Brief Skills for Safer Living (Brief-SfSL)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto
About this trial
The goal of this project is to assess the efficacy of Brief-Skills for Safer Living (Brief-SfSL) in a randomized control trial. The investigators will be testing 150 participants Canada-wide, half of which will be randomized to receive Brief-SfSL (B-TAU) and the other half will be randomized to receive Brief-SfSL after a 3 month waitlist (WL-TAU). The main questions this study seeks to answer are:
* Is B-TAU more efficacious than WL-TAU for reducing suicidal thoughts at 3 months? * Is B-TAU more efficacious than WL-TAU at 3 months for reducing depression severity, anxiety, and anhedonia? * Is B-TAU more efficacious than WL-TAU at 3 months for improving social connectedness, emotional regulation, functioning (work, life, social), executive control and social problem-solving? * Are adverse events equivalent between B-TAU and WL-TAU at 3 months?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suicidal ideation in the past week
Access to a computer or phone with a camera
Access to internet
Access to an emergency contact and hospital within commuting distance
Disqualifiers
Inability to undergo psychotherapy in English
Presence of cognitive impairment that would limit consent and understanding of Brief Skills for Safer Living or study procedures
Active psychosis that impairs capacity to consent, understand study procedures, or participate
Unwilling or unable to provide informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
Brief-SfSL
BehavioralBrief-SfSL is a single 90-minute intervention that that: 1. helps clients understand their suicide narrative, which explores the origin and meaning of their suicidal thoughts 2. builds specific skills to keep oneself safe from suicide even if suicidal thoughts are present 3. includes enhanced safety planning by identifying the barriers to enacting a safety plan and solutions to overcome them
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Brief-SfSL (B-TAU)Experimental treatment 1 intervention
Group B: Wait List (WL-TAU)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in suicidal ideation using Beck Scale for Suicide Ideation
Beck Scale for Suicide Ideation is a 21-item self-report scale that quantifies suicidal ideation. Items are scored 0 to 2 and yield a total score ranging from 0 to 38. Higher scores reflect greater severity of suicidal ideation.
Time frame
From baseline to 3 months post-interventionSecondary outcomes
1
Change in depression symptoms using the Quick Inventory of Depressive Symptoms 16-item scale (QIDS).
The QIDS is a 16-item validated depression scale. Total scores range from 0-27, with higher scores reflecting more severe depression.
Time frame
From baseline to 3 months post-intervention2
Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7)
The GAD-7 is a brief 7-item self-report scale measuring anxiety symptoms. Total scores range from 0 to 21, with higher scores reflecting more severe anxiety.
Time frame
From baseline to 3 months post-intervention3
Changes in anhedonia using the Dimensional Anhedonia Rating Scale (DARS)
The DARS is a validated 17-item self-report scale measuring anhedonia across four domains. Total scores range from 0-68, with higher scores indicating lower levels of anhedonia.
Time frame
From baseline to 3 months post-intervention4
Changes in feelings of social connectedness and burdensomeness using the Interpersonal Needs Questionnaire (INQ)
The INQ is a validated 15-item self-report scale assessing social connectedness and burdensomeness. Total scores range from 15-105, with higher scores indicating higher levels of social disconnectedness and burdensomeness.
Time frame
From baseline to 3 months post-interventionSponsors and contacts
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Source ClinicalTrials.gov