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A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL) (SAFEMIL)

Primary Purpose

Suicide, Suicide, Attempted

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Planning - Military (SAFE MIL)
Sponsored by
Henry M. Jackson Foundation for the Advancement of Military Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Suicide Prevention, Suicide Attempt, Suicide Ideation, Randomized Controlled Trial, Safety Planning

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Uniformed Services University of the Health Sciences
  • Walter Reed National Military Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Safety Planning - Military (SAFE-MIL)

E-CARE

Arm Description

Brief Safety Planning Using Stanley and Brown (2012) Model

Treatment As Usual and Assessment Services of Study; Control Condition

Outcomes

Primary Outcome Measures

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).
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 17, 2011
Last Updated
February 18, 2020
Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
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
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1. Study Identification

Unique Protocol Identification Number
NCT01360736
Brief Title
A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL)
Acronym
SAFEMIL
Official Title
A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicide, Attempted
Keywords
Suicide Prevention, Suicide Attempt, Suicide Ideation, Randomized Controlled Trial, Safety Planning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safety Planning - Military (SAFE-MIL)
Arm Type
Experimental
Arm Description
Brief Safety Planning Using Stanley and Brown (2012) Model
Arm Title
E-CARE
Arm Type
No Intervention
Arm Description
Treatment As Usual and Assessment Services of Study; Control Condition
Intervention Type
Behavioral
Intervention Name(s)
Safety Planning - Military (SAFE MIL)
Other Intervention Name(s)
Safety Planning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Suicide Ideation
Description
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).
Time Frame
discharge, 1 month, and 6 months post-discharge
Title
Acceptability and Initiation of Mental Health Care and Substance Use Treatment
Description
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.
Time Frame
discharge, 1 month, and 6-months post-discharge
Title
Suicide-related Coping
Description
Coping strategies will be measured using a checklist of tactics and coping strategies used by individuals to cope with suicidal thoughts, feelings, and urges.
Time Frame
discharge, 1 month, and 6 months post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjan G Holloway, Ph.D.
Organizational Affiliation
Uniformed Services University of the Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Brenner, Ph.D.
Organizational Affiliation
Denver VA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregory Brown, Ph.D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Glenn Currier, M.D., MPH
Organizational Affiliation
Canandaigua VA; University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kerry Knox, Ph.D.
Organizational Affiliation
Canandaigua VA; University of Rochester
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Stanley, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uniformed Services University of the Health Sciences
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22390597
Citation
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.
Results Reference
background
PubMed Identifier
25020008
Citation
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.
Results Reference
background

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A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL)

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