PDF(Pubmed)
Abstract：
BACKGROUND: 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).
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：研究试验的参与者通常会发现严重的抑郁症状，包括自我伤害和自杀意念的想法，在经过验证的自我管理问卷中，如患者健康问卷（PHQ-9）。然而,没有应对此类披露的标准协议，并且可能会错过支持处于危险中的人的机会。我们制定并评估了IBD-BOOST随机对照试验的风险评估方案（ISRCTN7161846109/09/2019）。
方法：参与者在基线和6个月和12个月随访时完成了PHQ-9。试验数据库自动提醒研究团队对参与者进行风险评估。试验研究人员，受过协议训练，通过电话联系参与者，完成了风险评估，并为参与者提供适当的专业服务。
结果：在试验中随机分配了780名参与者；41名参与者需要进行风险评估。一名参与者拒绝评估，因此完成了40项风险评估。24名参与者被评估为低风险，16名参与者被评估为中等风险。有12人宣布以前的自杀企图。没有人被评为高风险。试验参与者对被联系表示感谢，除两名外，所有人都希望获得有关专业支持服务的信息。审判风险评估人员报告了进行风险评估的积极经验，并提出了改进建议，这导致了对协议的微小修改。
结论：我们的评估表明，研究试验团队成功地对报告自我伤害想法的试验参与者进行风险评估方案是可行的。在高级同事的培训和支持下。培训和交付需要资源，但这并不过于繁重。试验参与者似乎认为完成评估是可以接受的。
方法：参与者在基线和6个月和12个月随访时完成了PHQ-9。试验数据库自动提醒研究团队对参与者进行风险评估。试验研究人员，受过协议训练，通过电话联系参与者，完成了风险评估，并为参与者提供适当的专业服务。
结果：在试验中随机分配了780名参与者；41名参与者需要进行风险评估。一名参与者拒绝评估，因此完成了40项风险评估。24名参与者被评估为低风险，16名参与者被评估为中等风险。有12人宣布以前的自杀企图。没有人被评为高风险。试验参与者对被联系表示感谢，除两名外，所有人都希望获得有关专业支持服务的信息。审判风险评估人员报告了进行风险评估的积极经验，并提出了改进建议，这导致了对协议的微小修改。
结论：我们的评估表明，研究试验团队成功地对报告自我伤害想法的试验参与者进行风险评估方案是可行的。在高级同事的培训和支持下。培训和交付需要资源，但这并不过于繁重。试验参与者似乎认为完成评估是可以接受的。
