Menu
Recruiting NCT06571916

Brief Skills for Safer Living (Brief-SfSL)

No phase Interventional Suicide Prevention Suicide Suicide and Self-harm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brief-SfSL.
Who it may be relevant to
Registry conditions: Suicide Prevention, Suicide, Suicide and Self-harm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigating the Efficacy of a Novel Therapy for Suicide Risk in Adults: A Randomized Controlled Trial of an Intensive Single Session of "Brief Skills for Safer Living"

Overview

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?

Detailed description

There are 2 million people in Canada at risk of death from suicide and suicide rates have not changed in the last 10 years. The COVID-19 pandemic also increased suicide risk and intensified a pre-existing lack of access to vital mental health services, with wait lists up to 1 year. To address this issue, the investigators developed "Brief Skills for Safer Living" (Brief-SfSL), a single-session individual psychotherapy intervention with the potential to make it easier to access care and shorten the time for people to access intervention. Derived from the proven success of the original SfSL 20-week group therapy, Brief-SfSL goes beyond conventional approaches by helping individuals understand their suicidal thoughts, build skills to manage these thoughts, and stay safe during crises. The strong results of the investigators single-arm trial of virtually-delivered Brief-SfSL in 77 adults with suicidal ideation across Canada show that Brief-SfSL is a feasible, acceptable, and safe intervention that has the potential to reduce suicide risk. To prove that it is, the investigators need to expand their study to include a treatment as usual (TAU) comparison group in a randomized controlled trial (RCT). The investigators will conduct an RCT that includes 2 groups: 75 participants who will receive TAU plus Brief-SfSL, and 75 who will receive TAU and be on a 3-month wait-list for Brief-SfSL. The aim is to compare the efficacy of Brief-SfSL vs. TAU on suicidal ideation and proxies for suicide risk (e.g., depression, anxiety) over 3 months. If the results confirm the efficacy of Brief-SfSL over TAU, this will provide definitive data to support the broad implementation of Brief-SfSL in hospitals and community mental health agencies across Canada. Study results will also be used to plan trials to assess the long-term impact of Brief-SfSL on suicide risk, healthcare system utilization, and health economics. Through this research, the investigators aim to save lives and also shift the paradigm of mental health intervention on a national scale.

Interventions

  • Behavioral Brief-SfSL
    Brief-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

Primary outcome measures

  • Change in suicidal ideation using Beck Scale for Suicide Ideation [Time frame: From baseline to 3 months post-intervention]
Secondary outcome measures (10)
  • Change in depression symptoms using the Quick Inventory of Depressive Symptoms 16-item scale (QIDS). [Time frame: From baseline to 3 months post-intervention]
  • Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7) [Time frame: From baseline to 3 months post-intervention]
  • Changes in anhedonia using the Dimensional Anhedonia Rating Scale (DARS) [Time frame: From baseline to 3 months post-intervention]
  • Changes in feelings of social connectedness and burdensomeness using the Interpersonal Needs Questionnaire (INQ) [Time frame: From baseline to 3 months post-intervention]
  • Changes in work, social and family functioning using the Sheehan Disability Scale (SDS) [Time frame: From baseline to 3 months post-intervention]
  • Changes in emotional dysregulation using the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF) [Time frame: From baseline to 3 months post-intervention]
  • Changes in executive control using Space Explorer (gamified behavioural task) [Time frame: From baseline to 3 months post-intervention]
  • Changes in social problem-solving using Jungle Treasure Hunt (gamified behavioural task) [Time frame: From baseline to 3 months post-intervention]
  • Participant safety as measured by adverse events [Time frame: Through study completion, an average of 3 months]
  • Suicide severity differences between groups as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) [Time frame: Through study completion, an average of 3 months]

Eligibility criteria

Inclusion criteria

  • 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
  • Not receiving other psychotherapy/counselling services concurrently
  • Willing to have the session recorded to determine therapy fidelity
  • Any psychiatric diagnosis is allowed
  • Follow-up visits with a psychiatrist and/or family doctor where a psychotherapeutic modality (e.g., Dialectical Behavioural Therapy, psychodynamic therapy, etc.) is not being used are allowable

Exclusion criteria

  • 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
  • Previously enrolled in the Brief-SfSL pilot study
  • Unwilling or unable to communicate verbally

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • St. Michael's Hospital — Toronto

Identifiers

NCT: NCT06571916 · BSL-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗