Ghahramanlou-Holloway Marjan, Brown Gregory K, Currier Glenn W, Brenner Lisa, Knox Kerry L, Grammer Geoffrey, Carreno-Ponce Jaime T, Stanley Barbara
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.
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.
Contemp Clin Trials. 2014 Sep;39(1):113-23. doi: 10.1016/j.cct.2014.07.003. Epub 2014 Jul 12.
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.
在美国国防部（DoD）内部，与心理健康相关的住院治疗和自杀都是重大的公共卫生问题。迄今为止，针对因自杀性自我伤害行为而住院接受精神科治疗的军事人员及其家属，几乎没有制定出基于证据的自杀预防项目。本文描述了一项名为“军事安全规划”（SAFE MIL）研究的基本原理和详细方法，该研究在美国最大的军事治疗机构进行随机对照试验（RCT）。本研究的目的是测试一种名为安全规划干预（斯坦利和布朗，2012年）的简短、易于获取且个性化治疗方法的疗效。主要结果由盲法评估人员在精神科出院后的1个月和6个月进行测量，包括自杀意念、与自杀相关的应对方式以及对寻求帮助的态度。此外，鉴于该研究关注的是高度脆弱的患者群体，本文还提供了关于人类受试者参与的安全考虑因素的描述。基于该研究团队的经验，在国防部环境中支持随机对照试验研究的基础设施的实施以及对高危自杀患者进行临床试验的监管审批流程预计需要18至24个月。本文还提供了加快国防部内部临床试验研究进展的建议，以实现成本效益最大化并缩小研究与实践之间的差距。
