Suicide Risk | PatientSAFE VETNCT01334541
A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans- Study 1
An observational study of Suicide Risk | Patient, run by VA Eastern Colorado Health Care System at 8 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Suicide Risk | Patient
- What is being tested?
- SAFE VET
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 600 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2009to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans who were seen in a VA Emergency Department and were identified as being at risk for suicide.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Denver VAMC
Denver, Colorado, 80220
Long Beach VAMC
Long Beach, California, 90822
Manhattan VAMC
Manhattan, New York, 10010
Milwaukee VAMC
Milwaukee, Wisconsin, 53295
Philadelphia VAMC
Philadelphia, Pennsylvania, 19104
Portland VAMC
Portland, Oregon, 97239
San Diego VAMC
San Diego, California, 92161
Bronx VAMC
The Bronx, New York, 10468
About this study
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).
Read the detailed description
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.
- Conditions
- Suicide Risk | Patient
- Being tested
- SAFE VET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAFE VETBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| SAFE VET | Not described Receives: Behavioral: SAFE VET | |
| E-CARE | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia Suicide-Severity Rating Scale (C-SSRS; Posner et al., 2006; Posner et al. 2008).
Measured: Baseline and 1, 3, and 6 month follow-up assessments
Secondary outcomes (1)
Scale for Suicide Ideation (SSI; Beck, Kovacs, & Weissman, 1979).
Measured: Baseline and 1, 3, and 6 month follow-up assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startSep 2009
- Primary completionNov 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicide Risk | PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Eastern Colorado Health Care System
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs, United States Department of Defense, Columbia University, University of Pennsylvania, Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
- Investigators
- Marjan Holloway, Ph.D., Principal investigator, Uniformed Services University of the Health SciencesGregory Brown, Ph.D., Principal investigator, University of PennsylvaniaLisa Brenner, Ph.D., Principal investigator, Denver VAMC, VISN 19 MIRECCBarbara Stanley, Ph.D., Principal investigator, Columbia UniversityKerry Knox, Ph.D., Principal investigator, Canadaigua VAMC- Center of ExcellenceGlenn Currier, M.D., Principal investigator, Canandaigua VAMC- Center of Excellence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334541
- Sponsor's protocol ID
- W81XWH-09-2-0129-1
- Acronym
- SAFE VET
- Status last verified
- Oct 2018
- First submitted
- 11 Apr 2011
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33884617Matarazzo 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.
PubMed 30368871
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans- Study 1
- ClinicalTrials.gov ID
- NCT01334541
- Acronym / sponsor ID
- SAFE VET / W81XWH-09-2-0129-1
- Conditions
- Suicide Risk | Patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- VA Eastern Colorado Health Care SystemUS federal agency
- Collaborators
- US Department of Veterans Affairs, United States Department of Defense, Columbia University, University of Pennsylvania, Uniformed Services University of the Health Sciences
- Study start
- Sep 2009 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 13 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAFE VET | – | Behavioral: SAFE VET |
| E-CARE | – | – |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans who were seen in a VA Emergency Department and were identified as being at risk for suicide.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAFE VETAll 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 | Behavioural | SAFE VET |
Primary outcome
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
1 secondary outcome
Scale for Suicide Ideation (SSI; Beck, Kovacs, & Weissman, 1979).
Time frame: Baseline and 1, 3, and 6 month follow-up assessments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Derived from this study: PubMed 33884617Witt 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.
- Derived from this study: PubMed 30368871Matarazzo 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.
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Not yet recruiting
Crisis Response Planning in Military Personnel With Mild Traumatic Brain Injury
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjan Holloway, Ph.D. principal investigator
Uniformed Services University of the Health Sciences
Gregory Brown, Ph.D. principal investigator
University of Pennsylvania
Lisa Brenner, Ph.D. principal investigator
Denver VAMC, VISN 19 MIRECC
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide Risk | Patient, run by VA Eastern Colorado Health Care System at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01334541, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.