A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL)
NCT ID: NCT01360736
Last Updated: 2020-02-20
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
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COMPLETED
NA
102 participants
INTERVENTIONAL
2009-09-30
2018-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Safety Planning - Military (SAFE-MIL)
Brief Safety Planning Using Stanley and Brown (2012) Model
Safety Planning - Military (SAFE MIL)
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.
E-CARE
Treatment As Usual and Assessment Services of Study; Control Condition
No interventions assigned to this group
Interventions
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Safety Planning - Military (SAFE MIL)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Baseline Assessment Completed within 48 Hours of Hospital Admission
* Age of 18 years or older.
Exclusion Criteria
* Expected Discharge within 72 Hours of Admission
* Expected Deployment within 1-Month
* Inability to read or understand English
* Inability to provide Informed Consent
18 Years
89 Years
ALL
No
Sponsors
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U.S. Army Medical Research and Development Command
FED
United States Department of Defense
FED
US Department of Veterans Affairs
FED
University of Pennsylvania
OTHER
University of Rochester
OTHER
Columbia University
OTHER
Henry M. Jackson Foundation for the Advancement of Military Medicine
OTHER
Responsible Party
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Marjan Holloway
Principal Investigator (Contact PI)
Principal Investigators
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Marjan G Holloway, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Uniformed Services University of the Health Sciences
Lisa Brenner, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Denver VA
Gregory Brown, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Glenn Currier, M.D., MPH
Role: PRINCIPAL_INVESTIGATOR
Canandaigua VA; University of Rochester
Kerry Knox, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Canandaigua VA; University of Rochester
Barbara Stanley, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Uniformed Services University of the Health Sciences
Bethesda, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Countries
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References
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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.
Ghahramanlou-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.
Other Identifiers
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W81XWH-09-2-0129 Study 2
Identifier Type: -
Identifier Source: org_study_id
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