Statistical analysis plans for two randomised controlled trials of the Narrative Experiences Online (NEON) Intervention: impact of receiving recorded mental health recovery narratives on quality of life in people experiencing psychosis (NEON) and people experiencing non-psychosis mental health problems (NEON-O)

作者：Clare Robinson, Chris Newby, Stefan Rennick‐Egglestone, Joy Llewellyn‐Beardsley, Fiona Ng, Rachel Elliott, Mike Slade · 发表于：Trials · 年份：2023 · DOI：10.1186/s13063-023-07246-8 · 被引用次数：9 · 研究领域：Mental Health and Patient Involvement、Mental Health and Psychiatry、Schizophrenia research and treatment

BACKGROUND: Mental health recovery narratives are a first-hand account of an individual's recovery from mental health distress, access to narratives can aid recovery. The NEON Intervention is a web-application providing access to a managed collection of narratives. We present the statistical analysis plan for assessing the effectiveness of the NEON Intervention in improving quality of life at 1-year post-randomisation. We pay particular focus on the statistical challenges encountered due to the online nature of this trial. METHODS AND DESIGN: The NEON Intervention is assessed in two trial populations, one for people with experience of psychosis in the last 5 years, and mental health distress in the last six months (NEON Trial) and one for people with experience of non-psychosis mental health problems (NEON-O Trial). Both NEON trials are two-arm randomised controlled superiority trials comparing the effectiveness of the NEON Intervention with usual care. The target sample size is 684 randomised participants for NEON and 994 for NEON-O. Participants were randomised centrally in a 1:1 ratio. RESULTS: The primary outcome is the mean score of subjective items on the Manchester Short Assessment of Quality-of-Life questionnaire (MANSA) at 52 weeks. Secondary outcomes are scores from the Herth Hope Index, Mental Health Confidence Scale, Meaning of Life questionnaire, CORE-10 questionnaire and Euroqol 5-Dimension 5-Level (EQ-5D-5L). CONCLUSION: This manuscript is the statistical analy...