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

Development and Preliminary Evaluation of a Suicidal Risk Assessment Protocol

Background

Participants in research trials often report severe depression symptoms, including thoughts of self-harm and suicidal ideation. The lack of a standard protocol to respond to such disclosures may result in missed opportunities to support at-risk individuals.

Methods

Participants in the IBD-BOOST trial completed the Patient Health Questionnaire (PHQ-9) at baseline and follow-ups. The trial database alerted the research team to conduct risk assessments. Trained trial researchers contacted participants by telephone, completed the risk assessment, and directed participants to appropriate professional services.

Results

Of 780 trial participants, 41 required risk assessment, with 40 assessments completed. Twenty-four participants were assessed as low-risk, 16 as medium-risk, and none as high-risk. Trial participants appreciated being contacted and expressed interest in receiving information about professional support services. Risk assessors reported positive experiences and provided suggestions for protocol improvement.

Discussion

The evaluation showed that it was feasible for the research trial team to conduct a risk-assessment protocol for participants reporting self-harm thoughts, with training and support. While resources are needed for training and delivery, the process was not overly burdensome, and participants found it acceptable.

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