Brief Skills for Safer Living (Brief-SfSL)
- Conditions
- SuicideSuicide and Self-harmSuicide Prevention
- Interventions
- Behavioral: Brief-SfSL
- Registration Number
- NCT06571916
- Lead Sponsor
- Unity Health Toronto
- 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, as well as improving quality of life?
* 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Suicidal ideation in the past week
- Access to a computer or phone with a camera
- Access to internet; access to an emergency contact
- Not receiving a concurrent psychotherapy modality
- 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.
- Inability to undergo psychotherapy in English
- Presence of cognitive impairment that would limit consent and understanding of Brief Skills for Safer Living
- Active psychosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brief-SfSL (B-TAU) Brief-SfSL Participants will receive the Brief-SfSL treatment within 1 week of their screening.
- Primary Outcome Measures
Name Time Method Change in suicidal ideation using Beck Scale for Suicide Ideation 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.
- Secondary Outcome Measures
Name Time Method Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7) From baseline to 3 months post-intervention 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.
Change in quality of life using the Quality of Life Scale (QoLS) From baseline to 3 months post-intervention The QoLS is a validated 15-item scale. Scores can range from 16 to 112, with higher scores reflecting a higher quality of life.
Suicide severity differences between groups as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) Through study completion, an average of 3 months The C-SSRS is a semi-structured clinical interview to assess suicidal ideation, attempt history and risk (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.
Change in depression symptoms using the Quick Inventory of Depressive Symptoms 16-item scale (QIDS). From baseline to 3 months post-intervention The QIDS is a 16-item validated depression scale. Total scores range from 0-27, with higher scores reflecting more severe depression.
Participant safety as measured by adverse events Through study completion, an average of 3 months 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.
Trial Locations
- Locations (1)
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada