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Completed

NCT Number: NCT01360736

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

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).

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Key information

Conditions

Suicide Behavior Behavioral Symptoms Self-Injurious Behavior Suicide Prevention Suicide, Attempted

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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]).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Safety Planning - Military (SAFE MIL)

Behavioral

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

Primary outcomes

  1. Suicide Ideation

    Time frame: 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).

  2. Acceptability and Initiation of Mental Health Care and Substance Use Treatment

    Time frame: 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.

  3. Suicide-related Coping

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Other

Collaborators

  • Columbia University
  • U.S. Army Medical Research and Development Command
  • US Department of Veterans Affairs
  • United States Department of Defense
  • University of Pennsylvania
  • University of Rochester

Registry information

Official study title

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

Acronym: SAFEMIL

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
May 26, 2011
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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