O'Connor Rory C, Ferguson Eamonn, Scott Fiona, Smyth Roger, McDaid David, Park A-La, Beautrais Annette, Armitage Christopher J
Suicidal Behaviour Research Laboratory, Institute of Health & Wellbeing, University of Glasgow, Glasgow, UK.
School of Psychology, University of Nottingham, Nottingham, UK.
Lancet Psychiatry. 2017 Jun;4(6):451-460. doi: 10.1016/S2215-0366(17)30129-3. Epub 2017 Apr 20.
We investigated whether a volitional helpsheet (VHS), a brief psychological intervention, could reduce repeat self-harm in the 6 months following a suicide attempt.
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.
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.
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.
Chief Scientist Office (CZH/4/704).
我们调查了一种简短的心理干预措施——自愿帮助手册(VHS)是否能在自杀未遂后的6个月内减少重复自我伤害行为。
我们开展了一项前瞻性、单中心、随机对照试验。在英国爱丁堡一家医院因自杀未遂入院的患者,如果年龄超过16岁、有自我伤害的自述病史、英语流利、身体状况适合接受访谈且未参与医院内的其他研究,则被认为符合研究条件。符合条件的患者通过基于网络的随机化方法被随机分配(1:1),分别接受VHS加常规治疗(干预组)或仅接受常规治疗(对照组)。随机化按性别和自我报告的既往自我伤害史进行分层。国民健康服务体系(NHS)信息服务部的工作人员以及从病历中提取数据的人员对参与者被分配到的研究组情况不知情。医院内的临床工作人员对参与者的随机分组状态也不知情。有三个主要结局:在6个月随访期内因自我伤害再次入院的参与者比例;在6个月随访期内参与者因自我伤害再次入院的次数;以及通过避免的每例自我伤害事件的估计增量成本衡量的VHS的成本效益。在所有随机分组的患者中分析主要结局。随访数据收集自NHS信息服务部和患者病历。该试验已在国际标准随机对照试验编号注册库注册,编号为ISRCTN99488269。
在2012年5月9日至2014年2月24日期间,我们评估了1308人是否符合条件。其中,259名患者被随机分配到干预组,259名患者被随机分配到对照组。我们获得了518名患者中512名(99%)的完整随访数据(干预组有5名参与者失访,对照组有1名参与者失访)。分配到干预组的11名患者未在医院完成VHS。总体而言,干预措施并未影响因自我伤害再次入院的人数(干预组254名患者中有67名[26%],对照组258名患者中有71名[28%],比值比[OR]为0.90,95%置信区间[CI]为0.58 - 1.39,p = 0.63)。干预措施对每名患者再次入院的次数没有影响(干预组平均再次入院次数为0.67[标准差2.55]次,对照组为0.85[2.79]次,发生率比[IRR]为1.65,95%CI为0.74 - 3.67,p = 0.21)。VHS干预组6个月内NHS医院服务的人均总费用为513英镑,对照组为561英镑,但差异不显著(95%CI为 - 353英镑至257英镑,p = 0.76)。在首次自杀未遂后的6个月内,有3名患者自杀死亡(干预组1名,对照组2名)。两组均未报告意外效应或不良事件。
对于主要结局,两组之间没有显著差异。尽管VHS没有总体效果,但事后分析表明,VHS可能对完成帮助手册且既往因自我伤害入院的自杀未遂者减少自我伤害重复次数有效。这是第一项调查VHS对自杀未遂者减少自我伤害有用性的研究。这些亚组研究结果需要重复验证。VHS在因不同动机自我伤害者中的潜在用途需要进一步探索。
首席科学家办公室(CZH/4/704)