BEACON Suicide Prevention in Men Study

NCT03473535 | Unknown DMC

• 1 other identifier: CTO-0790-B
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the use of problem-solving therapy (PST), supplemented by a smartphone application, in the treatment of men who present to the Emergency Departments in Ontario. A total of 100 men in 5 Emergency Departments will be enrolled and randomized to receive either face-to-face PST or face-to-face PST supplemented by the BEACON Suicide Prevention smartphone application. Face-to-face therapy may be provided via videoconference to accommodate patient preference and ongoing pandemic restrictions. Participants will complete six sessions of PST and outcomes will be measured at baseline, 6 weeks, two post-therapy follow-up time points (3 and 6 months). Participants will also be asked to complete a qualitative interview about their participation in the study and their experience with the smartphone application.

Conditions

Intentional Self-Harm; Suicide

Keywords

self-harm; problem-solving therapy; emergency department; e-therapy; suicide prevention

Outcome Measures

Primary Outcomes (1)

• Change in Measure of Suicidality - 24-Item Beck Scale for Suicidal Ideation (BSS)

  Self-reported measurement of the current intensity of a participant's attitudes, behaviours, and plans to die by suicide during the past week. It consists of 5 screening items, and 19 follow-up items. Each item is scored from 0 (moderate to strong) to 2 (none), yielding a total score ranging from 0 to 48, with higher scores indicating a higher risk of suicidality. Generally, scores above 24 are considered to be a clinical cutoff implying that the respondent is at significant risk for suicide.

  Baseline; Session 6; 3 months; 6 months Post-Enrollment.

Secondary Outcomes (20)

• Change in Severity of Depression Symptoms - 9-Item Patient Health Questionnaire (PHQ-9)

  Baseline; Session 6; 3 months; 6 months Post-Enrollment.

• Change in Severity of Anxiety Symptoms - 7-Item General Anxiety Disorder Questionnaire (GAD-7)

  Baseline; Session 6; 3 months; 6 months Post-Enrollment.

• Change in Post-Traumatic Stress Disorder Symptoms - 5-Item Primary Care Post-Traumatic Stress Disorder Screening Tool for DSM-5 (PC-PTSD-5)

  Baseline; Session 6; 3 months; 6 months Post-Enrollment.

• Change in Health-Related Quality of Life - 5-Item EuroQol 5 Dimensions Questionnaire (EQ-5D-5L)

  Baseline; Session 6; 3 months; 6 months Post-Enrollment

• Change in Health-Related Quality of Life - 5-Item EuroQol 5 Dimensions Questionnaire (EQ-5D-5L): Visual Analogue Scale (VAS)

  Baseline; Session 6; 3 months; 6 months Post-Enrollment.

Study Arms (2)

PST Alone

ACTIVE COMPARATOR

Participants will receive six sessions of face-to-face PST.

Behavioral: Problem-Solving Therapy

Blended-Therapy

EXPERIMENTAL

Participants with receive six sessions of face-to-face PST supplemented by the BEACON platform.

Combination Product: BEACON + Problem Solving Therapy

Interventions

BEACON + Problem Solving Therapy COMBINATION_PRODUCT

Six sessions of face-to-face PST delivered by a trained Research Therapist and access to the BEACON Suicide Prevention smartphone application.

Blended-Therapy

Problem-Solving Therapy BEHAVIORAL

Six sessions of face-to-face PST delivered by a trained Research Therapist.

PST Alone

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants who identify as male will be eligible for participation in the trial.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identifies as Male.
• years of age or older.
• Has presented via the Emergency Department with self-harm in the preceding 4 weeks
• Able to read and understand English, French or read or understand Oji Cree.
• Willing to attend six problem-solving therapy sessions for a period of up to eight weeks.
• Willing to use a smartphone application to facilitate the treatment of self-harm.
• Willing to return to the hospital for follow-up appointments.
• Willing and able to provide informed consent.
• Willing to use e-mail for study activities.

You may not qualify if:

• Identifies as female.
• Has presented to the Emergency Department for a reason other than self-harm.
• In the opinion of the investigator is unlikely to commit to a six-month long study.

Sponsors & Collaborators

• University of Ottawa: lead
• Ottawa Hospital Research Institute: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

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• Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1.

  PMID: 20053272 BACKGROUND

• Hatcher S, Heisel MJ, Ayonrinde O, Corsi D, Edgar NE, Kennedy SH, Rizvi SJ, Schaffer A, Sinyor M. 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. Trials. 2022 Oct 5;23(1):849. doi: 10.1186/s13063-022-06788-7.

  PMID: 36199120 DERIVED

• Hatcher S, Heisel M, Ayonrinde O, Campbell JK, Colman I, Corsi DJ, Edgar NE, Gillett L, Kennedy SH, Hunt SL, Links P, MacLean S, Mehta V, Mushquash C, Raimundo A, Rizvi SJ, Saskin R, Schaffer A, Sidahmed A, Sinyor M, Soares C, Taljaard M, Testa V, Thavorn K, Thiruganasambandamoorthy V, Vaillancourt C. 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. Trials. 2020 Nov 13;21(1):925. doi: 10.1186/s13063-020-04424-w.

  PMID: 33187542 DERIVED

MeSH Terms

Conditions

Self-Injurious Behavior; Suicide; Emergencies; Suicide Prevention

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Hatcher, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

• Marnin Heisel, PhD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Chair, Department of Psychiatry

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 22, 2018
• Study Start: March 31, 2020
• Primary Completion: March 31, 2023
• Study Completion: September 23, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)