Slade Mike, Rennick-Egglestone Stefan, Robinson Clare, Newby Chris, Elliott Rachel A, Ali Yasmin, Yeo Caroline, Glover Tony, Gavan Sean P, Paterson Luke, Pollock Kristian, Priebe Stefan, Thornicroft Graham, Keppens Jeroen, Smuk Melanie, Franklin Donna, Walcott Rianna, Harrison Julian, Robotham Dan, Bradstreet Simon, Gillard Steve, Cuijpers Pim, Farkas Marianne, Ben-Zeev Dror, Repper Julie, Kotera Yasuhiro, Roe James, Llewellyn-Beardsley Joy, Ng Fiona
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.
Lancet Reg Health Eur. 2024 Oct 23;47:101101. doi: 10.1016/j.lanepe.2024.101101. eCollection 2024 Dec.
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.
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.
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.
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.
National Institute for Health and Care Research (NIHR).
在线叙事体验（NEON）干预提供基于网络的自我管理方式，可获取心理健康康复叙事（共659篇）。我们评估了该干预措施对英格兰患有心理健康问题且近期有精神病体验的成年人改善生活质量的有效性和成本效益。
一项前瞻性注册的实用平行组随机对照试验，对照常规护理，从法定心理健康服务机构以及通过社区参与活动招募参与者，主要终点为52周（国际标准随机对照试验编号：ISRCTN11152837）。所有试验程序和NEON干预均通过一个集成网络应用程序提供。随机化通过独立生成的列表进行（无分层）。统计人员和首席研究员对分配情况保密，但参与者知晓。干预组参与者可立即访问NEON干预。对照组参与者在完成主要终点问卷后可获得访问权限。主要结局是通过曼彻斯特简短评估（MANSA）得出的生活质量。严重不良事件（SAE）通过基于网络的安全报告表收集，并从卫生服务使用数据中识别。主要分析采用前瞻性描述的意向性分析原则，排除多次注册的参与者，并对缺失数据进行多重插补。
在2020年3月9日至2021年3月1日期间，739名参与者被随机分组（干预组：370名；对照组：369名），有超过90%的把握度检测到MANSA评分中经基线调整后的差异为0.25。平均年龄为34.8岁（标准差（SD）12.0），561名（75.9%）为英国白人，443名（59.9%）为女性，609名（82.4%）曾使用过专科心理健康服务，698名（94.5%）曾使用过初级保健心理健康服务。对照组和干预组的平均基线MANSA评分为3.7（标准差分别为0.9和1.0）。565名（76.5%）参与者提供了主要终点MANSA数据，并得出两组的平均评分为4.1（标准差1.0）。我们发现在主要终点时两组之间的生活质量无显著差异（经基线调整后的差异为0.07，95%置信区间为-0.07至0.21，p = 0.35）。增量成本效益比（每质量调整生命年（QALY）110,501英镑）超过了前瞻性定义的成本效益阈值（每QALY 30,000英镑）。158名（42.8%）对照组和194名（52.4%）干预组参与者在NEON干预之外访问了叙事内容。未出现相关严重不良事件（SAE）。对照组参与者报告了116起无关SAE，干预组参与者报告了107起。
我们的研究结果并未表明所有有精神病体验的人都可使用NEON干预。未来研究应考虑：a）对当前心理健康服务使用者进行评估；b）进行优化，以便使用者能够找到促进希望的叙事内容。
国家卫生与保健研究所（NIHR）。
