title: Safety Planning for Military (SAFE MIL): rationale, design, and safety considerations of a randomized controlled trial to reduce suicide risk among psychiatric inpatients.
abstract: Mental health related hospitalizations and suicide are both significant public health problems within the United States Department of Defense (DoD). To date, few evidence-based suicide prevention programs have been developed for delivery to military personnel and family members admitted for psychiatric inpatient care due to suicidal self-directed violence. This paper describes the rationale and detailed methodology for a study called Safety Planning for Military (SAFE MIL) which involves a randomized controlled trial (RCT) at the largest military treatment facility in the United States. The purpose of this study is to test the efficacy of a brief, readily accessible, and personalized treatment called the Safety Planning Intervention (Stanley and Brown, 2012). Primary outcomes, measured by blinded assessors at one and six months following psychiatric discharge, include suicide ideation, suicide-related coping, and attitudes toward help seeking. Additionally, given the study's focus on a highly vulnerable patient population, a description of safety considerations for human subjects' participation is provided. Based on this research team's experience, the implementation of an infrastructure in support of RCT research within DoD settings and the processing of regulatory approvals for a clinical trial with high risk suicidal patients are expected to take up to 18-24 months. Recommendations for expediting the advancement of clinical trials research within the DoD are provided in order to maximize cost efficacy and minimize the research to practice gap.
authors.affiliation: Department of Medical & Clinical Psychology, F. Edward Hébert School of Medicine of the Uniformed Services University of the Health Sciences, Bethesda, MD, United States; Department of Psychiatry, F. Edward Hébert School of Medicine of the Uniformed Services University of the Health Sciences, Bethesda, MD, United States. Electronic address: marjan.holloway@usuhs.edu.
authors.forename: Marjan
authors.initials: M
authors.lastname: Ghahramanlou-Holloway
authors.affiliation: Department of Psychiatry, Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA, United States; Veterans Integrated Service Network (VISN) 4 Mental Illness Research, Education and Clinical Center (MIRECC), Philadelphia VA Medical Center, Philadelphia, PA, United States; Department of Veterans Affairs, Philadelphia, PA, United States.
authors.forename: Gregory K
authors.initials: GK
authors.lastname: Brown
authors.affiliation: VA Center of Excellence, Canandaigua, NY, United States; University of Rochester, NY, United States.
authors.forename: Glenn W
authors.initials: GW
authors.lastname: Currier
authors.affiliation: Denver VA Medical Center, VISN 19 MIRECC, Department of Veterans Affairs, Denver, CO, United States.
authors.forename: Lisa
authors.initials: L
authors.lastname: Brenner
authors.affiliation: VA Center of Excellence, Canandaigua, NY, United States; University of Rochester, NY, United States.
authors.forename: Kerry L
authors.initials: KL
authors.lastname: Knox
authors.affiliation: National Intrepid Center of Excellence, Walter Reed National Military Medical Center, Bethesda, MD, United States.
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Grammer
authors.affiliation: Department of Medical & Clinical Psychology, F. Edward Hébert School of Medicine of the Uniformed Services University of the Health Sciences, Bethesda, MD, United States; Department of Psychiatry, F. Edward Hébert School of Medicine of the Uniformed Services University of the Health Sciences, Bethesda, MD, United States.
authors.forename: Jaime T
authors.initials: JT
authors.lastname: Carreno-Ponce
authors.affiliation: Department of Psychiatry, Columbia University, New York, NY, United States; New York State Psychiatric Institute, New York, NY, United States.
authors.forename: Barbara
authors.initials: B
authors.lastname: Stanley
mesh_terms: D000223:Adaptation, Psychological; D006801:Humans; D007297:Inpatients; D001523:Mental Disorders / Q000188:drug therapy / Q000453:epidemiology; D008889:Military Personnel / Q000523:psychology*; D010342:Patient Acceptance of Health Care; D010353:Patient Education as Topic / Q000458:organization & administration*; D011567:Psychiatric Department, Hospital; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D019966:Substance-Related Disorders / Q000453:epidemiology / Q000628:therapy; D059020:Suicidal Ideation; D014481:United States; D000092864:Suicide Prevention
keywords: Inpatient psychiatry; Military; Prevention; Randomized controlled trial; Safety Planning Intervention; Suicide