P089 Development and preliminary evaluation of a suicidal risk assessment protocol in a research trial using the Patient Health Questionnaire (PHQ-9)

Abstract

Abstract Background People with Inflammatory Bowel Disease (IBD) have an increased risk of depression and self-harm. Participants in IBD 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-9 (PHQ-9). However, there is no standard protocol for responding to such disclosure in research trials 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). Methods Participants completed the PHQ-9 scale at baseline, six-month and 12-month follow-up. Responding to item 9: ‘Thoughts that you would be better off dead or of hurting yourself in some way’, if a participant indicated ‘More than half the days’ or ‘Nearly every day’, the trial database automatically alerted the research team to risk assess the participant. Trial risk assessors, trained in the protocol, contacted participants by telephone, completed the risk assessment protocol (Figure 1) and signposted participants to appropriate professional services. Risk assessments were completed at the first occurrence of a PHQ-9 item 9 response. Risk assessments were reviewed by the Chief Investigator and summarised to trial governing committees. Results 780 participants were randomised. Overall, there were 58 PHQ-9 risk alerts during the trial (baseline, six- or 12-month follow-up), 41 of which were new alerts and required risk assessment. One participant declined assessment so 40 risk assessments were completed. 24 participants were assessed as low-risk and 16 participants as medium-risk, with 12 declaring previous suicide attempts. No participants were rated as high-risk. The mean time for the risk assessment phone call was 14 minutes (range 5-36 minutes) and total time spent on calls was approximately nine hours. Trial participants who received a risk assessment expressed appreciation for being contacted and all except two wished to receive information about professional support services. In a focus group, trial risk assessors reported positive experiences of conducting the risk assessment with suggestions for improvement, which resulted in minor modifications to the protocol. Conclusion 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. The revised protocol will be made available for researchers to use.