5S Trial for Suicide Prevention

Recruiting at 1 trial location

Overseen By Diane Wisnieski, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

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)

Compensation: Varies

Number of Visits: Unknown

5250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on helping individuals released from jail by providing a pathway to prevent suicide. It harmonizes jail release data with health records to connect participants to effective suicide prevention and clinical care. Participants will either receive a special intervention aimed at preventing suicide (known as the 5S Trial) or continue with their usual healthcare services without knowing they are part of the study. This trial suits those recently released from jail, who have seen a doctor or mental health professional in the past three years, and who live in Michigan or Minnesota. As an unphased trial, it offers a unique opportunity to contribute to important research that could enhance suicide prevention strategies for others in similar situations.

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 prior data suggests that this protocol is safe for suicide prevention?

Research has shown that programs similar to the 5S Trial have been well-received. Efforts to improve care for individuals at risk of suicide have yielded promising results, significantly reducing suicide rates. Additionally, a previous study on a smartphone-based program aimed at reducing suicidal behavior showed positive outcomes without major safety concerns.

Specific safety data for the 5S Trial is not yet available, but a data safety and monitoring board actively oversees safety. This oversight suggests that the treatment is likely considered safe based on current evidence. However, more detailed safety data is needed for a complete understanding. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 5S Trial for suicide prevention because it explores a new intervention method aimed at this critical issue. Unlike standard treatments that often rely on medication or therapy sessions, this trial focuses on a novel intervention strategy that could provide a fresh approach to prevention. The hope is that by targeting specific factors in a different way, the trial may reveal effective methods that can be integrated into existing healthcare services, ultimately offering a more holistic solution to suicide prevention.

What evidence suggests that the 5S Trial's intervention could be effective for suicide prevention?

Research shows that the 5S Trial employs proven methods to help prevent suicide. Participants in this trial receive an intervention focused on suicide prevention. For instance, a strategy recommended by the World Health Organization, known as brief intervention and contact (BIC), significantly reduced suicide risk in a study involving 2,028 people. Another program in a different study lowered the suicide rate by 25% in the area where it was implemented. These studies demonstrate that specific interventions can effectively reduce the risk of suicide. Participants in the 5S Trial receive similar methods aimed at preventing suicide, which previous research has shown to be effective. ^{1 6 7 8 9}

Who Is on the Research Team?

Lauren Weinstock, PhD

Principal Investigator

Brown University

Rebecca C Rossom, MD, MSCR

Principal Investigator

HealthPartners Institute

Brian Ahmedani, PhD

Principal Investigator

Henry Ford Health

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. withpower.com withpower.com/trial/phase-3-suicide-5-2024-6b60f

5S Trial for Suicide Prevention The World Health Organization's brief intervention and contact (BIC) strategy significantly reduced the odds of suicide in a study of 2028 participants, showing ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8987906/

Effectiveness of a Suicide Prevention Module for Adults in ... In our pilot study, PARS showed excellent effectiveness and feasibility along with significant changes in patients' suicide knowledge, ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2790745

Effectiveness of a Suicide Prevention Module for Adults in ... In our pilot study, PARS showed excellent effectiveness and feasibility along with significant changes in patients' suicide knowledge, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S016517812400088X

The effectiveness of a suicide prevention program in ... The suicide rate in the intervention area decreased by 25% following the intervention. Implementation of the LinkPC-PH intervention was associated with ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07132099

Randomized Suicide Prevention Trial Using ASSIP and ... This is a randomized controlled trial that aims to compare the effectiveness of two psychological treatment approaches: the Attempted Suicide Short ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06506344

Syncing Screening and Services for Suicide Prevention ... Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10193260/

Effect of an Emergency Department Process Improvement ... The results of using CQI to improve suicide-related care in the Henry Ford Health System and others have found reductions in suicide by up to 75 ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2837367

A Digital Therapeutic Intervention for Inpatients With ... This randomized clinical trial evaluates the efficacy of a smartphone-based educational intervention in reducing suicidal behavior after ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421000276

A randomized, controlled trial of the safety planning ... The sample comprised patients 18 years and older presenting to one of three different emergency departments with suicide related emergencies (target n = 484).