SuicideSAFEMILNCT01360736
A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL)
A study testing Safety Planning - Military (SAFE MIL) in people with Suicide and Suicide, Attempted, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 2 sites in United States.
Trial summary
The investigators propose to test the efficacy of a brief, readily accessible, and personalized treatment called the Safety Planning for Military (SAFE MIL; Stanley and Brown, 2012). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Suicide, Suicide, Attempted
- What is being tested?
- Safety Planning - Military (SAFE MIL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Dec 2018
- Phase
- Interventional
- 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
Who may be able to join
- Patient Admitted Due to Recent Suicide Intent and/or Suicide Attempt within past month
- Baseline Assessment Completed within 48 Hours of Hospital Admission
- Age of 18 years or older.
Who cannot join
- Medical Incapacity to Participate and/or Serious Cognitive Impairment
- Expected Discharge within 72 Hours of Admission
- Expected Deployment within 1-Month
- Inability to read or understand English
- Inability to provide Informed Consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Uniformed Services University of the Health Sciences
Bethesda, Maryland, 20814
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
About this study
Official title: A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2
The investigators propose to test the efficacy of a brief, readily accessible, and personalized treatment called the Safety Planning for Military (SAFE MIL; Stanley and Brown, 2012).
Read the detailed description
Background: Mental health related hospitalizations and suicide are both significant public health problems within the United States Department of Defense (DoD). There are limited evidence-based suicide prevention interventions that have been developed for military personnel and veterans who are experiencing suicide ideation or who have made a suicide attempt.
Objectives: To evaluate the efficacy of the Safety Planning for Military (SAFE MIL) on suicide ideation, suicide-related coping, and attitudes toward help seeking for hospitalized military personnel at high suicide risk.
Methodology: To test the efficacy of the adapted intervention, the investigators will randomize 186 patients to one of two conditions: Safety Planning for Military (SAFE MIL) or Enhanced Usual Care (E-CARE). The SAFE MIL condition (intervention) will consist of the Safety Planning Intervention to help the suicidal individual with a collaboratively generated personal plan to mitigate or prevent a future suicidal crisis. The E-Care will consist of the usual care patients receive at an inpatient facility during their hospitalization in addition to assessment services provided by independent evaluators who work directly with our research team. Primary outcomes include suicide ideation, suicide-related coping, and attitudes toward help-seeking [acceptability and initiation of services]. Patients in both conditions will be assessed on the dependent measures at the time of hospital admission (i.e., baseline), at the time discharge (Follow-Up Interval 1 [FU-1]), at 1-month (Follow-Up Interval 2 [FU-2]) and at 6-month (Follow-Up Interval 3 [FU-3]).
- Conditions
- Suicide, Suicide, Attempted
- Being tested
- Safety Planning - Military (SAFE MIL)
- Keywords
- Suicide Prevention, Suicide Attempt, Suicide Ideation, Randomized Controlled Trial, Safety Planning
- Medical subject headings
- Suicide, Suicide, Attempted, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Planning - Military (SAFE MIL)Behavioural
Also called Safety Planning
The Safety Planning Intervention (SPI) which is delivered in the SAFE MIL condition aims to help individuals lower their imminent suicide risk by having them collaborate with the study clinician to generate a detailed, hierarchically-arranged action plan for managing suicidal thoughts and urges.
| Study group | Role | What they receive |
|---|---|---|
| Safety Planning - Military (SAFE-MIL) | Experimental | Brief Safety Planning Using Stanley and Brown (2012) Model Receives: Behavioral: Safety Planning - Military (SAFE MIL) |
| E-CARE | No intervention | Treatment As Usual and Assessment Services of Study; Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide Ideation
Suicide ideation will be measured using the Columbia Suicide Severity Rating Scale (C-SSRS) and the Scale for Suicide Ideation (SSI). Both measures assess for presence, intensity, frequency, and specificity of suicide related thoughts (ideations).
Measured: discharge, 1 month, and 6 months post-discharge
Acceptability and Initiation of Mental Health Care and Substance Use Treatment
Attitudes toward help-seeking [acceptability and initiation of services] will be assessed by the following measures: Attitudes Toward Seeking Professional Psychological Help Scale: modified shortened version (ATSPPH); Cornell Services Index (CSI); Perceived Barriers to Care (PBTC); Brief SAFE MIL Intervention Survey.
Measured: discharge, 1 month, and 6-months post-discharge
Suicide-related Coping
Coping strategies will be measured using a checklist of tactics and coping strategies used by individuals to cope with suicidal thoughts, feelings, and urges.
Measured: discharge, 1 month, and 6 months post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startSep 2009
- Primary completionDec 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 SuicideStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, United States Department of Defense, US Department of Veterans Affairs, University of Pennsylvania, University of Rochester, Columbia University
- Responsible party
- Principal investigator, Marjan Holloway, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Investigators
- Marjan G Holloway, Ph.D., Principal investigator, Uniformed Services University of the Health SciencesLisa Brenner, Ph.D., Principal investigator, Denver VAGregory Brown, Ph.D., Principal investigator, University of PennsylvaniaGlenn Currier, M.D., MPH, Principal investigator, Canandaigua VA; University of RochesterKerry Knox, Ph.D., Principal investigator, Canandaigua VA; University of RochesterBarbara Stanley, Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360736
- Sponsor's protocol ID
- W81XWH-09-2-0129 Study 2
- Acronym
- SAFEMIL
- Status last verified
- Feb 2020
- First submitted
- 17 May 2011
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Knox KL, Stanley B, Currier GW, Brenner L, Ghahramanlou-Holloway M, Brown G. An emergency department-based brief intervention for veterans at risk for suicide (SAFE VET). Am J Public Health. 2012 Mar;102 Suppl 1(Suppl 1):S33-7. doi: 10.2105/AJPH.2011.300501.
PubMed 22390597Ghahramanlou-Holloway M, Brown GK, Currier GW, Brenner L, Knox KL, Grammer G, Carreno-Ponce JT, Stanley B. Safety Planning for Military (SAFE MIL): rationale, design, and safety considerations of a randomized controlled trial to reduce suicide risk among psychiatric inpatients. Contemp Clin Trials. 2014 Sep;39(1):113-23. doi: 10.1016/j.cct.2014.07.003. Epub 2014 Jul 12.
PubMed 25020008
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. 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 2
- ClinicalTrials.gov ID
- NCT01360736
- Acronym / sponsor ID
- SAFEMIL / W81XWH-09-2-0129 Study 2
- Conditions
- Suicide, Suicide, Attempted
- Keywords
- Suicide Prevention, Suicide Attempt, Suicide Ideation, Randomized Controlled Trial, Safety Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command, United States Department of Defense, US Department of Veterans Affairs, University of Pennsylvania, University of Rochester, Columbia University
- Study start
- Sep 2009
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 26 May 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 test the efficacy of a brief, readily accessible, and personalized treatment called the Safety Planning for Military (SAFE MIL; Stanley and Brown, 2012).
Detailed description
Background: Mental health related hospitalizations and suicide are both significant public health problems within the United States Department of Defense (DoD). There are limited evidence-based suicide prevention interventions that have been developed for military personnel and veterans who are experiencing suicide ideation or who have made a suicide attempt.
Objectives: To evaluate the efficacy of the Safety Planning for Military (SAFE MIL) on suicide ideation, suicide-related coping, and attitudes toward help seeking for hospitalized military personnel at high suicide risk.
Methodology: To test the efficacy of the adapted intervention, the investigators will randomize 186 patients to one of two conditions: Safety Planning for Military (SAFE MIL) or Enhanced Usual Care (E-CARE). The SAFE MIL condition (intervention) will consist of the Safety Planning Intervention to help the suicidal individual with a collaboratively generated personal plan to mitigate or prevent a future suicidal crisis. The E-Care will consist of the usual care patients receive at an inpatient facility during their hospitalization in addition to assessment services provided by independent evaluators who work directly with our research team. Primary outcomes include suicide ideation, suicide-related coping, and attitudes toward help-seeking [acceptability and initiation of services]. Patients in both conditions will be assessed on the dependent measures at the time of hospital admission (i.e., baseline), at the time discharge (Follow-Up Interval 1 [FU-1]), at 1-month (Follow-Up Interval 2 [FU-2]) and at 6-month (Follow-Up Interval 3 [FU-3]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety Planning - Military (SAFE-MIL) | Experimental | Behavioral: Safety Planning - Military (SAFE MIL)Brief Safety Planning Using Stanley and Brown (2012) Model |
| E-CARE | No intervention | –Treatment As Usual and Assessment Services of Study; Control Condition |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient Admitted Due to Recent Suicide Intent and/or Suicide Attempt within past month
- Baseline Assessment Completed within 48 Hours of Hospital Admission
- Age of 18 years or older.
Key exclusion criteria (5 listed)
- Medical Incapacity to Participate and/or Serious Cognitive Impairment
- Expected Discharge within 72 Hours of Admission
- Expected Deployment within 1-Month
- Inability to read or understand English
- Inability to provide Informed Consent
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 |
|---|---|---|
| Safety Planning - Military (SAFE MIL)Also: Safety PlanningThe Safety Planning Intervention (SPI) which is delivered in the SAFE MIL condition aims to help individuals lower their imminent suicide risk by having them collaborate with the study clinician to generate a detailed, hierarchically-arranged action plan for managing suicidal thoughts and urges. | Behavioural | Safety Planning - Military (SAFE-MIL) |
Primary outcome
Suicide Ideation
Time frame: discharge, 1 month, and 6 months post-discharge
Suicide ideation will be measured using the Columbia Suicide Severity Rating Scale (C-SSRS) and the Scale for Suicide Ideation (SSI). Both measures assess for presence, intensity, frequency, and specificity of suicide related thoughts (ideations).
Acceptability and Initiation of Mental Health Care and Substance Use Treatment
Time frame: discharge, 1 month, and 6-months post-discharge
Attitudes toward help-seeking [acceptability and initiation of services] will be assessed by the following measures: Attitudes Toward Seeking Professional Psychological Help Scale: modified shortened version (ATSPPH); Cornell Services Index (CSI); Perceived Barriers to Care (PBTC); Brief SAFE MIL Intervention Survey.
Suicide-related Coping
Time frame: discharge, 1 month, and 6 months post-discharge
Coping strategies will be measured using a checklist of tactics and coping strategies used by individuals to cope with suicidal thoughts, feelings, and urges.
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 20 Feb 2020.
- Background: PubMed 22390597Knox KL, Stanley B, Currier GW, Brenner L, Ghahramanlou-Holloway M, Brown G. An emergency department-based brief intervention for veterans at risk for suicide (SAFE VET). Am J Public Health. 2012 Mar;102 Suppl 1(Suppl 1):S33-7. doi: 10.2105/AJPH.2011.300501.
- Background: PubMed 25020008Ghahramanlou-Holloway M, Brown GK, Currier GW, Brenner L, Knox KL, Grammer G, Carreno-Ponce JT, Stanley B. Safety Planning for Military (SAFE MIL): rationale, design, and safety considerations of a randomized controlled trial to reduce suicide risk among psychiatric inpatients. Contemp Clin Trials. 2014 Sep;39(1):113-23. doi: 10.1016/j.cct.2014.07.003. Epub 2014 Jul 12.
- Individual participant dataSharing planned: No
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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 G Holloway, Ph.D. principal investigator
Uniformed Services University of the Health Sciences
Lisa Brenner, Ph.D. principal investigator
Denver VA
Gregory Brown, Ph.D. principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Planning - Military (SAFE MIL) in people with Suicide and Suicide, Attempted, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 2 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 3 inclusion and 5 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 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Suicide Ideation (time frame: discharge, 1 month, and 6 months post-discharge). The study lists 3 primary outcomes in all. 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 NCT01360736, 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 20 Feb 2020.