Trials (Jan 2022)
Impact of receiving recorded mental health recovery narratives on quality of life in people experiencing non-psychosis mental health problems (NEON-O Trial): updated randomised controlled trial protocol
Abstract
Abstract Background Mental health recovery narratives are first-person lived experience accounts of recovery from mental health problems, which refer to events or actions over a period of time, and which include elements of adversity or struggle, and also self-defined or observable strengths, successes, or survival. Recorded recovery narratives are those presented in invariant form, including text, audio, or video. In a previous publication, we presented a protocol for three pragmatic trials of the Narrative Experiences Online (NEON) Intervention, a web application recommending recorded recovery narratives to participants. The aim of the definitive NEON Trial was to understand whether the NEON Intervention benefitted people with experience of psychosis. The aim of the smaller NEON-O and NEON-C trials was to evaluate the feasibility of conducting definitive trials of the NEON Intervention with people (1) experiencing non-psychosis mental health problems and (2) who informally care for others experiencing mental health problems. An open recruitment strategy with a 60-week recruitment period was developed. Recruitment for the NEON Trial and NEON-O Trial targeted mental health service users and people not using mental health services. The NEON Trial recruited to time and target. The NEON-O Trial achieved its target in 10 weeks. Analysis considered by a Programme Steering Committee after the target was achieved demonstrated a definitive result could be obtained if the trial was adapted for recruitment to continue. The UK Health Research Authority approved all needed amendments following ethical review. Purpose of this article To describe the decision-making process for amending the NEON-O Trial and to describe amendments made to the NEON-O Trial to enable a definitive result. The article describes amendments to the aims, objectives, design, power calculation, recruitment rate, process evaluation design, and informed consent documents. The extended NEON-O Trial adopts analysis principles previously specified for the NEON Trial. The article provides a model for other studies adapting feasibility trials into definitive trials. Trial registration All trials prospectively registered. NEON Trial: ISRCTN11152837 . Registered on 13th August 2018. NEON-C Trial: ISRCTN76355273 . Registered on 9th January 2020. NEON-O Trial: ISRCTN63197153 . Registered on 9th January 2020. The NEON-O Trial ISRCTN was updated when amendments were approved. Amendment details: NOSA2, 30th October 2020.
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