The BEACON Study: Protocol for a cohort study as part of an evaluation of the effectiveness of smartphone-assisted problem-solving therapy in men who present with intentional self-harm to Emergency Departments in Ontario

Abstract

Background: Patients who present to Emergency Departments (ED) after intentional self-harm are at an increased risk of dying by suicide. This applies particularly to men, who represent nearly two-thirds of those who die by suicide in Ontario. One way of potentially addressing this gap is to offer a course of blended problem-solving therapy (PST), comprised of a brief course of evidence-based psychotherapy for individuals at-risk for suicide, facilitated by the use of a patient-facing smartphone application and a clinician-facing "dashboard". This approach has the potential to combine the benefits of face to face therapy and technology to create a novel intervention.Methods: This is a cohort study, nested within a larger pragmatic multicentre pre-and post-design cluster randomized trial (cRCT). Suicidal ideas assessed by the Beck Scale for Suicide Ideation (BSS) is the primary outcome variable. Secondary outcome measures include: depression (PHQ-9); anxiety (GAD-7); PTSD (PC-PTSD); health-related quality of life (EQ-5D-5L); meaning in life (EMIL); perceived social supports (MSPSS); alcohol use (AUDIT); drug use (DAST-10); problem-solving skills (SPSI-R:S); self-reported health care costs; and, health service use measured using Ontario administrative health data. A process evaluation will also be conducted following study completion. Discussion:The cohort study will test whether better adherence to the intervention results in better outcomes. The value of the cohort study design is that we can examine in more detail certain subgroups or other variables that are not available in the larger cluster randomised trial. This trial will aim to improve standards by informing best practice in management of men who self-harm and present to hospitals in Ontario. Trial registration: ClinicalTrials.gov: NCT03473535, Registered on March 22, 2018, https://clinicaltrials.gov/ct2/show/NCT03473535

The BEACON study: an update to the protocol for a cohort study as part of an evaluation of the effectiveness of smartphone-assisted problem-solving therapy in men who present with intentional self-harm to emergency departments in Ontario

“…We originally proposed a cohort study nested within a larger cluster randomized trial wherein intervention sites would deliver the blended care, and control sites, whose personnel were not aware of their participation, would continue delivering usual care. The cohort study evaluated participant level outcomes as previously described by Hatcher et al (2020). Due to pandemic-related constraints, our number of participating sites dropped to five potential sites which left the cohort study underpowered.…”

“…The original study design was a cohort study nested within a larger pragmatic multicenter pre-and post-design cluster randomized trial [1]. The COVID-19 pandemic resulted in a priority shift away from research at our randomized community sites resulting in their complete drop-out from the trial, leaving the cohort study underpowered with only 5 potential sites.…”

“…This update describes amendments to study design, recruitment, implementation, and study outcomes and should be read alongside the previously published protocol [1]. The changes were employed due to the COVID-19 pandemic and the resulting impact on sites' ability to conduct study activities.…”

The BEACON Study: An update to the protocol for a cohort study as part of an evaluation of the effectiveness of smartphone-assisted problem-solving therapy in men who present with intentional self-harm to emergency departments in Ontario

“…We originally proposed a cohort study nested within a larger cluster randomized trial wherein intervention sites would deliver the blended care, and control sites, whose personnel were not aware of their participation, would continue delivering usual care. The cohort study evaluated participant level outcomes as previously described by Hatcher et al (2020). Due to pandemic related constraints, our number of participating sites dropped to ve potential sites which left the cohort study underpowered.…”

“…The original study design was a cohort study nested within a larger pragmatic multicenter pre-and postdesign cluster randomized trial (1). The COVID-19 pandemic resulted in a priority shift away from research at our randomized community sites resulting in their complete drop-out from the trial, leaving the cohort study underpowered with only 5 potential sites.…”