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

• Published in: Contemporary clinical trials 2016-03, Vol.47, p.325-333
• Main Authors: Marriott, Bernadette P, Hibbeln, Joseph R, Killeen, Therese K, Magruder, Kathryn M, Holes-Lewis, Kelly, Tolliver, Bryan K, Turner, Travis H
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Adults; Aged, 80 and over; Cardiovascular; Dietary Supplements; Double-Blind Method; Fatty Acids, Omega-3 - therapeutic use; Female; Hematology, Oncology and Palliative Medicine; Humans; Male; Middle Aged; Omega-3 fatty acids; Research Design; Resilience, Psychological; Suicide; Suicide - prevention & control; Suicide - psychology; Treatment Outcome; United States; Veterans - psychology; Veterans Health; Young Adult
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2016.02.002

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 ( f MRI) 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.