title: Design and methods for the Better Resiliency Among Veterans and non-Veterans with Omega-3's (BRAVO) study: A double blind, placebo-controlled trial of omega-3 fatty acid supplementation among adult individuals at risk of suicide.
abstract: Suicide remains the 10th leading cause of death among adults in the United States (U.S.). Annually, approximately 30 per 100,000 U.S. military Veterans commit suicide, compared to 14 per 100,000 U.S. civilians. Symptoms associated with suicidality can be treatment resistant and proven-effective pharmaceuticals may have adverse side-effects. Thus, a critical need remains to identify effective approaches for building psychological resiliency in at-risk individuals. Omega-3 highly unsaturated fatty acids (n-3 HUFAs) are essential nutrients, which must be consumed in the diet. N-3 HUFAs have been demonstrated to reduce symptoms of depression, anxiety, and impulsivity - which are associated with suicide risk. Here we present the design and methods for the Better Resiliency Among Veterans and non-Veterans with Omega-3's (BRAVO) study, which is a double blind, randomized, controlled trial among individuals at risk of suicide of an n-3 HUFA versus placebo supplementation in the form of all natural fruit juice beverages. The BRAVO study seeks to determine if dietary supplementation with n-3 HUFAs reduces the risk for serious suicidal behaviors, suicidal thinking, negative emotions, and symptoms associated with suicide risk. Sub-analyses will evaluate efficacy in reducing depressive symptoms, alcohol, and nicotine use. A sub-study utilizes functional magnetic resonance imaging (fMRI) to evaluate the neuropsychological and neurophysiological effects of n-3 HUFAs. We also outline selection of appropriate proxy outcome measures for detecting response to treatment and collection of ancillary data, such as diet and substance use, that are critical for interpretation of results.
authors: Nutrition Section, Division of Gastroenterology and Hepatology, Department of Medicine, and Military Division, Department of Psychiatry, College of Medicine, Medical University of South Carolina, 114 Doughty Street, Ste. 630D, MSC774, Charleston, SC 29425, USA. Electronic address: marriobp@musc.edu.
authors: Bernadette P
authors: BP
authors: Marriott
authors: Section on Nutritional Neurosciences, LMBB, NIAAA, NIH 5625 Fishers Lane, Rm 3N-07, MSC 9410, Bethesda, MD 20892, USA.
authors: Joseph R
authors: JR
authors: Hibbeln
authors: Department of Psychiatry and Behavioral Sciences, Addiction Sciences Division, Medical University of South Carolina, 67 President St., PO Box 25086, Charleston, SC 29425, USA.
authors: Therese K
authors: TK
authors: Killeen
authors: Department of Psychiatry & Behavioral Sciences, Military Science Division, Department of Public Health Sciences, Division of Epidemiology, Office of Research Integrity, Medical University of South Carolina, 109 Bee Street, Charleston, SC 29401, USA.
authors: Kathryn M
authors: KM
authors: Magruder
authors: Department of Psychiatry and Behavioral Sciences, Division of Brain Research and Integrative Neuropsychopharmacology, Medical University of South Carolina, 67 President Street, Charleston, SC 29425, USA.
authors: Kelly
authors: K
authors: Holes-Lewis
authors: Department of Psychiatry and Behavioral Sciences, Division of Addiction Sciences, Medical University of South Carolina, 67 President Street, Charleston, SC 29425, USA.
authors: Bryan K
authors: BK
authors: Tolliver
authors: Ralph H. Johnson VAMC, 109 Bee Street, Charleston, SC 29410, USA; Department of Psychiatry and Behavioral Sciences, Department of Neurosciences/Neurology, Medical University of South Carolina, 67 President St., Charleston, SC 29425, USA.
authors: Travis H
authors: TH
authors: Turner
mesh_terms: D000293:Adolescent; D000328:Adult; D000369:Aged, 80 and over; D019587:Dietary Supplements; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012107:Research Design; D055500:Resilience, Psychological; D013405:Suicide / Q000523:psychology; D016896:Treatment Outcome; D014481:United States; D014728:Veterans / Q000523:psychology*; D058014:Veterans Health; D055815:Young Adult; D000092864:Suicide Prevention
chemical_list: D015525:Fatty Acids, Omega-3
keywords: Adults; Omega-3 fatty acids; Suicide