A brief psychological intervention to reduce repetition of self-harm in patients admitted to hospital following a suicide attempt: a randomised controlled trial

BACKGROUND We investigated whether a volitional helpsheet (VHS), a brief psychological intervention, could reduce repeat self-harm in the 6 months following a suicide attempt. METHODS We did a prospective, single-site, randomised controlled trial. Patients admitted to a hospital in Edinburgh, UK, after a suicide attempt were deemed eligible for the study if they were over the age of 16 years, had a self-reported history of self-harm, were fluent in English, were medically fit to interview, and were not participating in other research studies within the hospital. Eligible patients were randomly assigned (1:1), via web-based randomisation, to receive either VHS plus usual treatment (intervention group) or only treatment as usual (control group). Randomisation was stratified by sex and self-reported past self-harm history. The Information Services Division of the National Health Service (NHS-ISD) staff and those extracting data from medical notes were masked to the study group the participant was allocated to. Clinical staff working within the hospital were also masked to participants' randomisation status. There were three primary outcomes: the proportion of paticipants who re-presented to hospital with self-harm during the 6-month follow-up period; the number of times a participant re-presented to hospital with self-harm during the 6-month follow-up period; and cost-effectiveness of the VHS as measured by estimated incremental cost per self-harm event averted. Primary outcomes were analysed in all randomised patients. Follow-up data collection was extracted from the Information Services Division of the NHS and from patient medical records. The trial is registered with International Standard Randomised Controlled Trial Number Registry, number ISRCTN99488269. FINDINGS Between May 9, 2012, and Feb 24, 2014, we assessed 1308 people for eligibility. Of these, 259 patients were randomly assigned to the intervention group and 259 to the control group. We obtained complete follow-up data on 512 (99%) of 518 patients (five participants were lost to follow-up in the intervention group and one in the control group). 11 patients assigned to the intervention group did not complete the VHS in hospital. Overall, the intervention did not affect the number of people who re-presented with self-harm (67 [26%] of 254 patients in the intervention group vs 71 [28%] of 258 patients in the control group, odds ratio [OR] 0·90, 95% CI 0·58-1·39, p=0·63). The intervention had no effect on the number of re-presentations per patient (mean 0·67 [SD 2·55] re-presentations for the intervention group vs 0·85 [2·79] for the control group, incident rate ratio [IRR] 1·65, 95% CI 0·74-3·67, p=0·21). Mean total costs per person for NHS hospital services in the VHS intervention group over the 6 months were £513 versus £561 in the control group but this difference was not significant (95% CI-£353 to £257, p=0·76). Three patients died by suicide in the 6 months following their index suicide attempt (one in the intervention group and two in the control group). There were no reported unintended effects or adverse events in either group. INTERPRETATION For the primary outcomes, there were no significant differences between groups. Although the VHS had no overall effect, post-hoc analyses suggest VHS might be effective in reducing the number of self-harm repetitions following a suicide attempt in people who complete the helpsheet and who have been previously admitted to hospital with self-harm. This is the first study to investigate the usefulness of the VHS to reduce self-harm among those who have attempted suicide. These subgroup findings require replication. The potential use of the VHS in those who self-harm for different motives requires further exploration. FUNDING Chief Scientist Office (CZH/4/704).