A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL)
SAFEMIL
1 other identifier
interventional
102
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2009
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 17, 2011
CompletedFirst Posted
Study publicly available on registry
May 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 20, 2020
February 1, 2020
9.3 years
May 17, 2011
February 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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).
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.
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.
discharge, 1 month, and 6 months post-discharge
Study Arms (2)
Safety Planning - Military (SAFE-MIL)
EXPERIMENTALBrief Safety Planning Using Stanley and Brown (2012) Model
E-CARE
NO INTERVENTIONTreatment As Usual and Assessment Services of Study; Control Condition
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicinelead
- U.S. Army Medical Research and Development Commandcollaborator
- United States Department of Defensecollaborator
- US Department of Veterans Affairscollaborator
- University of Pennsylvaniacollaborator
- University of Rochestercollaborator
- Columbia Universitycollaborator
Study Sites (2)
Uniformed Services University of the Health Sciences
Bethesda, Maryland, 20814, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814, United States
Related Publications (2)
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.
PMID: 22390597BACKGROUNDGhahramanlou-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.
PMID: 25020008BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marjan G Holloway, Ph.D.
Uniformed Services University of the Health Sciences
- PRINCIPAL INVESTIGATOR
Lisa Brenner, Ph.D.
Denver VA
- PRINCIPAL INVESTIGATOR
Gregory Brown, Ph.D.
University of Pennsylvania
- PRINCIPAL INVESTIGATOR
Glenn Currier, M.D., MPH
Canandaigua VA; University of Rochester
- PRINCIPAL INVESTIGATOR
Kerry Knox, Ph.D.
Canandaigua VA; University of Rochester
- PRINCIPAL INVESTIGATOR
Barbara Stanley, Ph.D.
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator (Contact PI)
Study Record Dates
First Submitted
May 17, 2011
First Posted
May 26, 2011
Study Start
September 1, 2009
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
February 20, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share