Citation

Ghahramanlou-Holloway M, Brown GK, Currier GW, Brenner LA, Knox KL, Grammer G, Carreno-Ponce JT, Stanley B. Contemp. Clin. Trials 2014; 39(1): 113-123.

Affiliation

Department of Psychiatry, Columbia University, and New York State Psychiatric Institute, New York, NY, United States.

Copyright

(Copyright © 2014, Elsevier Publishing)

DOI

10.1016/j.cct.2014.07.003

PMID

25020008

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(1). 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 is 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.

Language: en