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

Study Overview

• Status: Completed
• Conditions: Suicide, Attempted; Suicide
• Intervention / Treatment: Behavioral: Safety Planning - Military (SAFE MIL)

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20814
      • Uniformed Services University of the Health Sciences
    • Bethesda, Maryland, United States, 20814
      • Walter Reed National Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safety Planning - Military (SAFE-MIL); Brief Safety Planning Using Stanley and Brown (2012) Model	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 Names: Safety Planning
No Intervention: E-CARE; Treatment As Usual and Assessment Services of Study; Control Condition

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Collaborators: University of Pennsylvania; Columbia University; United States Department of Defense; US Department of Veterans Affairs; University of Rochester; U.S. Army Medical Research and Development Command
• Investigators: Principal Investigator: Marjan G Holloway, Ph.D., Uniformed Services University of the Health Sciences; Principal Investigator: Gregory Brown, Ph.D., University of Pennsylvania; Principal Investigator: Barbara Stanley, Ph.D., Columbia University; Principal Investigator: Lisa Brenner, Ph.D., Denver VA; Principal Investigator: Glenn Currier, M.D., MPH, Canandaigua VA; University of Rochester; Principal Investigator: Kerry Knox, Ph.D., Canandaigua VA; University of Rochester

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: May 17, 2011
• First Submitted That Met QC Criteria: May 25, 2011
• First Posted (Estimate): May 26, 2011

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Suicide Prevention; Safety Planning; Suicide Attempt; Suicide Ideation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide, Attempted
• Other Study ID Numbers: W81XWH-09-2-0129 Study 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO