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

150 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Brief Skills for Safer Living (Brief-SfSL) for suicide prevention?

Research on similar brief interventions, like the Safety Planning Intervention (SPI), shows they can help reduce suicidal thoughts and behaviors, decrease depression and hopelessness, and improve treatment attendance. These findings suggest that brief, focused treatments can be effective in suicide prevention. ^{1 2 3 4 5}

Is the Brief Skills Program for Suicide Prevention safe for humans?

The Safety Planning Intervention (SPI), which is similar to the Brief Skills Program for Suicide Prevention, has been found to be generally safe and acceptable for adults experiencing suicide-related distress. Studies suggest it is feasible and adaptable, with improvements in suicidal thoughts and behaviors, and reductions in depression and hospitalizations. ^{3 6 7 8 9}

How is the Brief Skills for Safer Living treatment different from other treatments for suicide prevention?

The Brief Skills for Safer Living treatment is unique because it is a group intervention specifically designed for individuals who have repeatedly attempted suicide, focusing on psychosocial and psychoeducational support to prevent future attempts. Unlike some other interventions, it targets the specific needs of those with a history of repeat suicide attempts, offering a tailored approach to reduce risk. ^{3 4 10 11 12}

What is the purpose of this trial?

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?

Research Team

Sakina Rizvi, PhD, MACP

Principal Investigator

Unity Health Toronto

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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 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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Intervention for suicide attempters: A randomized controlled study. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A Real-World Effectiveness Study Comparing a Priority Appointment, an Enhanced Contact Intervention, and a Psychotherapeutic Program Following Attempted Suicide. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Brief and Ultra-Brief Suicide-Specific Interventions. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Applied Suicide Intervention Skills Training (ASIST) in Lithuania. [2022]

6. England 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. [2022]

7. England 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

An outcome evaluation of the SOS Suicide Prevention Program. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Analysis of Suicides Reported as Adverse Events in Psychiatry Resulted in Nine Quality Improvement Initiatives. [2022]

10. England pubmed.ncbi.nlm.nih.gov

You feel it was written about you: client acceptability of a group intervention for repeat suicide attempts. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Validation of the Suicide Counseling Skills Inventory. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Suicide Safety Planning Interventions: A Systematic Review Informing Occupational Therapy. [2023]