A randomized, controlled trial of the safety planning intervention: Research design and methods

Abstract

BACKGROUND: Brief interventions for suicide risk among patients treated in acute care settings like the emergency department are needed. The Safety Planning Intervention is a promising approach but has yet to undergo a high quality, individual level randomized controlled trial. PURPOSE: This paper describes the methods associated with an individual level randomized controlled trial of the Safety Planning Intervention compared to a control condition comprised of reviewing risk factors and warning signs. METHODS: The sample comprised patients 18 years and older presenting to one of three different emergency departments with suicide related emergencies (target n = 484). Eligible patients were approached, consented, and randomized to the intervention (Safety Planning Intervention) or control (risk factors and warning signs). They were assessed at 1, 3 and 6 months after their index visit. The primary outcome is suicidal behavior. The study also assessed mechanisms of action. Data analyses are pending. CONCLUSIONS: We identified and addressed key challenges to studying suicidal patients in the emergency department, including difficulty enrolling during the emergency department visit, ascertaining outcomes in patients that are historically very difficult to follow, and addressing the ambiguity of suicidal behavior. ClinicalTrials.gov Identifier: NCT03227991.