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

Not Applicable

Completed

• Conditions: Suicide; Suicide, Attempted
• Interventions: Behavioral: Safety Planning - Military (SAFE MIL)

• Registration Number: NCT01360736
• Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

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 \[FU-3\]).

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2011-05-17
• Study First Submitted QC: 2011-05-25
• Study First Posted: 2011-05-26
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Safety Planning - Military (SAFE-MIL)	Safety Planning - Military (SAFE MIL)	Brief Safety Planning Using Stanley and Brown (2012) Model

Primary Outcome Measures

Name	Time	Method
Suicide Ideation	discharge, 1 month, and 6 months post-discharge	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	discharge, 1 month, and 6-months post-discharge	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	discharge, 1 month, and 6 months post-discharge	Coping strategies will be measured using a checklist of tactics and coping strategies used by individuals to cope with suicidal thoughts, feelings, and urges.

Trial Locations

Locations (2)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States

Uniformed Services University of the Health Sciences; 🇺🇸 Bethesda, Maryland, United States