Clinical trial NCT01360736: A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2 (SAFEMIL)
Official title: A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans - Study 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Suicide, Attempted
Keywords: Suicide Prevention
Suicide Attempt
Suicide Ideation
Randomized Controlled Trial
Safety Planning
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
name: United States Department of Defense
name: US Department of Veterans Affairs
name: University of Pennsylvania
name: University of Rochester
name: Columbia University
First posted: 2011-05-26
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[FU-3\]).

Eligibility criteria: 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

Primary outcomes:
measure: Suicide Ideation
timeFrame: discharge, 1 month, and 6 months post-discharge
measure: Acceptability and Initiation of Mental Health Care and Substance Use Treatment
timeFrame: discharge, 1 month, and 6-months post-discharge
measure: Suicide-related Coping
timeFrame: discharge, 1 month, and 6 months post-discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of the Health Sciences
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Marjan G Holloway, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Denver VA
name: Lisa Brenner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Gregory Brown, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Canandaigua VA; University of Rochester
name: Glenn Currier, M.D., MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Canandaigua VA; University of Rochester
name: Kerry Knox, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Barbara Stanley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.