5S Trial for Suicide Prevention

Recruiting at 1 trial location

Overseen By Diane Wisnieski, MSW

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Henry Ford Health System

Disqualifiers: Reside out of state, Translator needed, Others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

60000 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to harmonize jail release record data with electronic health record data in order to connect patients to an evidence-based suicide prevention and clinical care pathway upon jail release.

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 5S Trial treatment for suicide prevention?

Research shows that the WHO's brief intervention and contact (BIC) method significantly reduces the odds of suicide, suggesting that similar approaches in the 5S Trial could be effective. Additionally, a telephone intervention program showed long-term benefits in preventing suicide attempts, indicating that ongoing contact and support can be beneficial. ^{1 2 3 4 5}

What safety data exists for the 5S Trial for Suicide Prevention?

The research highlights the importance of clear definitions and consistent reporting of adverse events (unwanted effects from treatment) in suicide prevention trials. It emphasizes the need for safety and monitoring procedures to protect participants, especially those at high risk for suicidality. ^{6 7 8 9 10}

Is the treatment in the 5S Trial for Suicide Prevention a promising treatment?

The 5S Trial for Suicide Prevention could be promising because there are various strategies and interventions being developed to prevent suicide. Some of these interventions, like brief and ultra-brief treatments, have shown potential in helping people quickly and effectively. While not all studies have confirmed their effectiveness, there is suggestive evidence that certain types of interventions can be helpful, and ongoing research is exploring new ways to improve suicide prevention. ^{3 11 12 13 14}

Research Team

Lauren Weinstock, PhD

Principal Investigator

Brown University

Brian Ahmedani, PhD

Principal Investigator

Henry Ford Health

Rebecca C Rossom, MD, MSCR

Principal Investigator

HealthPartners Institute

Eligibility Criteria

This trial is for adults who have been released from jail between February 2021 and July 2028, had a primary care or behavioral health visit at a participating system in the last 3 years, and live in the same state as the study site. It's not for those who've opted out of research or need a translator.

Inclusion Criteria

Released from jail between February 2021 and July of 2028

Had a prior primary care visit or behavioral health visit at a participating health system in the past 3 years

I am 18 years old or older.

Exclusion Criteria

Previously requested to be excluded from research

Does not currently reside in the same state as the study site (i.e. Michigan, Minnesota)

Would require a translator to participate in the research according to EHR data

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive an intervention aimed at suicide prevention at the time of jail release

6 months

Follow-up

Participants are monitored for suicide attempt outcomes and behavioral health service engagement

6 months

Treatment Details

Interventions

• 5S Trial

Trial Overview The '5S Trial' aims to sync jail release records with health records to connect individuals to suicide prevention services after they leave jail. The goal is to create a seamless clinical care pathway that addresses suicide risks.

Participant Groups

Group I: 5S Trial Experimental Treatment 1 Intervention

Participants will receive an intervention aimed at suicide prevention in this group.

Group II: No-Contact Control Group Active Control 1 Intervention

Participants will be able to engage with healthcare services as usual and will have no knowledge of their involvement in the study.

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

HealthPartners Institute

Collaborator

Trials

196

Recruited

3,721,000+

Michigan State University

Collaborator

Trials

202

Recruited

687,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Findings from Research

The World Health Organization's brief intervention and contact (BIC) strategy significantly reduced the odds of suicide in a study of 2028 participants, showing an odds ratio of 0.20, indicating it is an effective prevention method.

Other interventions, such as cognitive-behavioral therapy (CBT) and lithium, did not show statistically significant effects on reducing suicide rates in the trials reviewed, suggesting that BIC may be the most promising strategy identified.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to prevent death by suicide: meta-analysis of randomised controlled trials. Riblet, NBV., Shiner, B., Young-Xu, Y., et al.[2022]

The OSPI-Europe project aims to enhance and evaluate a community-based suicide prevention program, building on the successful EAAD model, across four European countries with a combined population of nearly one million.

The intervention includes training for healthcare providers, public awareness campaigns, and support for high-risk groups, and will assess its effectiveness in reducing both fatal and non-fatal suicidal behaviors, as well as the economic impact of these strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing suicide prevention programs and their implementation in Europe (OSPI Europe): an evidence-based multi-level approach. Hegerl, U., Wittenburg, L., Arensman, E., et al.[2023]

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]

In a study of 104 psychiatric inpatients, those receiving the Collaborative Assessment and Management of Suicidality (CAMS) intervention showed significantly greater improvements in depression, suicidal ideation, and overall well-being compared to those receiving standard treatment.

While all patients improved during their stay, the benefits of CAMS were not maintained at the 6-month follow-up, indicating that ongoing support may be necessary to sustain the advantages of specialized interventions for suicidal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled comparison trial of the Collaborative Assessment and Management of Suicidality (CAMS) in an inpatient setting: Outcomes at discharge and six-month follow-up. Ellis, TE., Rufino, KA., Allen, JG.[2019]

A telephone intervention program significantly reduced the rate of suicide attempts in patients for up to 1 year after discharge from the emergency room, demonstrating its initial efficacy in preventing reattempts.

However, the benefits of this intervention did not persist over a 5-year follow-up period, indicating that while it is effective in the short term, long-term support strategies may be necessary for sustained prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone Management Program for Patients Discharged From an Emergency Department After a Suicide Attempt: A 5-Year Follow-Up Study in a Spanish Population. Cebria, AI., Pérez-Bonaventura, I., Cuijpers, P., et al.[2022]

There is an urgent need for safe and effective treatments specifically aimed at reducing suicidality in individuals with mental disorders, highlighting the importance of tailored interventions for this high-risk group.

The paper outlines essential considerations for researchers conducting treatment trials, including study design, monitoring procedures, and informed consent, to ensure the safety and efficacy of interventions targeting suicidality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention research with persons at high risk for suicidality: safety and ethical considerations. Pearson, JL., Stanley, B., King, CA., 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 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 STAR*D study successfully implemented NIMH guidelines to manage suicidal risk in a large clinical trial involving an anticipated 4000 participants, focusing on treatment-resistant depression.

Innovative methods, such as an interactive voice response system, were utilized to enhance safety monitoring and ensure timely alerts for clinicians and safety officers regarding suicidal subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide risk management for the sequenced treatment alternatives to relieve depression study: applied NIMH guidelines. Nierenberg, AA., Trivedi, MH., Ritz, L., et al.[2022]

A Scale for Suicide Ideation (SSI) score of 16 was identified as a critical cut-point to distinguish between stable out-patients and those in a suicidal emergency, demonstrating 100% sensitivity and 91% specificity in a study of 34 patients.

This finding suggests that using an SSI score of 16 could help safely exclude high-risk individuals from participating in clinical trials for depression, thereby enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A psychometric cut-point to separate emergently suicidal depressed patients from stable depressed outpatients. McCall, WV., Batson, N., Webster, M., et al.[2021]

Restricting access to lethal means, such as analgesics and suicide hotspots, has shown significant effectiveness in reducing suicide rates, with a 43% decrease in analgesic-related suicides and an 86% reduction in jumping-related suicides since 2005.

School-based awareness programs have been effective in reducing suicide attempts and suicidal ideation, with odds ratios indicating a 55% reduction in attempts and a 50% reduction in ideation, highlighting the importance of targeted educational interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide prevention strategies revisited: 10-year systematic review. Zalsman, G., Hawton, K., Wasserman, D., et al.[2022]

A systematic review identified only 13 randomized controlled trials and 2 case-control studies on suicide prevention, highlighting a lack of robust evidence in this area.

Most studies did not show significant effects of suicide-preventive interventions, often due to small sample sizes, indicating a need for more comprehensive research before implementing prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Are preventive measures against suicide efficient? A literature review]. Bilsbak, US., Bolstad, PJ., Fretland, S., et al.[2022]

Population-based strategies for suicide prevention have the potential to significantly reduce suicide rates, but few have been rigorously tested in trials.

The introduction of innovative trial designs, such as the 'dynamic wait-listed design' and multi-trial follow-up studies, can effectively evaluate the impact of suicide prevention programs, including a current study testing a gatekeeper training program in 32 schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of randomized trials in testing interventions for the prevention of youth suicide. Brown, CH., Wyman, PA., Brinales, JM., et al.[2007]

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. England pubmed.ncbi.nlm.nih.gov

Strategies to prevent death by suicide: meta-analysis of randomised controlled trials. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Optimizing suicide prevention programs and their implementation in Europe (OSPI Europe): an evidence-based multi-level approach. [2023]

3. India pubmed.ncbi.nlm.nih.gov

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

4. Ireland pubmed.ncbi.nlm.nih.gov

A controlled comparison trial of the Collaborative Assessment and Management of Suicidality (CAMS) in an inpatient setting: Outcomes at discharge and six-month follow-up. [2019]

5. Canada pubmed.ncbi.nlm.nih.gov

Telephone Management Program for Patients Discharged From an Emergency Department After a Suicide Attempt: A 5-Year Follow-Up Study in a Spanish Population. [2022]

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

Intervention research with persons at high risk for suicidality: safety and ethical considerations. [2022]

7. 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]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

Suicide risk management for the sequenced treatment alternatives to relieve depression study: applied NIMH guidelines. [2022]

10. India pubmed.ncbi.nlm.nih.gov

A psychometric cut-point to separate emergently suicidal depressed patients from stable depressed outpatients. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Suicide prevention strategies revisited: 10-year systematic review. [2022]

12. Norway pubmed.ncbi.nlm.nih.gov

[Are preventive measures against suicide efficient? A literature review]. [2022]

13. England pubmed.ncbi.nlm.nih.gov

The role of randomized trials in testing interventions for the prevention of youth suicide. [2007]

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

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