Brief Skills Program for Suicide Prevention

Overseen By Hailey Wright, BArts.Sc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: Cognitive impairment, Active psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Brief Skills for Safer Living to determine if it reduces suicidal thoughts more effectively than waiting for treatment. Researchers aim to find out if this program can also lessen depression and anxiety and improve quality of life. Participants will either begin the program immediately or after a three-month wait. This trial is open to those who have experienced suicidal thoughts in the past week, have internet access, and aren't currently receiving other types of therapy. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance mental health support for many.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot be receiving another type of psychotherapy while participating.

What prior data suggests that the Brief Skills for Safer Living program is safe?

Research has shown that the Brief Skills for Safer Living (Brief-SfSL) program is both effective and safe. One study found it to be a practical and acceptable way to lower the risk of suicide. Participants in that study handled the program well, experiencing no significant side effects. There are no major reports of harmful effects linked to this treatment. Overall, evidence suggests that Brief-SfSL is a safe choice for those seeking to reduce suicidal thoughts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brief Skills for Safer Living (Brief-SfSL) program because it offers a unique approach to suicide prevention by focusing on enhancing individuals' coping skills and resilience. Unlike standard treatments that often involve medication or long-term therapy, this program delivers targeted skills training in a brief and accessible format. The program's potential for quick implementation and its focus on empowering individuals with practical skills make it a promising addition to existing care options.

What evidence suggests that the Brief Skills for Safer Living program is effective for suicide prevention?

Research has shown that Brief Skills for Safer Living (Brief-SfSL), which participants in this trial may receive, helps reduce suicidal thoughts. One study found that just one remote session of Brief-SfSL effectively lowered the risk of suicide and was easy for participants to use and accept. Similar programs have also shown promise in reducing suicidal thoughts and actions. Brief-SfSL focuses on teaching skills and strategies to handle distress and stay safe. Early results suggest this method can greatly improve mental health. ^{1 2 3 5 6}

Who Is on the Research Team?

Sakina Rizvi, PhD, MACP

Principal Investigator

Unity Health Toronto

Are You a Good Fit for This Trial?

This trial is for individuals across Canada dealing with suicidal thoughts or behaviors. Participants will be selected to either receive the Brief-Skills for Safer Living (Brief-SfSL) immediately or after a 3-month waitlist. The study aims to include a diverse group of 150 participants.

Inclusion Criteria

Access to a computer or phone with a camera

Access to internet; access to an emergency contact

I am not currently undergoing any form of psychotherapy.

Exclusion Criteria

I cannot participate in psychotherapy in English.

Active psychosis

I do not have cognitive issues that prevent me from understanding safety skills.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person or virtual)

Waitlist

Participants in the WL-TAU group are placed on a waitlist for 3 months before receiving Brief-SfSL treatment

3 months

Regular check-ins (virtual)

Treatment

Participants receive the Brief-SfSL treatment, a single-session individual psychotherapy intervention

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for changes in suicidal ideation, depression, anxiety, and quality of life

3 months

Regular assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Brief Skills for Safer Living (Brief-SfSL)

Trial Overview The effectiveness of Brief-SfSL, a suicide prevention intervention, is being tested. Participants are randomly assigned to two groups: one receives the intervention right away (B-TAU), and the other after a delay (WL-TAU). The study compares outcomes in suicidal thoughts, depression, anxiety, and quality of life at 3 months.

How Is the Trial Designed?

Group I: Brief-SfSL (B-TAU) Experimental Treatment 1 Intervention

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

Group II: Wait List (WL-TAU) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Published Research Related to This Trial

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

The Safety Planning Intervention (SPI) is effective in reducing suicidal ideation and behavior, as well as improving depression and treatment engagement among adults experiencing suicide-related distress, based on a systematic review of 26 studies.

The SPI is adaptable and can be delivered in various formats (in-person or online) and as a standalone or combined intervention, making it a flexible tool in suicide prevention practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. Ferguson, M., Rhodes, K., Loughhead, M., et al.[2022]

A brief intervention and contact (BIC) program significantly reduced completed suicides among 680 suicide attempters, with an odds ratio of 35.4, indicating a strong protective effect.

The BIC program also lowered the rate of subsequent suicide attempts, with an odds ratio of 17.3, suggesting that this low-cost intervention could be an effective suicide prevention strategy in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention for suicide attempters: A randomized controlled study. Vijayakumar, L., Umamaheswari, C., Shujaath Ali, ZS., et al.[2021]

The study analyzed adverse events related to suicidality in 9 randomized placebo-controlled trials of duloxetine, revealing that while suicides were clearly identifiable, suicidal ideation and preparatory behaviors were often obscured due to the limitations of the medical coding dictionaries used, particularly COSTART.

The findings suggest that adverse event data in clinical study reports may not fully represent patient experiences, highlighting the importance of using detailed narratives and individual patient listings to capture a more accurate picture of potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study. Maund, E., Tendal, B., Hróbjartsson, A., et al.[2023]

The article reviews various ultra-brief and brief suicide-specific interventions, highlighting their potential to quickly stabilize individuals at risk of suicide, which is crucial given the rising suicide rates.

Several interventions, such as the Safety Planning Intervention and Cognitive Therapy for Suicide Prevention, have shown promising evidence for effectiveness, indicating a need for continued research to optimize these approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief and Ultra-Brief Suicide-Specific Interventions. Stanley, B., Brodsky, B., Monahan, M.[2023]

A systematic review of 22 studies found that suicide safety planning (SSP) is effective in reducing suicidal behavior and ideation, highlighting its importance as a suicide prevention strategy.

SSP can be delivered in various formats, including standard, enhanced, and electronically, but more research is needed to explore its impact on mental illness symptoms and resilience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Suicide Safety Planning Interventions: A Systematic Review Informing Occupational Therapy. Marshall, CA., Crowley, P., Carmichael, D., et al.[2023]

The Signs of Suicide (SOS) prevention program significantly reduced self-reported suicide attempts among high school students, as shown in a study involving 2,100 students across 5 schools.

Students in the intervention group also exhibited greater knowledge and more positive attitudes towards depression and suicide, indicating that the program not only helps reduce attempts but also improves understanding of these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An outcome evaluation of the SOS Suicide Prevention Program. Aseltine, RH., DeMartino, R.[2022]

In a review of 35 suicide cases reported as adverse events, only 6 had adequately documented suicide risk assessments, highlighting significant gaps in clinical care.

The assessments primarily focused on suicidal ideation rather than critical risk factors like previous attempts or substance abuse, indicating a need for quality improvement initiatives in training and documentation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Suicides Reported as Adverse Events in Psychiatry Resulted in Nine Quality Improvement Initiatives. Mackenhauer, J., Winsløv, JH., Holmskov, J., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06571916

NCT06571916 | Brief Skills for Safer Living (Brief-SfSL) The goal of this project is to assess the efficacy of Brief-Skills for Safer Living (Brief-SfSL) in a randomized control trial.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40441633/

Mitigating suicide risk with a single session of virtually- ... This national study tested the effectiveness of remote Brief-SfSL on suicidal ideation over 12 weeks, as well as feasibility and acceptability.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032725009541

Mitigating suicide risk with a single session of virtually- ... Results. The results demonstrated that Brief-SfSL is an effective, feasible, acceptable, and safe intervention for suicide risk. Conclusions.

4. researchgate.net researchgate.net/publication/392136404_Mitigating_suicide_risk_with_a_single_session_of_virtually-delivered_psychotherapy_An_open-label_trial_of_brief_skills_for_safer_living

Mitigating suicide risk with a single session of virtually- ... Mitigating suicide risk with a single session of virtually-delivered psychotherapy: An open-label trial of Brief Skills for Safer Living.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10189833/

Effectiveness of Suicide Safety Planning Interventions Evidence across a range of studies indicates that SSP is effective for reducing suicide behavior (SB) and ideation (SI).

6. psychiatryonline.org psychiatryonline.org/doi/full/10.1176/appi.focus.20220083

Brief and Ultra-Brief Suicide-Specific Interventions | Focus An RCT (37) of active-duty soldiers at risk for suicide demonstrated that those who received brief CBT with CRP were 60% less likely to ...