Brief Skills for Safer Living (Brief-SfSL)

NCT ID: NCT06571916

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-17
• Study Completion Date: 2028-12-31

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?

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.

Conditions

Suicide Prevention; Suicide; Suicide and Self-harm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brief-SfSL (B-TAU)

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

Group Type: EXPERIMENTAL

Brief-SfSL

Intervention Type: 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

Wait List (WL-TAU)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Brief-Skills for Safer Living

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
• Active psychosis
• Unwilling or unable to provide informed consent
• Previously enrolled in the Brief-SfSL pilot study
• Unwilling or unable to communicate verbally

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Health Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sakina Rizvi, PhD, MACP

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Anna Kiriakidis, RSSW, HBASc

Role: CONTACT

anna.kiriakidis@unityhealth.to

416-360-4000 ext. 7844

Onjoli Krywiak, HBSc

Role: CONTACT

onjoli.krywiak@unityhealth.to

Facility Contacts

Anna Kiriakidis, RSSW, HBASc

Role: primary

anna.kiriakidis@unityhealth.to

416-360-4000 ext. 7844

Onjoli Krywiak, HBSc

Role: backup

onjoli.krywiak@unityhealth.to

Other Identifiers

BSL-02

Identifier Type: -

Identifier Source: org_study_id