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Completed

NCT Number: NCT01334541

A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans- Study 1

The investigators propose to evaluate Suicide Assessment and Follow-up Engagement: Veteran Emergency Treatment (SAFE VET) which is currently being implemented in 4 VA ED/Urgent Care Units across the United States (Portland VA Medical Center (VAMC), Denver VAMC, Manhattan VAMC, and Philadelphia VAMC).

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Long Beach VAMC, Long Beach, California, United States

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About this study

Background: In 2009, a novel clinical demonstration project entitled Suicide Assessment and Follow-up Engagement: Veteran Emergency Treatment (SAFE VET) was initiated as a potential standard of care for suicidal Veterans who receive treatment at Veterans Affairs (VA) emergency departments (ED). SAFE VET is designed to attenuate suicide risk by helping Veterans manage suicidal thoughts and behaviors, and adhere to prescribed clinical care; thereby promoting resiliency and increased capacity to cope with suicidal states.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Veterans will be enrolled who:

  • have received the SAFE VET intervention in VA SAFE VET EDs or treatment-as-usual in E-CARE EDs;
  • aged 18 years or older;
  • identified as being at risk for suicide based upon presenting complaints and/or the assessment of an ED clinician;
  • able to provide 2 contacts with telephone numbers for tracking purposes; and
  • 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

Veterans will not be enrolled if they are:

  • unable to read and understand English;
  • 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
  • admitted to the VA inpatient psychiatric unit from the ED.

Treatment and study plan

SAFE VET

Behavioral

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:

  • Risk Assessment
  • 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.
  • Clinical Follow-Up Protocol

Primary outcomes

  1. Columbia Suicide-Severity Rating Scale (C-SSRS; Posner et al., 2006; Posner et al. 2008).

    Time frame: Baseline and 1, 3, and 6 month follow-up assessments

Secondary outcomes

  1. Scale for Suicide Ideation (SSI; Beck, Kovacs, & Weissman, 1979).

    Time frame: Baseline and 1, 3, and 6 month follow-up assessments

Sponsors and collaborators

Lead sponsor

VA Eastern Colorado Health Care System

Fed

Collaborators

  • Columbia University
  • US Department of Veterans Affairs
  • Uniformed Services University of the Health Sciences
  • United States Department of Defense
  • University of Pennsylvania

Registry information

Acronym: SAFE VET

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Apr 13, 2011
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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