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

Suicide Clinical Trial

— SAFEMIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01360736
• Other study ID #: W81XWH-09-2-0129 Study 2
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: December 2018

Study information

• Verified date: February 2020
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Intervention

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.

Locations

Country	Name	City	State
United States	Uniformed Services University of the Health Sciences	Bethesda	Maryland
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (7)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	Columbia University, U.S. Army Medical Research and Development Command, United States Department of Defense, University of Pennsylvania, University of Rochester, US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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:S33-7. doi: 10.2105/AJPH.2011.300501. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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