Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, UK.
Trials. 2024 Jul 12;25(1):476. doi: 10.1186/s13063-024-08276-6.
Participants in research trials often disclose severe depression symptoms, including thoughts of self-harm and suicidal ideation, in validated self-administered questionnaires such as the Patient Health Questionnaire (PHQ-9). However, there is no standard protocol for responding to such disclosure, and the opportunity to support people at risk is potentially missed. We developed and evaluated a risk assessment protocol for the IBD-BOOST randomised controlled trial (ISRCTN71618461 09/09/2019).
Participants completed the PHQ-9 at baseline and 6-month and 12-month follow-ups. The trial database automatically alerted the research team to risk assess participants. Trial researchers, trained in the protocol, contacted participants by telephone, completed the risk assessment, and signposted participants to appropriate professional services.
Seven hundred eighty participants were randomised in the trial; 41 required risk assessment. One participant declined assessment, so 40 risk assessments were completed. Twenty-four participants were assessed as low-risk and 16 participants as medium-risk, with 12 declaring previous suicide attempts. None were rated as high-risk. Trial participants expressed appreciation for being contacted, and all except two wished to receive information about professional support services. Trial risk assessors reported positive experiences of conducting the risk assessment with suggestions for improvement, which resulted in minor modifications to the protocol.
Our evaluation demonstrated that it was viable for a research trial team to successfully conduct a risk-assessment protocol for trial participants reporting thoughts of self-harm, with training and support from senior colleagues. Resources are required for training and delivery, but it is not unduly onerous. Trial participants appeared to find completing the assessment acceptable.
研究试验的参与者经常在经过验证的自我管理问卷（如 PHQ-9）中披露严重的抑郁症状，包括自我伤害和自杀意念的想法。然而，目前没有针对这种披露情况的标准应对方案，因此可能会错失支持处于风险中的人的机会。我们为 IBD-BOOST 随机对照试验（ISRCTN71618461 09/09/2019）开发并评估了一种风险评估方案。
参与者在基线和 6 个月及 12 个月的随访时完成 PHQ-9 问卷。试验数据库会自动向研究团队发出风险评估警报。接受过方案培训的试验研究人员通过电话联系参与者，完成风险评估，并为参与者提供适当的专业服务。
该试验共纳入 780 名参与者；其中 41 名需要进行风险评估。有 1 名参与者拒绝评估，因此完成了 40 次风险评估。24 名参与者被评估为低风险，16 名参与者为中风险，其中 12 名参与者曾有过自杀企图。没有人被评估为高风险。试验参与者对被联系表示赞赏，除了两人外，所有人都希望收到有关专业支持服务的信息。试验风险评估员报告称，他们对进行风险评估的经验感到满意，并提出了一些改进建议，这些建议导致方案进行了微小的修改。
我们的评估表明，对于一个研究试验团队来说，通过向资深同事进行培训和支持，成功地对报告有自杀想法的试验参与者进行风险评估是可行的。虽然需要资源进行培训和交付，但这并不是过于繁重的负担。试验参与者似乎对完成评估表示接受。
