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Improving outcomes in adult patients who self-harm—evaluating a brief psychological intervention in emergency departments (ASSURED): protocol of a randomised controlled clinical trial

McCabe, R. ORCID: 0000-0003-2041-7383, Suzuki, M. ORCID: 0000-0001-5242-0195, O’Keeffe, S. , Walker, N., Hooper, R., Priebe, S., Mihaylova, B., Feng, Y., Dickens, C., Aitken, P., Soares, V. A., Byng, R., Giacco, D., Kapur, N., Lee, W., Riou, P., Ryan, M., Simpson, A., Smith, H., Goldsmith, L. P. & Bakou, A. E. ORCID: 0000-0002-4813-7212 (2026). Improving outcomes in adult patients who self-harm—evaluating a brief psychological intervention in emergency departments (ASSURED): protocol of a randomised controlled clinical trial. Trials, 27(1), article number 172. doi: 10.1186/s13063-025-09411-7

Abstract

Background
Patients with self-harm and suicidal ideation are increasingly presenting in emergency departments (ED) in the UK. Self-harm is the strongest risk factor for suicide. Currently, there are no evidence-based interventions for self-harm offered in the context of general hospitals in the UK. This trial, funded by the National Institute for Health and Care Excellence (NIHR), aims to assess the clinical and cost-effectiveness of the ASSURED intervention. The ASSURED intervention includes up to five rapid follow-up contacts, comprising a narrative interview and enhanced safety planning session and three solution-focused sessions. The trial is sponsored by Devon Partnership NHS Trust and City St George’s, University of London.

Methods
ASSURED is a multicentre, two-arm, parallel-group, individually randomised, controlled trial comparing the ASSURED intervention with usual care. The primary outcome is whether study participants re-attend ED and are referred to liaison psychiatry within 18 months from the date of randomisation. Secondary outcomes include suicidality, self-reported self-harm, psychological wellbeing, social outcomes, experiences of attending the ED, and suicide. The study will also evaluate the cost-effectiveness of the intervention. The aim of this study was to recruit and randomise 620 patients across 14 acute hospital sites in London, Devon, Somerset, and the Midlands. Participants are invited to complete research assessments at baseline and 3, 9, and 18 months. The first participant was enrolled in the study in August 2022, and the recruitment target was met in December 2024.

Discussion
This will be the first UK trial to test the effectiveness and cost-effectiveness of a rapid intervention for patients presenting to EDs with self-harm and suicidal ideation and has the potential to improve outcomes for these patients.

Publication Type: Article
Additional Information: This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
Publisher Keywords: Self-harm, Non-suicidal self-injury, Suicidal ideation, Emergency department, Narrative interviewing, Safety plan, Psychological intervention, Solution-focused brief therapy, Randomised controlled clinical trial, Protocol
Subjects: B Philosophy. Psychology. Religion > BF Psychology
Departments: School of Health & Medical Sciences
School of Health & Medical Sciences > Department of Population Health & Policy
SWORD Depositor:
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