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Behavioral Intervention

intervention arm for Suicide (SP6+ Trial)

N/A

Recruiting

Led By Joseph A Simonetti, MD MPH

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Discharged home from the ED (rather than hospital admission)

Age >17 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of one year

Awards & highlights

SP6+ Trial Summary

This trial aims to test a safety intervention for Veterans who are at risk of suicide and seek emergency care. The intervention focuses on reducing access to lethal methods of self-harm, such as firearms and medications

Who is the study for?

This trial is for Veterans over 17 years old who visited a VHA emergency department or urgent care, are at intermediate to high suicide risk, and have access to firearms or medications. They must be discharged home, willing to review a safety plan, and able to consent. Those with severe illness, intoxication issues, unreliable phone access, homelessness without an address, or daily substance abuse can't join.Check my eligibility

What is being tested?

The study tests an enhanced lethal means Safety Plan intervention designed for Veterans identified as having elevated suicide risk in emergency settings. It aims to reduce the risk of suicide by limiting access to methods like firearms and medications.See study design

What are the potential side effects?

Since this trial involves a safety planning intervention rather than medication or medical procedures, traditional side effects are not applicable. However, participants may experience emotional discomfort discussing sensitive topics.

SP6+ Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I was sent home after my emergency department visit.

Select...

I am older than 17 years.

SP6+ Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comfort with intervention discussion

Feasibility of study follow up

Feasibility of study recruitment

+5 more

Secondary outcome measures

Beliefs about importance of secure firearm storage always

Beliefs about importance of secure firearm storage when someone is suicidal

Beliefs about importance of secure medication storage always

+15 more

SP6+ Trial Design

1Treatment groups

Experimental Treatment

Group I: intervention armExperimental Treatment1 Intervention

There is a single intervention arm with no comparator for this pilot study

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,254 Total Patients Enrolled

39 Trials studying Suicide

6,516 Patients Enrolled for Suicide

Joseph A Simonetti, MD MPHPrincipal InvestigatorRocky Mountain Regional VA Medical Center, Aurora, CO

1 Previous Clinical Trials

28 Total Patients Enrolled

1 Trials studying Suicide

28 Patients Enrolled for Suicide

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to participate in this research study?

"In order to be eligible for participation in this clinical trial, patients must demonstrate suicidal tendencies and fall within the age range of 18 to 100 years old. Approximately 30 individuals will have the opportunity to participate in this study."

Answered by AI

Is the registration process currently ongoing for this clinical trial?

"Indeed, the details on clinicaltrials.gov indicate that this ongoing clinical trial is actively searching for eligible candidates. The initial posting of the trial was recorded on January 8th, 2024 and it underwent its latest update on January 10th, 2024. Currently, there are openings for enrollment of up to 30 participants across a single location."

Answered by AI

Is the clinical trial open to individuals who are below 18 years old?

"This study seeks to recruit individuals who are at least 18 years old and less than 100 years of age."

Answered by AI

What is the current number of individuals receiving medical care as part of this research study?

"Indeed, the information provided on clinicaltrials.gov indicates that this ongoing clinical trial is currently seeking eligible participants. The initial posting date for this study was January 8th, 2024, and it was last updated on January 10th, 2024. The research team aims to recruit a total of 30 patients from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety Planning 6+

2024. "Safety Planning 6+". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06216327.

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