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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
U.S. Army Medical Research and Materiel Command
University of Pennsylvania
University of Rochester
Columbia University
Information provided by (Responsible Party):
Marjan Holloway, Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier:
NCT01360736
First received: May 17, 2011
Last updated: March 30, 2015
Last verified: March 2015

May 17, 2011
March 30, 2015
September 2009
June 2015   (final data collection date for primary outcome measure)
  • Suicide Ideation [ Time Frame: discharge, 1 month, and 6 months post-discharge ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Coping strategies will be measured using a checklist of tactics and coping strategies used by individuals to cope with suicidal thoughts, feelings, and urges.
Same as current
Complete list of historical versions of study NCT01360736 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL)
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).

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]).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Suicide
  • Suicide, Attempted
Behavioral: 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 Name: Safety Planning
  • Experimental: Safety Planning - Military (SAFE-MIL)
    Brief Safety Planning Using Stanley and Brown (2012) Model
    Intervention: Behavioral: Safety Planning - Military (SAFE MIL)
  • No Intervention: E-CARE
    Treatment As Usual and Assessment Services of Study; Control Condition

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
186
December 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01360736
W81XWH-09-2-0129 Study 2
Yes
Marjan Holloway, Henry M. Jackson Foundation for the Advancement of Military Medicine
Henry M. Jackson Foundation for the Advancement of Military Medicine
  • U.S. Army Medical Research and Materiel Command
  • Department of Defense
  • Department of Veterans Affairs
  • University of Pennsylvania
  • University of Rochester
  • Columbia University
Principal Investigator: Marjan G Holloway, Ph.D. (Contact) 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
Henry M. Jackson Foundation for the Advancement of Military Medicine
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP