This trial is active, not recruiting.

Conditions suicide, suicide, attempted
Treatment safety planning - military (safe mil)
Sponsor Henry M. Jackson Foundation for the Advancement of Military Medicine
Collaborator U.S. Army Medical Research and Materiel Command
Start date September 2009
End date December 2015
Trial size 186 participants
Trial identifier NCT01360736, W81XWH-09-2-0129 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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Brief Safety Planning Using Stanley and Brown (2012) Model
safety planning - military (safe mil) Safety Planning
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.
(No Intervention)
Treatment As Usual and Assessment Services of Study; Control Condition

Primary Outcomes

Suicide Ideation
time frame: discharge, 1 month, and 6 months post-discharge
Acceptability and Initiation of Mental Health Care and Substance Use Treatment
time frame: discharge, 1 month, and 6-months post-discharge
Suicide-related Coping
time frame: discharge, 1 month, and 6 months post-discharge

Eligibility Criteria

Male or female participants from 18 years up to 89 years old.

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

Additional Information

Official title A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2
Principal investigator Marjan G Holloway, Ph.D. (Contact)
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]).
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Henry M. Jackson Foundation for the Advancement of Military Medicine.