Suicide Prevention Interventions for Suicide Risk Management

Recruiting at 1 trial location

Overseen By Monika Lohani, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Outside U.S.

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

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

Trial Summary

What is the purpose of this trial?

Participants will be randomly assigned to 1 of the 4 interventions using a sequential stratified randomization procedure. We will use sex (M, F) and history of suicide attempts (never, 1, and multiple) as our randomization strata. Participants will be assessed before and after the intervention to study the potential effects of each approach on suicide-related clinical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Crisis Response Plan, Special K, Ketalar, Ketanest, Narrative Assessment, Safety Plan, Structured interview for suicide risk management?

Research shows that Safety Planning Interventions (SPI) are effective in reducing suicidal thoughts and behaviors, as well as decreasing depression and hopelessness. Additionally, the Chronological Assessment of Suicide Events (CASE Approach) is a practical strategy for identifying suicidal ideation, which can help in managing suicide risk. ^{1 2 3 4 5}

Is the Safety Planning Intervention (SPI) safe for humans?

The Safety Planning Intervention (SPI) is generally considered safe and is widely used in clinical settings to help prevent suicide. It is a brief, structured plan that helps individuals identify coping strategies and support resources, and studies suggest it is feasible and acceptable for use. ^{4 6 7 8 9}

How does the Safety Planning Intervention differ from other treatments for suicide prevention?

The Safety Planning Intervention (SPI) is unique because it is a short-term, structured plan that helps individuals identify early signs of a suicidal crisis and develop coping strategies, while also removing dangerous means for suicide. It is flexible, as it can be delivered in-person or online, and can be used alone or with other interventions, making it adaptable to various settings and needs. ^{2 4 8 10 11}

Research Team

Monika Lohani, PhD

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for individuals in the U.S. with a clinical diagnosis of suicidal ideation or those who have attempted suicide before. It's not open to people living outside the U.S.

Inclusion Criteria

You have been diagnosed with having thoughts of harming yourself.

You have attempted suicide in the past.

Exclusion Criteria

Geographic location outside the U.S.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomly assigned to one of four interventions and assessed before and after the intervention

2 weeks

Follow-up

Participants are monitored for changes in suicide relevant thoughts and behaviors

1 month

Treatment Details

Interventions

• Crisis Response Plan
• Narrative Assessment
• Safety Plan
• Structured interview

Trial Overview The study tests four different interventions: Safety Plan, Crisis Response Plan, Structured Interview, and Narrative Assessment. Participants are sorted into these groups based on gender and history of suicide attempts.

Participant Groups

Group I: Structured interview and Safety Plan Active Control 2 Interventions

In the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach. The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk.

Group II: Structured interview and Crisis Response Plan Active Control 2 Interventions

In the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach. Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation.

Group III: Narrative assessment and Safety Plan Active Control 2 Interventions

In the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis. The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk.

Group IV: Narrative assessment and Crisis Response Plan Active Control 2 Interventions

In the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis. Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Findings from Research

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 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 self-administered, Web-based safety planning application was developed and tested with 30 suicidal patients, showing strong usability ratings and enabling 90% of participants to complete at least 5 out of 6 safety planning steps.

Participants reported a significant decrease in suicidal ideation intensity after using the application, with pre-application scores averaging 5.11 and post-application scores averaging 4.46, indicating the potential effectiveness of this tool in enhancing coping abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer Administered Safety Planning for Individuals at Risk for Suicide: Development and Usability Testing. Boudreaux, ED., Brown, GK., Stanley, B., et al.[2023]

A 1-hour virtual training significantly improved clinicians' knowledge and self-efficacy in using electronic safety plans for suicide prevention, with lasting effects observed at a 6-month follow-up.

Among clinicians working with suicidal youth, 81% attempted to use the electronic safety plan template, and 63% completed it, indicating that this training can enhance the implementation of safety planning in community settings despite some challenges like technology issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Suicide Safety Planning Training on Clinician Knowledge, Self-Efficacy, and Use of Safety Plans in Community Mental Health Clinics. Whitmyre, ED., Esposito-Smythers, C., Goldberg, DG., et al.[2023]

The Safety Planning Intervention (SPI) is a structured six-step action plan designed to help individuals at risk of suicide by enhancing their coping strategies and social support, and by removing access to means of self-harm.

Research shows that SPI is highly effective in reducing suicidal behavior, making it a valuable tool in various settings such as emergency rooms and outpatient clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[SAFETY PLANNING INTERVENTION FOR SUICIDE PREVENTION]. Perlstein, J., Katzir, N., Lotan, A., et al.[2022]

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 successfully implemented the Safety Planning Intervention (SPI) for adolescent suicidality in emergency services, showing that training significantly improved providers' attitudes and knowledge about the intervention.

Collaboration with stakeholders and brief training were effective strategies for integrating structured safety planning into pediatric emergency settings, which is crucial for enhancing care for suicidal youths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Planning Intervention for Adolescents: Provider Attitudes and Response to Training in the Emergency Services Setting. Bettis, AH., Donise, KR., MacPherson, HA., 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]

References

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

Making it safer: a health centre's strategy for suicide prevention. [2022]

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

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

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

The chronological assessment of suicide events: a practical interviewing strategy for the elicitation of suicidal ideation. [2015]

4. England pubmed.ncbi.nlm.nih.gov

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

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

General Psychiatric Management for Suicidal Patients, With Remarks on Chronicity: Contending With the Angel of Death. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Computer Administered Safety Planning for Individuals at Risk for Suicide: Development and Usability Testing. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Suicide Safety Planning Training on Clinician Knowledge, Self-Efficacy, and Use of Safety Plans in Community Mental Health Clinics. [2023]

8. Israel pubmed.ncbi.nlm.nih.gov

[SAFETY PLANNING INTERVENTION FOR SUICIDE PREVENTION]. [2022]

9. 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]

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

Safety Planning Intervention for Adolescents: Provider Attitudes and Response to Training in the Emergency Services Setting. [2022]

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

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