Clinical trial NCT06571916: Brief Skills for Safer Living (Brief-SfSL)
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"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicide Prevention
Suicide
Suicide and Self-harm
Keywords: suicide
psychotherapy
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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.

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

Primary outcomes:
measure: Change in suicidal ideation using Beck Scale for Suicide Ideation
timeFrame: From baseline to 3 months post-intervention
Secondary outcomes:
measure: Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: From baseline to 3 months post-intervention
measure: Change in quality of life using the Quality of Life Scale (QoLS)
timeFrame: From baseline to 3 months post-intervention
measure: Change in depression symptoms using the Quick Inventory of Depressive Symptoms 16-item scale (QIDS).
timeFrame: From baseline to 3 months post-intervention
measure: Participant safety as measured by adverse events
timeFrame: Through study completion, an average of 3 months
measure: Suicide severity differences between groups as measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Sakina Rizvi, PhD, MACP
role: PRINCIPAL_INVESTIGATOR
References: