A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans- Study 1
NCT ID: NCT01334541
Last Updated: 2019-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
600 participants
OBSERVATIONAL
2009-09-30
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Using Telehealth to Improve Outcomes in Veterans at Risk for Suicide
NCT03724370
High Risk Suicidal Behavior in Veterans
NCT02462694
Randomized Clinical Trial of Re-Evaluating Suicidal Thoughts in Veterans
NCT05884476
Increasing Treatment Seeking Among Suicidal Veterans Calling the Crisis Line
NCT01771965
Suicide Risk Interventions
NCT05931289
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Objectives: Using a quasi-experimental design, the aim of this study is to compare the effectiveness of the SAFE VET intervention versus enhanced usual care (E-CARE)on the following: 1) the proportion of patients who attempt suicide within 6 months of index emergency department (ED) visit; 2) the severity of suicide ideation within 6 months after index ED visit; 3) the proportion of patients who attend \> 1 outpatient mental health or substance abuse treatment appointments within 30 days following index ED visit; and 4) the degree of suicide-related coping for attending treatment during the 6 month period.
Methodology: Six hundred Veterans, up to 300 per condition (SAFE VET or E-CARE), who meet inclusion/exclusion criteria will be enrolled. E-CARE sites are as follows: Long Beach VAMC, Bronx VAMC, Milwaukee VAMC, and San Diego VAMC. All subjects will participate in an approximately 1-hour long baseline assessment battery (index ED visit) by phone, and will be contacted by phone at approximately 1, 3, and 6 months after the index ED visit to complete follow-up measures. Medical records will also be reviewed to determine VA health service usage in the six-month period after study enrollment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SAFE VET
SAFE VET
All SAFE VET EDs provide a standardized intervention that is specifically adapted for use in the ED to mitigate suicide risk. Given that the SAFE VET intervention was developed for use in a busy ED setting, the length of the intervention is approximately 45 minutes. The SAFE VET intervention is administered by a clinical provider who has been specifically trained and consists of:
1. Risk Assessment
2. Safety Planning Intervention: Developed by Stanley and Brown (2008), Safety Planning Intervention consists of a hierarchically-arranged list of coping strategies identified for use during a subsequent suicidal crisis.
3. Clinical Follow-Up Protocol
E-CARE
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SAFE VET
All SAFE VET EDs provide a standardized intervention that is specifically adapted for use in the ED to mitigate suicide risk. Given that the SAFE VET intervention was developed for use in a busy ED setting, the length of the intervention is approximately 45 minutes. The SAFE VET intervention is administered by a clinical provider who has been specifically trained and consists of:
1. Risk Assessment
2. Safety Planning Intervention: Developed by Stanley and Brown (2008), Safety Planning Intervention consists of a hierarchically-arranged list of coping strategies identified for use during a subsequent suicidal crisis.
3. Clinical Follow-Up Protocol
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. have received the SAFE VET intervention in VA SAFE VET EDs or treatment-as-usual in E-CARE EDs;
2. aged 18 years or older;
3. identified as being at risk for suicide based upon presenting complaints and/or the assessment of an ED clinician;
4. able to provide 2 contacts with telephone numbers for tracking purposes; and
5. able to provide a home/residential/shelter address where the participant resides and either a home, cellular, or other telephone number where the participant can be reached.
Exclusion Criteria
1. unable to read and understand English;
2. unable or unwilling to give informed consent as determined either by the referring VA ED clinical staff or research personnel (see Mini Quiz below); and/or
3. admitted to the VA inpatient psychiatric unit from the ED.
18 Years
89 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
US Department of Veterans Affairs
FED
United States Department of Defense
FED
Columbia University
OTHER
University of Pennsylvania
OTHER
Uniformed Services University of the Health Sciences
FED
VA Eastern Colorado Health Care System
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marjan Holloway, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Uniformed Services University of the Health Sciences
Gregory Brown, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Lisa Brenner, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Denver VAMC, VISN 19 MIRECC
Barbara Stanley, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Kerry Knox, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Canadaigua VAMC- Center of Excellence
Glenn Currier, M.D.
Role: PRINCIPAL_INVESTIGATOR
Canandaigua VAMC- Center of Excellence
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Long Beach VAMC
Long Beach, California, United States
San Diego VAMC
San Diego, California, United States
Denver VAMC
Denver, Colorado, United States
Manhattan VAMC
Manhattan, New York, United States
Bronx VAMC
The Bronx, New York, United States
Portland VAMC
Portland, Oregon, United States
Philadelphia VAMC
Philadelphia, Pennsylvania, United States
Milwaukee VAMC
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
Matarazzo BB, Brown GK, Stanley B, Forster JE, Billera M, Currier GW, Ghahramanlou-Holloway M, Brenner LA. Predictive Validity of the Columbia-Suicide Severity Rating Scale among a Cohort of At-risk Veterans. Suicide Life Threat Behav. 2019 Oct;49(5):1255-1265. doi: 10.1111/sltb.12515. Epub 2018 Oct 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
W81XWH-09-2-0129-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.