU - P. Cuijpers AU - M. Farkas AU - D. Ben-Zeev AU - J. Repper AU - Y. Kotera AU - J. Roe AU - J. Llewellyn-Beardsley AU - F. Ng A1 - AB - BACKGROUND: The Narrative Experiences Online (NEON) Intervention provides self-managed web-based access to mental health recovery narratives (n = 659). We evaluated effectiveness and cost-effectiveness in improving quality of life for adults resident in England with mental health problems and recent psychosis experience. METHODS: Prospectively registered pragmatic parallel-group randomised trial controlling for usual care, recruiting from statutory mental health services and through community engagement activities, with a 52-week primary endpoint (ISRCTN11152837). All trial procedures and the NEON Intervention were delivered by an integrated web-application. Randomisation was through an independently generated list (no stratification). Allocation was masked for statistical staff and the Chief Investigator but not participants. Intervention arm participants received immediate NEON Intervention access. Control arm participants received access after completing primary endpoint questionnaires. The primary outcome was quality of life through the Manchester Short Assessment (MANSA). Serious Adverse Events (SAEs) were collected through web-based safety report forms and identified from health service usage data. The primary analysis was by a prospectively described Intention To Treat principle excluding participants who had registered multiple times, with multiple imputation for missing data. FINDINGS: Between 9 March 2020 and 1 March 2021, 739 participants were randomised (intervention:370; control: 369), providing more than 90% power to detect a baseline-adjusted difference of 0.25 in the MANSA score. Mean age was 34.8 years (standard deviation (SD) 12.0), 561 (75.9%) were white British, 443 (59.9%) were female, 609 (82.4%) had accessed specialist care mental health services, and 698 (94.5%) had accessed primary care mental health services. Mean baseline MANSA score was 3.7 for control and intervention arms (SD 0.9 and 1.0). 565 (76.5%) participants provided primary endpoint MANSA data with a mean score of 4.1 (SD 1.0) for both arms. We found no significant difference in Quality of Life between the two arms at the primary endpoint (baseline-adjusted difference 0.07, 95% CI -0.07 to 0.21, p = 0.35). The incremental cost-effectiveness ratio (£110,501 per quality-adjusted life-year (QALY)) exceeded the prospectively defined cost-effectiveness threshold (£30,000 per QALY). 158 (42.8%) control arm and 194 (52.4%) intervention arm participants accessed narratives outside of the NEON Intervention. There were no related serious adverse events (SAEs). 116 unrelated SAEs were reported by control arm participants, and 107 by intervention arm participants. INTERPRETATION: Our findings do not indicate NEON Intervention access for all people with psychosis experience. Future research should consider a) evaluation with current mental health services users; b) optimisation to enable users to find hope-promoting narratives. FUNDING: National Institute for Health and Care Research (NIHR). AD - School of Health Sciences, Institute of Mental Health, University of Nottingham, Nottingham, UK.; Health and Community Participation Division, Faculty of Nursing and Health Sciences, Nord University, Namsos, Norway.; Centre for Evaluation and Methods, Wolfson Institute of Population Health, Pragmatic Clinical Trials Unit, Queen Mary University of London, London, UK.; School of Medicine, University of Nottingham, Nottingham, UK.; Manchester Centre for Health Economics, Division of Population Health, Health Services Research & Primary Care, University of Manchester, Manchester, UK.; Department of Architecture and Built Environment, Faculty of Engineering, University of Nottingham, UK.; DRT Software, Nottingham, UK.; School of Health Sciences, University of Nottingham, Nottingham, UK.; Unit for Social and Community Psychiatry, East London NHS Foundation Trust, London, UK.; Centre for Implementation Science and Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.; Department of Informatics, King's College London, London, UK.; Centre for Genomics and Child Health, Blizard Institute, Queen Mary University of London, London, UK.; NEON Lived Experience Advisory Panel, Nottingham, UK.; School of Health and Related Research, University of Sheffield, Sheffield, UK.; Black Communication and Technology Lab, Department of Communication, University of Maryland, College Park, MD, USA.; McPin Foundation, London, UK.; Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.; School of Health Sciences, City, University of London, London, UK.; Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.; Babeș-Bolyai University, International Institute for Psychotherapy, Cluj-Napoca, Romania.; Center for Psychiatric Rehabilitation, College of Health and Rehabilitation Sciences, Boston University, Boston, MA, USA.; Behavioral Research in Technology and Engineering (BRiTE) Center, School of Medicine, University of Washington, Seattle, WA, USA.; ImROC, Nottingham, UK.; Center for Infectious Disease Education and Research, Osaka University, Osaka, Japan.; National Institute for Health and Care Research (NIHR) Applied Research Collaboration East Midlands, University of Nottingham, Nottingham, UK. AN - 39507771 BT - Lancet Reg Health Eur C5 - Healthcare Disparities; HIT & Telehealth DA - Dec DO - 10.1016/j.lanepe.2024.101101 DP - NLM ET - 20241023 JF - Lancet Reg Health Eur LA - eng N2 - BACKGROUND: The Narrative Experiences Online (NEON) Intervention provides self-managed web-based access to mental health recovery narratives (n = 659). We evaluated effectiveness and cost-effectiveness in improving quality of life for adults resident in England with mental health problems and recent psychosis experience. METHODS: Prospectively registered pragmatic parallel-group randomised trial controlling for usual care, recruiting from statutory mental health services and through community engagement activities, with a 52-week primary endpoint (ISRCTN11152837). All trial procedures and the NEON Intervention were delivered by an integrated web-application. Randomisation was through an independently generated list (no stratification). Allocation was masked for statistical staff and the Chief Investigator but not participants. Intervention arm participants received immediate NEON Intervention access. Control arm participants received access after completing primary endpoint questionnaires. The primary outcome was quality of life through the Manchester Short Assessment (MANSA). Serious Adverse Events (SAEs) were collected through web-based safety report forms and identified from health service usage data. The primary analysis was by a prospectively described Intention To Treat principle excluding participants who had registered multiple times, with multiple imputation for missing data. FINDINGS: Between 9 March 2020 and 1 March 2021, 739 participants were randomised (intervention:370; control: 369), providing more than 90% power to detect a baseline-adjusted difference of 0.25 in the MANSA score. Mean age was 34.8 years (standard deviation (SD) 12.0), 561 (75.9%) were white British, 443 (59.9%) were female, 609 (82.4%) had accessed specialist care mental health services, and 698 (94.5%) had accessed primary care mental health services. Mean baseline MANSA score was 3.7 for control and intervention arms (SD 0.9 and 1.0). 565 (76.5%) participants provided primary endpoint MANSA data with a mean score of 4.1 (SD 1.0) for both arms. We found no significant difference in Quality of Life between the two arms at the primary endpoint (baseline-adjusted difference 0.07, 95% CI -0.07 to 0.21, p = 0.35). The incremental cost-effectiveness ratio (£110,501 per quality-adjusted life-year (QALY)) exceeded the prospectively defined cost-effectiveness threshold (£30,000 per QALY). 158 (42.8%) control arm and 194 (52.4%) intervention arm participants accessed narratives outside of the NEON Intervention. There were no related serious adverse events (SAEs). 116 unrelated SAEs were reported by control arm participants, and 107 by intervention arm participants. INTERPRETATION: Our findings do not indicate NEON Intervention access for all people with psychosis experience. Future research should consider a) evaluation with current mental health services users; b) optimisation to enable users to find hope-promoting narratives. FUNDING: National Institute for Health and Care Research (NIHR). PY - 2024 SN - 2666-7762 SP - 101101 ST - Effectiveness and cost-effectiveness of online recorded recovery narratives in improving quality of life for people with psychosis experience (NEON Trial): a pragmatic randomised controlled trial T1 - Effectiveness and cost-effectiveness of online recorded recovery narratives in improving quality of life for people with psychosis experience (NEON Trial): a pragmatic randomised controlled trial T2 - Lancet Reg Health Eur TI - Effectiveness and cost-effectiveness of online recorded recovery narratives in improving quality of life for people with psychosis experience (NEON Trial): a pragmatic randomised controlled trial U1 - Healthcare Disparities; HIT & Telehealth U3 - 10.1016/j.lanepe.2024.101101 VL - 47 VO - 2666-7762 Y1 - 2024 ER -