Suicide PreventionNCT06571916
Brief Skills for Safer Living (Brief-SfSL)
A study testing Brief-SfSL in people with Suicide Prevention and Suicide, run by Unity Health Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Prevention, Suicide, Suicide and Self-harm
- What is being tested?
- Brief-SfSL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 17 Nov 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Onjoli Krywiak, HBSc contact
Canada1 site, 1 recruiting
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1M8
Anna Kiriakidis, RSSW, HBASc, 416-360-4000 ext. 7844, anna.kiriakidis@unityhealth.to
Onjoli Krywiak, HBSc, onjoli.krywiak@unityhealth.to
About this study
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"
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?
Read the 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
- Being tested
- Brief-SfSL
- Keywords
- suicide, psychotherapy
- Medical subject headings
- Suicide Prevention, Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief-SfSLBehavioural
Also called Brief-Skills for Safer Living
Brief-SfSL is a single 90-minute intervention that that:
- helps clients understand their suicide narrative, which explores the origin and meaning of their suicidal thoughts
- builds specific skills to keep oneself safe from suicide even if suicidal thoughts are present
- includes enhanced safety planning by identifying the barriers to enacting a safety plan and solutions to overcome them
| Study group | Role | What they receive |
|---|---|---|
| Brief-SfSL (B-TAU) | Experimental | Participants will receive the Brief-SfSL treatment within 1 week of their screening. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
The QIDS is a 16-item validated depression scale. Total scores range from 0-27, with higher scores reflecting more severe depression.
Measured: From baseline to 3 months post-intervention
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.
Measured: From baseline to 3 months post-intervention
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.
Measured: From baseline to 3 months post-intervention
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.
Measured: From baseline to 3 months post-intervention
Changes in work, social and family functioning using the Sheehan Disability Scale (SDS)
The SDS is a validated 3-item self-report scale that assesses work, social and family functioning. Total scores range from 0-30, with higher scores indicating higher impairment.
Measured: From baseline to 3 months post-intervention
Changes in emotional dysregulation using the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
The DERS-SF is an 18-item self-report scale that assesses emotional dysregulation across 6 subscales: (1) non-acceptance of emotional responses, (2) difficulties engaging in goal-directed behaviour, (3) impulse control difficulties, (4) lack of emotional awareness, (5) limited access to emotional regulation strategies and (6) lack of emotional clarity. Total scores range from 18-90, with higher scores reflecting more severe emotional dysregulation.
Measured: From baseline to 3 months post-intervention
Changes in executive control using Space Explorer (gamified behavioural task)
The Space Explorer task is an Aversive Go/No-Go task that assesses active-escape biases or the reduced ability to withhold an escape response when exposed to an aversive context. The 2x2 factorial task design results in 4 different conditions, each associated with a distinct visual cue in the form of "space junk". The meanings of the cues are learned from experience across trials based on trial outcomes: neutral (e.g., silence, absence of any aversive/rewarding visual cues) or aversive/rewarding (e.g., aversive white noise, loss/gain of points, advancing in the game, etc.). Participants are naturally incentivized to try to maximize neutral/positive outcomes and avoid aversive outcomes by choosing the right action for a given cue: Go (pressing a button), or No-go (doing nothing and simply waiting). This task takes 10-15 minutes to complete.
Measured: From baseline to 3 months post-intervention
Changes in social problem-solving using Jungle Treasure Hunt (gamified behavioural task)
The Jungle Treasure Hunt task tests players' ability to infer the intentions of others and adapt under uncertainty as they pursue rewarding outcomes. Players must navigate through a jungle and collect treasure by choosing between two paths on each trial. An avatar in the form of a monkey appears before each draw and recommends which path to take, with a speech bubble above the monkey stating "Choose the LEFT path" or "Choose the RIGHT path". The player then selects the left or right path and decides how many steps to take. The reward they receive is proportional to the number of steps they take, but if they choose the wrong path, they will lose rewards. The player's total score is shown and they are informed if they were correct or incorrect. Before the game starts, the player is told that the avatar's advice may not always be accurate. This task takes 15-20 minutes to complete.
Measured: From baseline to 3 months post-intervention
Participant safety as measured by adverse events
Participants will be asked to report any adverse events experienced at each visit. Investigators will measure if there are any differences in the number, severity or relatedness between group to ensure the intervention is safe.
Measured: Through study completion, an average of 3 months
Suicide severity differences between groups as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a semi-structured clinical interview to assess suicidal ideation and behaviour (lifetime, current, and since last visit). Investigators will be analyzing if there is any difference in C-SSRS severity between groups to ensure safety of the intervention. Suicidal ideation is scored from 0-5, with 5 indicating greater severity. Intensity of suicidal ideation is scored from 0-5, with 5 indicating greater intensity. Lethality of actual suicide attempts is scored from 0-5, with 5 indicating greater lethality.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start17 Nov 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sakina Rizvi, PhD, MACP, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571916
- Sponsor's protocol ID
- BSL-02
- Status last verified
- Nov 2025
- First submitted
- 16 Aug 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT06571916
- Acronym / sponsor ID
- BSL-02
- Conditions
- Suicide Prevention, Suicide, Suicide and Self-harm
- Keywords
- suicide, psychotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief-SfSL (B-TAU) | Experimental | Behavioral: Brief-SfSLParticipants will receive the Brief-SfSL treatment within 1 week of their screening. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief-SfSLAlso: Brief-Skills for Safer LivingBrief-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 | Behavioural | Brief-SfSL (B-TAU) |
Primary outcome
Change in suicidal ideation using Beck Scale for Suicide Ideation
Time frame: From baseline to 3 months post-intervention
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Onjoli Krywiak, HBSc contact
Sakina Rizvi, PhD, MACP principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief-SfSL in people with Suicide Prevention and Suicide, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Kiriakidis, RSSW, HBASc (416-360-4000 ext. 7844, anna.kiriakidis@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in suicidal ideation using Beck Scale for Suicide Ideation (time frame: From baseline to 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.