Brief Skills for Safer Living (Brief-SfSL)

NCT06571916 | Recruiting

• 1 other identifier: BSL-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Suicide; Suicide and Self-harm; Suicide Prevention

Keywords

suicide; psychotherapy

Outcome Measures

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.

  From baseline to 3 months post-intervention

Secondary Outcomes (10)

• Change in depression symptoms using the Quick Inventory of Depressive Symptoms 16-item scale (QIDS).

  From baseline to 3 months post-intervention

• Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7)

  From baseline to 3 months post-intervention

• Changes in anhedonia using the Dimensional Anhedonia Rating Scale (DARS)

  From baseline to 3 months post-intervention

• Changes in feelings of social connectedness and burdensomeness using the Interpersonal Needs Questionnaire (INQ)

  From baseline to 3 months post-intervention

• Changes in work, social and family functioning using the Sheehan Disability Scale (SDS)

  From baseline to 3 months post-intervention

Study Arms (2)

Brief-SfSL (B-TAU)

EXPERIMENTAL

Participants will receive the Brief-SfSL treatment within 1 week of their screening.

Behavioral: Brief-SfSL

Wait List (WL-TAU)

NO INTERVENTION

Participants will be put on a wait list and receive the Brief-SfSL treatment 3 months after their screening.

Interventions

Brief-SfSL BEHAVIORAL

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

Also known as: Brief-Skills for Safer Living

Brief-SfSL (B-TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to undergo psychotherapy in English
• Presence of cognitive impairment that would limit consent and understanding of Brief Skills for Safer Living
• Active psychosis
• Unwilling or unable to provide informed consent
• Previously enrolled in the Brief-SfSL pilot study
• Unwilling or unable to communicate verbally

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1M8, Canada

RECRUITING

MeSH Terms

Conditions

Suicide Prevention; Suicide; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Sakina Rizvi, PhD, MACP

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Kiriakidis, RSSW, HBASc

CONTACT

416-360-4000; anna.kiriakidis@unityhealth.to

Onjoli Krywiak, HBSc

CONTACT

onjoli.krywiak@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: August 26, 2024
• Study Start: November 17, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 22, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)