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

Study Overview
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Brief Summary
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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
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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]).

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

Conditions
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Suicide, Suicide, Attempted

Intervention / Treatment
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* Behavioral: Safety Planning - Military (SAFE MIL)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safety Planning - Military (SAFE-MIL)<br>Brief Safety Planning Using Stanley and Brown (2012) Model | Behavioral: Safety Planning - Military (SAFE MIL)<br>* 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.<br>* Other names: Safety Planning;|
| No Intervention: E-CARE<br>Treatment As Usual and Assessment Services of Study; Control Condition | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suicide Prevention, Suicide Attempt, Suicide Ideation, Randomized Controlled Trial, Safety Planning